Office for Human Research Protections (OHRP)

Policy Guidance [by topics]

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Guidance Topics

Related Documents

• May 12, 2004 Conflict of Interest Final Guidance
• Belmont Report
• Common Rule
• Ethical Issues in Research Involving Human Participants, Bibliography
• Ethical and Legal Aspects of Human Subjects Research in Cyberspace; a report from the AAAS Program on Scientific Freedom, Responsibility and Law, in collaboration with NIH/OPRR (http://www.aaas.org/spp/sfrl/projects/intres/report.pdf)
• Evaluation of NIH Implementation of Section 491 of the PHS Act, Mandating a Program of Protection for Research Subjects - "Bell Report"
• Federal Register Notices (Archive)
  includes Fetal Tissue Transplantation Research, Public Law 103-43, Section 498A
• Protection of Human Subjects (1994 Presidential Memorandum)
• Statutory Basis for 45 CFR 46
• FDA Regulations (21 CFR 50 and 56)
• National Bioethics Advisory Commission (http://www.georgetown.edu/research/nrcbl/nbac/)
• Nuremberg Code

AIDS

• AIDS Research, Guidance for IRBs
• HIV Serostatus, Informing Those Tested, PHS Policy
• HIV Serostatus, Sex-Partner Notification, PHS Policy

Certificate of Confidentiality

• Certificate of Confidentiality: Privacy Protection for Research Subjects [PDF] [HTML}

Common Rule

• Federal Policy for the Protection of Human Subjects
• 45 CFR 46
• Federal Register Notice announcing the final rule
• Portions of the Federal Register Notice announcing the final rule:
  • Common Rule 1
  • Common Rule 2
  • Common Rule 3
  • Common Rule 4

Consent - See Informed Consent

Continuing Review [PDF] [HTML]

• Regulatory Requiremments
• Substantive and Meaningful Continuing Review
• Continuing Review in Multi-Center Trials Monitors by a DSMB, DMC, Other Similar Body, or Sponsor?
• Expedited Review for Continuing Review
• Date for Continuing Review - How to Determing
• Lapse in Continuing Review
• IRB Composition for Continuing Review

Databases and Data Storage

• Repositories, Tissue Storage Activities, Data Banks

Decision Charts

• Human Subject Regulations Decision Charts

Emergency Research

• Emergency Research Informed Consent Requirements
• Emergency Medical Care

Engagement in Research

• Engagement of Institutions in Research
• Engagement of Pharmaceutical Companies in HHS-Supported Research

Exculpatory Language

• Exculpatory Language in Informed Consent Documents

Exempt Research/Exemptions

• Exemptions for Public Benefit and Service Programs
• Exempty Research vs Research That May Undergo Expedited Review

Expedited Review

• Exempt Research vs Research Appropriate for Expedited Review
• Expedited IRB Review - Categories
• Expedited IRB Review, Protocols Closed to New Enrollments
• Research That May Be Reviewed Through an Expedited Procedure? [PDF] [HTML]

Fetal Tissue

• Fetal Tissue Transplantation [PDF] [HTML]
• Fetal Tissue Transplantation Research, Public Law 103-43, Section 498A

HHS Funding Support

• IRB Review of Applications for HHS Support

HIV/AIDS

• AIDS Research, Guidance for IRBs
• HIV Serostatus, Informing Those Tested, PHS Policy
• HIV Serostatus, Sex-Partner Notification, PHS Policy

Human Subjects

• Basic Protections for Human Subjects
• Human Subject Research Decision Charts

Informed Consent

• Emergency Research Informed Consent Requirements
• Exculpatory Language in Informed Consent Documents
• Informed Consent Tips
• Informed Consent Checklist
• Informed Consent, Legally Effective and Prospectively Obtained
• Informed Consent, Non-English Speakers

IRB (Institutional Review Board )

• AIDS Research, Guidance for IRBs
• Designation of an Independent IRB
• Expedited Review--1998 Revised Categories
• Knowledge of Local Research Context
• Meetings Convened via Telephone Conference Call
• Multicenter Clinical Trials, Local IRB Review
• Multicenter Clinical Trials, Local IRB Review, DAIDS, NIAID
• Reliance on Another Institution's IRB
• Review of Applications for HHS Support
• Written Institutional Review Board (IRB) Procedures [PDF] [HTML]

International Research

• International Research - An Introduction

Multicenter Clinical Trials

• Multicenter Clinical Trials, Local IRB Review
• Multicenter Clinical Trials, Local IRB Review, DAIDS/NIAID

Pharmaceutical Companies

• Engagement of Pharmaceutical Companies in HHS - Supported Research

Prisoners

• Prisoner Research [PDF] [HTML]

Repositories (see also Tissue Storage/Repositories)

• Repositories, Tissue Storage Activities, Data Banks

Research

• Engagement of Institutions in Research
• Engagement of Pharmaceutical Companiesin HHS - Supported Research

Stem Cells

• Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance for Investigators and Institutional Review Boards

Tissue Storage/Repositories

• Repositories, Tissue Storage Activities, Data Bank (11/97)

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