Human Subjects Research at the University of Michigan

1. Human Subjects Research at the University of Michigan Module 3 Ethics and Law

2. Introduction This module contains information about ethical principals and the law including: • Belmont Report • Common Rule: 45 CFR 46 • Conflict of Interest • Federal, State, and Local Laws • HIPAA • FERPA

3. Belmont Report The Belmont Report is a statement of the basic ethical principles and guidelines that should be used to resolve the ethical problems that surround the conduct of research with human subjects. It identifies three basic ethical principles that underlie all human subject research. These principles are commonly called the Belmont Principles. • Respect for persons • Beneficence • Justice Belmont Report

4. Vulnerable Populations Vulnerable populations are groups of individuals who may be subject to coercion. This includes: prisoners, children, pregnant women (whose choice impacts their unborn child), mentally disabled persons. There are additional protections put in place for these populations.

5. What is the Common Rule? • The term Common Rule refers to 45 CFR 46. CFR is the Code of Federal Regulations (administrative law that governs research with human subjects and codifies the ethical principles of the Belmont Report.) It defines what constitutes “research” as well as defines “human subject.” 45 CFR 46

6. What is a Human Subject? • A living individual about whom an investigator conducting research obtains: • data through intervention or interaction with the individual or • identifiable personal or private information

7. What is regulated research? • Systematic investigation • including research development • testing and evaluation designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d) • Generally, if you intend to publish the results of your study "outside the walls" of the University, or your study is not a single "case study," journalism, or oral history, then your study is regulated research and under IRB jurisdiction.

8. Informed Consent • Informed Consent is: • The voluntary choice of an individual to participate in research based on a complete and accurate understanding of the study. • It is not a single event or document but rather an ongoing process that takes place between the investigator (or designees) and the research participant. • Requires full disclosure of the nature of the research and the participant’s role in that research, understanding of that role by the potential participant and the participant’s voluntary choice to join the study.

9. Consent Document • Consent is documented by use of a Consent Form approved by the IRB unless a waiver of Informed Consent or waiver of documentation of informed consent is approved by the IRB.

10. Elements of Consent • A statement that the study involves research, the purpose of the research, expected duration of participation, and a description of procedures. • A description of reasonably foreseeable risks or harms. • A description of any benefits to the subjects or others. • Disclosure of appropriate alternative treatments/procedures. (not required for research that does not involve clinical trials.) • Description of protection of confidentiality of records • If more than minimal risk, a description of compensation & injury procedures if injury occurs. • Contact information for PI and IRB (this is standard on our Consent form templates) • A statement that participation is voluntary, subject my withdraw at any time with no penalty or loss of benefit.

11. Consent Waivers • Waiver of consent: • Waiver of documentation of consent:

12. Waiver of Informed Consent An IRB may waive or alter the requirements for informed consent only if it finds and documents that: • The research involves no more than minimal risk to the subjects; • The waiver or alteration will not adversely affect the rights and welfare of the subjects; • The research could not practicably (i.e., feasibly) be carried out without the waiver or alteration; and • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

13. Waiver of Documentation of Informed Consent • Documentation may be waived under two circumstances: 1. The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research, and the consent document is the only record linking the subject with the research. 2. Study participation presents minimal risk of harm to the subject and the research involves no procedures requiring consent outside the context of participation in a research study.

14. Conflict of Interest • Conflict of interest arises when a faculty or staff member, in relationship to an outside organization is in a position to influence the university’s business, research or other decisions in ways that could lead directly or indirectly to financial gain for the faculty or staff member or a member of his / her family or give improper advantage to others to the detriment of the University. • Financial conflicts are not inherently wrong and should always be disclosed in the research context. • The University and individual academic units have established mechanisms to identify and manage potential conflicts including annual disclosure requirements and questions in the eResearch IRB and Proposal Management systems. • COI’s that involve Sponsored Projects are reviewed by OVPR.

15. Other Federal, State, and Local Laws • HIPPAHealth Insurance Portability and Accountability Act: Establishes a Federal floor of privacy protections for most individually identifiable health information by establishing conditions for its use and disclosure by certain health care providers, health plans, and health care clearinghouses. • FERPA Family Educational Rights and Privacy Act: The regulations provide that educational agencies and institutions that receive funding under a program administered by the U. S. Department of Education must provide students with access to their education records, an opportunity to seek to have the records amended, and some control over the disclosure of information from the records. With several exceptions, schools must have a student's consent prior to the disclosure of education records.

16. Module 3 Conclusion If you have any questions or concerns please contact: Deb Schneider IRB Administrator (313) 593-5468 dbn-research@umd.umich.edu