Yale University Research-Related Policies

• Yale University Institutional Review Boards Operations Manual

HIC Policies:

• Accessing Pathology and YNHH Tumor Registry Data

• Adverse Event Reporting to the Human Investigation Committee

• Banking of Data and Biologics for Future Use

• Certificate of Confidentiality

• Data and Safety Monitoring Plan (DSMP)

• Delegation
• of Authority

• Development, Review, and Approval of HIC Policies and Standard Operating Procedures

• Genetic and Related Testing

• HIC Operations / Billing

• Informed Consent for Human Research New
  • Competent Adult Participation
  • Deception in Research
  • Non-English Speaking Participants
• International Research
• Noncompliance New
  • Reporting Noncompliance
  • Complaints
  • Review of Noncompliance
  • Suspension and Termination
  • Noncompliance Checklist
  • Noncompliance Decision Tree
• Participation of Children in Research revised!
  • Procedure for Consent
  • Submission of Protocols for Research Involving Children
  • Research Conducted in Schools
• Participation of Individuals with Impaired Consent New
  • Assessment of Capacity to Consent

• Participation of Pregnant Women and Fetuses in Research

• Participation of Prisoners in Research New
  • Prisoner Research Guidance
  • When a Research Participant Becomes a Prisoner
  • Certification of Prisoner Research

• Participation of Students and Employees in Research revised!

• Permission to Serve as Principal Investigator

• Planned Emergency Research

• Protocol-Related Conflict of Interest (COI)

• Protocol Deviation

• Recruitment of Subjects (revised 1/17/09)

  • Advertising Procedures

  • Guidance on Posting Recruitment Notices

  • Procedures: Recruitment Timeframes and Settings

  • Procedures: Who May Contact Participants

  • Guidance on Phone Screening for Recruitment into Human Research Projects

• Review of Uses of Radiation Connected with Research Protocols

• Unanticipated Problems Involving Risks to Subjects or Others
• Use of CIRB
• Use of WIRB
• Use of Excess Clinical Samples for Research