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Assurance

UNR (IORG0000132) holds a federalwide assurance of compliance with the HHS Office for Human Research Protections. The federalwide assurance number is FWA00002306, which expires on June 23, 2016.

• Biomedical IRB registration number: IRB00000215
• Social Behavioral IRB registration number: IRB00000216

Accreditation

UNR earned full accreditation of its human research protection program (HRPP) by the Association for Accreditation of Human Research Protection Programs (AAHRPP) on September 22, 2009. The UNR HRPP has been accredited since June 16, 2006.

Federal Offices of Research Regulation

Office for Human Research Protections (OHRP)

• 45 CFR 46 (DHHS: Protection of Human Subjects)

U.S. Food and Drug Administration (FDA)

• 21 CFR 50 (FDA: Protection of Human Subjects)
• 21 CFR 56 (FDA: Institutional Review Boards)

Federal Guidance

OHRP:

• Expedited Review Categories
• Guidance on Continuing Review
• Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
• Guidance on Research Involving Coded Private Information or Biological Specimens
• Guidance on the Involvement of Prisoners in Research

NIH:

• Certificates of Confidentiality Kiosk
• HIPAA Privacy Rule and Its Impact on Research
• HIPAA Privacy Booklet

FDA:

• Information Sheets

NSF:

• Human Subjects
• Frequently Asked Questions and Vignettes: Behavioral and Social Science Research

U.S. Dept. of Education:

• Family Policy Compliance Office / FERPA

U.S. Dept. of Veterans Affairs:

• See VA Resources on our VA Research page.

Training / Education

Cooperative Institutional Training Initiative (CITI)

NIH: Protecting Human Research Participants

Public Responsibility in Medicine and Research (PRIM&R)

Ethical Codes / International Guidelines

Belmont Report

Nuremberg Code

Declaration of Helsinki (2008)

American Anthropology Association: Statement on IRBs / Code of Ethics

American Psychological Association: Ethical Principles of Psychologists and Code of Conduct

American Sociological Association: Code of Ethics

International Conference on Harmonisation Guideline for Good Clinical Practice [ICH GCP E6 (R1)]

Sponsors and Human Subjects Research

DHHS: Public Health Service Grant PHS 398 (see Part II: Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan)

NSF: Proposal & Award Policies & Procedures Guide (see II-24: Proposals Involving Human Subjects)

Office of Naval Research: Human Subject Documentation Requirements

U.S. Dept. Of Agriculture: Assurances Regarding the Protection of Human Subjects, Providing Humane Treatment of Animals, and Monitoring the Use of Recombinant DNA

U.S. Dept. of Defense: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

U.S. Dept. of Education: Protection of Human Subjects in Research

U.S. Dept. of Justice, National Institute of Justice: Guidelines: How to Submit Applications (see page 11, Confidentiality of Information and Human Subjects Protection)