General Information

Is it Research?

GOALS OF UMF IRB

The primary goal of the IRB is to assure that the rights and welfare of human subjects participating in research are adequately protected.

UMF IRB reviews all planned research involving human subjects prior to initiation of the research, approves research that meets established criteria for protection of human subjects, and monitors approved research to ascertain that human subjects are indeed protected. Further, through educational sessions and focused discussions, the IRB educates the research community on ethical and procedural issues related to human subjects protection.

The IRB office requests that researchers allow at least a thirty day window for a completed eResearch application to go through the approval process.

WHO WE SERVE

The colleges and schools submitting proposals to the IRB include:

  • College of Arts & Sciences
  • School of Education of Human Services
  • School of Health Professions and Studies
  • School of Management

 

DEFINITIONS FOR THE USE OF HUMAN SUBJECTS IN RESEARCH

The following federal definitions apply to all research reviewed by UMF IRB.

Human Subject (45 CFR 46.102(f)):
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) indentifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e. the identity of the subject is, or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Research (45 CFR 46.102(d)):
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes (for example, some demonstration and service programs may include research activities).

Minimal Risk (45 CFR 46.102(i)):
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

MONITORING OF RESEARCH

UMF IRB is authorized and organized to review any and all types of research in which human subjects are involved, including projects that are not subject to federal oversight.

AUTHORITY OF UMF IRB

The UMF IRB employs a review process in conformity with the Federal Policy for the Protection of Human Subjects (45 CFR 46) and the Federalwide Assurance (FWA) enacted between the University of Michigan and the Office for Human Research Protections (OHRP) under the Department of Health and Human Services (DHHS).

The review process is the same for all research involving human subjects supported or otherwise subject to regulation by any federal department or agency, sponsored by any other extramural entity, or initiated and funded within the University of Michigan.

The authority conveyed to the UMF IRB includes decisions to approve, disapprove, require modifications, monitor, suspend and/or terminate research projects involving human subjects. Under no circumstance may a decision of the UMF IRB to disapprove a project be reversed by another agency of the University of Michigan.

Certain populations of human subjects may be particularly vulnerable in a research setting: children, prisoners, pregnant women, fetuses, mentally disabled persons, economically or educationally disadvantaged persons. In undertaking its review of these subject populations, UMF IRB will apply additional protective safeguards as required by federal and state law, institutional guidelines, and any other applicable agency/entity regulations.