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Saybrook IRB

Welcome to the Institutional Review Board!

The Saybrook Institutional Review Board (IRB) ensures that all Saybrook faculty, staff, and students research is designed ethically to protect human participants. Following our federal-wide assurance (FWA# 00014486), the Saybrook IRB committee reviews research to ensure compliance with the requirements of the federal Health and Humans Services (HHS) Protection of Human Subjects regulations (45 CFR 46), state, and local regulations.

Saybrook Institutional Review Board (IRB)

The Saybrook Institutional Review Board (IRB) ensures that all Saybrook faculty, staff, and students research is designed ethically to protect human participants. Following our federal-wide assurance (FWA# 00014486), the Saybrook IRB committee reviews research to ensure compliance with the requirements of the federal Health and Humans Services (HHS) Protection of Human Subjects regulations (45 CFR 46), state, and local regulations.

Reseach with Human Subjects

Researchers are responsible for obtaining appropriate IRB approval before conducting research involving human subjects (called "participants" at Saybrook given our humanisitc psychology origins). The need for approval rests on three seemingly obvious but not always easy-to-interpret considerations: 1) whether the work qualifies as research, 2) whether it involves human subjects, and 3) whether it is exempt (please see more about this in the Starting an Application section). All three considerations are discussed in the Code of Federal Regulations (called the "Common Rule") and guide decision making about the use of human subjects in research. The authority to make decisions about the need for approval rests with the IRB. 

Research. The Common Rule defines research as “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (§ 46.102(d)). This means that a project or study is research if it:

  • is conducted with the intention of drawing conclusions that have some general applicability, and
  • uses a commonly accepted scientific method.

The random collection of information about individuals that has no general applicability is not research. Scientific investigation that leads to generalizable knowledge is.

Human Subjects. Human subjects are “living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information” (§ 46.102(f)). Humans are considered "subjects" and covered by Federal regulations if the researcher:

  • interacts or intervenes directly with them, or
  • collects identifiable private information.

If one of these two conditions applies and if the project or study qualifies as research, then IRB approval is needed before any work is undertaken.

https://ori.hhs.gov/content/chapter-3-The-Protection-of-Human-Subjects-Definitions

Under federal regulations, an Institutional Review Board (IRB) is a group formally designated to review and monitor research involving human participants. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research participants.

The purpose of IRB review is to ensure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and recruitment materials) to protect the rights and welfare of human research participants.

In 1974, the National Research Act codified 45 CFR 46, the regulations related to the Protection of Human Subjects that established the IRB. In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report, which established the ethical principles underlying the use of human research participants and created guidelines for medical and psychological and behavioral research.  The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is the federal administrative agency that monitors IRBs, their activities, and compliance.

The mission of an IRB is to protect the rights, welfare and ethical considerations of human subjects research (called participants at Saybrook, given our humanistic psychology underpinnings).   Each IRB must have at least five members, with varying backgrounds to complete adequate reviews of research activities conducted by the institution's PIs and Co-PIs.  IRB membership is comprised of "scientists" (members whose training and background would incline them to view research within a behavioral or biomedical context), "non-scientists" (members whose training and background would incline them to view research outside of a behavioral or biomedical context), and one "comunity" member (sometimes called "external" or "nonaffiliated") who is not otherwise directly associated with the institution. The non-scientist and community member may be the same individual.  At Saybrook, faculty members are considered "scientists," while "non-scientists" and "community members," are people who would be senstitive to such isses as community attitudes.   Currently at Saybrook, we have a Full Board of 11 members; 10 faculty/scientist members and 1 non-scientist who is also external to our institution.    

 

Office of Research Innovation & Sponsored Programs

The Saybrook Office of Research Innovation and Sponsored Programs (ORISP) advances and promotes research, scholarship, and creative activities through excellent education and training, administrative support, and by cultivating a culture of equity, inclusiveness, transparency, integrity, and rigor.

The Saybrook Office of Research Innovation and Sponsored Programs builds research capacity through education, collaboration, and service.  The Office of Research Innovation and Sponsored Programs is comprised of four units: