Other Resources

Investigator Manual

The Investigator Manual is designed to guide investigators through the policies and procedures relating to the conduct of human research that are specific to Texas A&M.

•  Investigator Manual (HRP-103)

HRPP Standard Operating Procedures (SOPs)

• Standard Operating Procedures

University Rules & Standard Administrative Procedures (SAPs)

• Human Subjects in Research (15.99.01M1)
• Responsible Stewardship of Research Data (15.99.03.M1.03)
• Financial Conflicts of Interest in Sponsored Research (15.01.03.M1)
• Institutional Conflict of Interest in Human Subjects Research (15.99.01.M1.01)

Additional Resources

Research Ethics

Information about the ethical codes that serve as the foundation for the conduct of research with human participants may be found here:

• The Belmont Report
• Declaration of Helsinki
• The Nuremberg Code

Regulatory Agencies

Many federal agencies have specific regulations or requirements with regard to research with human participants.

Office for Human Research Protections – (OHRP)

• Code of Federal Regulation Title 45 CFR Part 46
• OHRP FAQs related to:
  • 45 CFR 46
  • Research with Children
  • Research with Prisoners
  • Informed Consent
  • Investigator Responsibilities
• DHHS Educational Videos
• International Compilation of Human Subject Research Protections (OHRP)

Food and Drug Administration – (FDA)

• Clinical Trials and Human Subject Protection
• Regulations Relating to Good Clinical Practice and Clinical Trials

Comparison of FDA and OHRP Regulations

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)

• Guidance for Industry, E6(R2) Good Clinical Practice: Consolidated Guidance

National Institutes of Health – (NIH)  

• NIH’s Definition of Clinical Trial (Background, Definition, Case Studies, FAQs & Decision Tree)
• New Human Subjects and Clinical Trial Form

• Video: How to View, Edit, and Submit Human Subjects Studies through the Human Subject System
• Video: A Walk-through of the PHS Human Subjects & Clinical Trails Information Form
• NIH policies, regulations, training and resources on Human Subjects Research
• Funding Opportunity Announcement (FOA):
  • Funding Opportunity Announcement by Clinical Trail Allowability
  • FAQ’s on Clinical Trial-specific FOAs
• NIH Policy and related guidance for Data and Safety Monitoring (this link provides general and NIH Institute and Center-specific guidance)
• NIH Certificates of Confidentiality Kiosk

National Science Foundation – (NSF)

• Human Subjects in Behavioral and Social Science Research FAQ

Department of Defense (DoD)

• Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

FERPA and PPRA

• Family Educational Rights and Privacy Act (FERPA)
• Protection of Pupil Rights of Amendment (PPRA)

HIPAA

• PHI in research

International Research

Conducting Research outside of the U.S. (general guidelines on over 100 countries)

• OHRP International Compilation of Human Research Standards

Conducting Human Research in QATAR

Human Research conducted in Qatar must be reviewed by a Qatari IRB. For more information please contact Texas A&M HRPP or Texas A&M, Qatar to guide you through the process.

• Qatar Supreme Council of Health guidelines, regulations and policies
• IRB Review Board Process for Texas A&M University-Qatar Investigators