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The human subject protections codified in the CFR are founded on the ethical guidelines outlined in the:
- Belmont Report (HHS website)
- Declaration of Helsinki (World Medical Association)
U-M investigators conducting human subjects research are expected to be familiar with the Belmont Report principles through training.
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (eBook from the Council for International Organizations of Medical Sciences )
The University of Michigan's human research participants policy as outlined in the Standard Practice Guide (SPG) defines the role of the Human Research Protection Program (HRPP) at the institution. The HRPP policy is guided in turn by federal regulations, such as the "Common Rule" and ethical guidance, such as the Belmont Report.
- SPG 303.05 Policy for Research with Human Participants
- HRPP Operations Manual - U-M's human research protections policy detailed in 12 parts. The Operations Manual is the main resource for human subjects research policy and requirements.
- U-M Federalwide Assurance (pdf)
- U-M Electronic Signature Certification - per FDA requirements (pdf)
- U-M Assessment: eResearch Compliance with 21CFR, Part 11-Electronic Records, Electronic Signatures (pdf)
- Class Assignments and IRB Approval
- Department of Defense (DOD): Additional Requirements for Investigators (pdf)
- Department of Education (ED): Additional Requirements for Investigators (pdf)
- Department of Energy (DOE): Additional Requirements for Investigators (pdf)
- Department of Justice (DOJ): Additional Requirements for Investigators (pdf)
- Environmental Protections Agency (EPA): Additional Requirements for Investigators (pdf)
- Protecting Participant Privacy and Maintaining Confidentiality of Data (pdf)
- International Conference on Harmonization: Good Clinical Practice (ICH-GCP) (pdf)
- Electronic Human Research Documentation Certification Guidance (pdf)
Related U-M Policies & Resources
The following lists the U-M policies for activities that have a human subjects research component:
- SPG 201.65-1 Conflicts of Interest and Conflicts of Commitment
- SPG 303.01 Implementation of Regents' Policy Concerning Research Grants, Contracts, and Agreements
- SPG 303.03 Policy Statement on the Integrity of Scholarship and Procedures for Investigating Allegations of Misconduct in the Pursuit of Scholarship and Research
- SPG 501.07 Research Subject Incentives
- SPG 520.01 Acquisition, Use and Disposition of Property (Exclusive of Real Property) - precautions regarding removal of protected health information or other data regarding human subject research prior to disposal of devices (e.g., laptops)
- SPG 601.34 Children on Campus - outlines the institutional requirements for U-M employees and students interacting with children participating in a U-M human research study, regardless of whether the study is conducted on campus or elsewhere. Additional details can be found on the University’s Children on Campus - Research webpage.
The Common Rule guidelines are codified into law in the Code of Federal Regulations (CFR) and published in the Federal Register by the agencies of the U.S. government. The list below represents a few of the federal agencies from which U-M receives support for human subjects research. The links below reference federal websites or documents that contain policies, explain specific provisions, and provide links to resources for that agency.
U.S. Department of Health and Human Services (HHS) Regulations
- Policy for the Protection of Human Research Subjects, 45 CFR Part 46 (pre-2018 and 2018 requirements)
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, 45 CFR Parts 160 & 164 (subparts A & E)
- Federalwide Assurance (FWA) for the Protection of Human Subjects - outlines general terms of commitment for institutions to comply with requirements 45 CFR Part 46, maintained by the HHS Office of Human Research Protections (OHRP)
Food and Drug Administration (FDA) Regulations
- Protection of Human Subjects, 21 CFR Part 50
- Institutional Review Boards, 21 CFR Part 56
- Investigational New Drugs (INDs), 21 CFR Part 312
- Investigational Device Exemption (IDE), 21 CFR Part 812
- Electronic Records, Electronic Signatures, 21 CFR Part 11
Department of Defense (DoD) Regulations
- Protection of Human Subjects, 32 CFR 219
- Limitations on the Use of Humans as Experimental Subjects, 10 USC 980
- Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, DoD Instruction 3216.02
Data Protection Policies
Federal and other data privacy and protection policies may impact human subjects research, including:
- FERPA (Family Educational Rights and Privacy Act, U.S. Department of Education) - protects the privacy of student education records and establishes guidelines for accessing records.
- GDPR (General Data Protection Regulation, European Union (EU)) - mandates standards for handling certain personal data of EU residents and non-EU citizens located in the EU.
To ask a question, express concerns, or provide suggestions about human research protections at U-M, please send a message to email@example.com.