Our collective efforts are guided by our plan.

More than a program

At the Health Sciences, we aim to promote a culture of compliance with the highest legal and ethical standards and we are committed to the education of our research community and outreach to our collaborators and communities we serve.

Principles

WMA Declaration of Helsinki

Ethical principles for medical research involving human subjects

Belmont Report

Respect for Persons

Involves the recognition of the personal autonomy and dignity of individuals, and the need for special protections of individuals with diminished autonomy. Under this principle, individuals must be given sufficient information to decide whether to participate in a study, they must be able to comprehend the information, and their consent must be given voluntarily and free from coercion and undue influence. Respect for Persons also means honoring the subjects' privacy and confidentiality.

IRBs are expected to be particularly sensitive to these factors when vulnerable subjects are involved, and ensure that extra measures are taken to protect the immature and incapacitated. IRBs may even require that they be excluded from participating in certain research.

Beneficence

Entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. This principle requires assessing the nature and scope of the risks and benefits. All possible harms must be considered; not just physical and psychological injury. All possible benefits including societal benefits that might be gained from research must also be considered. Benefits to the subjects, or generalizable knowledge to be gained from the research should always outweigh the risks.

In assessing the risks and benefits, the appropriateness of involving vulnerable populations is considered.

Justice

Requires that the benefits and burdens of research be distributed fairly. Subjects must be fairly selected and may not be selected either because they are favored by a research or held in disdain. Social justice requires an order of preference in selection of classes of subjects, for example, adults before children. The principle cautions that researchers should not systematically select subjects because of their easy availability, their compromised position, or their social, racial, sexual, or economic position, or because of cultural biases institutionalized in society. Investigators should base inclusion criteria on those factors that most appropriately address the research problem.

Regulations

Department of Health and Human Services

Food and Drug Administration

Policies

The University of New Mexico

Public Responsibility and Accountability

We are committed to ensuring that all of the human subjects research conducted by our investigators are done at the highest standards.

Our compliance statement Delegation of authority

UNM Health Sciences Institutional Review Board

At the Health Sciences, we have 3 federally mandated Institutional Review Boards (aka Human Research Review Committee - HRRC).

Authority

Approve, require modifications to secure approval, defer, and disapprove all human research overseen and conducted by the organization, with the exception of approved external IRBs as provided in the Investigator’s Manual. All human research must be approved by a HRRC designated by the Institutional Official. Officials of this organization may not approve human research that has not been approved by the HRRC or an approved external IRB as provided in the Investigator’s Manual.
Suspend or terminate approval of human research not being conducted in accordance with the HRRC's requirements or that has been associated with unexpected serious harm to subjects.
Observe the consent process and the human research process.
Determine whether an activity is human research.
Evaluate financial interests of investigators and research staff and have the final authority to decide whether the financial interest and management plan as written, allows the human research to be approved.
Place limitations or conditions on an investigator's or research staff's privilege to conduct human research, related to non-compliance with approved protocols

Responsibility

IRB members have the responsibility to follow and apply Human Research Protection Program policies and procedures that apply to the IRB members.

The members of the IRB volunteer their time to serve on the committees. Members are expected to:

Attend one meeting per month.
Thoroughly review study documents prior to the meeting.
Participate in meeting discussions.
Serve for a minimum of 3 years.

Connect with us if you are interested in serving on one of the IRBs.

Required trainings for prospective members:

CITI Human Research Protections online training modules
- Create an account at citiprogram.org (University of New Mexico Health Sciences Center affiliate)
- Required Modules: Biomedical Responsible Conduct of Research HRRC Members and Staff Basic Course
Huron IRB system training
- Log in through Learning Central
- Course: HSC 115-001
In-person training with a senior staff member to review responsibilities of an IRB member's completion of Click IRB Reviewer Workbook, and a competency test.

UNM Health Sciences Institutional Review Board

Institutional Review Board

At the Health Sciences, we have 3 federally mandated Institutional Review Boards (aka Human Research Review Committee - HRRC).

Authority

Approve, require modifications to secure approval, defer, and disapprove all human research overseen and conducted by the organization, with the exception of approved external IRBs as provided in the Investigator’s Manual. All human research must be approved by a HRRC designated by the Institutional Official. Officials of this organization may not approve human research that has not been approved by the HRRC or an approved external IRB as provided in the Investigator’s Manual.
Suspend or terminate approval of human research not being conducted in accordance with the HRRC's requirements or that has been associated with unexpected serious harm to subjects.
Observe the consent process and the human research process.
Determine whether an activity is human research.
Evaluate financial interests of investigators and research staff and have the final authority to decide whether the financial interest and management plan as written, allows the human research to be approved.
Place limitations or conditions on an investigator's or research staff's privilege to conduct human research, related to non-compliance with approved protocols

Responsibility

IRB members have the responsibility to follow and apply Human Research Protection Program policies and procedures that apply to the IRB members.

Member commitment

The members of the IRB volunteer their time to serve on the committees. Members are expected to:

Attend one meeting per month.
Thoroughly review study documents prior to the meeting.
Participate in meeting discussions.
Serve for a minimum of 3 years.

Volunteer your time to human research

Connect with us if you are interested in serving on one of the IRBs.

Required trainings for prospective members:

CITI Human Research Protections online training modules
- Create an account at citiprogram.org (University of New Mexico Health Sciences Center affiliate)
- Required Modules: Biomedical Responsible Conduct of Research HRRC Members and Staff Basic Course
Huron IRB system training
- Log in through Learning Central
- Course: HSC 115-001
In-person training with a senior staff member to review responsibilities of an IRB member's completion of Click IRB Reviewer Workbook, and a competency test.

FWA# 00003255

UNM Health Sciences Human Research Protections Program

Brad Dolin, JD
UNM Health Sciences HRPP director

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Physical location:
Fitz Hall, B71

Mailing address:
MSC 08 4560
1 University of New Mexico
Albuquerque, NM, 87131-0001

Call: 505-272-1129
Email: hsc-hrpo@salud.unm.edu