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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
Forms Microsoft Office document icon Amendment Application Request changes to IRB approved documents or change in PI 08/04/2017
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 08/04/2017
Forms Microsoft Office document icon Continuing Review Application Request continuing review of active study 08/04/2017
Forms Microsoft Office document icon Deferred Projects Annual Report Provide status update of study deferred to external IRB 08/04/2017
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 08/04/2017
Forms Microsoft Office document icon HIPAA Waiver Request Request a waiver of HIPAA Authorization 06/12/2017
Forms Microsoft Office document icon Request an exception to PI Eligibility policy Request an exception to PI Eligibility policy 08/08/2017
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.) 06/29/2017
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 105.3 IRB Records Management and Retention Policies for UNM IRB record keeping 07/28/2017
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 503.3 Compensating Participants Policies related to compensation for research participants 06/19/2017
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 505.1 HIPAA in Research Procedures for IRB reviews involving HIPAA related issues in protocols 11/27/2017
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
PAM File Compensation Log To track compensation given to participants. It may be useful for projects that compensate participants with money or gift cards. 09/20/2017
PAM File Complaint Report Complaints can come from participants or others and this form helps to record the details of the issue, investigation, and resolution. 09/20/2017
PAM File Event Reporting Log To keep track of events that have occurred, even if they did not require reporting to the UNM IRB. 09/20/2017
PAM File Informed Consent Process Checklist To document that the consent process includes all of the required components and that it is following the approved process in the protocol. 09/20/2017
PAM File Linking and Screening Log To keep track of participant names and participant codes.For projects that involve screening, it can be used to track the screening process. 09/20/2017
PAM PDF icon MAC Tools Cover Sheet This cover sheet gives a brief explanation of the UNM OIRB MAC Tools. 09/20/2017
PAM File Note to file To document the ongoing conduct of a research project. Examples of appropriate use of a note to file includes failure of research team to sign and/or date a signed consent form, documenting a missed time point to complete a survey, etc. 09/20/2017
PAM File Participant Contact Information (Excel) To organize and store participant contact information. 09/20/2017
PAM File Participant Contact information (Word) To organize and store participant contact information. 09/20/2017
PAM File Regulatory Files Checklist To establish organizational compliance for research documentation at the beginning of the project. 09/20/2017
PAM File Research Staff Training Log To document that project staff have completed all required and necessary trainings to ethically and accurately conduct the research. 09/20/2017
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 06/08/2016
Guidance PDF icon HIPAA Decision Tree Determine when HIPAA applies to research 09/01/2017
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 Prisoner Research Definition of prisoner and considerations when conducting research with prisoners 04/12/2017
Guidance PDF icon Research in K-12 Schools Special considerations for conducting research in K-12 schools 08/11/2017
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) 07/06/2017
Guidance PDF icon Research involving VO2 Max Testing Considerations when conducting research involving maximal exercise testing 08/31/2017
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