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Document Category Document File Description Version Date
Forms Microsoft Office document icon Amendment Application Request changes to IRB approved documents or change in PI 08/01/2016
Forms Microsoft Office document icon Amendment Application Project Team Request addition or removal of project team members 08/13/2015
Forms Microsoft Office document icon Closure Application Request study closure 08/01/2016
Forms Microsoft Office document icon Continuing Review Application Request continuing review of active study 08/01/2016
Forms Microsoft Office document icon Deferred Projects Annual Report Provide status update of study deferred to external IRB 12/02/2016
Forms Microsoft Office document icon Device Form Provide information related to use of an investigational device 04/27/2016
Forms Microsoft Office document icon Event Report Provide information related to adverse event or unanticipated problem 08/13/2015
Forms Microsoft Office document icon HIPAA Waiver Request Request a waiver of HIPAA Authorization 06/12/2017
Forms Microsoft Office document icon PI Eligibility Request Form Request an exception to PI Eligibility policy 07/20/2016
Forms Microsoft Office document icon Project Team Form Provide list of study team members and associated role 02/17/2014
Forms Microsoft Office document icon Project Information Form Provide information on a new study 05/01/2016
Forms Microsoft Office document icon Protocol Deviations Report Provide information on protocol deviations that occurred since last review 09/16/2015
Forms File Request for External IRB Review Request for deferral of oversight to external IRB 06/09/2016
Forms Microsoft Office document icon Scientific Validity Review Form Provide documentation of review of scientific validity 04/24/2017
Forms File Self-Assessment Tool Conduct and document a self-audit 02/04/2016
Forms Microsoft Office document icon Translation Certification Form Certify the qualifications of the translator used for study documents 12/02/2015
Templates Microsoft Office document icon Child Assent Form Generally for use with youth ages 7-11. 09/28/2015
Templates Microsoft Office document icon Consent Form - Additional Elements Additional elements that may be required in the consent form (e.g. HIPAA, tDCS, EEG, specimen collection, payment for injury, etc.) 08/31/2016
Templates Microsoft Office document icon Consent Form - Standard Informed Consent Template 07/07/2016
Templates Microsoft Office document icon Consent Form - Survey/Interview/Focus Group Simplified informed consent template 07/07/2016
Templates Microsoft Office document icon HIPAA Authorization Separate HIPAA Authorization for use of PHI through covered entities 04/29/2016
Templates Microsoft Office document icon Protocol Research protocol template 07/25/2016
Templates File Recruitment Email Sample recruitment email 07/05/2016
Templates File Recruitment Flyer 1 Sample recruitment flyer with pull tabs 07/05/2016
Templates File Recruitment Flyer 2 Another recruitment flyer with pull tabs; different style 07/05/2016
Templates File Recruitment Flyer 3 Recruitment flyer in a poster style 07/05/2016
Templates Microsoft Office document icon Recruitment Script Sample recruitment script 07/05/2016
Policies PDF icon 101.5 Composition and Membership of the Institutional Review Board Defines policies and procedures for appointing IRB members and maintaining the membership roster 04/25/2017
Policies PDF icon 102.0 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 09/01/2015
Policies PDF icon 103.6 IRB Meeting Conduct Defines the conduct for full board meetings of the IRB in accordance with federal regulations 07/08/2016
Policies PDF icon 104.4 IRB Meeting Minutes Procedures for completing the minutes of the convened meetings of the UNM IRB 03/07/2017
Policies PDF icon 105.2 IRB Records Management and Retention Policies for UNM IRB record keeping 08/05/2016
Policies PDF icon 106.0 SOP Preparation Issuance and Management Procedures for developing, reviewing, revising, and distributing SOPs for the IRB 06/01/2015
Policies PDF icon 107.2 HRPP Quality Assessment Program Post approval monitoring and quality assessment of HRPP 02/01/2017
Policies PDF icon 108.4 IRB Member and Staff Training Required training for IRB members and OIRB staff 11/30/2016
Policies PDF icon 109.3 Staff Processing of Submissions OIRB intake, pre-review, and administrative review functions 03/24/2017
Policies PDF icon 201.0 IRB Member and Consultant Conflict of Interest Identifying and managing conflicts of interest that could impact reviews 06/01/2015
Policies PDF icon 202.2 Ethical and Legal Standards and Practices for Human Subject Research Standards for the conduct of human research at UNM 07/25/2016
Policies PDF icon 203.2 Review of Scientific Validity and Merit Process for scientific validity review required before IRB review 05/01/2017
Policies PDF icon 204.0 IRB Use of Outside Expertise-Consultants Use of relevant experts to assist with review of protocols 09/01/2015
Policies PDF icon 205.0 Review Standards for Research Not Covered by FWA Process for IRB reviews using equivalent protections for protocols not covered by FWA 05/01/2016
Policies PDF icon 206.2 Ethical Obligations of IRB Members and Staff Ethical standards for the UNM IRB members and staff 07/25/2016
Policies PDF icon 207.2 Reliance on External IRBs Deferral of HSR conducted by UNM researchers to external IRBs 02/01/2017
Policies PDF icon 208.0 Undue Influence of IRB and OIRB Staff Procedures for investigations of attempts to unduly influence IRB members or staff 07/07/2016
Policies PDF icon 301.2 Determination of Activities that Require IRB Review Procedures for determining whether activities qualify as human research or clinical investigations 07/07/2016
Policies PDF icon 302.4 Exempt Review Process for exempt review 07/08/2016
Policies PDF icon 303.3 Initial Full Review Process for new project review by convened IRB 07/07/2016
Policies PDF icon 304.2 Initial Expedited Review Process for new project review using expedited procedures 08/03/2016
Policies PDF icon 305.4 Continuing Review Requirements for submitting and process for reviewing continuing reviews 07/11/2016
Policies PDF icon 306.4 Review of Changes to Approved Protocols-Amendments Process for review of changes (amendments) to previously approved protocols 03/14/2017
Policies PDF icon 307.0 Data and Safety Monitoring Plans IRB review of data and safety monitoring plans 03/31/2016
Policies PDF icon 401.2 Reporting and Review of Events Involving Risk to Participants or Others Procedures for prompt reporting of reportable events for IRB review 03/09/2017
Policies PDF icon 402.3 Research Noncompliance Process for IRB investigations of alleged noncompliance 06/27/2016
Policies PDF icon 403.1 Suspension or Termination of Approved Research Policies and procedures for suspending or terminating research approved by the IRB 09/15/2015
Policies PDF icon 404.3 Mandated Reporting to External Agencies Process for ensuring prompt reporting by the IRB to external agencies 07/07/2016
Policies PDF icon 405.0 Reporting of Protocol Deviations Requirements for reporting minor protocol deviations to the IRB 09/15/2015
Policies PDF icon 406.0 Directed and Self-Audits Types of post approval monitoring of projects and process for auditing 12/01/2015
Policies PDF icon 407.0 Participant Concerns_Complaints Procedures for handling concerns, complaints, or questions received about a project 10/15/2015
Policies PDF icon 408.6 Expiration of IRB Approval The consequences when a PI does not obtain final IRB approval prior to expiration date 01/01/2017
Policies PDF icon 410.1 Study Closure Procedures for closing a project with the IRB 03/10/2016
Policies PDF icon 501.3 Informed Consent Requirements and expectations for obtaining and documenting informed consent/assent 08/02/2016
Policies PDF icon 502.2 Protection of Vulnerable Subjects Considerations for including vulnerable subjects in research 08/03/2016
Policies PDF icon 503.2 Compensating Participants Policies related to compensation for research participants 07/25/2016
Policies PDF icon 504.1 Researcher Conflict of Interest Coordination Procedures for identifying and managing COIs for UNM researchers impacting HSR 01/18/2017
Policies PDF icon 505.0 HIPAA in Research Procedures for IRB reviews involving HIPAA related issues in protocols 10/01/2015
Policies PDF icon 506.0 Translation for Non-English Speaking Participants Policies for preparing translated study documents 12/01/2015
Policies PDF icon 507.2 Principal Investigator Eligibility PI eligibility for UNM Main and Branch campus researchers 11/01/2016
Policies PDF icon 508.0 External and Multi-Site Research UNM IRB requirements for research conducted at external sites 03/31/2016
Policies PDF icon 509.2 Researcher Responsibilities Qualifications and Training Required training, qualifications, and accountability for UNM researchers 07/06/2016
Policies PDF icon 510.1 Advertisement and Recruitment for Human Research Appropriate processes for recruiting potential research participants 07/25/2016
Policies PDF icon 511.1 Compliance with Applicable Laws and Regulations Summary of local laws, state statutes, and international regulations that may apply to HSR 07/07/2016
Policies PDF icon 512.1 Institutional Conflict of Interest Procedures for identifying and managing institutional COI that could affect HSR 03/17/2017
Guidance PDF icon Activities Requiring IRB Review Descriptions of activities that may or may not need IRB review 09/10/2015
Guidance PDF icon Additional Requirements for Federally Funded Research Summary of additional federal regulations for Dept of Justice and Dept of Education 04/01/2016
Guidance PDF icon Assessing and Minimizing Risk in Human Research How to assess and minimize risk in SBER 02/29/2016
Guidance PDF icon CITI Instructions Step-by-step instructions for accessing CITI Main Campus Researcher training 05/02/2017
Guidance PDF icon Community-Based Participatory Research Considerations when developing a CBPR protocol 05/11/2016
Guidance PDF icon Decision Trees: IRB Review Required? Determine what projects need IRB review 09/14/2015
Guidance PDF icon Family Educational Rights and Privacy Act (FERPA) Considerations when accessing student records for research 09/22/2015
Guidance PDF icon HIPAA Decision Tree Determine when HIPAA applies to research 08/08/2016
Guidance PDF icon IRB Submission Checklist Required documents for IRB review 05/17/2017
Guidance PDF icon IRBNet Submission Instructions How to submit online using IRBNet software 11/20/2015
Guidance PDF icon NIH Certificates of Confidentiality When Certificates of Confidentiality apply to research and related IRB requirements. 06/21/2017
Guidance PDF icon Research Involving Alcohol Administration Considerations when conducting alcohol related research 02/04/2016
Guidance PDF icon Research involving Transcranial Direct Current Stimulation Considerations when conducting transcranial direct current stimulation (tDCS) 09/15/2015
Guidance PDF icon Research involving VO2 Max Testing Considerations when conducting research involving maximal exercise testing 01/08/2016
Guidance PDF icon UNM Human Research Data Security Standards Standards for the protection of human research data 08/08/2017
Guidance PDF icon UNM IRB Researcher Handbook This handbook provides guidance to Main and Branch Campus researchers who conduct research with people. 06/13/2017