University of New Mexico Health Sciences Center
The HRRCs are responsible for reviewing all human research falling within the following categories:
The HRRCs also oversee all uses of investigational drugs and devices. These categories cover all research in which the UNMHSC and its faculty, staff, and students may be involved. In addition, the UNMHSC HRRCs may review research submitted by faculty, staff, or students from main campus who are conducting biomedical research, with the appropriate departmental or other approvals.
Under the FWA, the HRRCs must review research even if it will be conducted at another institution with an IRB (for instance, under a sub-award agreement). In such situations, the investigator and institution remain legally responsible for the conduct of research at the other institution. Where another IRB also has jurisdiction over the research, the investigator should inform the HRRC Support Office. The general policy of the HRRC is to require submission of the project to the HRRCs for review first, with submission to the other institution’s IRB to follow. Final HRRC approval of the project (consent document, etc.) as amended by the other IRB is required.
2.2.1 Reporting Relationships
The Vice President for Translational Research (under the general direction of the Executive Vice President for Health Sciences) is responsible for overseeing the effective operation, policies, and compliance of the HRRCs and the conduct of human subject research at the UNMHSC. The Executive Vice President for Health Sciences is the UNMHSC’s signatory for its FWA, and ultimately responsible for the oversight of human subject research activities.
The Executive Vice President for Health Sciences grants the HRRC the following independent authority as required by federal regulations for the protection of human subjects in research (Memorandum for the Record):
Research that has been approved by the HRRC may be subject to further appropriate review and approval or disapproval by officials of the UNM HSC. However, those officials may not approve any research that has not been approved by the HRRC. No person or other committee--whether internal or external--can overturn an HRRC decision to disapprove, terminate, or suspend a research protocol. 45 C.F.R. 46.112
Attempts to inappropriately influence the HRRC should be reported to the Director of Research Protections or an HRRC Chairman at 272-1129. These individuals are granted the responsibility and authority to respond to attempts to unduly influence the HRRC and will respond to such attempts as follows:
A signed and completed HRRC Departmental Review of Research Using Human Subjects form must accompany applications for HRRC review. In addition to HRRC review, all human research projects must be reviewed for scientific merit and institutional appropriateness by a department chair, dean or designee or other accepted scientific review committee. Ideally, this review should be accomplished by a research committee; however an individual with sufficient expertise is satisfactory. Accepted scientific review committees include: VA Research & Development Committee, SOM Medical Student Research Committee, New Mexico Cancer Care Alliance Scientific Review Committee, UNMHSC Cancer Center Protocol Review Committee and SOM Resident Research Committee. A faculty member, including a Chair, may not review his or her own research project. The departmental/scientific review should focus on, among other things, the research methodology/scientific merit of the proposal, qualifications of the investigator, adequacy of facility and resources to conduct the study, and proposed subject population. Any concerns about the project should be forwarded to the HRRC Support Office. An investigator may appeal a departmental disapproval to the Sr. Associate Dean for Research, SOM.
In addition to HRRC approval, the following committees or entities also must approve research projects falling within their purview:
Review and approval is required for any research conducted at VA facilities or using VA patients, in addition to HRRC approval. Call (505) 256-2810.
Investigators should be aware of regulations and guidelines concerning use of radioisotopes and x-rays in the research environment. Review and approval is required for any research involving ionizing radiation in excess of standard of care, in addition to HRRC approval. Call (505) 277-2753.
Review and approval is required for all research proposals that will use these facilities. Call UH 5-East, (505) 272-2366.
Research activities that are conducted in IHS facilities (including IHS-funded Tribal* or urban health facilities), or involving IHS personnel or other IHS resources, shall submit a research application to an IHS IRB. For more information you can contact the IHS IRB.
Researchers planning to conduct research on a reservation or pueblo are subject to the jurisdiction of the Tribal government and must obtain the approval of either the Tribal Council or the Tribal health authorities. The IHS IRB will review non-IHS research based upon request of the Tribal authorities. Research conducted off-reservation but planning to target members of such communities as their subject population, should determine whether Tribal authorities need to be consulted.
*IHS-funded: The exception to this rule is that if a Tribe has filed its own Federal Wide Assurance (FWA), then the Tribe will tell you which IRB to take the proposal to. The IHS IRB must review studies for Tribes that do not have their own FWA.
The HRRCs have the following authority and responsibility over research at UNMHSC:
The HRRC Support Office notifies investigators by written document of approval, revisions, and disapprovals (or terminations), with enough detail in the latter situation to explain the disapproval to the investigator.
Although research may receive HRRC approval, the department chair and other UNMHSC administration may conclude that the research does not meet the policies and goals of the UNMHSC, or other obligations (legal or otherwise), and may disapprove, suspend, or terminate a project. 45 C.F.R. 46.112.
Should the HRRC disapprove or terminate a research project, the principal investigator may request to present more information either in person or in writing to the HRRC, explaining why he or she believes the project should be approved or continued. However, a final HRRC decision to require modifications in, disapprove, suspend or terminate a project is final. No other committee or official (University or Federal) can override these HRRC decisions. Further, no committee or person can approve an investigator to conduct any research that an HRRC has not approved. 45 C.F.R. 46.112.
Non-compliance includes failure to comply with the regulations (including VA, as applicable) or the requirements or determinations of the HRRC. Failure to report adverse events in a timely manner or failure to submit progress reports is considered non-compliance.
Serious Non-compliance includes failure to comply with the regulations or the requirements or determinations of the HRRC which affect the rights and welfare of research subjects or increase the risks to the subjects.
Continuing Non-compliance includes a pattern of failing to comply with the regulations or the requirements or determinations of the HRRC or a lack of knowledge which may affect the rights and welfare of research subjects or lead to increased risks to the subjects.
The Office of Research, Division of Research Protections and the Human Research Review Committee (HRRC) may become aware of possible non-compliance by any of several venues. These include initial and continuing review of submitted proposals, adverse event reports, quality improvement reviews and reports from investigators, research staff, visitors, study participants and others.
Reports of possible noncompliance should be made via one of the following mechanisms:
Any employee or student of the UNMHSC or agent of another organization whose human research falls under the jurisdiction of the HRRC must report suspected non-compliance. Anyone, regardless of affiliation, who suspects non-compliance, is invited to report. The person submitting the allegation (complainant) may be asked to submit a written description of the information surrounding the alleged non-compliance. To the extent possible every effort will be made to maintain confidentiality regarding the individual(s) submitting the allegation. Non-compliance may also be reported by the investigator as an adverse event/unanticipated problem. Reports should include a description of the concern, names of individuals involved and their department or organization, how the complainant became aware of the information and complainant’s contact information (unless made anonymously).
If the HRRC staff becomes aware of non-compliance that is clearly neither serious nor continuing in which the investigator may simply respond and remediate (i.e. missing document or incomplete submission), the staff member may request required information, verify its appropriateness and take no further action. If there is any question about whether something could constitute serious or continuing non-compliance or the staff member feels he/she cannot handle it appropriately then it is brought to the Director of Research Protections or Manager of Research Protections Operations. All other allegations of noncompliance must be brought to the Director of Research Protections or Manager of Research Protections Operations.
If a report of noncompliance is submitted as an adverse event/unanticipated problem or accompanies a progress report for continuing review HRRC staff will refer it to an HRRC Chair.
The Director of Research Protections or Manager of Research Protections Operations may initiate an investigation, if additional information is needed to determine if non-compliance has occurred. The Director of Research Protections or Manager of Research Protections Operations will direct the investigation. An investigation may consist of an interview with the complainant or others, inquiries via telephone or email, and/or a Quality Assurance Review of an investigator’s project(s). Such a review may also examine research data, informed consent/assent documents, medical records, inclusion/exclusion criteria, HRRC records, and other relevant information. A summary of the allegations will be prepared to which the complainant is given an opportunity to comment.
The person directing the investigation will determine the extent of the investigation based on the type of information needed to determine the truth of the allegation, and whether the allegation represents serious or continuing non-compliance.
The Director of Research Protections or Manager of Research Protections Operations may determine that the allegation was false, or does not constitute serious or continuing non-compliance and take no further action. Unless such a determination is made, the allegation will be shared with an HRRC Chair. If in the judgment of the Director of Research Protections or Manager of Research Protections Operations the allegation cannot be investigated adequately through the HRRC review mechanism, the Director of Research Protections or Manager of Research Protections Operations will refer the allegation to UNMHSC Legal Counsel, Risk Management, Clinical Affairs, or other appropriate administrator or administrative body. The results of this investigation will be referred to an HRRC Chair.
If an HRRC chair judges the allegation/complaint to be unjustified, it may be dismissed without further action. If an HRRC Chair judges non-compliance to be clearly neither serious nor continuing, the HRRC may work with the investigator to implement the corrective action plan; or if the HRRC Chair judges that the corrective action plan to be adequate to protect participants, and that the investigator understands the need to implement the corrective action plan, no further action need be taken. Otherwise the HRRC Chair refers the matter to the convened IRB for review.
The HRRC chair who handled the allegation will serve as a primary reviewer or will designate a primary reviewer.
The primary reviewer and all HRRC members will be provided and are expected to review:
The convened HRRC determines whether the non-compliance is serious or continuing.
The HRRC considers what actions should be taken and specifically considers the following actions:
The HRRC Executive Committee will review all IRB determinations of serious and continuing non-compliance and assures uniformity of action between the HRRCs.
Investigators may appeal the decisions of an HRRC with regard to non-compliance to the Executive Committee. Investigators must outline the reasons for their appeal in writing within 30 days of an HRRC decision. The Executive Committee will review the appeal. The Executive Committee determines whether there is basis for appeal. If not, the initial determination of the HRRC stands. Otherwise the Executive Committee forwards their written recommendations to the HRRC that made the initial decision. The HRRC will consider the Executive Committee recommendations, and reconsider their determination. This determination is final and is not subject to further appeal.
The University of New Mexico has a separate policy and procedure for dealing with Research Misconduct (fabrication, falsification or plagiarism in proposing, conducting, reporting or reviewing sponsored or unsponsored research). The Director of Research Protections will forward all such allegations to the Vice President for Research or Vice President for Health Sciences, as appropriate.
Generally, the HRRCs review only research conducted at or involving UNM employees, sponsorship, or information. However, on occasion, such as where another entity that does not have an IRB is the recipient of a grant under which UNMHSC faculty will be conducting the research (under a subcontract/award) the UNMHSC may agree that an HRRC can serve as the IRB for the grantee. Where the UNMHSC agrees to this arrangement, the federal granting agency will require the company to file an FWA designating the UNMHSC HRRC as the IRB (assuming the arrangement has been sanctioned). An IRB Authorization Agreement must also be signed by the company and UNMHSC outlining the conditions of the agreement. Different federal requirements may apply for different arrangements. The HRRC Support Office coordinates with the Office of the University Counsel for the HSC to ensure that any necessary legal documents for these arrangements (such as an IRB Authorization Agreement) will also be drafted and signed.
The model for collaborations needs to include either the UNM HRRC signing as an IRB for another institution where the research is to be conducted or UNMHSC sub-awarding funding to another institution to conduct research, including the following: