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Human Research Protection Policy Manual

Below is the complete Human Research Protection Policy Manual.

Contact us with any questions at (775) 327-2368 or gwenns@unr.edu.

Oversight of Human Research Protection

• 1. Institutional Authority for Human Research Protection
• 2. Designation of IRBs
• 3. Authority of IRBs
• 5. Independence of IRBs
• 6. Attempts to Limit IRB Independence
• 20. Institutional Support for the RIO and IRB
• 22. Roles and Responsibilities: Office of the Vice President for Research and Innovation
• 23. Roles and Responsibilities: Offices of General Counsels for UNR and for UNSOM
• 25. Roles and Responsibilities: Departmental Research Administrators
• 26. Roles and Responsibilities: RIO Director and Staff
• 30. Roles and Responsibilities: Institutional Review Boards
• 31. Roles and Responsibilities: IRB Members
• 32. Roles and Responsibilities: IRB Chairs and Vice Chairs
• 35. Requirements for University of Nevada, Reno Principal Investigators
• 36. Roles and Responsibilities: Investigators
• 37. Roles and Responsibilities: Student Investigators
• 40. Roles and Responsibilities: Office of Sponsored Projects
• 41. Roles and Responsibilities: Environmental Health and Safety
• 42. Institutional Animal Care and Use Committee
• 43. University Committee on Conflict of Interest and Conflict of Commitment
• 45. Roles and Responsibilities: Other Institutional Components

The above policies replace the following:

• Policy I1B Institutional Support and Management of the Human Research Protection Program
• Policy I1C Authority and Independence of the Institutional Review Boards
• Policy I2 Institutional Support and Resources for the Human Research Protection Program
• I1D GD3 Investigator Responsibilities
• II5 GD3 Record-Keeping Requirements for Investigations

Policy I1A Human Research Protection Program Oversight Responsibilities

Procedure

• I1A PR1 Determining When Projects Require Oversight or IRB Approval

Guidance

• I1A GD1 Activities that May or May Not Require Research or IRB Oversight
• I1A GD2 Overview: Humanities Projects and Human Research Protection Requirements

Policy I1D Ethical Standards and Regulations and Responsibilities for Application

Guidance

• I1D1 GD1 Additional Federal Regulations and Guidance Applicable to Human Subjects Research
• I1D GD2 Applicable Nevada State Laws
• I1D GD4 Department of Defense Research: Additional Regulatory Requirements
• I1D GD5 Department of Education Research: Additional Regulatory Requirements
• l1D GD6 Environmental Protection Agency: Additional Regulatory Requirements

Reviewer Checklists

• I1D CH4 Review of Research Involving the Department of Defense
• I1D CH5 Review of Research Involving the Department of Education
• l1D CH6 Review of Research Involving the Environmental Protection Agency

Policy I1E Human Research Protection Training and Education

Procedure

• I1E PR1 Human Research Protection Basic Training Requirements

Policy I1F Assessment of the Scientific or Scholarly Validity of Proposed Research

Guidance

• I1F GD1 Scientific and Ethical IRB Review

Policy I3 Conducting Human Subjects Research Outside the United States and US Territories

Guidance

• I3 GD1 Additional Requirements for International Research

Policy I4 Reporting Venues and Outreach, and Community Involvement in Research

Policy I5D Noncompliance

Procedures

• I5D PR1 Reporting Noncompliance to the IRB
• I5D PR2 IRB Review and Investigation of Reports of Noncompliance

Policy I6 Disclosures and Management of Personal and Institutional Interests in Human Subjects Research

Procedures

• I6 PR1 Procedures for Disclosing Financial and Non‐financial Interests Related to Research: IRB Members, Staff and Consultants
• I6 PR2 Disclosing Financial and Non-Financial Interests Related to Specific Human Research Projects: Research Team Members and Departmental Chairs
• I6 PR3 IRB Review of Financial and Non-Financial Interests Related to Human Research Projects

Guidance

• I6 GD1 Factors for Assessing Financial and Non-financial Interests and Relationships Among IRB Members

Policy I7 Investigational Drugs and Devices: Research, Treatment and Emergency Use

Procedures

• I7 PR1 Emergency Use of an Investigational Drug or Device
• I7 PR2 Compassionate Use of an Investigational or Unapproved Device

Reviewer Checklist

• I7 CH1 Review of Research Involving Investigational Drugs or Devices

Policy I7-HUD Use of Humanitarian Use Devices in Humans

Policy II1 Recruitment, Appointment, Terms and Evaluation of IRB Members and Chairs

Procedures

• II1 PR1 Reviewer Expertise for Evaluating Scientific Validity and Scholarly Merit
• II1 PR2 Updating IRB Rosters

Guidance

• II1 GD1 Review of IRB Protocols by Consultants

Policy II2 IRB Review of Research Protocols

Procedures

• II2 PR1 Convened IRB Review and Record Keeping
• II2 PR2 Expedited Review Procedures and Record Keeping
• II2 PR3 Exemption Determinations
• II2 PR4 Sponsored Research with Indefinite Plans for the Involvement of Human Subjects
• II2 PR5 Study Completion

Guidance

• II2 GD1 Overview: IRB Reviewer Checklists
• II2 GD2 Criteria for Review by Expedited Procedures

Reviewer Checklists

• II2 CH1 Review of Exempt Research
• II2 CH2 Review of New Protocol
• II2 CH3 Review of Expedited Categories, New Protocol
• II2 CH4 Review of Renewals and Amendments
• II2 CH5 Review of Renewal, Expedited Category 8(a)
• II2 CH6 Review of Renewal, Expedited Category 8(b)
• II2 CH7 Review of Renewal, Expedited Category 8(c)

Policy II2F Adverse Events and Unanticipated Problems

Procedures

• II2F PR1 Reporting Adverse Events to the IRB
• II2F PR2 Reporting Unanticipated Problems Involving Risks to Subjects or Others to the IRB
• II2F PR3 IRB Review and Reporting Requirements: Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others
• II2F PR4 Suspension and Termination of Human Research

Policy II2H Research Partnerships with External Investigators and Institutions

Procedure

• II2H PR1 Authorization Agreements with Other IRBs

Guidance

• II2H GD1 Reviews by External IRBs

Policy II3B Data and Safety Monitoring

Procedure

• II3B PR1 Sharing Study Findings with Participants

Guidance

• II3B GD1 Data and Safety Monitoring Plan
• II3B GD2 Depression and Suicidality in Human Research

Policy II3C Recruitment of Research Participants

Procedures

• II3C PR1 Who May Contact Eligible Participants
• II3C PR2 Recruitment Time Frames and Settings
• II3C PR3 Advertisements, Notices and Scripts Used for Recruitment

Guidance

• II3C GD1 Phone Screening for Recruitment into Human Research Projects
• II3C GD2 Use of E-mail for Human Research Recruitment

Policy II3D Privacy in Human Subjects Research

Procedure

• II3D PR1 Authorization for Research Uses and Disclosures of Protected Health Information

Guidance

• II3D GD1 Release of Student Directory Information to External Researchers

Policy II3E Data Confidentiality and Human Subjects Research

Procedures

• II3E PR1 Certificate of Confidentiality
• II3E PR2 Data Repositories and Banks: Collection, Banking and Use of Data and Specimens

Guidance

• II3E GD1 Protecting Participants' Research Data

Policy II3F Informed Consent

Procedure

• II3F PR1 Informed Consent for Competent Adults to Participate in Research

Guidance

• II3F GD1 Inclusion of Non-English Speaking Participants in Research
• II3F GD2 Use of Short Form to Obtain Consent from Non-English Speaking Participants
• II3F GD3 Deception in Human Subjects Research
• II3F GD4 Information Sheet or Script: Items for Consideration

Reviewer Checklist

• II3F CH1 Review of Consent and HIPAA Authorization Waivers

Policy II4A Participation of Students and Employees in Research

Procedure

• II4A PR1 Students as Research Participants

Guidance

• II4A GD1 Extra Credit for Students Participating in Research

Policy II4A-B Participation of Pregnant Women, Women of Childbearing Potential, Fetuses or Neonates in Research

Procedure

• II4A-B PR1 Intended or Coincidental Inclusion of Pregnant Women in Research

Guidance

• II4B-B GD1 Reproductive Risks and Contraception

Reviewer Checklist

• II4A-B CH Review of Research Involving Pregnant Women, Human Fetuses and Neonates

Policy II4A-C Participation of Prisoners in Research

Procedure

• II4A-C PR1 Measures to be Taken When a Current Research Participant Becomes a Prisoner

Guidance

• II4A-C GD1 Additional Considerations for Prisoner Research

Reviewer Checklist

• II4A-C CH Review of Research Involving Prisoners

Policy II4A-D Participation of Children in Research

Procedure

• II4A-D PR1 Informed Consent in Research Involving Children
• II4A-D PR2 Submission of Protocols for Research Involving Children

Guidance

• II4A-D GD1 K-12 School-Based Research

Reviewer Checklist

• II4A-D CH Review of Research Involving Children

Policy II4A-E Participation of Individuals with Impaired Consent Capacity

Procedure

• II4A-E PR1 Assessing Capacity to Consent

Policy II4A-F Participation of Economically or Educationally Disadvantaged Persons in Research

Policy II4C Planned Emergency Research Which Necessitates a Waiver of Informed Consent

Policy II5 IRB Requirements for Record-keeping, and Biological Specimen Retention and Transfer

Procedure

• II5 PR1 Preparation and Maintenance of IRB Minutes

Guidance

• II5 GD1 Documentation of IRB Submission, Review and Approval
• II5 GD2 Document Management: IRB Protocols