What IRB consent reviewers check for

Updated February 9, 2007. Reason: the IRB now only requires the PI to be listed on the consent form

Required by FHCRC

1. Heading incorporating FHCRC
2. Name, affiliation and telephone number of the principal investigator
3. Telephone number for participants to call in case of an emergency
4. Consents must state IRB has access to participants' records

Required by Section 46.116(a) of 45 CFR 46

1. Statement that the study involves research.
2. Explanation of purposes of the research.
3. Explanation of expected duration of participation.
4. Identification of procedures, which are experimental.
5. Description of any foreseeable risks or discomforts to the participants.
6. Description of any benefits to the participants or to others that may be reasonably expected from the research.
7. Disclosure of appropriate alternative procedures.
8. Statement describing the extent to which confidentiality of records will be maintained.
9. Explanation as to whether compensation will be provided.
10. Explanation as to whether medical treatments are available if injury occurs, and, if so, where further information can be obtained.
11. Explanation of whom to contact for answers to pertinent questions about the research and in the event of a research related injury to the participant.
12. Explanation of whom to contact for answers to questions about research participant’s rights.
13. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits, and that the participants may discontinue participation at any time without loss of benefits to which they are otherwise entitled.

Additional elements (whenever appropriate)

1. Language of consent is understandable to the subject or representative (Simplified lay person language).
2. Approximate number of participants in study.
3. If the study involves an FDA investigational drug, device or biologics, is the word "investigational" used in describing the drug, device or biologics?
4. Is an emergency contact person and phone number listed if an emergency can potentially occur during the study?
5. The Purpose section should refer to the patient population, not the individual participant.
6. The Benefits section should refer to the patient population, not the individual patient.
7. Statement about risks to participants (or embryo or fetus if participant becomes pregnant) which are currently unforeseeable.
8. Additional costs participant may incur by participation in study.
9. In the "Costs" section, is it clearly stated what the participant and/or the sponsor are responsible for? For example "Sponsor will only provide the drugs at no cost".
10. Is a financial contact number included in the "Costs" section?
11. Circumstances under which investigator may terminate participants.
12. Consequences of decision to withdraw.
13. Procedures for orderly termination.
14. A statement that significant new findings that might affect decision to participate will be disclosed included?
15. If radioactive material is used, is the additional risk(s) outlined in the Risk Section?
16. If this study involves a cooperative group (e.g. Children's Cancer Group), is it listed in the confidentiality of records' section?
17. If an investigational drug, device or biologics is used in this study, the FDA must be listed in the "Will My Medical Information Be Kept Private?" section.
18. Medical Staff Statement includes a discussion of "risks".

COG studies

1. A model consent form is to be included for all Cooperative Oncology Group studies. The risks and alternatives are to be duplicated from the model consent in the FHCRC consent form. If this is a COG study, has this been done? If no, the investigator is required to provide written justification for the omission of risks and/or alternatives.

UW Consortium studies

1. Is the University of Washington (UW) included in the header?
2. Does the compensation/cost section include one of the two (2) UW template language? (i) "If you have a physical injury as a direct result of being in this study, we will treat you or refer you for treatment. This treatment will be provided at no cost to you." (ii) "If you have a physical injury as a direct result of being in this study, we will treat you or refer you for treatment. Company C, the sponsor of this study, will pay for this treatment."
3. If a separate HIPAA authorization form is used, was the UW HIPAA form used?

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