Institutional Review Board

MVHS, Inc. Institutional Review Board

Mohawk Valley Health System (MVHS) is committed to protecting the rights and welfare of human subjects involved in research. Our Institutional Review Board (IRB) ensures research conducted at MVHS adheres to the highest ethical standards.

What is the IRB?

The Institutional Review Board (IRB) protects the rights, welfare and privacy of human subjects involved in research. This designated committee is scheduled to assembly periodically to review, approve, and monitor biomedical and behavioral research involving human subjects. In accordance to U.S. Food and Drug Administration (FDA) IRB has the authority to approve, require minor or major modifications in securing approval, or disapprove research protocols.  The IRB must comply with regulations established by the U.S. FDA and the Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services (HHS).

The IRB meeting schedule

The IRB meets monthly, for schedule and meeting dates, see below. Please confirm a specific meeting date if you have protocols which need full IRB review. Meetings are held virtually via Zoom. IRB submissions will be made available to the board no later than 7 business days prior to the scheduled meeting.

Contacts

IRB Main Office 

Mary Ann Healy Rodriguez PhD
Ph.D, RN, NEA-BC
Senior Vice President & Chief Quality Officer
IRB Committee Chair
Mohawk Valley Health System, Inc.
Wynn Hospital
mhealyro@mvhealthsystem.org

Linda Lovrin
IRB Coordinator 
Executive Secretary to the SVP/CQO and the Quality Management Department
Mohawk Valley Health System, Inc.
Wynn Hospital
llovrin@mvhealthsystem.org
315-917-7761

When is IRB Review Required?

1. Activities meeting the definition of research and involving human subjects must be submitted to the IRB for review.
2. If a research study is planned, an IRB review should be obtained BEFORE initiating the study protocol. 
3. Definitions:
   • Research: a systematic investigation designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)).
   • Clinical Trial: research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes (45 CFR 46.102(b)).
   • Human subjects: a living individual about whom an investigator (whether professional or student) conducting research
     • (i) obtains information/ data or biospecimens through observation, intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
     • (ii) obtains, uses, studies, analyzes, or generates information/ data or biospecimens. (45 CFR 46.102(e)(1))
   • Biospecimen: A sample of material, such as urine, blood, tissue, cells, DNA, RNA, or protein, from humans, animals, or plants. Biospecimens may be used for a laboratory test or stored in a biorepository to be used for research.
   • Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or subject’s environment that are performed for research purposes. (45 CFR 46.102(e)(2))
   • Interaction includes communication or interpersonal contact between the investigator and the subject. (45 CFR 46.102(e)(3)).
   • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). (45 CFR 46.102(4))

Before submitting a research proposal to the IRB, investigators and their staff must complete the following:

1. Required Training:
   • CITI Program: The CITI Program offers different training modules to ensure researchers understand the ethical considerations specific to their area of research. If your research role includes biomedical and social and behavioral research, please check Biomedical Research
     • Biomedical Research: is the broad area of science that looks for ways to prevent and treat diseases that cause illness and to develop programs to improve health and wellness. This general field of research includes many areas of both the life and physical sciences. This includes but is not limited to clinical trials, studies that involve behavioral or medical interventions or the development of public health programs. Most researchers at MVHS will fall into this category. 
     • Social & Behavioral Research: The term “social-behavioral” refers to human motivations, activities, psychological processes, and interactions (small groups, families, communities, and whole societies). Social-behavioral research applies the behavioral and social sciences to the study of humans. Such research is commonly conducted in the following academic disciplines: education, sociology, psychology, anthropology, economics, political science, and history. This includes but is not limited to curriculum development, survey research, focus groups, and behavioral observations.
     • Good Clinical Practice Modules: These specialized modules provide in-depth training for research teams. Select the GCP module that best aligns with your role in the research (e.g., investigators may need different training than research coordinators). There are also new modules available, including “Clinical Trial Billing Compliance,” and “Research Study Design.”
     • The link is https://www.citiprogram.org/and the institutional affiliation is Mohawk Valley Health System.

3. Current Curriculum Vitae (CV): Include a signed and dated copy of your CV with your IRB application. Document must be dated within the past two years and indicate that MVHS is the current place of employment.
4. Current medical licensure (as appropriate): Documentation of current MD, RN, NP, PA, pharmacy, phlebotomy, etc, licensure.

IRB Actions

The IRB can take several actions regarding review of your protocol. These include: exempt from review, expedited review or Full IRB review. The IRB reserves the right to postpone review of protocols at convened meetings due to incompleteness or needed revisions. A brief description of these actions is included below for reference.

Exempt: Includes reviews of existing data collections, specimens, documents as long as the patient data is not identifiable. It is reviewed by the IRB Chair or designated official.

Expedited: Involves minimal risk of harm or discomfort is no more than encountered in daily life, routine physical exam, or psychological exam. Clinical studies of drugs and medical devices when research is not a new drug application, or device is cleared for marketing and is in accordance with approved label use. Data collection noninvasive procedures employed in routine clinical practice. Materials collected solely for research purposes. Continuing review of previously done research investigation. Carried out by the IRB chair or designee.

Full IRB Review: When IRB determines risk is more than minimal/unacceptable, chair disapproves the research. When research is not complete within one year.