Vulnerable Populations
Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research (pdf) - To help investigators to understand and comply with the NIH's inclusion policies
- IRB requirements for research with children,
- Inclusion/Exclusion of Children
- Ethical Principles & Concerns
- Making Exclusion Decisions
- Appropriate Consent Form Language
Data & Privacy
- Learn how to perform HIPAA compliant research
- What to do for existing studies?
- How to keep Research Data Protected and Secure
- Guidance on Coded Data⁄Human Specimens
- IRB Recommendations for Storage
- Suggestions for Informed Consent and Consent Forms
- Data Safety Monitoring requirements of the IRB
- Data Safety Monitoring Boards and Plans
- Protect identifiable research information from forced disclosure
- NIH Statement on Certificates of Confidentiality
- NIH Guidelines on the use of Certificates of Confidentiality
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- Federal Regulations
- Federal Guidelines
- Board of Regents Policies and Procedures
- Getting Started
- Points of Emphasis
- Responsibilities
Other Topics
- Advice for Advisors
- Tips from Students
- Resources Specific to Social Research
- Common Errors
- Useful Definitions
- Resources Specific to Social Research
- IRB Review of International Research
- BioEthics around the World
- How to request approval for a Class Protocol
- Guidelines for Class Protocols
- Suggestions for Avoiding Coercion of Students
- Suggestions for Using Employees as Research Subjects
Granted in "Emergency Use" cases for drugs or devices, typically life-threatening, situations.
Outlines Specific Documents Which Demonstrate Compliance For Sponsors and Regulatory Agencies
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