1) Resource Links

• CTC Guidance  
• Office of Research Integrity
• New FAQs on the Review Process for Human Gene Transfer Trials Posted on OBA Web Site - OBA has developed a set of Frequently Asked Questions (FAQs) about the process by which OBA and its Recombinant DNA Advisory Committee review human gene transfer protocols. These FAQs were developed in response to the many queries that OBA receives and may be of interest to OBA_NEWS subscribers. In particular, they may be a useful educational tool for gene transfer investigators, institutional administrators, and others who wish to learn more about the process and its requirements. 

2) Federal Agencies Guidelines and Regulations

• Office for Human Research Protections (OHRP)
• OHRP Decision Charts http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm: A link to charts that provide graphic illustration of criteria used by the IRB to determine if an activity needs review, if an exemption or expedited review is required, and whether informed consent or its documentation may be waived. (Reminder: Penn State University policy requires that these determinations be made by the IRB. The charts are provided here for reference only).
• Code of Federal Regulations for Human Subject Protection (45 CFR 46)
• Tissue repository guidance
  
• Office of Civil Rights (OCR)
• HIPAA Privacy Rule (full text of federal regulation)
• DHHS Guidebook for HIPAA Privacy Rule
  
• Food & Drug Administration (FDA)
• FDA Medwatch Information
• FDA Information Sheets-Guidance for IRBs and Clinical Investigators
• FDA Resources
• Guideline for Industry - E6 Good Clinical Practice
• Protection of Human Subjects (21 CFR Part 50)
• Institutional Review Boards (21 CFR Part 56)
• Investigational New Drug Application (21 CFR Part 312)
• Drug Application Form 1571and 1572
• Applications for FDA Approval to Market a New Drug (21 CRF Part 314)
• Biological Products (21 CFR Part 600)
• FDA Centers (21 CRF Part 814)
• Center for Biologics Evaluation and Research (CBER)
• Center for Drug Evaluation and Research (CDER)
• Certificate of Confidentiality (COC) -  FDA's Certificates of Confidentiality Application Instructions.
• Clinical Investigator resources

http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr314_03.html

• National Institutes of Health (NIH)
• Required Education in the Protection of Human Research Participants
• Frequently Asked Questions for the Requirement for Education on the Protection of Human Subjects
• Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications
• NIH's guidance on the collection and storage of tissue and data for research
• Guidance on collection and storage of tissue and data for research
• Consents that include collection and research use of human biological materials
• National Cancer Institute (NCI)

3) Forms for Federal Agencies

• FDA forms (e.g. 1571, 1572, etc.)
• MedWatch
  · MedWatch Voluntary Reporting Form (form 3500)
  · MedWatch Mandatory Reporting Form (form 3500A)  

4) Ethical Principles of Human Subjects Protection

•  The Belmont Report 
• Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The Belmont Report) is the foundation on which the U. S. system of human subjects protection is based.
• The Belmont Report Historical Archive includes a short video, oral history transcripts and a brief history of the Belmont Report.
• IRB Guidebook  
  Provides help for IRB members and researchers in understanding the regulations and standards that govern research with human subjects and outlines issues to consider in designing and reviewing research proposals.
• The Nuremberg Code
  A 10 point code of human experimentation ethics developed during the military war crimes trial.
• Declaration of Helsinki  
  The World Medical Association's ethical principles for medical research involving human subjects.
• ICH Consolidated Guidance
  Web site for International Conference on Harmonization (ICH) guidance for ethical and quality standards for research involving humans (also see FDA link for E6 Good Clinical Practice below)

5) Certificates of Confidentiality

• About Certificates of Confidentiality
  Certificates of Confidentiality protect identifiable research information from forced disclosure, such as for civil or criminal proceedings.
• Clinical Research and the HIPAA Privacy Rule 
• HIPAA Information
• Agency Contacts to Apply for Certificates of Confidentiality 
  The agency to contact for a certificate of confidentiality depends on the type of research. See this resource for contacts.
• NIH Certificate of Confidentiality Kiosk 
  This page includes detailed information about certificates, a slide presentation that provides background information and explains eligibility for certificates and NIH contacts to apply for certification.

FDA Studies - If a Certificate of Confidentiality is needed for a study involving investigational new drugs (IND), follow the FDA's Certificates of Confidentiality Application Instructions. If a study is also NIH funded, applications for both agencies may be required. Coordinate with the FDA first.