Regulations & Ethics

Federal Regulations

Office for Human Research Protections (OHRP)

• 45 CFR 46 - Protection of Human Subjects
• OHRP FAQ - Human Research Question & Answers

U.S. Food and Drug Administration (FDA)

• 21 CFR 50 - Protection of Human Subjects
• 21 CFR 54 - Financial Disclosure by Clinical Investigators
• 21 CFR 56 - Institutional Review Boards
• 21 CFR 312 - Investigational New Drug Application
• 21 CFR 812 - Investigational Device Exemptions

Federal Guidelines

National Institutes of Health (NIH)

• Guidelines on Women and Minorities
• Inclusion of Women and Minorities as Participants in Research Involving Human Subjects - Policy Implementation Page
• Inclusion of Children Policy Implementation
• Research Involving Individuals with Questionable Capacity to Consent: Points to Consider

U.S. Department of Health & Humans Services (HHS) - Office for Civil Rights (OCR)

• HIPAA - National Standards to Protect the Privacy of Personal Health Information

Federal Advisory Committee on Human Subjects Research

• Secretary's Advisory Committee on Human Research Protections (SACHRP)

International Research Issues

• OHRP International Issues
• International Compliation of Human Subject Research Protections.pdf

Ethical Codes

• Belmont Report
• World Medical Association Declaration of Helsinki

Organizations

• Public Responsibility in Medicine and Research (PRIM&R)
  PRIM&R is committed to the advancement of strong research programs and to the consistent application of ethical precepts in both medicine and research.

Other Sites of Interest

• University of Minnesota Center for Bioethics
• NIH Bioethics Resources on the Web
• Secretary's Advisory Committee on Human Research Protections (SACHRP)
  provides advice and recommendations on issues pertaining to or associated with the protection of human research subjects
• President's Council on Bioethics
• Bioethics.net
• Human Genome Project
  
  more Biomedical & Health Care Ethics Resources on the web

University Roles & Responsibilities

Principal Investigators

Co-Investigators

Student and Post-Doctoral Researchers

Board of Regents Policies & Procedures

Research Involving Human Subjects

Individual Business or Financial Conflicts of Interest

Institutional Conflict of Interest

Principal Investigator Eligibility On Sponsored Projects

Investigational Drugs & Devices

• Policy 2.1.9 Using Legend and Investigational New Drugs for Clinical Research
• Procedure 2.1.9.1 Conducting Inpatient Clinical Research Using Legend or Investigational New Drugs
• Procedure 2.1.9.2 Conducting Outpatient Clinical Research Using Legend/Investigational New Drugs

Sponsor-Investigator Investigational New Drug (IND) Applications or Investigational Device Exemptions (IDE)

• Policy 2.1.10 Reporting Sponsor-Investigator Investigational New Drug Applications (IND) or Investigational Device Exemption (IDE)
• Procedure 2.1.10.1 Request Assistance from IND/IDE Program
• Procedure 2.1.10.2 Submitting Copies of FDA Correspondence

Human Embryos or Embryonic Stem Cells

• Policy 2.1.11 Conducting Research with Human Embryos or Embryonic Stem Cells
• Procedure 2.1.11.1 Preparing to Conduct Research Involving Human Embryos or Embryonic Stem Cell Lines Ineligible for Federal/State Funding
• Procedure 2.1.11.2 Project Administration for Research Involving Human Embryos or Embryonic Stem Cell Lines Ineligible for Federal/State Funding

Human Fetal Transplantation

• Policy 2.1.12 Conducting Human Fetal Transplantation Research
• Procedure 2.1.12.1 Preparing to Conduct Human Fetal Transplantation Research Ineligible for Federal/State Funding
• Procedure 2.1.12.2 Satisfying Regulatory Requirements for Human Fetal Transplantation Research

Hazardous Biological Agents

• Research Involving Recombinant DNA and Hazardous Biological Materials
• Policy 2.1.13 Using Potentially Hazardous Biological Agents for Research or Teaching
• Procedure 2.1.13.1 Storing and Using Potentially Hazardous Biological Agents
• Procedure 2.1.13.2 Additional Procedures for Storing and Using Select Agents
• Procedure 2.1.13.3 Additional Procedures for Using Recombinant DNA

Payment to Subjects, Confidentiality, and 1099 Reporting

• Policy 3.9.2 Paying Human Subjects and Maintaining Confidentiality and 1099 Reporting
• Procedure 3.9.2.1 Paying Human Subjects Directly
• Procedure 3.9.2.2 Making Payments to a Third Party

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