IRB Review of Informed Consent

1. IRB Review of Informed Consent The purpose of this presentation is to provide instruction, tips and techniques about how to review the consent process and the consent document.

2. The Belmont Report • Belmont Principle #1: Respect for Persons • Individuals are treated as autonomous agents. • Persons with diminished autonomy are given protection. There are 4 conditions that follow directly from this principle and are thus requirements for IRB approval of research: • Voluntary consent to participate in research • Informed consent to participate in research • Protection of privacy and confidentiality • The right to withdraw from research participation without penalty

3. The Consent Process An Investigator shall seek legally effective informed consent of the subject or the subject’s legally authorized representative. This consent must be obtained 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. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor the institution or its agents from liability for negligence.

4. Investigators presenting a research study to a potential research participant should: Pause during consent process, ask potential participant to paraphrase essential information Evaluate understanding Re-explain missed info Re-evaluate understanding Re-explain again Re-evaluate Simple but effective: Investigators should talk with patients or potential research participants. Investigators should evaluate subject understanding of the 5 essential elements: Purpose of the research Procedures associated with the research Risks of the research Benefits of the research Research is VOLUNTARY The Consent Process

5. The Consent Document Required Elements(DHHS Regulated Research 45 CFR Part 46.116 & FDA Regulated Research 21 CFR Part 50.25) • 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 which are experimental • A description of any reasonably foreseeable risks or discomforts to the subject; • A description of any benefits to the subject or to others which may reasonably be expected from the research • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained • 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 • 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 • 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

6. The Consent Document Additional Elements(DHHS Regulated Research 45 CFR Part 46.116b & FDA Regulated Research 21 CFR Part 50.25b) When appropriate, one or more of the following elements of information shall also be provided to each subject: • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent • Any additional costs to the subject that may result from participation in the research • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject • 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 • The approximate number of subjects involved in the study • If applicable, a statement that the study will be included on www.clinicaltrials.gov

7. The Consent Document Additional elements of the NHRMC consent document: • The researcher should include the name, department and contact info of the Principal Investigator and any Co-PIs involved in the informed consent process. • The study title • The funding source, and disclosure of any conflicts of interest. • HIPAA Authorization is combined into the consent form

8. Consent Form Review Before the Full Board Meeting: Read the consent document 3 times. • First, read the consent for general information about the study; can you clearly describe the study after reading the consent form? For studies involving medical treatments, can you distinguish standard-of-care from research procedures? • Second, read it for readability (6th-8th grade level); did it seem easy, or did you have to re-read for understanding? Could a junior-high school student explain the study after reading the consent form? • Finally, read it for content; are the required elements of informed consent included in the form? Does the researcher include the appropriate additional elements of consent? Resist the urge to make minor wording changes unless it will influence human subjects protection. Make changes to the consent form or note questions for the researcher to address at the IRB meeting.

9. QUESTIONS? NEXT: Waiver of Informed Consent versus Waiver of Documentation of Informed Consent.