Policies & Procedures

The University of Nebraska-Lincoln’s (UNL) Human Research Protection Program (HRPP) and the projects that are approved through the IRB must follow, Federal regulations, state regulations, institutional policies. The following list includes the most up-to-date HRPP policies and procedures.

If you do not find the information you are looking for, please reference our Guidance Topics (A-Z) page.

Comprehensive Policy Document (PDF)

Abbreviation List

Organizational Commitment to the HRPP

Notice

The implementation of the 2018 Requirements has been delayed until January 21, 2019. The 2018 Requirements Policies are not currently available for use. We will make these available once it is closer to the January 21st deadline.

WDN.initializePlugin(‘notice’);

2018 Requirements

1.001     The Institution and its Commitment to the HRPP

1.002    Federal Wide Assurance

1.003     Vision, Mission and Values Statement of UNL

1.004     Vision, Mission and Values Statement for the HRPP

1.005     IRB Charter, Appointments and Administrative Structure               

1.006     Authority Granted by UNL to the IRB Operating in HRPP

IRB Membership & Standard Operating Procedures

2018 Requirements

2.001     IRB Membership Requirements and Responsibilities

2.002     IRB Meetings and IRB Member Responsibilities

2.003     IRB Consultants

2.004     Orientation and Initial Training for New IRB Members and HRPP Staff

2.005     IRB Member Conflict of Interest Management

2.006     Continuing Education Requirements for IRB Members and HRPP Staff

2.007     Evaluation of IRB Members

2.008     IRB Member Confidentiality

2.009     Full Board IRB Reviewer Assignment

2.010     Written Reviews by IRB Members and Development of the IRB Review Letter

2.011     IRB Quorum and Voting Requirements

2.012     IRB Minutes

2.013     HRPP Policy Review and Approval

2.014     IRB Records

2.015     Ongoing Research Transition to 2018 Requirements

Initial IRB Review of Protocols

2018 Requirements

3.001     Investigational Activities Requiring IRB Review and Approval

3.002     Ethical Principles Governing Research Under the Jurisdiction of the IRB

3.003     Initial Application Submission

3.004     Criteria for IRB Approval of Research

3.005     IRB Initial Review Categories

3.006     Scientific and Scholarly Merit Review of Proposals

3.007     Conflict of Interest Review by the IRB and Office of Sponsored Programs

3.008     Qualification and Responsibilities of Research Personnel

3.009     Required Training in the Protection of Human Participants

3.010     Assessing the Need for Interim Continuing Review, Monitoring and Verification for Sources Other than the Investigator

3.011     Certificate of Confidentiality

3.012     IRB Approval of Multi-Site or Cooperative Research

3.013     Research Records Retention and Security

3.014     PI Disagreements with IRB Decisions

3.015     Compensations and Incentives for Research Participants

3.016     Recruitment of Participants Through Advertisements

3.017     Individual Investigator Agreements

3.018     Human Participant Research Involving Ionizing Radiation

Exempt & Expedited review

2018 Requirements

4.001     Exempt Research

4.002     Expedited Research

4.003     Limited Review

Vulnerable Populations and Special Classes of Participants

2018 Requirements

5.001     Additional Protections for Vulnerable Populations

5.002     Research Involving Pregnant Women, Human Fetuses and Neonates

5.003     Research Involving Prisoners

5.004     Research Involving Children

5.005     Research Involving Decisionally Impaired Participants

5.006    Research Involving Extra Credit Compensation

Funding Agencies

2018 Requirements

Reserved

Random Compliance Review

Pre-2018 Requirements

7.001: Random Compliance Reviews

2018 Requirements

7.001     Random Compliance Reviews

General Requirements and Guidelines

2018 Requirements

8.001     Students as Researchers

8.002     Epidemiological Research Guidelines

8.003     Exercise Protocol Guidelines

8.004     Research Conducted in Foreign Countries

8.005     Community-Based Participatory Research

8.006     Enhancing Understanding of Participants, Prospective Participants, and the Community

8.007     Incidental Findings

8.008     Pregnancy Testing of Females of Childbearing Potential

8.009     Use of Deception in Research

8.010     Banking Human Biological Material for Future Research

8.011     Use of Human Biological Material in Research

8.012     Participant Registries and Data

8.013     Registering Clinical Trials (Clinical Trials.gov)

 

Informed Consent

2018 Requirements

9.001     Required Elements for Informed Consent Documents

9.002     Development of the Informed Consent Document

9.003     Telephone Consent

9.004     Re-consent/Assent Research Participants

9.005     Absence of Valid Consent: Re-Consent and Use of Data

9.006     Waiver or Alteration of Consent

9.007    Use of Short Form Consent Document

Protected Health Information & Research

2018 Requirements

10.001   Use of Protected Health Information in Research and Registries

Continuing Review

2018 Requirements

11.001   Continuing Reviews

11.002   IRB Disapproval, Study Hold, Suspension, and Termination

Amendments to Approved Protocols

Pre-2018 Requirements

12.001: Request for Change

2018 Requirements

12.001   Request for Change

Reportable New Information

2018 Requirements

13.001   Reportable New Information (Protocol Deviations, Violations, Unanticipated Problems Involving Risk and Adverse Events)

13.002   Study Related Complaints

Compliance

2018 Requirements

14.001   Noncompliance

14.002   Reporting Incidents to OHRP or Department and Agency Heads

14.003   Audits by Outside Agencies

Funding Requirements

2018 Requirements

15.001   Human Research Compliance with Department of Education Regulations

15.002   Human Research Compliance with Environmental Protection Agency Regulations

15.003   Human Research Compliance with Department of Justice Regulations

15.004   Human Research Compliance with Department of Defense Regulations

15.005   Human Research Compliance with Department of Energy Regulations

15.006   Sponsored Research

15.007 Certification of Review to Funding Agencies

Institutional Conflict of Interest

2018 Requirements

16.001   Institutional Conflict of Interest Management

16.002   Institutional Conflict of Interest