Polices & Procedures

The University of Nebraska-Lincoln’s (UNL) Human Research Protection Program (HRPP) and the projects that are approved through the IRB must follow, a set of policies and procedures that are developed and maintained through 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 in a particular policy, please reference the guidance page.

Comprehensive Policy Document (PDF)

Abbreviation List

Organizational Commitment to the HRPP

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 the HRPP

IRB Membership & Standard Operating Procedures

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

Initial IRB Review of Protocols

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 RB 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: External IRB Approval of 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

Exempt & Expedited review

4.001: Exempt Research

4.002: Expedited Research

Vulnerable Populations and Special Classes of Participants

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

6.001: Certification of Review to Funding Agencies

Random Compliance Review

7.001: Random Compliance Reviews

General Requirements and Guidelines

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

Education and Outreach

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

Informed Consent

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

Protected Health Information & Research

10.001: Definition and Description of Protected Health Information Identifiers

10.002: Limited Data Set

10.003: Research Utilizing Medical Records

10.004: Review of Protected Health Information in Preparation for Research

Continuing Review

11.001: Continuing Reviews

Continuing Review and Suspension and Termination

11.002: Suspension and Termination

Amendments to Approved Protocols

12.001: Request for Change

Unanticipated Problems & Adverse Events

13.001: Unanticipated Problems Involving Risk and Adverse Events

Compliance

14.001: Noncompliance

14.002: Reporting Incidents to OHRP or Department and Agency Heads

14.003: Audits by Outside Agencies

Specific Agency/Sponsored Research

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

Institutional Conflict of Interest

16.001: Institutional Conflict of Interest Management

16.002: Institutional Conflict of Interest