• Policies
• Investigator Forms
• IRB Schedule
• Training
• IRBManager
• For IRB Members
• Research at External Sites
• Student Research
• VA Research
• K-12 School-Based Research
• Quality Improvement
• Links
• Resources
• FAQ
• Reviewer Checklists

Human Research Protection Program Policy Manual, March 2012

To find the information you are seeking, scroll down the list of policies, procedures, guidance and reviewer checklists; or search our website. To search, enter key words in the box provided and select the blue OHRP SEARCH button at the top, right-hand side of the page.

If you don't find the information you need, let us know so we can improve the search function or create a policy! We'll also answer your question. You may reach us by calling 775.327.2368 or sending an email to gwenns@unr.edu.

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 I1B Institutional Support and Management of the Human Research Protection Program

Policy I1C Authority and Independence of the Institutional Review Boards

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 GD3 Investigator Responsibilities

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 I2 Institutional Support and Resources for the Human Research Protection Program

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

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 orNeonates 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

II5 GD3 Record-Keeping Requirements for Investigators