University of New Mexico Health Sciences Center
Each HRRC committee is scheduled to meet once a month to conduct reviews.
HRRC meetings are held on the first, second, third and fourth Tuesday of each month to review research proposals and to conduct related business. Categories for submission are as follows:
Full Committee Review: Proposals must be received two (2) weeks before the scheduled meeting of the full committee (refer to HRRC Meeting Dates and Deadlines) Note: There is a six study maximum for each meeting. Proposals will be reviewed on a first come first served basis
Expedited Category: Proposals will be processed and reviewed upon receipt of the protocol. Proposals will be reviewed on a first come first served basis
Exempt Category: Proposals will be processed and reviewed upon receipt of the protocol. Proposals will be reviewed on a first come first served basis
Time Sensitive Category: Proposals in this category will be processed and reviewed upon receipt of the protocol. Refer to section 4.8 for eligibility and procedures.
New project submission applications are assigned to a particular committee for review (as noted, each committee meets once a month). Once a project is assigned to one of the committees, all initial review matters related to that project that require full committee review will be reviewed by that same committee.
Applications requiring full committee review are generally assigned to at least one primary reviewer (usually two reviewers are assigned to each project and one may be designated a "secondary reviewer"). These reviewers are provided all documents submitted by the investigator, while the remainder of the HRRC members receive only copies of the consent documents, the full review applications and any recruitment materials, although they have access to all other documents upon request. The primary Reviewer(s) may request additional information from investigators to resolve questions prior to the meeting. The primary reviewer(s) will present the project to the HRRC members at the committee meeting, after which the full committee will discuss the project and vote. The project may also be assigned to a consultant reviewer at the HRRC’s discretion.
Reviews of projects involving acute care/emergency research informed consent waivers may be handled differently, under separate policy designed to ensure compliance with the additional requirements of that waiver. See Section 7.5.5 for more information.
The HRRC Support Office prepares an agenda for each HRRC meeting, listing all projects that will be reviewed at the upcoming meeting (new and continuing), any adverse event reports to be reviewed by the committee, the projects that have been approved by expedited review, and any other items for discussion.
Reviews of all full review applications (all projects other than exempt or expedited) will be conducted only at convened meetings at which a majority of the members of the HRRC are present, including at least one member whose primary interests are in nonscientific areas. Thus, for example, if HRRC-1 has 12 members, at least seven members must be present, one of whom is a nonscientific member, during review of the protocols. The attendance of the vulnerable population representatives must be assured prior to the meeting and these representatives must be present during the discussion and vote of each study on the agenda that involves children or pregnant women, prisoners or veterans. To approve a project, the majority of the members present at the meeting must have voted for approval. Any HRRC member who is involved in any way in a research project being reviewed, or who has any other conflict of interest, may not participate in the deliberations (other than to provide information as requested), nor vote on it. The HRRCs’ policy is to have such member leave the room during deliberations. The meetings will be chaired by the Chair or Vice Chair, or in his/her absence, the Executive Chair.
HRRC members will discuss each project and vote to approve or disapprove the project or proposed modification to an already approved project, or to defer a decision until revisions are implemented, additional information is provided, or further expert review is obtained (including invitation of consultants, Section 3.4). The members will also determine the date of the next review of new or continuing projects. Under certain circumstances, if minor revisions in the submitted documents are required or a missing document of minor importance is to be obtained, the HRRC may delegate the Chair, Executive Chair, or primary reviewer to subsequently approve the project on behalf of the HRRC, upon completion of these tasks.
After each HRRC meeting, the HRRC Support Office will notify the principal investigator in writing of the outcome of the review. The investigator will be informed, in writing, of whether the project was approved, whether it requires revisions before approval may be granted, whether additional information is needed from the investigator before approval can be voted upon, or whether it was disapproved (in sufficient detail for the investigator to understand). The investigator will also be informed at the time of approval, in writing, when the next continuing review is required.
Normally, human research protocols must be received at least two weeks prior to the committee meeting at which they will be reviewed. This allows assigned reviewers enough time to conduct a thorough review prior to the scheduled meeting of the full committee.
On certain occasions, however, some protocols require a rapid response due to extenuating circumstance that fall beyond the control of the Principal Investigator. Protocols in this category may warrant a waiver of the required two-week submission period to allow a review by the HRRC at the earliest regularly scheduled meeting. These protocols will be designated "Time Sensitive" and will be placed on a "Fast Track".
The Executive Chair of the HRRC is responsible for reviewing protocols in this category, which must be submitted with a memorandum explaining the circumstances giving rise to the request in enough detail that the request may be considered. The Executive Chair will make a determination whether the protocol qualifies for special handling and if it does, will advance the protocol to the very next HRRC meeting for early review. * A memorandum will be sent to the investigator documenting the granting of this request.
*Please be reminded that most research protocols involving protected populations (fetuses, pregnant women, children, cognitively impaired persons, prisoners, or human invitro fertilization refer to section 6.3 on vulnerable subjects.) must go before the full committee for review and recommendations.
If an investigator disagrees with an HRRC request or decision, s/he may appeal that request/decision by submitting a written defense outlining, in detail, why the HRRC request/decision should be reconsidered.
If the appeal addresses a relatively minor request, the investigator’s defense will be considered at an administrative level. If the appeal addresses more substantive issues, the HRRC will appoint an appropriately constituted sub-committee to consider the issue. The sub-committee will be chaired by the HRRC Chair, Director, or Executive Chair.
The sub-committee will review the appeal and present it, along with their recommendations, to the full HRRC. If the HRRC has additional questions about the protocol and the appeal, they may invite the investigator to attend their next scheduled meeting.
The full HRRC will vote to approve or disapprove the appeal; this decision will be final.