Office of Research Integrity and Outreach

HRPP Resources

Human Research Protection Program (HRPP) Definitions

HRPP Guidance

HRPP Policies and Procedures

University of Maine System Information Security Policy & Standards

Sensitive Information / Special Subject Populations

Categories of Sensitive Information

  1. Information relating to sexual attitudes, preferences, or practices.

  2. Information relating to the use of alcohol, drugs, or other addictive products.

  3. Information pertaining to illegal conduct.

  4. Information that, if released, could reasonably damage an individual's financial standing, employability, or reputation within the community.

  5. Information that would normally be recorded in a patient's medical record and the disclosure of which could reasonably lead to social stigmatization or discrimination.

  6. Information pertaining to an individual's psychological well-being or mental health.

  7. Genetic information.

Special Subject Populations

  1. Minors (under 18 years of age). Please contact the Office of Research Integrity and Outreach.

  2. Fetuses or products of labor and delivery

  3. Pregnant women (in studies that may influence maternal health)

  4. Prisoners

  5. Individuals with a diminished capacity to give informed consent

OHRP: Research Involving Vulnerable Populations video

IRB Member Resources

Ethical Principles:

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Declaration of Helsinki 

Nuremberg Code

Federal Regulations:

45 CFR 46

Common Rule

FDA

HIPAA

FERPA

FAQs:

45 CFR 46 FAQs

Children: Research with Children FAQs

Informed Consent FAQs

Prisoner Research FAQs

Informed Consent

Guidance Materials

USM Policies and Procedures

 Protocol Review:

OHRP Guidance

eProtocol Reviewer - Visual Guide

eProtocol Approving a Protocol - Visual Guide

Useful Links

·        Office for Human Research Protections (OHRP) (external link)

·        Distinguishing Public Health Research and Public Health Nonresearch (pdf)

·        Program for Readability in Science and Medicine (PRISM) (external link)

·        Understanding the HIPPA Privacy Rule (external link)