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 of all 2018 Policies and Procedures)
Organizational Commitment to the HRPP
Pre-2018 Requirements
1.001: The Institution and its Commitment to the HRPP
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
Pre-2018 Requirements
2.001: IRB Membership Requirements and Responsibilities
2.002: IRB Meetings and IRB Member Responsibilities
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
2.013: HRPP Policy Review and Approval
2018 Requirements
2.001: IRB Membership Requirements and Responsibilities
2.002: IRB Meetings and IRB Member Responsibilities
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
2.013: HRPP Policy Review and Approval
2.015: Ongoing Research Transition to 2018 Requirements
Initial IRB Review of Protocols
Pre-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 RB and Office of Sponsored Programs
3.008: Qualification and Responsibilities of Research Personnel
3.009: Required Training in the Protection of Human Participants
3.011: 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: Research Participant Payment and Incentives
3.016: Recruitment of Participants Through Advertisements
3.017: Individual Investigator Agreements
3.018: Human Participant Research Involving Ionizing Radiation
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
3.011: 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: Research Participant Payment and Incentives
3.016: Recruitment of Participants Through Advertisements
3.017: Individual Investigator Agreements
3.018: Human Participant Research Involving Ionizing Radiation
Exempt & Expedited review
Vulnerable Populations and Special Classes of Participants
Pre-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
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
Random Compliance Review
General Requirements and Guidelines
Pre-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
8.008: 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 Repositories
8.013: Registering Clinical Trials (Clinical Trials.gov)
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
8.008: 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 Repositories
8.013: Registering Clinical Trials (ClinicalTrials.gov)
Informed Consent
Pre-2018 Requirements
9.001: Elements for Informed Consent Documents
9.002: Development of the Informed Consent Document
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
2018 Requirements
9.001: Required Elements for Informed Consent Documents
9.002: Development of the Informed Consent Document
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 and Consent Documentation
9.007: Use of the Short Form Consent Document
Protected Health Information & Research
Continuing Review
Amendments to Approved Protocols
Reportable New Information
Compliance
Funding Requirements
Pre-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
2018 Requirements
15.001: Human Research Compliance with Department of Education Regulations
15.002: Human Research Compliance with Environmental Protection Agency Regulations
15.003 Reserved: The Department of Justice (DOJ) is not a signatory of the Revised Common Rule. Please see the Pre-2018 policy #15.003 for HRPP Requirements.
15.004: Human Research Compliance with Department of Defense Regulations
15.005: Human Research Compliance with Department of Energy Regulations
