IRBIS does NOT generate these documents with application-specific information.
Concise Summary examples can be found here .
Guidance on the use of plain language in consent forms:
There are a few additional forms that are not provided online and may be accessed below. As needed, these should be completed and uploaded to your IRB application.
COVID-19 Related Forms:
Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).
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On this page you will find information on:
What is Informed Consent
Before enrolling in a clinical trial, the following information must be given to each potential research subject
When Appropriate, one or more of the following elements of information must also be provided in the informed consent document
A potential research subject must have an opportunity to
Informed consent may not include language that
To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with:
adequate information to allow for an informed decision about participation in the clinical investigation.
facilitating the potential participant's understanding of the information.
an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.
obtaining the potential participant's voluntary agreement to participate.
continuing to provide information as the clinical investigation progresses or as the subject or situation requires.
To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. ( 21 CFR 50.20 .) FDA considers this to include allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)
As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find. Clinical trials are used to answer questions such as:
Are new medical products safe enough to outweigh the risks related to the underlying condition?,
How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),
How effective is the medical product at relieving symptoms, treating or curing a condition.
The main purpose of clinical trials is to “study” new medical products in people. It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient.
While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:
may not benefit from the clinical trial,
may be exposed to unknown risks,
are entering into a study that may be very different from the standard medical practices that they currently know
To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:
what will be done to them,
how the protocol (plan of research) works,
what risks or discomforts they may experience,
participation being a voluntary decision on their part.
This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.
A central part of the informed consent process is the informed consent document. The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document, but does require certain basic elements of consent be included.
A statement explaining that the study involves research.
An explanation of the purposes of the research.
The expected length of time for participation.
A description of all the procedures that will be completed during enrollment on the clinical trial.
Information about all experimental procedures the will be completed during the clinical trial.
A description of any predictable risks.
Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the research.
Any possible benefits that may be expected from the research.
Information about any alternative procedures or treatment (if any) that might benefit the research subject.
A statement describing:
the confidentiality of information collected during the clinical trial,
how records that identify the subject will be kept
the possibility that the FDA may inspect the records.
For research involving more than minimal risk information including
an explanation as to whether any compensation or medical treatments are available if injury occurs,
what they consist of, or
where more information may be found.
questions about the research,
research subjects' rights,
injury related to the clinical trial.
Research subject participation is voluntary,
Research subjects have the right to refuse treatment and will not losing any benefits for which they are entitled,
Research subjects may choose to stop participation in the clinical trial at any time without losing benefits for which they are entitled.
Contact information will be provided for answers to :
A statement that:
A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).
Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).
Added costs to the research subject that may result from participating in the trial.
The consequence of leaving a trial before it is completed (e.g. if the research and procedures require a slow and organized end of participation).
A statement that important findings discovered during the clinical trial will be provided to the research subject.
The approximate number of research subjects that will be enrolled in the study.
read the consent document,
ask questions about anything they do not understand.
Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, friend or advocate.
An investigator should only get consent from a potential research subject if:
enough time was given to the research subject to consider whether or not to participate
the investigator has not persuaded or influenced the potential research subject.
The information must be in language that is understandable to the research subject.
the research subject is made to ignore or appear to ignore any of the research subject's legal rights,
releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.
Participating in clinical trials is voluntary. You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully. Ask questions about any information you don’t understand or find confusing.
Draft Guidance: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
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What is informed consent and when, why, and how must it be obtained.
The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b) ; (2) the IRB finds and documents that informed consent can be waived ( 45 CFR 46.116(c) or (d) ); or (3) the IRB finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings. When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117 . [Food and Drug Administration (FDA) regulations at 21 CFR part 50 may also apply if the research involves a clinical investigation regulated by FDA.]
The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46 . This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. The Belmont Report states that an autonomous agent is “an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” Respect for persons requires that prospective research subjects “be given the opportunity to choose what shall or shall not happen to them” and thus necessitates adequate standards for informed consent.
The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements.
The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study. For the purposes of the HHS regulations at 45 CFR part 46, “investigators” are individuals who conduct human subjects research projects, including individuals directly involved in seeking the voluntary informed consent of potential subjects. Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others.
The informed consent process should be an active process of sharing information between the investigator and the prospective subject. The exchange of information between the investigator and prospective subjects can occur via one or more of the following modes of communication, among others: face-to-face contact; mail; telephone; video; or fax. Prospective subjects should be provided with ample opportunity to ask questions and seek clarification from the investigator. The prospective subjects should be in a position to freely decide whether to initially enroll in the research, or later, to withdraw or continue participating in the research. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective subjects or their legally authorized representatives adequately understand the research so that they can make informed choices.
The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate as a research subject. Thus, the information must be conveyed in language understandable to those being asked to participate as subjects in the research ( 45 CFR 46.116 ).
For most research, informed consent is documented using a written document that provides key information regarding the research. The consent form is intended, in part, to provide information for the potential subject’s current and future reference and to document the interaction between the subject and the investigator. However, even if a signed consent form is required, it alone does not constitute an adequate consent process. The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question and answer sessions, community meetings, and videotape presentations. In all circumstances, however, individuals should be provided with an opportunity to have their questions and concerns addressed on an individual basis.
The consent process and its documentation should be revised when deficiencies in its accuracy or completeness are noted, when new information about reasonably foreseeable risks and potential benefits becomes available, or when other additional information becomes known that will improve the consent process. Such revisions must be reviewed and approved by an IRB prior to the revised consent being utilized except when necessary to eliminate apparent immediate hazards to subjects ( 45 CFR 46.103(b)(4) ).
Yes, in certain circumstances it is possible to obtain legally effective informed consent in an urgent or emergency care setting. For a particular research study, the answer depends on (1) the expected medical condition of the prospective subject population; (2) the nature of the research; (3) whether there is sufficient time for the potential subjects or their legally authorized representatives to consider participation; and (4) whether the circumstances for obtaining informed consent appropriately minimize the possibility of coercion or undue influence. The Institutional Review Board (IRB) and investigator(s) would have to consider several variables. For example, what is the likely health and emotional condition of the patient population being considered for the proposed research (e.g., conscious but receiving emergency care, undergoing preparation prior to surgery)? What is the likely ability of this population during the consent process to process information, ask questions, and consider the risk involved? What is the timing of the consent process and is it so close to the receipt of care that the patient might blur the distinction between treatment and research?
Because individuals receiving urgent or emergent medical care frequently may be vulnerable to coercion or undue influence, even if temporarily, additional protections may be required to ensure the subject's consent to participate in research is truly voluntary and sought under circumstances that minimize the possibility of coercion or undue influence ( 45 CFR 46.111(b) , ( 45 CFR 46.116 ). In addition, in some cases, it might be possible to obtain consent from a legally authorized representative (e.g., in the case of decisionally incapacitated individuals). In certain emergency circumstances, the Secretarial waiver of informed consent under 45 CFR 46.101(i) may be applicable. It should be noted that if the research is regulated by FDA, the Secretarial waiver permits the research to be conducted under a comparable provision.
See the Office for Human Research Protections' (OHRP) guidance ; and HHS policy (PDF - 22KB) .
The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a) . Also see OHRP Informed Consent Tips .
The regulations require that the following information must be conveyed to each subject:
Additional elements are described at 45 CFR 46.116(b)
When determined to be appropriate by the Institutional Review Board (IRB), subjects must be provided with one or more of the following additional elements of information during the informed consent process (see 45 CFR 46.116(b) ):
It is up to the IRB to determine in a particular instance whether some or all of the above additional elements must be included as part of the informed consent process for a particular study. The IRB should make this determination based on the nature of the research and its knowledge of the local research context. If the IRB determines that additional elements are appropriate to the research study, this additional information should be considered just as essential as the eight basic elements of informed consent described in the HHS regulations at 45 CFR 46.116(a) .
Furthermore, an IRB may require that additional information beyond the basic and additional elements be given to subjects during the informed consent process, when in the IRB’s judgment the additional information would meaningfully add to the protection of the rights and welfare of the subjects 45 CFR 46.109(b) .
Terms such as “passive” or “implied” consent are not referenced in the HHS regulations. However, OHRP is aware that these terms are sometimes used by investigators or IRBs to describe a process in which consent or parental permission requirements have been altered or waived, or for which the requirement to document consent or parental permission has been waived.
HHS regulations at 45 CFR 46.116 state that no investigator may involve a human being as a subject unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. However, under conditions specified in the regulations at 45 CFR 46.116(c) or (d) an IRB may approve a consent procedure that does not include, or that alters some or all of the elements of informed consent set forth in 45 CFR 46.116 . In some cases, an IRB also can waive the requirement to obtain consent ( 45 CFR 46.116(c) and (d) ). In addition, under conditions specified in the regulations at 45 CFR 46.117 , an IRB may also waive the requirement for documentation of informed consent. (Note that the regulations at 45 CFR 46.408(c) also permit an IRB to waive parental permission.)
For example, a researcher conducting a survey (that does not qualify for an exemption under 45 CFR 46.101(b) mails a survey questionnaire to a random sample of adults. The survey materials clearly state that by responding to the questions and mailing the survey back, the recipients have agreed to participate in the research. However, the materials accompanying the questionnaire do not include all of the elements of consent listed at 45 CFR 46.116(a) and do not require that the subject sign a consent form. If the IRB has approved this alteration of the consent process and has waived the need for documentation of consent, then such procedures are permissible under the regulations. By sending back a completed survey the recipient has implied that he or she consents to participate but has not signed an informed consent document. Although some might call this “implied informed consent,” OHRP would consider this to be a permissible informed consent process if the IRB has approved the informed consent alteration and waived the requirement for documentation of informed consent.
The term “passive consent” is sometimes used in research with children to describe situations in which the investigator can assume that a parent is permitting a child to participate. For example, researchers collecting survey and behavioral data from children at school provide parents with information regarding the study by mail and ask the parent(s) to return a form if they do not want their child to participate. Sometimes this practice is referred to as an opt out procedure, which is not consistent with the regulatory requirement for seeking and obtaining parental permission. If the IRB determines that the conditions for waiver of parental permission can be met, then the IRB could waive the requirement for parental permission under 45 CFR 46.408(c) or 45 CFR 46.116(c) or (d) . Even though not required by the regulations, an IRB may require that parents be given the opportunity to refuse permission even when the IRB has waived the regulatory requirement to obtain parental permission.
The HHS regulations state that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence” ( 45 CFR 46.116 ). This requirement applies to all nonexempt human subjects research not eligible for a waiver of the consent requirements.
Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.
Undue influence , by contrast, often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized.
In addition to undue influence that can arise with the offering of rewards, undue influence also can be subtle. For example, patients might feel obligated to participate in research if their physician is also the investigator, or students might feel pressure to participate in research if everyone else in the class is doing so. Because influence is contextual, and undue influence is likely to depend on an individual’s situation, it is often difficult for IRBs to draw a bright line delimiting undue influence. It is up to the IRB to use its discretion in determining which circumstances give rise to undue influence. For example, an IRB might consider whether the informed consent process will take place at an appropriate time and in an appropriate setting, and whether the prospective subject may feel pressured into acting quickly or be discouraged from seeking advice from others.
Because of their relative nature and lack of clear-cut standards on the boundaries of inappropriate and appropriate forms of influence, investigators and IRBs must be vigilant about minimizing the possibility for coercion and undue influence. Reasonable assessments can be made to minimize the likelihood of undue influence or coercion occurring. For example, IRBs may restrict levels of financial or nonfinancial incentives for participation and should carefully review the information to be disclosed to potential subjects to ensure that the incentives and how they will be provided are clearly described. Known benefits should be stated accurately but not exaggerated, and potential or uncertain benefits should be stated as such, with clear language indicating how much is known about the uncertainty or likelihood of these potential benefits.
The regulatory requirements for IRB review and approval also specify the need for the IRB -- in order to approve research covered by the HHS regulations -- to ensure that “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children , prisoners , pregnant women , mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects” ( 45 CFR 46.111(b) ). Thus, inducements that would ordinarily be acceptable in some populations may become undue influences for these vulnerable subject groups.
The HHS regulations require that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence” ( 45 CFR 46.116 ).
Paying research subjects in exchange for their participation is a common and, in general, acceptable practice. However, difficult questions must be addressed by the IRB. For example, how much money should research subjects receive, and for what should subjects receive payment -- their time, inconvenience, discomfort, or some other consideration -- IRBs must be sensitive to whether any aspect of the proposed remuneration will be an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent.
Remuneration for participation in research should be just and fair. However, the specifics of each protocol will influence how those determinations are made. Both researchers and IRBs need to be familiar with the study population and the context of the research in order to make reasonable judgments about how compensation might affect participation. Wherever the remuneration is set, it will influence the decisions of some more than others. In particular, it will be more important to those for whom it will make a significant financial difference. Thus, IRBs should be cautious that payments are not so high that they create an “undue influence” or offer undue inducement that could compromise a prospective subject’s examination and evaluation of the risks or affect the voluntariness of his or her choices.
Information submitted to IRBs should indicate and justify proposed levels and purposes of remuneration, which also should be clearly stated in the accompanying consent forms.
Some institutions have adopted policies regarding the recruitment and payment of volunteers. IRBs and investigators should ensure that the consent process includes a detailed account of the terms of payment, including a description of the conditions under which a subject would receive partial or no payment (e.g., what will happen if he or she withdraws part way through the research or the investigator removes a subject from the study for medical or noncompliance reasons).
Finally, in studies of considerable duration or that involve multiple interactions or interventions, OHRP recommends that payment be prorated for the time of participation in the study rather than delayed until study completion, because the latter could unduly influence a subject’s decision to exercise his or her right to withdraw at any time. For example, if the study is conducted over a period of 6 months, there might be a monthly or bi-monthly payment. Or, if the study involves 12 sessions, there might be payment after every two sessions.
The above principles would apply to remuneration offered to parents whose children are prospective subjects.
[ Note: The previous version of the response to this FAQ included the following sentences. “In no case should remuneration be viewed as a way of offsetting risks; that is, it should not be considered a benefit to be weighed against study risks. The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration.” The first sentence has been struck because this FAQ focuses on potential undue influence in the consent process (45 CFR 46.116) rather than on IRB considerations under 45 CFR 46.111. However, OHRP continues to assert that IRBs should not consider remuneration as a way of offsetting risks. The second sentence has been deleted to clarify that remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for agreeing to participate in research. In addition, the previous version contained the following sentence, which has been struck because it is focused on IRB considerations under 45 CFR 46. 111 rather than informed consent, and was misplaced in this FAQ: “IRBs may need to request of the investigator some plan for monitoring subject recruitment to ensure that such inducements do not result in inequitable subject recruitment (e.g., recruiting only economically disadvantaged individuals).” ]
Yes, in certain circumstances. Non-monetary incentives (e.g., extra credit for students, access to services or programs) also can create undue influence on a potential subject’s decision about research participation. Informed consent always must be voluntary ( 45 CFR 46.116 ).
IRBs should ensure that non-financial incentives are not so great as to diminish the voluntariness of consent or cloud someone’s appreciation of risks or potential benefits that might be gained from participating in a study ( 45 CFR 46.116 ). Moreover, it must be clear that choosing to not participate will not adversely affect an individual’s relationship with the institution or its staff or the provision of services in any way (e.g., loss of credits or access to programs) ( 45 CFR 46.116(a)(8) ).
Overt coercion (e.g., threatening loss of services or access to programs to which the potential subjects are otherwise entitled) is never appropriate. However, it might be permissible to provide incentives to participate that do not constitute undue influence. Using enrollment incentives to recruit subjects may be ethically permissible as long as the IRB has determined that, although they may be a factor in a subject’s decision to participate, they have not served to unduly influence the subject to participate. To make this determination, IRBs should know who the subject population will be, what incentives are being offered, and the conditions under which the offer will be made.
The regulations require that the investigator seek consent only under circumstances that minimize the possibility of coercion or undue influence ( 45 CFR 46.116 ). The Office for Human Research Protections (OHRP) recommends that institutions have policies in place that clarify for students and faculty that any participation of students in research must be voluntary. Reasonable levels of extra credit or rewards may be offered for participating in research. If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. However, if participation in research is a course requirement, students must be informed of non-research alternatives involving comparable time and effort to fulfill those requirements in order for the possibility of undue influence to be minimized. Moreover, students must not be penalized for refusing to participate in research ( 45 CFR 46.116(a)(8) ).
In addition, some research institutions use a so-called “student subject pool” to identify students who might be willing to participate in research, even when the exact nature of the research to be conducted has not yet been determined. Extra credits or other rewards are often offered as an incentive to encourage participation. Students who sign up for such pools have not legally consented to participate in a research study since they have not been provided with sufficient information concerning the exact study in which they would participate. Thus, signing up to be in a subject pool is only a first and preliminary step by which individuals can indicate their willingness to be considered for research participation. The student must also provide informed consent, unless the consent requirement is waived by an IRB once he or she is being considered for a specific study ( 45 CFR 46.116 ). Furthermore, individuals in the pool must be free to decline participation in any available research projects without penalty ( 45 CFR 46.116(a)(8) ).
The issues involving employees as research subjects are essentially identical to those involving students as research subjects: that is, investigators and IRBs must be cautious about the potential for coercion or undue influence and the need to protect confidentiality.
Employee participation raises questions about the ability of employees to exercise free choice, for example, because of the possibility that a decision to participate could affect performance evaluations or job advancement, even if it is only the employee’s perception that this is the case. In the case of coercion, refusal to participate might result in a loss of benefits (e.g., salary increases, time off). In the case of undue influence, a decision to participate could result in a job promotion. Employees are likely to view their employers as authority figures to whom they must show deference, which could undermine the freedom of their choice.
Yes, in some circumstances. The HHS regulations require that an investigator obtain legally effective informed consent from subjects or a legally authorized representative before the subjects may be involved in research ( 45 CFR 46.116 ), unless this requirement has been waived by an IRB . Likewise, for research involving children, permission of the potential subjects' parents or guardians must be obtained ( 45 CFR46.408(c) ), unless an IRB has waived this requirement . Ensuring an adequate consent or parental permission process may require repeating or supplementing the initial consent procedure. The regulations also stipulate that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimizes the possibility of coercion or undue influence” ( 45 CFR 46.116 ). This requirement also might necessitate repeating or supplementing the initial consent procedure.
Informed consent and parental permission should be viewed as an ongoing process. The regulations do not explicitly describe all of the circumstances that might require repeating or supplementing the informed consent process. However, they do require that potential subjects be provided, when appropriate, with a “statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject” ( 45 CFR 46.116(b)(5) ). Thus, to ensure that consent remains legally effective -- for example, if the protocol design or risks have changed, or if a substantial period of time has elapsed between the time consent was obtained and the study begins -- it might be necessary to ensure that subjects still want to participate in the research. For example, the prospective subject may no longer be interested in participating, may no longer meet the eligibility criteria, may no longer find the risks acceptable, or may no longer have the time to complete all study-related activities.
The IRB must review and approve any changes in the approved consent procedure, including alterations of the content, as described in the elements listed at 45 CFR 46.116 , or in its timing, and may consider whether there is a need to reiterate the process ( 45 CFR 46.103(b)(4) ). The IRB should take into account whether the changes could potentially affect a subject’s understanding of the nature of the study or potentially affect a subject’s willingness to participate. If so, such changes need to be made in the informed consent document. Even without significant changes to a protocol or informed consent document, periodic reiteration or affirmation of consent is often a good idea, especially if the study takes place over a long period of time or is particularly complex. Minor changes, such as correcting nonsubstantive typographical errors in the consent document, would not generally rise to a level requiring repeating the consent process.
The HHS regulations at 45 CFR part 46 do not specify how far in advance of study entry a subject can provide consent. The amount of time required by a subject to make a decision would presumably depend on the nature of the study, taking into account, among other factors, the degree of risk, potential benefits, alternatives, and desire to consult with family members or others. However, if a prolonged period of time elapses from the date of consent to the date of entry into the study even if there have been no changes in the study design or no new significant findings affecting the study it might be prudent to review the information contained in the consent form with the subject prior to initiating any research procedures with the subject.
Yes, under certain circumstances. Although the HHS regulations do not specifically reference this type of activity, sometimes referred to as “preparatory to research,” such an activity must be reviewed and approved by an IRB in accordance with HHS regulations at 45 CFR 46.109(a) when:
In general, informed consent of the subjects, or parental permission for children involved in research, must be sought and documented in accordance with, and to the extent required by, HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 respectively.
However, an IRB may approve a consent or parental permission procedure that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirements to obtain informed consent ( 45 CFR 46.116(c) or (d) ). In order to permit investigators to obtain and record identifiable private information for the purposes of identifying potential subjects, OHRP expects that IRBs routinely will waive the requirement for informed consent for such activities. In assessing the level of risk to determine whether a waiver of informed consent or parental permission is permissible for the identification of potential subjects, the IRB need only consider the risk of investigators accessing the subjects’ identifiable private information, not the risks of the research in toto.
The procedures used in obtaining informed consent and parental permission should be designed to inform the subject population or the parents of the subject population about the research in terms that they can understand. Therefore, informed consent and parental permission language and its documentation in the accompanying forms (especially explanation of the study’s purpose, duration, experimental procedures, alternatives, risks, and benefits) should be provided in language that is understandable and culturally sensitive to those being asked to participate or provide permission for their child’s participation.
If the prospective subjects include, for example, persons whose primary language is not English, or populations with low literacy levels, the IRB should take special care to ensure that both oral presentations and consent or permission forms are comprehensible to all subjects or the parents of subjects who are children. Subjects who do not speak English should be presented with a consent or permission document written in a language understandable to them. OHRP strongly encourages the use of such a document whenever possible. (See OHRP guidance on this topic at http://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html ; for information about requirements for child assent, see FAQs regarding research with children .)
In general, ordinary language should replace technical terms (e.g., upper extremities are better referred to as arms, venipuncture as taking blood from your arm with a needle, and so forth).
Some IRBs find that their lay members (e.g., community or non-scientist members) are particularly helpful in suggesting necessary modifications to language. Others ask members of the proposed subject population (e.g., clinic patients) to review consent or permission forms and indicate which parts they do not understand.
Yes, under certain circumstances. First, the investigator and the IRB need to be aware of relevant laws pertaining to electronic signatures in the jurisdiction where the research is going to be conducted.
Unless the IRB waives the requirement for the investigator to obtain a signed consent or permission form based on the HHS regulations at 45 CFR 46.117(c) , a written consent or permission form, which may be an electronic version, must be given to and signed by the subjects or the subjects' legally authorized representatives or the parents of subjects who are children. Some form of the consent document must be made available to the subjects or the parents of subjects who are children in a format they can retain. OHRP would allow electronic signature of the document if such signatures are legally valid within the jurisdiction where the research is to be conducted.
OHRP does not mandate a specific method of electronic signature. Rather, OHRP permits IRBs to adopt such technologies for use as long as the IRB has considered applicable issues such as how the electronic signature is being created, if the signature can be shown to be legitimate, and if the consent or permission document can be produced in hard copy for review by the potential subject. One method of allowable electronic signatures in some jurisdictions is the use of a secure system for electronic or digital signature that provides an encrypted identifiable “signature.” If properly obtained, an electronic signature can be considered an “original” for the purposes of recordkeeping.
Yes, if it is more convenient for the subjects or parents of children who are subjects to fax a signed copy of the consent or permission form to the investigator, the research subjects or parents may fax the signed form. The subjects or parents need not provide the investigator with the original signed consent or parental permission documents.
When a written consent or parental permission form is used that embodies some or all of the elements of informed consent required by the regulations at 45 CFR 46.116 , the regulations only require that the informed consent or parental permission document be signed by the subjects or the subjects' legally authorized representatives or by the parents of children who are subjects ( 45 CFR 46.117(a) ) and 45 CFR 46.408(d) ). Only in situations where a short form is used, stating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject’s legally authorized representative or to the parent(s) of a child who is a subject, are there additional requirements for signatures ( 45 CFR 46.117(b)(2) ).
For the consent or parental permission process using the short form, the regulations state that there must be a witness to the oral presentation, who then signs both the short form and a copy of the IRB-approved written summary of what is to be said to the subject or the subject's legally authorized representative or to the parent(s) of a child who is a subject. The subject or the subject’s legally authorized representative or the parent(s) must sign the short form, and the person actually obtaining the consent must sign the copy of the summary ( 45 CFR 46.117(b)(2) ). Thus, three types of persons are involved in this specific consent process -- the subject or legally authorized representative or parent(s) of a child who is a subject, the person obtaining consent, and the witness.
Although the HHS regulations at 45 CFR 46.117 do not require the consent form to be dated at the time it is signed, OHRP recommends that it be dated so that the IRB and others can document that informed consent was obtained prior to a subject’s participation in the research.
Legally authorized representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research ( 45 CFR 46.102(c) ). The regulations state that “no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative” ( 45 CFR 46.116 ). The issue as to who can be an LAR is determined by the laws of the jurisdiction in which the research is conducted (e.g., local or state law). Some states have statutes, regulations, or common law that specifically address consent by someone other than the subject for participation in research. Most states have no law specifically addressing the issue of consent in the research context. In these states, law that addresses who is authorized to give consent on behalf of another person to specific medical procedures or generally to medical treatment may be relevant if the research involves those medical procedures or medical treatment.
When the laws of the jurisdiction in which the research is being conducted provide a reasonable basis for authorizing an individual to consent on behalf of a prospective subject to their participation in the research procedure(s), OHRP would consider such an individual to be an LAR as defined by HHS regulations at 45 CFR 46.102(c) . IRBs may wish to consult with legal counsel when deciding who can serve as an LAR for subjects of proposed research.
In answering this question, the HHS regulations at 45 CFR part 46 should be consulted in addition to the laws of the jurisdiction in which the research is conducted. As a general matter, if an adult lacks capacity to consent, for example, as a result of trauma, mental retardation, some forms of mental illness, or dementia - whether temporary, progressive, or permanent - only a legally authorized representative for that adult can give consent for participation in the research, unless the requirement to obtain informed consent is waived by the IRB in accordance with the requirements at 45 CFR 46.116(c)(d) , or in accordance with the provisions for emergency waiver, which are permitted under the authority of the HHS Secretary at 45 CFR 46.101(i) .
( See the Federal Register notice of this waiver .) Should the subject regain or develop the capacity to consent, then his or her consent must be obtained for any further research, as the consent of the legally authorized representative is no longer valid.
The HHS regulations are silent on the consent procedures specific to subjects with impaired decision-making capacity, for example, as a result of trauma, mental retardation, some forms of mental illness, or dementia, whether temporary, progressive, or permanent. The regulations do require that the IRB ensure that “additional safeguards have been included in the study to protect the rights and welfare” of all subjects that are “likely to be vulnerable to coercion or undue influence.” The regulations include “mentally disabled persons” in this category ( 45 CFR 46.111(b) ).
In research involving adult subjects with mental illnesses or cognitive impairments, the IRB and investigator(s) must be knowledgeable about the condition and any level of impairment that is likely to be present in the subject population. The regulations do speak to the fact that the IRB must possess “the professional competence necessary to review specific research activities” ( 45 CFR 46.107(a) ). This is achieved either by having members with the appropriate experience and expertise or inviting consultants with competence in the special area to assist in the review of issues that require expertise beyond or in addition to that available on the IRB ( 45 CFR 46.107(a) and (f) ). Ensuring such expertise on the IRB improves its ability to make determinations about subject recruitment, enrollment, and informed consent requirements that best match the needs of the subjects.
In some research, such as longitudinal studies involving progressive disorders or aging populations, enrolled subjects may be competent to consent on their own behalf at the outset, yet may experience effects of progressive or intermittent disorders that lead to decisional impairment during the course of the study. In these situations IRBs and investigators should consider the need to discuss with the prospective subjects whether they should designate someone to serve as a legally authorized representative at the outset of the study, consistent with all applicable laws. Even if a subject has consented on his or her own accord, a designated representative would be ready to step in as the legally authorized representative if the subject’s ability to assess his or her own needs and interests becomes compromised during the study.
The IRB must determine, to the extent required by 45 CFR 46.116 , that adequate provisions are made for soliciting the assent of the children -- when in the judgment of the IRB the children are capable of providing assent -- as well as the permission of the parents ( 45 CFR 46.408 ). Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research ( 45 CFR 46.402(c) ).
By regulatory definition, children are “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” ( 45 CFR 46.402(a) ). In the United States the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state; in a large majority of states 18 years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. State law also may address specific circumstances in which a person younger than the age of adulthood is legally authorized to consent to medical procedures: for example, some states allow children younger than the legal age of adulthood to consent to the provision of contraceptive services. Certain states provide a mechanism for the emancipation of minors, through which a child younger than the legal age of adulthood may gain certain civil rights, which might include the legal ability to consent to research participation.
The definition of children also takes into account the particular interventions or interactions involved in the proposed research (e.g., surveys, blood tests). For example, in some places individuals who are 16 years of age may legally consent to certain clinical interventions or interactions. If the involvement of human subjects in a proposed research activity consists of these interventions or interactions, then those individuals may be considered as adults for that purpose. If a proposed activity includes an intervention or interaction for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.
Under 45 CFR 408(b) the IRB may find that the permission of one parent is sufficient for research to be conducted under 45 CFR 46.404 or 45 CFR 46.405 . Where research is conducted under 45 CFR 46.406 or 45 CFR 46.407 , permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
Although the regulations state that children are unable to provide legally effective informed consent to participate in research, some might be able to give their assent. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent ( 45 CFR 46.402(b) ).
If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted regarding assent, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under certain circumstances in accord with 45 CFR 46.116 and 45 CFR 46.408(a) .
Waiver or alteration of the requirements for obtaining informed consent from adult subjects can occur under any of the following three provisions:
For research involving children, an IRB may waive the requirements for obtaining parental or guardian permission under any of the following four provisions:
The term guardian means “an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care” ( 45 CFR 46.402(e) ) The role of a guardian in the context of research involving a child who is a ward is to provide permission, in lieu of a child’s biological or adoptive parents, for the ward to participate in the research ( 45 CFR 46.402(c) ). For a more extensive discussion see FAQs on Research with Children .
The Office for Human Research Protections (OHRP) notes that informed consent should be viewed as an ongoing process throughout the duration of a research project. When a child who was enrolled in research with parental or guardian permission subsequently reaches the legal age of consent to the procedures involved in ongoing research, the subject’s participation in the research is no longer regulated by the requirements of 45 CFR part 46.408 regarding parental or guardian permission and subject assent.
Unless the Institutional Review Board (IRB) determines that the requirements for obtaining informed consent can be waived, the investigators should seek and obtain the legally effective informed consent, as described in 45 CFR 46.116 , for the now-adult subject for any ongoing interactions or interventions with the subjects. This is because the prior parental permission and child assent are not equivalent to legally effective informed consent for the now-adult subject. However, the IRB could approve a waiver of informed consent under 45 CFR 46.116(d) , if the IRB finds and documents that the required conditions are met.
Similarly, if the research does not involve any ongoing interactions or interventions with the subjects, but continues to meet the regulatory definition of “human subjects research” (for example, it involves the continued analysis of specimens or data for which the subject’s identity is readily identifiable to the investigator(s)), then it would be necessary for the investigator(s) to seek and obtain the legally effective informed consent of the now-adult subjects. The IRB may consider, if appropriate, a waiver under 45 CFR 46.116(d) of the requirements for obtaining informed consent in order for the subjects to continue their participation in the research.
The HHS regulations allow the IRB to waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under 45 CFR 46.116(a) and (b) .
Waiving the requirement for obtaining informed consent or parental permission means that the IRB has determined that investigators need not obtain the subjects’ informed consent to participate in research. For example, some research about natural behavior may require that subjects be unaware that the research is taking place. Such research can only be approved by the IRB if the research meets the criteria for a waiver of informed consent under HHS regulations and for approving research according to 45 CFR 46.111 .
An IRB may approve research for which some or all of the elements of informed consent at 45 CFR 46.116 (a) and (b) have been altered, or for which some elements have been left out. For example, some research designs require that subjects be left unaware of the particular purpose of the research, because the subjects’ responses might be biased if they know in advance what the investigators are seeking. Such research designs do not preclude offering potential subjects some information about the research and giving them the opportunity to decide whether to participate. The IRB may approve such research in which investigators will leave out or alter elements of informed consent, so long as the research meets the criteria for approving research in 45 CFR 46.111 , and the research meets the criteria specified in the HHS regulations for leaving out or altering those elements.
The conditions under which an IRB may waive the requirement for obtaining informed consent or parental permission or may approve a consent procedure that leaves out or alters some or all of the elements of informed consent derive from four sources in the HHS regulations.
Under 45 CFR 46.116(c) , an IRB may waive the requirement for obtaining informed consent or parental permission or approve a consent or parental permission procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that the following two criteria are satisfied:
the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
Note that this criterion means that only public benefit or service program research activities that are under state or local authority meet this criterion; similar research conducted under federal authority would not qualify here and is treated elsewhere in the regulations. Research conducted by or subject to the approval of only a private entity also would not qualify.
This criterion means that the practical circumstances of the research are such that the research is not feasible if the informed consent of the subjects must be obtained. For example, a study of identifiable private information about program benefit recipients using 20-year-old records might meet this criterion, if current contact information for those recipients is not available.
Under 45 CFR 46.116(d) the IRB may waive the requirement for obtaining informed consent or approve a consent procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that all of the following four criteria are met:
In 1996, the HHS Secretary announced, under 45 CFR 46.101(i) , a waiver of the applicability of the regulatory requirement for obtaining and documenting informed consent for a strictly limited class of research, that is, research that may be carried out in human subjects who are in need of emergency therapy and for whom, because of the subjects’ medical condition and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained. This waiver applies to research involving adults or children, but does not apply to research involving pregnant women, human fetuses, neonates of uncertain viability, and nonviable neonates, or prisoners.
For more detailed information, see OHRP’s guidance on Emergency Research Consent Waiver . It should be noted that FDA also has a comparable provision for a waiver of informed consent for emergency research at 21 CFR 50.24 .
When an Institutional Review Board (IRB) has not waived the requirement for seeking prospective informed consent of the subjects or the parental permission of children who are subjects, under the HHS regulations at 45 CFR 46.117(c) , it may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
Some subjects might refuse a copy of the consent form once signed out of concern that their possession of the form could compromise their privacy. This is fully consistent with the idea behind one of the bases for a waiver of the requirements for documentation of informed consent - that harm would result to the subject if his/her identity were compromised by the documentation itself. The investigator may document that the subject refused a copy of the informed consent document and still include the subject in the study.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or the parents of children who are subjects with a written statement regarding the research.
Yes, under certain circumstances. An IRB may waive the requirements for obtaining parental or guardian permission if either of the following two conditions is met:
The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition ( 45 CFR 46.408(c) ).
Note that an IRB may waive the requirement for obtaining parental or guardian permission under 45 CFR 46.408(c) even if the research involves more than minimal risk to the child subjects.
No, the IRB is responsible for deciding whether child assent is required in proposed research activities. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent ( 45 CFR 46.402(b) ). Child assent is required, except in the following three circumstances described at 45 CFR 46.408(a) :
The HHS regulations do not require documentation of assent. The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent. Based on such considerations as the child’s age, maturity, and degree of literacy, the IRB should decide what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent’s assent.
If young children are involved who are as yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place. The IRB may also decide that documentation of assent is not warranted.
Informed consent is legally effective if it is both obtained from the subject or the subject’s legally authorized representative and documented in a manner that is consistent with the HHS protection of human subjects regulations and with applicable laws of the jurisdiction in which the research is conducted. In general terms, the regulations stipulate that an investigator should seek consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information provided should be in language that is understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language .
It is important to note that the informed consent requirements in the regulations are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed for consent to be legally effective ( 45 CFR 46.116(e) ).
For more information on HHS's web notification policies, see Website Disclaimers .
Informed consent is a communication process by which researchers reach agreement with people about whether they wish to participate in research. Confusing informed consent with a signed consent form may violate the ethical intent of informed consent, which is to communicate clearly and respectfully, to foster trust, comprehension, and good decision making, and to ensure that participation is voluntary.
Consent forms are often written in “legalese” and are long, complex, and often inappropriate to the culture or language of the potential subject, insulting, and virtually impossible for most people to comprehend. They convey to some the impression that signing such a formal-looking document commits them to participation. Among subjects who willingly sign documents, most sign the consent form without reading it.
How has this come to pass? Early concern with ethics of human research was about biomedical research and focused on the necessity of obtaining informed consent. Over the decades, the elements of informed consent have grown in number, as has the idea that informed consent is a form that is to be signed by the subject. According to the Federal Regulation of Human Research 46.117(a):
Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.
However, many researchers and the Institutional Review Boards that govern their research fail to recognize that 46.117(c) provides for a waiver of signed consent forms:
(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern, or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
The reason for obtaining a signed consent form has always been much more to protect the researcher and the institution than to serve the interests of the research subject. In case the subject claims later that consent was inadequate or omitted, the researcher can counter by showing the form. Recently, the Office of Human Research Protection has imposed highly publicized and costly sanctions against a few research institutions. Understandably, IRBs and research administrators consider it in their self-interest to make highly conservative decisions. Since IRBs must take steps to justify waiving documentation of informed consent by deeming the research to be minimal risk, many consider it safer not to do so, fearing that such an action might leave them open to questions by the OHRP. Thus, the reason for obtaining a signed consent form is typically to protect the institution, not the subject. Researchers, science, institutions, subjects, and IRBs would all be better off if they made intelligent interpretations of the requirements of the Common Rule.
The Social and Behavioral Sciences Working Group has made various recommendations based on the Common Rule, designed to guide social and behavioral researchers and IRBs out of such conundrums. The authors, both members of the Working Group, developed recommendations concerning informed consent, some of which are summarized here:
1. Informed consent should take the form of an open, easily understood communication process. Typically, this means a friendly verbal exchange between researcher and subject, with a written summary of the information for the subject to keep, as appropriate. (The copy for the subject to keep would be inappropriate if the written record of the subject’s participation could be damaging to the subject, as when the research is about domestic violence, or illegal behavior). Both the verbal and written discussion should be brief, and simply phrased at such a level that all of the subjects can understand it.
2. Subjects must receive enough easily understood, accurate information to judge whether the risk or inconvenience involved is at a level they can accept. The responsibility rests with the investigator to describe any risks accurately and understandably. There are many kinds of minor or everyday risks or inconveniences that most persons would gladly undertake if it were their choice to do so, but which they would not wish to have imposed upon them unilaterally. However, some may make a rational decision that the experience would be too stressful, risky, or unpleasant for some idiosyncratic reason that applies to them and not to other subjects.
3. Especially when the research procedure is long and complex, the researcher must make it quite clear that the subject is free to ask questions at any time. Informed consent, as a conversation (not a form), needs to be available throughout the research, as subjects do not necessarily develop questions or concerns about their participation until they are well into the research experience. For example, a discussion of confidentiality may not capture subjects’ attention or comprehension until they are asked some quite personal questions in the ensuing research experience.
4. When subjects can readily refuse to participate by hanging up the phone or tossing out a mailed survey, the informed consent can be extremely brief (a sentence or two). Courtesy and professionalism require that the identity of the researcher and research institution be mentioned, along with the nature and purpose of the research. However, if there are no risks, benefits, or confidentiality issues involved, these topics and the right to refuse to participate need not be mentioned, as such details would be gratuitous and might decrease participation by implying greater risk that actually exists. If the researcher has any connection with the institution at which the subjects receive health care or other essential services, it is necessary to mention the right of the research subject to refuse or withdraw without prejudice. Such rights may be honored implicitly by making it clear that you are asking their permission to involve them as research subjects.
5. Verbal informed consent need not be detailed and written consent is not appropriate when the research is not concerned with sensitive personal information and when subjects are peers or superiors of the researcher.
6. The cultural norms and life-styles of subjects should be considered when deciding how to approach informed consent. For example, research on homeless injection drug users should probably be preceded by a several week-long process of “hanging out” and talking with them. The resulting informal communication will raise issues they wish to discuss with the researcher. The conditions under which the research is conducted can then be negotiated orally between the researcher and the community members, as appropriate. Written documents and signed forms would expose subjects to risk of arrest and serve no redeeming purpose.
7. A wide range of media are appropriate for administering informed consent. Video tapes, brochures, group discussions, web sites, community newsletters, and the “grape vine” can be more appropriate ways of communicating with potential subjects than the potentially confusing formal consent forms that often are used.
8. When written or signed consent places subjects at risk, it must be waived. There are times when the written record is the only evidence that the subject has participated in a study in which there is acknowledgement or appearance of situations that would place the subject at risk.
9. When it is important to have some record of the informed consent but when written or signed consent would place the subject at risk or be difficult for the subject to read, one useful procedure is to have a trusted colleague witness the verbal consent.
10. Community consultation, or meeting with community leaders of the potential subjects, is a useful way to plan research that is likely to raise sensitive questions among those to be studied and members of their community. This is not a substitute for individual informed consent, but often clears the way for potential subjects to be ready to decide whether to participate.
11. In certain circumstances, persons are not in a position to decide whether to consent until immediately after their participation, e.g., in brief sidewalk interviews, which persons are likely to welcome.
12. Some research cannot validly be conducted if all details are disclosed at the outset. The alternatives to outright deception of subjects are to a) obtain permission to provide only a description of what the subject will experience, with an agreement that the full details of the study will be disclosed afterward; b) obtain permission to engage in concealment or deception with the understanding that pilot research has shown that peers of the subject do not find such concealment or deception objectionable and that a full explanation will follow their participation, c) explain that the subject might be enrolled in one of several possible conditions and to gain permission to disclose in which of these the subject was actually enrolled after his or her participation is completed.
Author’s Note: The Social and Behavioral Sciences Working Group (formerly a part of the National Human Research Protections Advisory Council but now an independent body) chaired by Felice Levine helped to develop these ideas.
Reference Melton, G., Levine, R. J., Koocher, G., Rosethal, R., & Thompson, W. (1988). Community Consultation in Socially Sensitive Research: Lessons from Clinical Trials on Treatments for AIDS. American Psychologist , 43, 573-581.
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Joan Sieber is professor of psychology at California State University, Hayward. She received her bachelor's, master's, and doctorate from the University of Delaware. Robert J. Levine is professor of medicine and co-chair of the interdisciplinary bioethics project at Yale University. He is also the founding editor of IRB: A Review of Human Subjects Research.
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Human Research Protections Office
620 W. Lexington St. Second Floor Baltimore, MD 21201
P 410-706-5037
Office hours are 8:30 a.m.-4:30 p.m., Monday through Friday.
* The Human Research Protections Office is working remotely and is ready to assist our community during the COVID-19 pandemic. During this time, we request you contact us via email to promote a prompt response. With apologies, currently voicemail messages may be delayed in reaching us and cause a longer wait time for us to respond to your requests. We thank you for your patience and look forward to assisting you.
* Only the UMB IRB approved consent/assent templates (with the UMB logo) will be accepted when UMB IRB is the IRB of record
** Effective December 4th, 2023, the University of Maryland Baltimore Human Research Protections Program (HRPO) will adopt a revised version of the informed consent document (ICF) template. This announcement applies to new studies only that submit their application in CICERO after December 4th, 2023.
Informed consent is required to be presented in language understandable to potential participants. The HSHSL Health Literacy guide contains a list of Plain Language resources .
The Health Sciences and Human Services Library offers a Research Consent Form Review service to improve consent form readability. Library staff will review your consent form and suggest changes that will help simplify the language, lower the reading grade level, and make the consent form more understandable to potential participants. * As a free service to all UMB faculty, researchers are strongly encouraged to use this service.
Click Here To Request a Research Consent Form Review
Basic elements of informed consent.
Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
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Consent Form for Participation in a Research Study
To administrate a Consent Form to each participant is mandatory for any research involving human subjects. Please find below (or download here ) a template of consent form.
ESSEC Business School
Title of Study
DESCRIPTION: You are invited to participate in a research study on ( describe project in non-technical language; include types of questions that will be asked, if applicable; explain purpose of the research). You will be asked to (describe procedures ; mention video/audio taping, if applicable, and what will become of tapes after use, e.g., shown at scientific meetings; describe the final disposition of the tapes).
TIME INVOLVEMENT: Your participation will take approximately (insert duration ).
PROTECTION OF CONFIDENTIALITY: The information that you give in the study will be handled confidentially. Your information will be assigned a code number. The list connecting your name to this code will be kept in a locked file. When the study is completed and the data have been analyzed, this list will be destroyed. Your name will not be used in any report.
The information that you give in the study will be handled confidentially. Your data will be anonymous which means that your name will not be collected or linked to the data.
PAYMENTS: You will receive (describe reimbursement; where there is none, state as such) as payment for your participation.
PARTICIPANT’S RIGHTS: If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time . In this case, you will not earn any money (or credits). You have the right to refuse to answer particular questions. The results of this research study may be presented at scientific or professional meetings or published in scientific journals.
If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled . You have the right to refuse to answer particular questions. The results of this research study may be presented at scientific or professional meetings or published in scientific journals.
DEBRIEFING: A debriefing will be done at the end of the study.
CONTACT INFORMATION:
If you have any questions, concerns or complaints about this research, its procedures, risks and benefits, contact the Researcher, (name and email of Researcher).
I agree to participate in the research study described above.
Signature: ________________________________________ Date: _____________
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July 2024 irb connection newsletter, irb efficiency initiatives and results to date, irb efficiency initiative: current and upcoming, herky hint: help messages, aahrpp accreditation: preparing for site visit interviews, course-related student projects: is irb approval required, learning opportunity: irb overview lecture in icon, in the news, upcoming educational events, irb efficiency initiative s and results to date, by kelly o’berry and michele countryman.
Beginning in January 2024, the Human Subjects Office (HSO) rolled out six major initiatives to improve Institutional Review Board (IRB) and Human Research Protection Program (HRPP) review processes. This article provides an evaluation of previous programming changes that were presented at the May IRB Efficiency Initiative Information Session .
Here’s a brief overview of the initiatives and results to date:
60-Day Withdrawal Due to PI Inactivity (effective 1/29/24): 1,059 New Project and Modification Forms submitted since implementation. Of these, 106 forms were withdrawn (10%), 17 were recreated, and 9 were resubmitted.
DSP Approval Timing (effective mid-February 2024): The new process for faster signoffs from the Division of Sponsored Programs allowed the release of HRPP approvals an average of 48 days earlier ( 36 days median).
Required Actions After the IRB Meeting (effective 4/1/24): the average time to provide the PI with required actions from IRB meeting minutes has gone from 9 days to less than 24 hours since April 1.
Assign a Meeting Date Goal (effective 4/1/24): Limited data is available, but 71% of studies met the date goal. More in-depth information will be available after the June rollout that separated IRB review from HRPP Committee Approvals.
HawkIRB forms are automatically withdrawn if there is no response to workflow in 60 days . This change will allow for more accurate metrics for IRB review time.
In addition to the two-week reminders, a new 55-day HawkIRB email notice states that the form will be withdrawn in five days. The form in the PI’s inbox shows the number of days in Workflow over the total days since submission. At 55 days , the form is highlighted in red in the PIs inbox.
Evaluation data for New Project forms and Modification forms:
The 106 withdrawn forms represent a considerable timesaving for HSO staff reviewers. Most withdrawn forms have not been recreated and very few recreated forms have been submitted to the IRB.
NOTE: For a withdrawn form, the PI can only use the “recreate” link once. It is best to hold off on recreating the form until all issues that were holding up the response to the workflow questions in the original form have been resolved.
Division of Sponsored Programs (DSP) approval is required in HawkIRB for industry-initiated, industry-funded clinical trials where a research contract is required to document institution and sponsor expectations. The research application can be approved by the IRB, but not released to the study team until DSP approval is documented. In February, DSP updated their “contract approval” process for these industry-sponsored clinical trials. DSP approval used to be documented when the contract was fully executed; contract negotiations were complete, all signatures in place (institution, PI, and sponsor), and budget approved. Now DSP issues approval in HawkIRB when contract negotiations are complete, even if signatures and/or budget remain pending. This removed a significant delay in the HRPP approval process. Note: The PI must continue to work with the sponsor to obtain signatures and finalize the budget prior to initiating the research.
This change affected 38 studies from mid-February to early June. Faster DSP sign off allowed the release of HRPP approvals 48 days earlier than the previous average. For these studies, the median turnaround for IRB approval was 36 days , which is considerably below the goal of a 45-day median from submission to approval for full board review.
Application Analysts can now set an IRB meeting date goal, and a due date for meeting this goal, at the beginning of the IRB review process.
NOTE: There were several limiting factors for evaluation of this change. IRB meeting agendas were full through April 22 when this change took effect on April 1. The first New Project form included in this evaluation was submitted on April 2 and scheduled to a meeting on May 9. This evaluation is based on data from early May through mid-June.
Also, when this change took effect the hold for three Human Research Protection Program (HRPP) committees prevented scheduling forms to an IRB meeting. The IRB Efficiency Initiative rollout on June 14, 2024, lifted this hold by separating the IRB and HRPP Committee approvals. Future data will provide a more in-depth evaluation.
HSO staff can now provide required actions to the PI shortly after the IRB meeting, which gives the PI/research team a head start to address required actions before receiving the full set of IRB meeting minutes.
Before April 1, 2024, the average time to provide required actions to the PI in the full meeting minutes was 9 days. The goal is to provide required actions within 24 hours and the full set of meeting minutes within four business days.
Of 167 sets of meeting minutes completed between April 1 and mid-June, HSO staff effectively decreased the average time to provide required actions to the PI to less than 24 hours. The research community has provided positive feedback about this change.
Seventeen sets of minutes (10%) did not meet the goal due to the complexity of the issues the board discussed. Approximately half of these minutes were from a monthly IRB-01 Executive Committee meeting. The Executive Committee reviews more complex study design and compliance-related issues.
See IRB Efficiency Initiative Announcements and Updates for information about o ther initiatives that are in progress or have been implemented since June 2024, including: launching the new HSO website , adding a chair designee to assist with IRB-02 post-approval forms, onboarding a new IRB-02 chair, Primary Reviewer process enhancements and more.
The IRB Efficiency Initiative rollout in June 2024 separated IRB review and approval from the other Human Research Protection Program (HRPP) committee approvals. This article provides an overview of that change and a summary of other initiatives in progress, updated documents, policies and procedures and information session/demonstration recordings.
HawkIRB programming changes rolled out June 14, 2024, separated IRB review and approval from other HRPP Committee approvals. Prior to this change, the IRB could not begin the convened board review process until the issuance of approval from three committees/entities: Conflict of Interest in Research (CIRC) , Protocol Review and Monitoring Committee (PRMC, in Holden Comprehensive Cancer Center) , and Research Billing Compliance (RBC) . The HSO can now schedule a New Project or Modification form to a convened IRB meeting before the completion of these HRPP committee reviews/approvals.
The second programming change allows the IRB to grant full IRB approval before the issuance of all HRPP approvals. Prior to this efficiency initiative, the IRB would hold approval pending approval from these additional HRPP committees: Pharmacy & Therapeutics (P&T) , Medical Radiation and Protection Committee (MRPC) , Institutional Biosafety Committee and Nursing Research Committee (NRC) . Additionally, the IRB can now grant approval before the Division of Sponsored Programs (DSP) signs off on the grant or contract.
The Principal Investigator (PI) can now submit a Modification form in HawkIRB to address requests from HRPP Committees that complete their review after the IRB approves the New Project form. The New Project form is released when the Modification form is approved and released in HawkIRB.
Several documents, policies and procedures were updated or added in June. See a detailed list at the end of this article .
The following initiatives are in progress or have already been implemented since the June IRB Efficiency Initiative Information Session:
New IRB review and approval structure for IRB-02 (social/behavioral research) – Effective at the start of Fiscal Year 2025, we added an IRB Chair Designee to assist with approval of post approval forms (e.g., Modification, Continuing Review, or Modification/Continuing Review) meeting an expedited or exempt criteria for approval. This enhancement is consistent with a long-standing IRB-01 review structure and is consistent with IRB practices across the nation. The new IRB-02 Chair Designee is an experienced IRB member who is already serving as an IRB-01 Chair Designee.
New IRB-02 Chair – The new IRB-02 Chair, an experienced IRB member, will begin onboarding and training in August as part of succession planning for IRB-02 Chairs.
Primary Reviewer process enhancements for full board review – HawkIRB programming is underway to update the Primary Reviewer Checklist used at convened board meetings and enhance the training process for Primary Reviewers.
HawkIRB Application Redesign – This initiative to streamline the HawkIRB application began with the rollout of Section III updates on January 29, 2024. The goal is to make forms easier for researchers to complete and more efficient for the IRB review. This is a continuation of the 2022-2023 initiative to update the HawkIRB form for projects that qualify for Exempt Status. The next HawkIRB application redesign rollout will focus on updates to the single IRB review process. This is in preparation for the anticipated FDA adoption of the revised Common Rule regulations regarding the use of a single IRB for multi-site projects.
New HSO website – The new HSO website is now live! HSO staff are still making final tweaks and corrections to URLs. It will take time for search engines to only identify pages of the new website. Use the gold buttons on the home page and the menu options to find what you need. We welcome your feedback. For assistance with finding anything on the new website or to provide feedback, please contact us at [email protected].
AAHRPP Accreditation Site Visit – 2024-2025 is our HRPP reaccreditation period and will involve a significant amount of HSO time and resources. There are two steps in the reaccreditation process. The UI is currently at Step I; the initial application was submitted in March, and we are currently responding to AAHRPP review of submission materials. Step II is the site visit which will occur this fall. The site visit includes interviews with select PIs and research staff. See February through July IRB Connection Newsletter articles for additional information about accreditation and preparing for the site visit.
The following documents were updated or added during the June IRB Efficiency Initiative rollout:
New Resources:
Other HRPP Committee Tool – Includes an organizational chart, information about each committee and when their review is required, and regulatory references for these reviews. [Link at end of first paragraph]
HRPP Committee Review Process Flow Chart – Illustrates the timing of steps in the IRB review process and HRPP committee approvals. [Link in first sentence of the second full paragraph]
UI IRB Standard Operating Procedures and Researcher Guide
Updated Policies and Procedures:
External IRB Standard Operating Procedures
VA Researcher Guide
May 2024 IRB Efficiency Initiative Information Session (recording)
Trainings and Demos:
HawkIRB demo: Separating IRB and HRPP Committee Approvals (recording)
WCG Training (recording, June 19, 2024)
IRB ICON Course for Researchers – Slides, recordings, demo recordings and instruction documents
By rachel kinker, mpa.
Are you working on your HawkIRB application and not sure how to answer a particular question? Within the application, there are little blue circles with “i” (for “information”) associated with most of the questions in the HawkIRB application.
For example, the Help Message on the index page provides a lot of information:
Overview of the HawkIRB system
Template Consent Forms and Other Attachments
Resources for assistance with preparing HawkIRB applications
About the Help Messages
Resources on the Human Subjects Office website
Principal Investigator (PI) Responsibilities
HawkIRB Delegates
Guidance for Community-Based Research
Throughout the application, other Help Messages provide guidance for what information to include in response to specific questions in the HawkIRB form. When you click on the Help Message, a new window will appear with additional text describing what to include in the response to each question.
For example, in section VII.E., each Help Message describes what to submit and how to respond to the question.
The Help Messages may also contain links to other departments that you may need to connect with or specific policies you should know. For example, the cash handling policy appears in the Help Message for question VII.E.9
Utilizing the Help Messages throughout the application can answer researcher questions along the way and may expedite the application process by reducing workflow. If you have suggestions for how to improve the existing Help Messages, please contact [email protected].
By emily shultz, cip .
The Human Subjects Office (HSO) is preparing for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) site visit that will take place in late summer/early fall 2024. The University of Iowa Human Research Protection Program (HRPP) has maintained accreditation since 2003. The practice of becoming accredited and maintaining accreditation is one of receiving input on how well the UI is following policies and procedures, and how well these policies and procedures meet the accreditation standards.
About six weeks prior to the site visit, AAHRPP staff will send an email that contains:
the names of the site visit team members,
a draft agenda for the site visit,
a list of personnel who will be interviewed.
During the virtual site visit, the site visitors will meet (via Zoom) with small groups of HSO staff, IRB Chairs, IRB members, UI researchers and UI research team members, as well as members of committees with research oversight responsibilities, such as:
Medical Radiation Protection Committee
Pharmacy & Therapeutics Committee
Institutional Biosafety Committee
Nursing Research Committee
Division of Sponsored Programs
Conflicts of Interest in Research Committee
The interviews are typically done with two site visitors and 2 or 3 interviewees. Most interview time is with the IRB chairs, IRB members, and staff.
Utilizing the documents submitted with the application for reaccreditation and the information gathered during the site visit, AAHRPP site visitors will look for evidence that, “the entire HRPP meets accreditation standards—and that protecting research participants is a shared organizational priority.” A month or two after the site visit, the HSO will receive feedback on how well the UI HRPP is meeting the requirements and will receive recommendations on areas where improvements can be made.
Site Visit Interviews
Andy Bertolatus , emeritus associate professor of internal medicine and one of the UI IRB-01 chairs, has been an AAHRPP site visitor for more than 20 years. The following information is based on insights he provided, in addition to information available from AAHRPP.
When site visitors meet with members of the research community, they do not expect anyone to be able to recite federal regulations on the required elements of consent or the criteria for approval. When interviewing researchers, the site visitors will likely ask questions about the researcher’s:
Areas of expertise and type(s) of research conducted
Approach to conducting the consent processes
Feelings about working with the IRB
How they find out about changes in IRB policies/procedures
Where they go for information or whom they contact for questions
Resources Available
For the UI research community, many resources are available online. These include, but are not limited to the following:
UI IRB Standard Operating Procedures and Researcher Guide
Human Subjects Office (HSO) website
Conflict of Interest in Research website
HHS Electronic Code of Federal Regulations 45 CFR 46
OHRP Guidance
FDA Regulations Part 50
FDA Regulations Part 56
FDA Guidance
This is the final article in the AAHRPP Accreditation series. Previous articles are available on the HSO website IRB Connection page . Information for this article was adapted from the AAHRPP website .
Students may conduct some research projects with human participants as a course assignment without approval from the Institutional Review Board (IRB). According to the UI and IRB policies, all human subjects research conducted by University of Iowa faculty, staff, or students must have approval from the IRB prior to initiation. IRB review is required if the project is intended to “develop or contribute to generalizable knowledge,” including thesis or dissertation projects. However, research methods course projects are generally more limited in scope and are intended to help students learn how to conduct research. These projects satisfy curriculum requirements and are not intended to further scientific knowledge in a particular field or discipline.
IRB Approval Not Required
Course-related research activities would not require IRB approval if:
The purpose of the assignment is to teach research methodology.
The results of the assignment will not “contribute to generalizable knowledge” because they are only used to satisfy a course requirement or because of limits on who will have access to the results of the project.
The procedures will be limited to surveys, questionnaires, interview procedures, observation of public behavior, or standard educational exercises.
The projects will not include people who are incarcerated or minors as participants or utilize data about these two populations.
Data will be recorded without any identifying information (such as code numbers, birth dates, etc.) or identified data are not sensitive in nature (i.e., do not pose a risk of harm to the participants’ reputation, employment, financial standing, or do not put them at risk for criminal or civil liability).
The project is not receiving monetary compensation or direct financial support from an external company, organization, or agency.
The project will not be conducted at the Veteran’s Administration Health Care System (VAHCS) or use any VA resources.
The project is not conducted or supported by a federal department or agency that follows the federal regulations for the protection of human subjects (the ‘Common Rule’).
NOTE: Honors, master’s, and doctoral thesis and dissertation projects always require IRB approval if they involve research with human subjects. If any aspect of the class project is intended to be used for a thesis or dissertation, students must obtain IRB approval prior to any study activities (recruitment, data collection, etc.).
Policy and Checklist
The “Course-Related Student Project” policy specifies the parameters for class projects that can be conducted without IRB approval and contains a link to the Course-Related Student Projects Checklist .
The checklist is a fillable pdf that helps students and instructors determine whether a project qualifies as a course-related student project. If any aspect of the project design indicates that IRB approval might be required, a pop-up message directs the student to submit a Human Subjects Research Determination (HSRD) form in the HawkIRB system to ask if the project needs IRB approval. If that occurs, there will be a red STOP on the completed checklist.
Students should complete the Course-Related Student Project Checklist based on their project design and submit it to the instructor. Based on the completed Checklist, the instructor is authorized to determine that a project complies with the policy and can be conducted without IRB approval. If there is a red STOP in the Checklist, the instructor should advise the student to submit an HSRD form and receive a determination before conducting any research activities.
The policy and the checklist can be found in the UI Standard Operating Procedures and Researcher Guide ( Section I, Part 12.D). See also the Course Instructor Responsibilities for using the Course-Related Student Project policy and checklist.
Information for Participants
Even when a course-related student project can be conducted without IRB approval, it is a recommended best-practice that the student share the following information with potential subjects:
Student name and name of the course
Course instructor name and their contact information
Who will have access to individual and summarized results (e.g., instructor, group/team members, the whole class, an outside company/agency/organization)
That participation is voluntary, and they may stop participating at any time.
Resources
For more information, students and instructors may review the Course-Related Student Research Projects web page and the Course-Related Student Research Projects Policy and Procedures educational tool the Human Subjects Office website.
(link sends e-mail)
By rachel kinker, mpa .
Do you work with or teach individuals who are new to the University of Iowa and learning to conduct human subjects research? The recorded IRB Overview presentation posted in the IRB ICON Course for Researchers provides a general orientation to the UI IRB and the IRB approval requirements for human subjects research.
This is an excellent supplemental lecture for any research methods or responsible conduct of research course. It is also ideal for students doing research as a course requirement. Learners must access the IRB ICON course through the portal on the HSO website . After the first login, the course will appear in your ICON Dashboard.
This presentation covers:
Regulatory definition of human subjects research
Guidelines for human subjects research: why and when IRB approval is required
Basic ethical principles for the conduct of human subjects research
Student Principal Investigator (PI) training requirements (HawkIRB Part 1 and 2 trainings)
Criteria for IRB approval
Information about the UI IRB
What to expect from the IRB review process
Research off campus or outside the United States
Course-related student projects
Additional resources exist for courses where students complete a research project as a course requirement. The IRB policy on Course Related Student Projects outlines conditions under which IRB approval is not required for these projects. Instructors should use the Course Related Student Project Checklist to determine whether IRB approval may be required.
If your class needs further guidance on specific research-related topics, please reach out to [email protected] to discuss additional options.
NIH researchers discover a new face-detecting brain circuit – NIH
The Human Subjects Office invites the UI research community to attend monthly information sessions about the IRB Efficiency Initiative on the fourth Wednesday of the month from 12-1 pm, via Zoom. We will discuss the changes and demonstrate HawkIRB enhancements being implemented to streamline the IRB review process. The monthly sessions will cover upcoming enhancements and expected roll out dates. Pre-register to receive the Zoom link.
Wednesday, August 28, 2024
12:00 PM-1:00 PM
Pre-register to recieve the Zoom link
Human Subjects Office staff host IRB Office Hours via Zoom to provide assistance with electronic IRB applications (in HawkIRB) and to discuss study proposals prior to submission. All researchers are welcome to attend. No appointment is necessary.
Summer office hours run June 5th through August 28th.
Wednesdays (2:00 PM-4:00 PM) via Zoom
Visit the Human Subjects Office website for complete information about IRB Office Hours and the Zoom link.
The IRB ICON Course for Researchers HawkIRB training sessions provide an orientation to the electronic IRB application and review system. These sessions are for anyone preparing to submit a HawkIRB application for the first time and for those who would like guidance about the proper completion of HawkIRB forms. Five recorded trainings are available 24/7.
The recorded trainings are available on ICON at IRB ICON Course for Researchers .
Note: HawkIRB training Parts 1 and 2 satisfy the Student PI Training Requirement.
COMMENTS
lly-sponsored AND participants are adultsStandard Informed Consent Template for Research. se this template if your research is NOT. derally-sponsore. A. D participants are adults.Avoid Common Problems with Consent Forms. Read these tips!1. ustomize this template to reflect the specifics of your study and participan.
If you like, a summary of the results of the study will be sent to you. If you have any other concerns about your rights as a research participant that have not been answered by the investigators, you may contact the Smith College Institutional Review Board at [email protected] or (413) 585-3562.
A collection of informed consent, assent, and debriefing templates that can be used for your human participant research study. General Consent Form Templates Social and Behavioral Research Projects (last updated 03/16/2023)
Informed Consent in Research. Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate. It is a cornerstone of ethical research involving human subjects and is intended to protect the rights and welfare of ...
The following is a sample consent form for a research project. It is a research project on faculty life on campus, carried out by the principle investigator (PI) of this project from the fake-named Century University. The interviewer (the investigator) should have the interviewee read this form carefully and ask any questions the interviewee ...
Consent for participation in research requires an informed consent process. This process involves an information exchange and on-going communication that takes place between the investigator (researcher) and the potential research participant (subject). ... After a verbal explanation, provide the potential subject the written consent form or ...
Researchers must take the steps necessary to ensure that all participants in the research understand the process in which they are to be engaged, including why their participation is necessary, how it will be used, and how and to whom it will be reported so that the prospective participant can make an informed decision about whether they really do want to take part.
this section, and all sections of the consent form, use simple, plain English. This section is required.) Procedures to be followed: (Here describe the research procedures to be followed, including duration of the subject's participation. Experimental procedures must be identified. This section is required.) Risks to study participants:
Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve. The informed consent process is one of the central components of the ethical conduct of research with human subjects. The consent process typically includes providing a written consent ...
Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, ... Competent subjects able to comprehend the research-related information should personally decide and provide the consent on research participation.
Assent Form Ages 7-14. 2023-06-27. Information or Fact Sheet. 2023-04-10. The following documents are samples. IRBIS does NOT generate these documents with application-specific information. Exempt Research Information Sheet. 2017-10-30. Addendum to provide additional information to subject after original consent.
participation being a voluntary decision on their part. This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the ...
This template is a guide to help researchers design study information sheets and consent forms. It has been designed with reference to HRA Participant Information Sheet Preparation Guidance. Sample text is italicised. Alter or delete as required as you produce the draft. Standard required text is underlined.
Consent. I have read this form and have been able to ask questions of the PI and/or discuss my participation with someone I trust. I understand that I can ask additional questions at any time during this research study and am free to withdraw from participation at any time. Author.
It should also be made known that participation is voluntary and that the participants can withdraw from the study. A step-by-step guide to filling out a general research informed consent form can be found below. Instructions - Use to fill in the blank template. How to Write. Step 1 - Download in PDF, MS Word, or OpenDocument.
Consent Addendum This is a consent addendum to allow already enrolled participants to agree to additional study procedures not disclosed in the initial consent form. This form supplements the consent and HIPAA authorization the subject already provided for a research study. Consent Addendum. 3-11-2020.
As a general matter, if an adult lacks capacity to consent, for example, as a result of trauma, mental retardation, some forms of mental illness, or dementia - whether temporary, progressive, or permanent - only a legally authorized representative for that adult can give consent for participation in the research, unless the requirement to ...
Confusing informed consent with a signed consent form may violate the ethical intent of informed consent, which is to communicate clearly and respectfully, to foster trust, comprehension, and good decision making, and to ensure that participation is voluntary. Consent forms are often written in "legalese" and are long, complex, and often ...
An example of an online informed consent form is posted at the end of this document. Telephone: Typically, these components will be written as the beginning of the "script" and verbal consent will be requested before beginning the telephone survey. A copy of the script must be provided to the IRB. Paper Survey: Typically, these components ...
This study involves participating in an upsetting and stressful computer task involving viewing shocking, repulsive, disturbing, horrific, lewd, erotic, or gory images and words. Most people will find this 25-minute task difficult, unpleasant, upsetting, and stressful. You should not participate in this study if have any history of mental or ...
The following basic elements of informed consent are required to be disclosed in all research consent forms pursuant to 45 CFR 46(a-b): Basic elements of informed consent. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the ...
ESSEC Business School. Consent Form for Participation in a Research Study . Title of Study. DESCRIPTION: You are invited to participate in a research study on (describe project in non-technical language; include types of questions that will be asked, if applicable; explain purpose of the research). You will be asked to (describe procedures; mention video/audio taping, if applicable, and what ...
This form is used to provide information to the research participant (or parent/guardian) and to document written informed consent, minor assent, and/or parental permission. • When written documentation is required, the researcher keeps the original, signed form.
For this research study, your child's participation will be required for [provide information about the time commitments of the research including both the duration of the research and any follow-up, if needed]. Rights. You do not have to agree to authorize your child's participation in this research study.
Events. August 24, 2022. 2022 Federal Plain Language Summit. On August 24, 2022, our summit brought together federal employees to highlight plain language successes in many federal agencies at all stages of the communications journey.
HawkIRB programming changes rolled out June 14, 2024, separated IRB review and approval from other HRPP Committee approvals. Prior to this change, the IRB could not begin the convened board review process until the issuance of approval from three committees/entities: Conflict of Interest in Research (CIRC), Protocol Review and Monitoring Committee (PRMC, in Holden Comprehensive Cancer Center ...