The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(b). OHRP also has a tips sheet for informed consent.
The regulations require that the following information must be conveyed to each subject or the subject's legally authorized representative:
(1) 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 procedures to be followed, and identification of any procedures that are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
(i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
(ii) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
Additional elements are described at 45 CFR 46.116(c).
Go to the “Forms” page on this IRB website and look under the category “consent form templates”. Look for "DUHS Sample Consent". Please do not use old templates that you may have saved on your computer.
Yes, enrollment can continue using the currently approved consent form (assuming it is not an expired consent form). However, if the revised consent form contains new information that may affect the subject’s willingness to continue (such as additional risks), the IRB may require re-consent as soon as approval of the continuing review is granted. In certain circumstances, the IRB may require enrollment to be temporarily suspended until the revised consent form is approved and will notify the Principal Investigator/study coordinator in writing of this requirement.
Common examples would be:
- Revisions to the consent form contain new information that may affect the subject’s willingness to continue (such as additional risks, study procedures and additional visits)
- A subject who is a minor turns 18 years old while on the study and must be re-consented as an adult
- A subject regains decision-making capacity as a result of change in medical status
In cases where your funder (e.g. NIH) or journal publisher require data sharing, if you are too restrictive in your consent language, you may need to re-consent participants, which can be both time consuming and challenging. Go to the standard language page and look for the "data sharing" standard language as you design your consent form to prospectively plan for communicating data sharing during the consent process.
If a research participant who is a minor turns 18 years old while on a study, the IRB requires that the participant be re-consented as an adult.
If a child is capable of assent and the Institutional Review Board (IRB) requires that assent be sought, it must be obtained before the child can participate in the research activity. Thus, if the child dissents from participating in research, even if his or her parents or guardian have granted permission, the child’s decision prevails.
However, the regulations state at 45 CFR 46.408(a) that the IRB may waive the assent requirements if the intervention or procedure involved in the research holds out the prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of research. Conversely, if a child assents to participate in research, and parental permission has not been waived by the IRB, the permission of the parents or guardian is also required before the child can be enrolled in the research.
The DUHS IRB has a policy regarding male research subjects’ partners who become pregnant while the male subject is involved in a research study using an investigational drug. When a sponsor requests the use of or submits a pregnant partner consent form, please use the new template information sheet, rather than the sponsor-provided form. The policy and template may be found on the DUHS IRB web site.
This template and policy give the pregnant partner information regarding why she is being asked to provide PHI (for herself and/or her infant), make it clear that providing this information is voluntary, and require the use of either DUHS’s “Authorization to Release Protected Health Information” (medical release form) or the authorization/release form at the entity where the pregnant partner is a patient. Study specific language can be added/revised as appropriate, but key points to remember are that this is an information form, not a consent form. The pregnant partner is not a subject in the study. Permission/authorization occurs when the pregnant partner signs the medical release form.
When submitting the information sheet, please upload as an other study document and not in the consent form section of iRIS. It is not considered a consent and will not be watermarked.
A new DUHS IRB policy was developed to address consent form placement in the medical record. A research consent form must be placed in the subject’s medical record if it meets the definition of being ‘clinically relevant’. ‘Clinically relevant’ is defined as any study-related activity that could have an effect, adverse or otherwise, on the clinical treatment of the subject. This definition includes investigational drugs, devices, or biologics that could, separately or in combination with other substances or activities, interfere with the clinical treatment of the subject or place the subject at greater risk of harm. The research consent form must always be placed in the participant’s medical record in the case of FDA-regulated research studies. In all other cases, it is left to the discretion of the Principal Investigator (PI) whether to place a copy of the consent form in the subject’s medical record or to maintain it only in the regulatory binder for the study.
A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:
- The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she wants documentation) OR
The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, surveys or interviews, no more than minimal risk).
A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:
- The research involves no more than minimal risk
- The waiver of informed consent will not adversely affect the rights and welfare of the subjects
- It is not practicable to conduct the research without the waiver or alteration
- Whenever appropriate, participants will be provided with additional pertinent information after their participation.
Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent.
No. The DUHS IRB requires that consent documents are printed single-sided only, for ease of use, and to reduce the likelihood that a page will be skipped over by the potential research participant.