IRB Policies & Guidance

This page houses all standard operating procedures and guidance documents that describe current requirements and expectations for human research conducted at or on behalf of the University of New Mexico or otherwise under the purview of the UNM IRB.

File NameDocument DescriptionCategoryVersion Date
Resuming Research During the COVID-19 PandemicThis is the most recent guidance provided by the UNM IRB on how to resume or begin research during the COVID-19 Pandemic.Guidance06/11/2020
Human Research and COVID-19Guidance on conducting research during the COVID-19 pandemic, as issued by the UNM OVPR and OIRB.Guidance03/23/2020
Family Educational Rights and Privacy Act (FERPA)Considerations when accessing student records for researchGuidance03/04/2020
Response to Modifications Submission ChecklistRequired documents for a submission response to modifications from the IRBGuidance08/21/2019
New Project Submission ChecklistDocuments required for a New Project submissionGuidance08/21/2019
IRB Submission ChecklistRequired documents for IRB reviewGuidance08/21/2019
Continuing Review or Reactivation Submission ChecklistDocuments required for a Continuing Review or Reactivation submissionGuidance08/21/2019
Amendment Submission ChecklistDocuments required for an Amendment submissionGuidance08/21/2019
UNM IRB Researcher HandbookThis handbook provides guidance to Main and Branch Campus researchers who conduct research with peopleGuidance08/15/2019
Additional Requirements for Federally Funded ResearchSummary of additional federal regulations for Dept of Justice and Dept of EducationGuidance08/09/2019
Research involving VO2 Max TestingConsiderations when conducting research involving maximal exercise testingGuidance06/19/2019
FDA Regulated Drugs and DevicesResearcher responsibilities for research with drugs or devicesGuidance06/04/2019
101.7 Composition and Membership of the Institutional Review BoardDefines policies and procedures for appointing IRB members and maintaining the membership rosterPolicies01/21/2019
Informed Consent Online TrainingThis online training explains aspects of the informed consent process, forms, and waiversGuidance01/01/2019
Common Submission MistakesThis is an online training about the most common mistakes researchers make when submitting the UNM IRBGuidance01/01/2019
Assessing and Minimizing Risk in Human ResearchHow to assess and minimize risk in SBERGuidance11/01/2018
UNM Human Research Data Security StandardsStandards for the protection of human research dataGuidance09/18/2018
NIH Certificates of ConfidentialityWhen Certificates of Confidentiality apply to research and related IRB requirements.Guidance08/09/2018
102.1 Performance Evaluation of IRB Chairs, Vice-Chairs, and MembersDescribes the process for evaluating IRB members as a part of the overall evaluation of the HRPPPolicies05/03/2018
Mental Health Safety PlansSafety plans for research where participants may express extreme distressGuidance03/27/2018
CITI InstructionsStep-by-step instructions for accessing CITI Main Campus Researcher trainingGuidance03/19/2018
CITI COI Tracking InstructionsThese instructions explain the PI responsibility to ensure appropriate training and disclosure status including how to review a CITI Report.Guidance01/19/2018
Guidelines for Handling Crisis Situations with Research Participants in ABQConsiderations for different participant crisis situationsGuidance01/08/2018
HIPAA Decision TreeDetermine when HIPAA applies to researchGuidance09/01/2017
Research with American Indian CommunitiesConsiderations for working with American Indian CommunitiesGuidance08/29/2017
Research in K-12 SchoolsSpecial considerations for conducting research in K-12 schoolsGuidance08/11/2017
Research involving Transcranial Direct Current StimulationConsiderations when conducting transcranial direct current stimulation (tDCS)Guidance07/06/2017
Prisoner ResearchDefinition of prisoner and considerations when conducting research with prisonersGuidance04/12/2017
Community-Based Participatory ResearchConsiderations when developing a CBPR protocolGuidance05/11/2016
Research Involving Alcohol AdministrationConsiderations when conducting alcohol related researchGuidance02/04/2016
IRBNet Submission InstructionsHow to submit online using IRBNet softwareGuidance11/20/2015
Decision Trees: IRB Review Required?Determine what projects need IRB reviewGuidance09/14/2015
Activities Requiring IRB ReviewDescriptions of activities that may or may not need IRB reviewGuidance09/10/2015
203.3 Review of Scientific Validity and MeritProcess for scientific validity review required before IRB review Policies03/01/2019
514.0 Research Supported by the Department of DefenseDoD supported human research must comply with DoD requirements as discussed in this policy Policies07/01/2018
513.0 Compliance with the European Unions general Data Protection Regulation GDPRExpectations regarding EU citizen data privacy Policies05/25/2018
512.2 Institutional Conflict of InterestProcedures for identifying and managing institutional COI that could affect HSR Policies03/01/2019
511.3 Compliance with Applicable Laws and RegulationsSummary of local laws, state statutes, and international regulations that may apply to HSR Policies03/01/2019
510.2 Advertisement and Recruitment for Human ResearchAppropriate processes for recruiting potential research participants Policies03/01/2019
509.3 Researcher Responsibilities Qualifications and TrainingRequired training, qualifications, and accountability for UNM researchers Policies03/01/2019
508.1 Research at External SitesUNM IRB requirements for research conducted at external sites Policies05/18/2018
507.3 Principal Investigator EligibilityPI eligibility for UNM Main and Branch campus researchers Policies11/02/2017
506.1 Translation for Non-English Speaking ParticipantsPolicies for preparing translated study documents Policies03/01/2019
505.1 HIPAA in ResearchProcedures for IRB reviews involving HIPAA related issues in protocols Policies11/27/2017
504.2 Researcher Conflict of Interest CoordinationProcedures for identifying and managing COIs for UNM researchers impacting HSR Policies11/02/2018
503.4 Compensating ParticipantsPolicies related to compensation for research participants Policies03/01/2019
502.4 Protection of Vulnerable PopulationsConsiderations for including vulnerable participants in research Policies05/16/2019
501.6 Informed ConsentRequirements and expectations for obtaining and documenting informed consent/assent Policies08/13/2019
410.3 Project ClosureProcedures for closing a project with the IRB Policies03/01/2019
409.0 Post Approval Monitoring ProgramDescription of the Post Approval Monitoring (PAM) program and components Policies01/19/2018
408.7 Expiration of IRB ApprovalThe consequences when a PI does not obtain final IRB approval prior to expiration date Policies02/23/2018
407.1 Participant Concerns_ComplaintsProcedures for handling concerns, complaints, or questions received about a project Policies03/01/2019
406.2 Directed Audits and Full AssessmentsProcess for for cause and random audits Policies07/18/2018
405.1 Reporting of Protocol DeviationsRequirements for reporting minor protocol deviations to the IRBPolicies03/01/2019
404.5 Mandated Reporting to External AgenciesProcess for ensuring prompt reporting by the IRB to external agenciesPolicies02/12/2019
403.3 Suspension or Termination of Approved ResearchPolicies and procedures for suspending or terminating research approved by the IRBPolicies05/30/2019
402.4 Research NoncomplianceProcess for IRB investigations of alleged noncompliancePolicies03/01/2019
401.3 Reporting and Review of Events Involving Risk to Participants or OthersProcedures for prompt reporting of reportable events for IRB reviewPolicies03/01/2019
308.0 Review of FDA Regulated Drugs and DevicesWhen FDA regulations apply and review of FDA regulated researchPolicies01/30/2019
307.1 Data and Safety Monitoring PlansIRB review of data and safety monitoring plansPolicies03/01/2019
306.7 Review of Changes to Approved Protocols-AmendmentsProcess for review of changes (amendments) to previously approved protocolsPolicies02/06/2020
305.6 Continuing ReviewRequirements for submitting and process for reviewing continuing reviewsPolicies01/21/2019
304.5 Expedited Review of Federally Funded ResearchProcess for conducting expedited reviews of human researchPolicies03/01/2019
303.5 Initial Full ReviewProcess for new project review by convened IRBPolicies01/21/2019
302.7 Exempt Review of Federally Funded ResearchProcess for exempt review for federally funded researchPolicies05/30/2019
301.4 Determination of Activities that Require IRB ReviewGuidelines for determining whether UNM is engaged in researchPolicies03/25/2019
209.1 UNM Policy on Engagement in Human ResearchGuidelines for determining whether UNM is engaged in researchPolicies03/25/2019
208.1 Undue Influence of IRB and OIRB StaffProcedures for investigations of attempts to unduly influence IRB members or staffPolicies03/01/2019
207.5 IRB Reliance ProcessDeferral of HSR conducted by UNM researchers to external IRBsPolicies05/24/2019
206.3 Ethical Obligations of IRB Members and StaffEthical standards for the UNM IRB members and staffPolicies03/01/2019
205.1 Review Standards for Research Not Covered by FWAProcess for IRB reviews using equivalent protections for protocols not covered by FWAPolicies01/19/2018
204.1 IRB Use of Outside Expertise-ConsultantsUse of relevant experts to assist with review of protocolsPolicies03/01/2019
202.3 Ethical and Legal Standards and Practices for Human Subject ResearchStandards for the conduct of human research at UNMPolicies03/01/2019
201.1 IRB Member and Consultant Conflict of InterestIdentifying and managing conflicts of interest that could impact reviewsPolicies03/01/2019
109.4 Staff Processing of SubmissionsOIRB intake, pre-review, and administrative review functionsPolicies03/01/2019
108.5 IRB Member and Staff TrainingRequired training for IRB members and OIRB staffPolicies01/21/2019
107.3 HRPP Quality Assessment ProgramPost approval monitoring and quality assessment of HRPPPolicies01/21/2019
106.1 SOP Preparation Issuance and ManagementProcedures for developing, reviewing, revising, and distributing SOPs for the IRBPolicies03/01/2019
105.4 IRB Records Management and RetentionPolicies and procedures for UNM IRB record keepingPolicies03/01/2019
104.5 IRB Meeting MinutesProcedures for completing the minutes of the convened meetings of the UNM IRBPolicies03/01/2019
103.7 IRB Meeting ConductDefines the conduct for full board meetings of the IRB in accordance with federal regulationsPolicies01/21/2019