HRPP Policies & Procedures

This section includes policies, procedures, guidance and checklists that aid members of the Yale human 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 of its research participants.

Persons conducting, supporting or reviewing research subjects for Yale IRB approval should familiarize themselves with these policies, procedures and guidance. This section should be referenced regularly as policies, procedures and guidelines are revised to stay current with evolving issues and regulations related to human research.

In this section:

HRPP General
100) IRB Review
200) Informed Consent
300) Vulnerable Populations
400) Special Issues
500) Financial Interests
600) IND/IDE/HUDs/Emergency Research
700) Post-Approval Issues
800) Education & Training
900) IRB Memberships, Agreements & Collaborations

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Human Research Protection

University Policy 1360: Human Research Protection

100’s) IRB Review

Policy 100: IRB Review of Research Protocols

• Procedure 100 PR1: Review by a Full Convened IRB
• Procedure 100 PR2: Expedited Review
• Procedure 100 PR3: Exemption Determinations
• Procedure 100 PR4: DoD Funded Research

Guidance:

100 GD1:	Humanities Projects and IRB Review
100 GD4:	Scientific and Ethical Review of Protocols by the IRB
100 GD5:	Clinical Quality Improvement Projects and IRB Review
100 GD6:	Review of IRB Protocols by Consultants
100 GD7:	Select State and Federal Laws and Regulations Applicable to Human Research
100 GD9:	Exemption from IRB Review
100 GD12:	Preparation and Maintenance of IRB Minutes

Checklists:

100 CH3:	HSC Protocol Approval Criteria
100 CH5:	HSC New Protocol Regulatory Review
100 CH7:	HIC Amendment Review
100 CH8:	HIC Clinical Research
100 CH9:	HIC Clinical Quality Improvement
100 CH10:	HSC Continuing Review, Regulatory
100 CH11:	HSC Expedited Review
100 CH12:	HSC Exemption
100 CH13:	HIC Committee Member Comments
100 CH14:	HIC Primary Reviewer Response Form (Reapproval)
100 CH15:	HIC Electronic Regulatory Review
100 CH16:	HIC Regulatory Review
100 CH17:	HIC Continuing Review 8A
100 CH18:	HIC Continuing Review 8B
100 CH19:	HIC Continuing Review 8C
100 CH20:	HIC Triage
100 CH21:	HIC Termination Review
100 CH22:	HIC Medical Records Review
100 CH23:	HIC Medical Record Renewal Review
100 CH24:	HIC Amendment Primary Reviewer

• Policy 110: Fees Charged for IRB Review of Industry-Sponsored Studies

200’s) Informed Consent in Research

• Policy 200: Informed Consent for Research Involving Human Participants
  • Procedure 200 PR1: Informed Consent for Research Involving Competent Adults

  Guidance:

  200 GD1:	Deception in Human Research
  200 GD2:	Inclusion of Non-English Speaking Participants in Human Research

  Checklists:

  200 CH1:	HIC Informed Consent
  200 CH2:	HSC Informed Consent
  200 CH3:	HSC Waivers of Consent and Authorization

300’s) Vulnerable Populations in Research

• Policy 310: Participation of Children in Research
  • Procedure 310 PR1: Informed Consent in Research Involving Children
  • Procedure 310 PR2: Submission of Protocols for Research Involving Children

  Guidance:

  310 GD1:

  K-12 School-Based Research

  Checklists:

  310 CH1:

  Childrens Findings

• Policy 320: Participation of Prisoners in Research
  • Procedure 320 PR1: Measures to be Taken when a Current Research Participant Becomes a Prisoner
  • Procedure 320 PR2: Institutional Certification of Prisoner Findings to OHRP

  Guidance:

  320 GD1:

  Prisoner Research

  Checklists:

  320 CH1:

  Prisoner Findings

• Policy 330: Participation of Pregnant Women, Women with Childbearing Potential, Fetuses and Neonates in Research
  • Procedure 330 PR1: Inclusion of Pregnant Women or Women of Childbearing Potential in Research

  Guidance:

  330 GD1:

  Reproductive Risks and Contraception

• Policy 340: Participation of Individuals with Impaired Consent Capacity in Research
  • Procedure 340 PR1: Assessment of Capacity to Consent

  Checklists:

  340 CH1:

  Studies Involving Participants with Permanently or Transiently Impaired Capacity or Who are Expected to Become Permanently or Transiently Impaired

• Policy 350: Participation of Yale Students and Employees in Research

  Checklists:

  350 CH1:

  Yale Student and Employee Participants

400’s) Special Issues in Research

• Policy 400: Confidentiality of Information
  • Procedure 400 PR1: Protecting Participants’ Research Data
  • Procedure 400 PR2: Certificate of Confidentiality
  • Procedure 400 PR3: Use of Genetic Tests and Investigational Genetic Tests in Human Research
• Policy 410: Recruitment of Research Participants
  • Procedure 410 PR1: Who May Contact Eligible Research Participants
  • Procedure 410 PR2: Recruitment Time Frames and Settings
  • Procedure 410 PR3: Advertisements, Notices and Scripts Used for Recruitment

  Guidance:

  410 GD1:	Posting Recruitment Notices
  410 GD2:	Phone Screening for Recruitment into Human Research Projects
  410 GD3:	Use of Email for Research Recruitment

• Policy 420: Data and Safety Monitoring
  • Guidance:

  • 420 GD1:

    Data and Safety Monitoring Plan

• Policy 440: Data and Biological Specimens in Human Research
  • Procedure 440 PR1: Development of Data Banks and Repositories for Research     
• Policy 445: Use of Stored Data and Biological Specimens in Human Research
• Policy 450: International Research

  Guidance:

  450 GD1:

  International Research: Required Documents and Additional Consideration

  Checklists:

  450 CH1:

  Yale Investigator International Research Checklist

500’s) Financial Interests in Research

• Policy 500: Disclosures and Management of Personal Interests in Human Research
  • Procedure 500 PR1: Procedures for Disclosing Financial and Non-Financial Interests Related to Research: IRB Members, Staff and Consultants
  • Procedure 500 PR2: Procedures for Disclosing Financial and Non-Financial Interests Related to Research: Research Team Members and Departmental Chairs
  • Procedure 500 PR3: IRB Review  of Financial and Non Financial Interests Related to Human Research Projects

  Checklists:

  500 CH1:

  Determining Financial and Non-Financial Interests Related to Human Research

600’s) IND/IDE/HUD/Emergency Research

• Policy 600: Use of Investigational New Drugs (INDs) and Devices (IDEs) in Human Research
  • Procedure 600 PR1: Emergency Use of an Investigational New Drug or Device
  • Procedure 600 PR2: Compassionate Use of an Investigational or Unapproved Device

  Guidance:

  600 GD1:

  Data and Document Management Responsibilities for the IND Sponsor Investigator

• Policy 610: Use of Humanitarian Use Devices in Human Research
• Policy 620: Planned Emergency Research

700’s) Post-Approval Issues

• Policy 700: Noncompliance
  • Procedure 700 PR1: Reporting Noncompliance
  • Procedure 700 PR2: Soliciting and Responding to Research Participant Feedback and Concerns
  • Procedure 700 PR3: IRB Review and Investigation of Reports of Noncompliance
  • Procedure 700 PR4: Suspension and Termination of Research

  Guidance:

  700 GD1:	Noncompliance Decision Tree
  700 GD2:	Interdepartmental Collaboration on Research Subject Complaints

  Checklists:

  700 CH1:

  Noncompliance

• Policy 710: Reporting Adverse Events and Unanticipated Problems
  • Procedure 710 PR1: Reporting Adverse Events to the IRB
  • Procedure 710 PR2: Reporting Unanticipated Problems Involving Risks to Subjects or Others to the IRB
  • Procedure 710 PR3: IRB Review of Reports of Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others
• Policy 720: Findings with Possible Health and Safety Significance for Research Participants

  Guidance:

  720 GD1:	Sharing Study Findings with Participants
  720 GD2:	Incidental Findings of Depression and Suicidality in Human Research

• Policy 730: Human Research Record Retention and Transfer

800’s) Education & Training

• Policy 800: Human Research Protection Orientation, Training and Education
  • Procedure 800 PR1: Human Research Training, Orientation and Education

900’s) IRB Memberships, Agreements & Collaborations

• Policy 900: Recruitment, Appointment, Terms and Evaluation of IRB Members and Chairs
  • Procedure 900 PR1: Recruitment, Appointment, Terms and Evaluation of IRB Members, Consultants and Chairs
  • Procedure 900 PR2: Updating IRB Rosters
• Policy 910: Collaborating Investigators Assisting in the Conduct of Research
  • Procedure 910 PR1: Collaborating Investigator Requests

Guidance:

910 GD1:

Collaborating Investigator Instructions

• Policy 920: Research Partnerships with Individuals and Institutions External to Yale

  • Procedure 920 PR1: Research Affiliate Requests
  • Procedure 920 PR2: Authorization Agreements with Other IRBs
  • Procedure 920 PR3: Renewal of IRB Authorization Agreements
  • Procedure 920 PR4: Use of Western IRB for Review and Oversight of Research Involving Yale Investigators (Under Revision)
  • Procedure 920 PR5: Use of the National Cancer Institute Central IRB (CIRB) for Review and Oversight of Research Involving Yale Investigators
  • Procedure 920 PR6: Use of NICHD IRB for Review and Oversight of Research Involving Yale Investigators 

• Policy 930: Development, Review and Approval of Human Research Protection Policies and Procedures
  • Procedure 930 PR1: Development, Approval and Maintenance of Human
    Research Protection Program and Institutional Review Board Policies
    and Procedures
• Policy 940: Radiation Safety Committee Reviews Required of Research Protocols Using Radiation