Policies and Guidance

**NOTE: The DHHS Office of Human Research Protections (OHRP) has recently re-designed its website.  We are aware that many links are being updated and, as a result, links to OHRP webpages within our documents may be broken.  To link to specific OHRP webpages, please go to the main OHRP page - http://www.hhs.gov/ohrp/ - and use the menu to navigate to OHRP resources cited in VCU IRB materials or use key words with the search function.

POLICIES:

• VCU IRB Written Policies and Procedures (WPPs) – text searchable policies and procedures for the IRB, investigators, and research personnel.
• Federalwide Assurance (FWA) (expires 10-18-2016)and  Terms of the Federalwide Assurance
• VCU Research Compliance Matrix - designed to facilitate the responsible conduct of research by providing investigators with a single point of access for policy information, education & training programs, forms & submission processes, and more.

GUIDANCE (by topic)

Collaborations with other institutions

• Involvement of Non-VCU Institutions in VCU Human Subjects Research(pertains to non-exempt, federally supported research) (v. 3-29-07) 

Community-based Research

• Community-based participatory research (CBPR) and the IRB 
  Materials for a 6 part audioseminar on CBPR and research ethics. 
• Looking at Community-Based Participatory Research (CBPR) Through the Lens of the IRB (v. 10-30-08)
• Ethics and Research in the Community
  A training tutorial for lay individuals who do research in the community, funded by the Office of Research Integrity. Training topics include: "The Research Protocol", "Recruiting Participants", "Confidentiality", "Professionalism", and "Applications."

Conflict of Interests

Data -Collection, Retention

• RedCap survey and database tool
  Web-based tool for research comprised of two components; database and survey
  
• Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues - released by the Office for Human Research Protections

Determining What Is Human Research

• How do I determine if my project is 'human subjects research? (v. 3-29-07) 

Ethical Principles

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

Exempt Review (Qualifying for)

• OHRP Decision Charts #2-7
• WPP II-2; WPP VIII-1

Expedited Review (Qualifying for)

• OHRP Guidance and OHRP Decision Chart #8
• WPP VIII-2

Genetic Research

• WPP XVII-5
• Genetic Information Nondiscrimination Act (GINA)
• Genome-Wide Association Studies (GWAS)
• GWAS Points to Consider for IRBs and Institutions
• GWAS: What does the IRB need to do?

Good Clinical Practice (and related ICH guidelines)

• ICH E6: Good Clinical Practice Guidelines 
• ICH E10: Choice of Control Group and Related Issues in Clinical Trials 

HIPAA

• HIPAA Guidance
• Information; WPP XII-3; HIPAA and Research     
• Navigating HIPAA Regulations
• HIPAA for Research and the IRB: A New Partnership for Privacy Protections

Informed Consent (and Waiver of I.C. / Documentation of I.C.)

• Informed Consent Tips (OHRP web site)
• Informed Consent Checklist (OHRP web site)
• Informed Consent Evaluation Instrument 
• Waiver of Consent & Waiver of Documentation (v. 3-29-07) 
• WPP XI-1; WPP XI-2; WPP XI-3

Internet-based Research

• Using the Internet to Conduct Research: What Investigators and IRB Members Should Know (v. 1-29-09) 

Payment to Research Subjects

• VCU guidance on research participant payment
• VCU guidelines on gift and bank card payment for research subject compensation
• WPP XVII-2 Subject Recruitment and Compensation

Post-Approval Monitoring

• Post approval monitoring and education (PAME) Process
• Post-Approval Monitoring & Education Study Evaluation Tool (PAME SET) for Biomedical Research
• Post-Approval Monitoring & Education Study Evaluation Tool (PAME SET) for Social-Behavioral Research
• WPP X-3

Privacy and Confidentiality

• Protecting Privacy and Maintaining Confidentiality of Data Collected for Research Purposes: IRB Perspectives (v. 12-7-07) 
• Privacy and Confidentiality: IRB Considerations and PI Requirements (v. 5-31-07) 

Protocol Examples (for IRB Applications)

•  Example of exempt study using students enrolled in a class as subjects. 
• In addition to the “mock” exempt study listed above, several VCU investigators have graciously agreed to share their IRB protocol (i.e., research synopsis) and related documents as examples for others to review as they prepare their submissions.  These are confidential documents to be used by VCU personnel as examples only. Click here to access more examples of IRB Protocols (requires VCU eID and password)

Regulations and Laws

• DHHS 45 CFR Part 46 (includes Subparts A, B, C, and D)
• FDA Regulations:  21 CFR Parts: 50 - Human Subjects; 54 - Financial Disclosure; 56 - IRB; 312 - IND; 812 - IDE
• Searchable Code of Virginia:  § 32.1-162.16 (Def.); § 32.1-162.18 (Inf. Consent)

Research in the VCU Health System

• Conduct of Clinical Research In VCU Health System Patient Care Areas

Reviewer Toolkit (for IRB Members)

• Reviewer Guide
• Review Sheets (Required)

  Review Type	Special Populations
  Exempt Review Sheet	Children
  Expedited Review Sheet	Pregnant Women, Fetuses and Neonates
  Full Board Review Sheet	Prisoners
  IRB Pre-Review Screening Form
  IRB Pre-Review Determination Form

School-based research

• Planning to Conduct Research in the Schools: Working with the Schools and the VCU IRB  
  Powerpoint presentation developed in collaboration with the VCU School of Education faculty, Richmond-area school divisions, and the IRB.

Vulnerable Research Participants

• Protecting Vulnerable Research Participants (v. 3-29-07) 

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