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 Name | Document Description | Category | Version Date |
|---|---|---|---|
| Resuming Research During the COVID-19 Pandemic | This is the most recent guidance provided by the UNM IRB on how to resume or begin research during the COVID-19 Pandemic. | Guidance | 04/28/2021 |
| Human Research and COVID-19 | Guidance on conducting research during the COVID-19 pandemic, as issued by the UNM OVPR and OIRB. | Guidance | 03/23/2020 |
| Family Educational Rights and Privacy Act (FERPA) | Considerations when accessing student records for research | Guidance | 07/02/2021 |
| IRB Submission Checklist | Required documents for IRB review | Guidance | 07/28/2022 |
| UNM IRB Researcher Handbook | This handbook provides guidance to Main and Branch Campus researchers who conduct research with people | Guidance | 05/18/2022 |
| Additional Requirements for Federally Funded Research | Summary of additional federal regulations for Dept of Justice and Dept of Education | Guidance | 02/16/2022 |
| Research involving VO2 Max Testing | Considerations when conducting research involving maximal exercise testing | Guidance | 06/19/2019 |
| FDA Regulated Drugs and Devices | Researcher responsibilities for research with drugs or devices | Guidance | 06/04/2019 |
| 101.7 Composition and Membership of the Institutional Review Board | Defines policies and procedures for appointing IRB members and maintaining the membership roster | Policies | 01/21/2019 |
| Informed Consent Online Training | This online training explains aspects of the informed consent process, forms, and waivers | Guidance | 01/01/2019 |
| Common Submission Mistakes | This is an online training about the most common mistakes researchers make when submitting the UNM IRB | Guidance | 01/01/2019 |
| Assessing and Minimizing Risk in Human Research | How to assess and minimize risk in SBER | Guidance | 11/01/2018 |
| UNM Human Research Data Security Standards | Standards for the protection of human research data | Guidance | 09/18/2018 |
| NIH Certificates of Confidentiality | When Certificates of Confidentiality apply to research and related IRB requirements. | Guidance | 08/09/2018 |
| 102.2 Performance Evaluation of IRB Chairs and Members | Describes the process for evaluating IRB members as a part of the overall evaluation of the HRPP | Policies | 05/01/2022 |
| Mental Health Safety Plans | Safety plans for research where participants may express extreme distress | Guidance | 03/27/2018 |
| CITI Instructions | Step-by-step instructions for accessing CITI Main Campus Researcher training | Guidance | 06/01/2022 |
| CITI COI Tracking Instructions | These instructions explain the PI responsibility to ensure appropriate training and disclosure status including how to review a CITI Report. | Guidance | 01/19/2018 |
| Guidelines for Handling Crisis Situations with Research Participants in ABQ | Considerations for different participant crisis situations | Guidance | 01/08/2018 |
| HIPAA Decision Tree | Determine when HIPAA applies to research | Guidance | 09/01/2017 |
| Research with American Indian Communities | Considerations for working with American Indian Communities | Guidance | 08/29/2017 |
| Research in K-12 Schools | Special considerations for conducting research in K-12 schools | Guidance | 08/11/2017 |
| Research involving Transcranial Direct Current Stimulation | Considerations when conducting transcranial direct current stimulation (tDCS) | Guidance | 07/06/2017 |
| Prisoner Research | Definition of prisoner and considerations when conducting research with prisoners | Guidance | 04/12/2017 |
| Community-Based Participatory Research | Considerations when developing a CBPR protocol | Guidance | 05/11/2016 |
| Research Involving Alcohol Administration | Considerations when conducting alcohol related research | Guidance | 02/04/2016 |
| Decision Trees: IRB Review Required? | Determine what projects need IRB review | Guidance | 09/14/2015 |
| Activities Requiring IRB Review | Descriptions of activities that may or may not need IRB review | Guidance | 09/10/2015 |
| 110.0 Emergency Preparedness and Response Plan | Procedures for initiating a response to an emergency impacting the UNM IRB and/or HRPP operations. | Policies | 09/07/2023 |
| 203.4 Review of Scientific Validity and Merit | Process for scientific validity review required before IRB review | Policies | 05/02/2022 |
| 514.0 Research Supported by the Department of Defense | DoD supported human research must comply with DoD requirements as discussed in this policy | Policies | 07/01/2018 |
| 513.0 Compliance with the European Unions general Data Protection Regulation GDPR | Expectations regarding EU citizen data privacy | Policies | 05/25/2018 |
| 512.2 Institutional Conflict of Interest | Procedures for identifying and managing institutional COI that could affect HSR | Policies | 03/01/2019 |
| 511.3 Compliance with Applicable Laws and Regulations | Summary of local laws, state statutes, and international regulations that may apply to HSR | Policies | 03/01/2019 |
| 510.2 Advertisement and Recruitment for Human Research | Appropriate processes for recruiting potential research participants | Policies | 03/01/2019 |
| 509.3 Researcher Responsibilities Qualifications and Training | Required training, qualifications, and accountability for UNM researchers | Policies | 03/01/2019 |
| 508.2 Research at External Sites | UNM IRB requirements for research conducted at external sites | Policies | 01/28/2021 |
| 507.4 Principal Investigator Eligibility | PI eligibility for UNM Main and Branch campus researchers | Policies | 05/09/2022 |
| 506.1 Translation for Non-English Speaking Participants | Policies for preparing translated study documents | Policies | 03/01/2019 |
| 505.2 HIPAA in Research | Procedures for IRB reviews involving HIPAA related issues in protocols | Policies | 05/09/2022 |
| 504.2 Researcher Conflict of Interest Coordination | Procedures for identifying and managing COIs for UNM researchers impacting HSR | Policies | 11/02/2018 |
| 503.4 Compensating Participants | Policies related to compensation for research participants | Policies | 03/01/2019 |
| 502.4 Protection of Vulnerable Populations | Considerations for including vulnerable participants in research | Policies | 05/16/2019 |
| 501.8 Informed Consent | Requirements and expectations for obtaining and documenting informed consent/assent | Policies | 03/08/2024 |
| 410.4 Project Closure | Procedures for closing a project with the IRB | Policies | 05/09/2022 |
| 409.1 Post Approval Monitoring Program | Description of the Post Approval Monitoring (PAM) program and components | Policies | 05/09/2022 |
| 408.8 Expiration of IRB Approval | The consequences when a PI does not obtain final IRB approval prior to expiration date | Policies | 05/09/2022 |
| 407.1 Participant Concerns_Complaints | Procedures for handling concerns, complaints, or questions received about a project | Policies | 03/01/2019 |
| 406.3 Directed Audits and Full Assessments | Process for for cause and random audits | Policies | 05/09/2022 |
| 405.2 Reporting of Protocol Deviations | Requirements for reporting minor protocol deviations to the IRB | Policies | 05/09/2022 |
| 404.5 Mandated Reporting to External Agencies | Process for ensuring prompt reporting by the IRB to external agencies | Policies | 02/12/2019 |
| 403.3 Suspension or Termination of Approved Research | Policies and procedures for suspending or terminating research approved by the IRB | Policies | 05/30/2019 |
| 402.4 Research Noncompliance | Process for IRB investigations of alleged noncompliance | Policies | 03/01/2019 |
| 401.3 Reporting and Review of Events Involving Risk to Participants or Others | Procedures for prompt reporting of reportable events for IRB review | Policies | 03/01/2019 |
| 308.2 Review of FDA Regulated Drugs and Devices | When FDA regulations apply and review of FDA regulated research | Policies | 05/26/2021 |
| 307.1 Data and Safety Monitoring Plans | IRB review of data and safety monitoring plans | Policies | 03/01/2019 |
| 306.8 Review of Changes to Approved Protocols-Amendments | Process for review of changes (amendments) to previously approved protocols | Policies | 05/02/2022 |
| 305.7 Continuing Review | Requirements for submitting and process for reviewing continuing reviews | Policies | 05/16/2022 |
| 304.6 Expedited Review of Federally Funded Research | Process for conducting expedited reviews of human research | Policies | 05/02/2022 |
| 303.7 Initial Full Review | Process for new project review by convened IRB | Policies | 05/02/2022 |
| 302.8 Exempt Review of Federally Funded Research | Process for exempt review for federally funded research | Policies | 05/02/2022 |
| 301.5 Determination of Activities that Require IRB Review | Guidelines for determining whether UNM is engaged in research | Policies | 05/02/2022 |
| 209.1 UNM Policy on Engagement in Human Research | Guidelines for determining whether UNM is engaged in research | Policies | 03/25/2019 |
| 208.1 Undue Influence of IRB and OIRB Staff | Procedures for investigations of attempts to unduly influence IRB members or staff | Policies | 03/01/2019 |
| 207.8 IRB Reliance Process | Deferral of HSR conducted by UNM researchers to external IRBs | Policies | 05/02/2022 |
| 206.3 Ethical Obligations of IRB Members and Staff | Ethical standards for the UNM IRB members and staff | Policies | 03/01/2019 |
| 205.1 Review Standards for Research Not Covered by FWA | Process for IRB reviews using equivalent protections for protocols not covered by FWA | Policies | 02/18/2022 |
| 204.1 IRB Use of Outside Expertise-Consultants | Use of relevant experts to assist with review of protocols | Policies | 03/01/2019 |
| 202.3 Ethical and Legal Standards and Practices for Human Subject Research | Standards for the conduct of human research at UNM | Policies | 03/01/2019 |
| 201.1 IRB Member and Consultant Conflict of Interest | Identifying and managing conflicts of interest that could impact reviews | Policies | 03/01/2019 |
| 109.6 Staff Processing of Submissions | OIRB intake, pre-review, and administrative review functions | Policies | 05/02/2022 |
| 108.6 IRB Member and Staff Training | Required training for IRB members and OIRB staff | Policies | 05/02/2022 |
| 107.4 HRPP Quality Assessment Program | Post approval monitoring and quality assessment of HRPP | Policies | 07/01/2023 |
| 106.1 SOP Preparation Issuance and Management | Procedures for developing, reviewing, revising, and distributing SOPs for the IRB | Policies | 03/01/2019 |
| 105.5 IRB Records Management and Retention | Policies and procedures for UNM IRB record keeping | Policies | 05/02/2022 |
| 104.6 IRB Meeting Minutes | Procedures for completing the minutes of the convened meetings of the UNM IRB | Policies | 05/02/2022 |
| 103.8 IRB Meeting Conduct | Defines the conduct for full board meetings of the IRB in accordance with federal regulations | Policies | 05/02/2022 |
| Tipsheet Submitting PAM | Guidance on submitting post approval monitoring to the IRB | Guidance | 08/16/2022 |
| Tipsheet Submitting an Event | Guidance on how to submit an event | Guidance | 03/20/2024 |
| Tipsheet Legacy IRBNet FAQ | Guidance on accessing and maintaining legacy IRBNet protocols in Streamlyne | Guidance | 07/25/2022 |
| Tipsheet PI Approval | Guidance on how to approve a protocol that has been routed to the PI | Guidance | 07/25/2022 |
| Tipsheet Legacy IRBNet Notify IRB | Guidance on how to close Legacy IRBNet studies in Streamlyne | Guidance | 07/25/2022 |
| Tipsheet Personnel Permissions | Guidance on editing and changing study personnel protocol access. | Guidance | 06/30/2022 |
| Streamlyne New User Manual | Detailed guidance on using Streamlyne Research | Guidance | 06/30/2021 |
| Streamlyne IRB Researcher Manual | Detailed guidance for researchers submitting in Streamlyne Research | Guidance | 05/17/2022 |
| Tipsheet Submitting an Amendment | Overview on creating and submitting an amendment | Guidance | 05/20/2022 |
| Tipsheet Submitting a Closure Request | Guidance on how to submit a closure | Guidance | 05/20/2022 |
| Tipsheet View Approval Letter | Guidance on how to view an approval letter in Streamlyne Research | Guidance | 05/20/2022 |
| Tipsheet Routing Protocol to PI | Guidance on routing a protocol to a PI for approval before submitting to the IRB | Guidance | 07/05/2022 |
| Tipsheet Submitting a Renewal | Guidance on submitting a renewal (continuing review) | Guidance | 05/20/2022 |
| Tipsheet Respond to Return to PI | Guidance on how to respond to a Return to PI request | Guidance | 05/18/2022 |
| Tipsheet Requesting External IRB Review | Brief overview of how to initiate and submit a request for a deferral to an external IRB | Guidance | 05/18/2022 |
| Tipsheet New Protocol | Brief overview of how to initiate and submit a protocol in Streamlyne Research | Guidance | 05/18/2022 |
| Tipsheet IRB Review Not Required | Guidance on how to initiate and submit a request for a Not Human Research Determination | Guidance | 05/20/2022 |
| Tipsheet External Partners | Guidance for External Partners when submitting to the UNM IRB in Streamlyne. | Guidance | 05/17/2022 |
| Tipsheet Adding and Removing Study Personnel | Guidance on adding and removing study personnel | Guidance | 01/23/2024 |
| Guidance on Program Evaluation | Guidance to help distinguish when program evaluation requires IRB review | Guidance | 02/06/2019 |
