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Policies, Procedures, Guidance, and Checklists
This section includes policies, procedures, guidance documents, and checklists that aid members of the Yale human subject research community in fulfilling their obligations to ensure that research is designed, conducted, and approved consistently and in compliance with applicable laws, regulations and Yale’s commitment to the protection or its research participants.
Persons conducting, supporting, or reviewing human subject research that is subject to Yale IRB approval should familiarize themselves with these documents. This section should be referenced regularly as policies, procedures, and guidelines are revised to stay current with evolving issues and regulations related to human subject research.
To the Members of the Research Community
On December 16, 2016, the Yale University IRBs fully converted to a new online protocol submission system called IRES IRB. Current IRB policies, procedures and guidance documents do not reference the change to IRES IRB. References to Coeus and email submission procedures are therefore outdated. Please be advised that the HRPP leadership will update affected IRB policies, procedures and guidance documents to reflect the change to the new electronic system.
Please contact the HRPP at firstname.lastname@example.org if you have questions or require a specific statement regarding this issue.
HRPP Policy Changes (last updated - 1/9/17)
PLEASE CLICK ON THE APPLICABLE POLICY BELOW TO REVIEW THE POLICY ITSELF AND TO SEE THE RELATED PROCEDURES, GUIDELINES AND CHECKLISTS.
- 100 PR.1 - Review by a Convened Institutional Review Board (IRB)
- 100 PR.2 - Expedited Review
- 100 PR.3 - Exemption Determinations
- 100 PR.4 - Department of Defense Supported Research
- 100 PR.6 - Environmental Protection Agency (EPA) Research
- 100 GD.1 - Humanities Projects and IRB Review
- 100 GD.2 - IRB Approval and Expiration Dates
- 100 GD.4 - Scientific and Ethical Review of Protocols by the IRB
- 100 GD.5 - Quality Improvement and Quality Assurance Projects and IRB Review
- 100 GD.6 - Review of Institutional Review Board (IRB) Protocols by Consultants
- 100 GD.7 - Select State and Federal Laws and Regulations Applicable to Human Research
- 100 GD.9 - Guidance on Exemption from IRB Review
- 100 GD.12 - Preparation and Maintenance of Institutional Review Board (IRB) Minutes
- 200 PR.1 - Informed Consent for Research Participation: Competent Adult Participants
- 200 PR.2 - Exception From Informed Consent (EFIC) Research
- 200 GD.1 - Deception in Human Research
- 200 GD.2 - Guidance on Inclusion of Non-English Speaking Participants in Human Research
- 200 GD.3 - Re-Consent and/or Notification of Significant New Findings That Develop During the Course of Research
- 320 PR.1 - Measures to be Taken When a Current Research Participant Becomes a Prisoner
- 320 PR.2 Institution Certification of Prisoner Findings to OHRP
- 410 PR.1 - Who May Contact Prospective Research Participants
- 410 PR.2 - Recruitment Time Frames and Settings
- 410 PR.3 - Advertisements, Notices and Scripts Used for Recruitment
- 500 PR.1 - Procedures for Disclosing Financial and Non Financial Interests Related to Research
- 500 PR.2 - Procedure for Review of Disclosures of Financial and Non - Financial Interests Related to Human Research Projects
- 600 PR.1 - Emergency Use of an Investigational New Drug (IND) or Investigational Device Exemption (IDE)
- 600 PR.2 - Compassionate Use of an Investigational or Unapproved Device
- 700 PR.1 - Reporting Noncompliance and Protocol Deviations to the IRB
- 700 PR.2 - Soliciting and Responding to Research Participant Feedback and Concerns
- 700 PR.3 - IRB Review and Investigation of Reports of Noncompliance
- 700 PR.4 - Suspension and Termination of Human Research Studies
- 700 PR.5 - Expiring or Expired Yale Institutional Review Board (IRB) Approval
- 700 PR.6 - Procedure for Single Subject Protocol Modification/Deviation
- 700 GD.1 - Determining When a Protocol Deviation or an Incident of Possible Noncompliance Must be Reported
- 700 GD.2 - Interdepartmental Collaboration on Research Subject Complaints
- 920) HRPP Policy 920 Research Partnerships with Institutions and Other Organizations External to Yale
- 920 PR.2 - Authorization Agreements with Institutions Having Their Own Institutional Review Board
- 920 PR.3 - Renewal of IRB Authorization Agreements (IAAs)
- 920 PR.4 - Use of External IRBs for Review and Oversight of Research Involving Human Subjects
- 920 PR.5 - Use of National Cancer Institute Central IRB (CIRB) for Review and Oversight of Research Involving Yale Investigators