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IRB Library

The IRB Library houses submission documents, guidance, and policies for the research community to access and download.

  • Forms - IRB application documents
  • Templates - sample documents for an IRB submission
  • Guidance - information on important topics such as FERPA and data security
  • Policies - standard operating procedures (SOPs) for the review of human subjects research
  • PAM - post approval monitoring, documents to assist researchers with ongoing monitoring of research
Document Category Document File Document Description Version Date
Policies PDF icon 101.7 Composition and Membership of the Institutional Review Board Defines policies and procedures for appointing IRB members and maintaining the membership roster 01/21/2019
Policies PDF icon 102.1 Performance Evaluation of IRB Chairs, Vice-Chairs, and Members Describes the process for evaluating IRB members as a part of the overall evaluation of the HRPP 05/03/2018
Policies PDF icon 103.7 IRB Meeting Conduct Defines the conduct for full board meetings of the IRB in accordance with federal regulations 01/21/2019
Policies PDF icon 104.5 IRB Meeting Minutes Procedures for completing the minutes of the convened meetings of the UNM IRB 03/01/2019
Policies PDF icon 105.4 IRB Records Management and Retention Policies and procedures for UNM IRB record keeping 03/01/2019
Policies PDF icon 106.1 SOP Preparation Issuance and Management Procedures for developing, reviewing, revising, and distributing SOPs for the IRB 03/01/2019
Policies PDF icon 107.3 HRPP Quality Assessment Program Post approval monitoring and quality assessment of HRPP 01/21/2019
Policies PDF icon 108.5 IRB Member and Staff Training Required training for IRB members and OIRB staff 01/21/2019
Policies PDF icon 109.4 Staff Processing of Submissions OIRB intake, pre-review, and administrative review functions 03/01/2019
Policies PDF icon 201.1 IRB Member and Consultant Conflict of Interest Identifying and managing conflicts of interest that could impact reviews 03/01/2019
Policies PDF icon 202.3 Ethical and Legal Standards and Practices for Human Subject Research Standards for the conduct of human research at UNM 03/01/2019
Policies PDF icon 203.3 Review of Scientific Validity and Merit Process for scientific validity review required before IRB review 03/01/2019
Policies PDF icon 204.1 IRB Use of Outside Expertise-Consultants Use of relevant experts to assist with review of protocols 03/01/2019
Policies PDF icon 205.1 Review Standards for Research Not Covered by FWA Process for IRB reviews using equivalent protections for protocols not covered by FWA 01/19/2018
Policies PDF icon 206.3 Ethical Obligations of IRB Members and Staff Ethical standards for the UNM IRB members and staff 03/01/2019
Policies PDF icon 207.5 IRB Reliance Process Deferral of HSR conducted by UNM researchers to external IRBs 05/24/2019
Policies PDF icon 208.1 Undue Influence of IRB and OIRB Staff Procedures for investigations of attempts to unduly influence IRB members or staff 03/01/2019
Policies PDF icon 209.1 UNM Policy on Engagement in Human Research Guidelines for determining whether UNM is engaged in research 03/25/2019
Policies PDF icon 301.4 Determination of Activities that Require IRB Review Procedures for determining whether activities qualify as human research or clinical investigations 01/21/2019
Policies PDF icon 302.7 Exempt Review of Federally Funded Research Process for exempt review for federally funded research 05/30/2019
Policies PDF icon 303.5 Initial Full Review Process for new project review by convened IRB 01/21/2019
Policies PDF icon 304.5 Expedited Review of Federally Funded Research Process for conducting expedited reviews of human research 03/01/2019
Policies PDF icon 305.6 Continuing Review Requirements for submitting and process for reviewing continuing reviews 01/21/2019
Policies PDF icon 306.7 Review of Changes to Approved Protocols-Amendments Process for review of changes (amendments) to previously approved protocols 02/06/2020
Policies PDF icon 307.1 Data and Safety Monitoring Plans IRB review of data and safety monitoring plans 03/01/2019
Policies PDF icon 308.0 Review of FDA Regulated Drugs and Devices When FDA regulations apply and review of FDA regulated research 01/30/2019
Policies PDF icon 401.3 Reporting and Review of Events Involving Risk to Participants or Others Procedures for prompt reporting of reportable events for IRB review 03/01/2019
Policies PDF icon 402.4 Research Noncompliance Process for IRB investigations of alleged noncompliance 03/01/2019
Policies PDF icon 403.3 Suspension or Termination of Approved Research Policies and procedures for suspending or terminating research approved by the IRB 05/30/2019
Policies PDF icon 404.5 Mandated Reporting to External Agencies Process for ensuring prompt reporting by the IRB to external agencies 02/12/2019
Policies PDF icon 405.1 Reporting of Protocol Deviations Requirements for reporting minor protocol deviations to the IRB 03/01/2019
Policies PDF icon 406.2 Directed Audits and Full Assessments Process for for cause and random audits 07/18/2018
Policies PDF icon 407.1 Participant Concerns_Complaints Procedures for handling concerns, complaints, or questions received about a project 03/01/2019
Policies PDF icon 408.7 Expiration of IRB Approval The consequences when a PI does not obtain final IRB approval prior to expiration date 02/23/2018
Policies PDF icon 409.0 Post Approval Monitoring Program Description of the Post Approval Monitoring (PAM) program and components 01/19/2018
Policies PDF icon 410.3 Project Closure Procedures for closing a project with the IRB 03/01/2019
Policies PDF icon 501.6 Informed Consent Requirements and expectations for obtaining and documenting informed consent/assent 08/13/2019
Policies PDF icon 502.4 Protection of Vulnerable Populations Considerations for including vulnerable participants in research 05/16/2019
Policies PDF icon 503.4 Compensating Participants Policies related to compensation for research participants 03/01/2019
Policies PDF icon 504.2 Researcher Conflict of Interest Coordination Procedures for identifying and managing COIs for UNM researchers impacting HSR 11/02/2018
Policies PDF icon 505.1 HIPAA in Research Procedures for IRB reviews involving HIPAA related issues in protocols 11/27/2017
Policies PDF icon 506.1 Translation for Non-English Speaking Participants Policies for preparing translated study documents 03/01/2019
Policies PDF icon 507.3 Principal Investigator Eligibility PI eligibility for UNM Main and Branch campus researchers 11/02/2017
Policies PDF icon 508.1 Research at External Sites UNM IRB requirements for research conducted at external sites 05/18/2018
Policies PDF icon 509.3 Researcher Responsibilities Qualifications and Training Required training, qualifications, and accountability for UNM researchers 03/01/2019
Policies PDF icon 510.2 Advertisement and Recruitment for Human Research Appropriate processes for recruiting potential research participants 03/01/2019
Policies PDF icon 511.3 Compliance with Applicable Laws and Regulations Summary of local laws, state statutes, and international regulations that may apply to HSR 03/01/2019
Policies PDF icon 512.2 Institutional Conflict of Interest Procedures for identifying and managing institutional COI that could affect HSR 03/01/2019
Policies PDF icon 513.0 Compliance with the European Union's general Data Protection Regulation (GDPR) Expectations regarding EU citizen data privacy 05/25/2018
Policies PDF icon 514.0 Research Supported by the Department of Defense DoD supported human research must comply with DoD requirements as discussed in this policy 07/01/2018