PHS Institutional Review Board
Presbyterian Healthcare Services’ (PHS) Institutional Review Board (IRB) serves as a review board for all human subjects protocols involving biomedical and behavioral research conducted at PHS and all research proposals from requesting staff members of the PHS Medical, Dental or Allied Health personnel.
Welcome to the Presbyterian Healthcare Services Institutional Review Board (PHS IRB)
The PHS IRB has been established to assure the protection of all human subjects in research projects conducted by anyone on the premises of clinics or facilities in the Central or Regional Delivery Systems and for research conducted elsewhere by faculty, students, staff, or non-affiliated practitioners in connection with their request to work with PHS patients.
What is an Institutional Review Board (IRB)?
An IRB is a committee whose primary responsibility is to protect the rights and welfare of human research subjects and to perform ethical review of proposed research. The IRB seeks to create a collaborative relationship with the research community to assure that research with human subjects is conducted in accordance with legal requirements and ethical principles of Respect for Persons, Beneficence and Justice.
In accordance with Department of Health and Human Services (DHHS), Office of Human Research Protections and the Food and Drug Administration (FDA) regulations, an IRB reviews research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects can participate in the research. The authority conveyed to the IRB includes decisions to approve, disapprove, require modifications, monitor, suspend and terminate research projects involving human subjects.
The IRB also ensures that human subjects are only allowed to volunteer to participate in research after the Primary Investigator has provided legally effective informed consent. Investigators may not solicit subject participation or begin data collection at Presbyterian Healthcare Services until they have received approval from the PHS IRB or written concurrence that the research has been determined to be exempt from IRB review.
Certain populations of human subjects may be particularly vulnerable in a research setting, e.g., children, prisoners, pregnant women, fetuses, persons with physical or mental disabilities, and economically or educationally disadvantaged persons. When reviewing research involving these subject populations, the IRB will apply additional protective safeguards as required by federal and state law, institutional guidelines, and any other applicable agency/entity regulations.
Membership and Composition of the IRB:
In accordance with Health and Human Services Regulations for Protection of Human Subjects (45 CFR 46), an institutional review board committee, composed of members from a variety of scientific disciplines as well as community members, assists investigators in the protection of the rights and welfare of human subjects. The PHS IRB is composed of a dedicated group of volunteers from practitioners within and from outside of PHS, and members from the surrounding community, this includes a Chair (Jeffrey Huser, MD) a Vice-Chair (Charles Lohr, III, MD), members, and alternate members, as well as consultants to the IRB. The IRB also serves to facilitate valuable human subject research as well as protect the investigator and the institution through a comprehensive review process. All human research projects must be reviewed and approved by the IRB prior to initiation and then conducted in full compliance with the IRB guidelines.
The PHS IRB holds a Federalwide Assurance (FWA#: FWA00006178) from the Office for Human Research Protections (OHRP) in the Department of Health and Human Services. This FWA is an agreement between DHHS and the IRB to review and approve federally-sponsored research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46.
Meeting Dates and Deadlines
The PHS IRB meeting is on the fourth Tuesday of each month except in December when it meets on the third Tuesday of the month. All materials that are going to reviewed by the IRB should be submitted no later than the end of the first week of the month to: PHS Medical Education and Research, Attn: Lisa Nowakow, 1100 Central Ave SE, Floor S-1; Albuquerque, NM 87106 or emailed to Lisa Nowakow at email@example.com. Deadlines for paper and electronic submissions are 4:30 p.m. Please note: If you are making an electronic submission, you must complete your department's internal review process by the 4:30 p.m. deadline.
Where can I call to speak with the IRB Coordinator?
Please call or email Lisa Nowakow at 505-841-1436 or email her at firstname.lastname@example.org .