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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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Basic Folder Information

21.3 Required Elements of Informed Consent


Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

July 31, 2008



policy

The IRB shall recognize that the readability, cultural sensitivity and format of informed consent documents contribute to participant comprehension and satisfaction and decrease anxiety associated with the consent process. To assure these goals, eight required elements of informed consent have been defined by federal regulations [45 CFR 46.116(a) and 21 CFR 50.25(a)]. HSRO staff may examine informed consent documents for compliance with the required elements, seek clarifications from Principal Investigators as appropriate and make recommendations to the IRB. The IRB may seek clarifications from Principal Investigators as appropriate and shall determine whether required elements of informed consent are adequately addressed during their deliberations on approval/disapproval of the documents.

The eight required elements which, unless waived by the IRB, must be included in the informed consent are:

  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 which are experimental
  2. A description of any reasonably foreseeable risks or discomforts to the subjects
  3. A description of any benefits to the subjects or to others which 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 subjects
  5. A statement describing the extent, if any, to which confidentiality of records identify the subjects 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, and 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 subjects
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subjects is otherwise entitled, and the subjects may discontinue participation at any time without penalty or loss of benefits to which the subjects is otherwise entitled

In addition to the eight required elements, federal regulations [45 CFR 46.116(b) and 21 CFR 50.25(b)]include six additional elements of informed consent. When appropriate, one or more of these elements of information shall be provided to each subject:

  1. A statement that the particular treatment or procedure may involve risks to the subjects (or to the embryo or fetus, if the subjects is or may become pregnant) which are current unforeseeable
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
  3. Any additional costs to the subjects that may result from participation in the research
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subjects
  5. 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
  6. The approximate number of subjects involved in the study

For studies that are subject to the requirements of the FDA regulations,  consent documents and the process of obtaining consent should inform participants of the possibility that the FDA may inspect the study records including those of the participant.



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