Overview: Institutional Review Board Review Considerations

Reviewing Proposals

The IRB reviews proposals monthly.

  • Review begins on the first of each month.
  • If more information is needed to do the review, the primary investigator will be contacted by email. Upon receipt of the requested information, the proposal will be re-reviewed.
  • Decisions are made by the 15th of the month the completed proposal is submitted (or the next business day if the 15th falls on a day the college is closed).
  • If the requested information is not received before the 15th of the month, the proposal will be rolled over into the next month.

Policy for Protecting Subjects

Empire State College is responsible for the protection of the rights and welfare of people who volunteer to participate as subjects in research projects conducted under the auspices of the college.

  • In accordance with state laws and federal regulations, the college has a policy for protecting human research subjects.
  • The Institutional Review Board is the body charged with implementing that policy. In reviewing research proposals, the IRB ensures that researchers apply established ethical principles in research projects involving human beings.
  • To protect the subjects, college and researcher, for each proposal the IRB evaluates:  
    • the risks and benefits of participation to the subjects
    • equity in subject selection
    • informed consent for the subjects
    • privacy of personal information
    • confidentiality of data.

After determining that a project is research involving human subjects, the reviewers evaluate the project's:

  • contribution
  • value
  • design.

Elements of the Proposal

The proposal must be written so that someone unfamiliar with the field and subject can make sense of them, and should include:

  •  the statement of the problem
  • a fully developed methodology
  • the argument for the research and the methodology
  • a literature review that supports those arguments.

A fully developed proposal is required before a review can take place and judgments can be made.

  • A well-documented argument for the contribution and value of the project provides information needed to determine the risks and benefits of the project.
  • The project design and detailed description of the methodology provide information about the risks associated with a project.

The four pieces of information necessary for a complete proposal are:

  1. The proposal should be grounded in the literature of the field and make the case for the research project.It should address the following questions in a clear and reasoned way. Aside from direct benefits to the subjects, other benefits of the research generally arise from the contribution that the research makes to the field. The proposal must consider:
    • Why is the study important? What is its significance?
    • What will the project add to the knowledge base? How does it contribute to the field?
    • To what extent does it relate to other research, in both the field and in related fields?
    • What will the project do to help the subjects, the population and/or society?
    • What work has been done or what already has been written that supports the arguments for these questions?
  2. The methodology should be clearly defined and fully described.
    • Risks generally arise from the research methods and the data collected; they must be clearly delineated.
    • The methodology section should include the procedures for subject selection, informed consent, maintaining confidentiality, data collection, debriefing subjects and closing down the project. It should descibe interventions and interactions with the subjects and any private information that may be collected.
  3. The researcher is responsible for the first analysis of the risks and benefits of the project.  Faculty advising students on research projects have a responsibility to make a judgment about the efficacy of the project and whether the benefits outweigh the risks. Only with a clear statement of purpose, rationale for the project and well-defined methodology in place can a risk-benefit analysis be made. 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.
  4. Once the researcher and faculty advisor (if the researcher is a student) have made a good argument for the research project and are sure that the benefits outweigh the risks, the details of human subjects' protection must be addressed.  They should be included in the methodology section of the proposal, and address:
    • who will be the subjects and how and why they will be selected
    • how any special or vulnerable subjects will be protected
    • informed consent (and assent) procedures
    • how the researcher will monitor the project to identify flaws in the study design early in the project and to reevaluate the risks to human subjects to assure they are no greater than initially predicted
    • maintaining confidentiality of the data collected
    • how the project will be closed down
    • the researcher's ability to carry out the project.

When these four elements are in place, the proposal is submitted to the IRB chair, who will determine if s/he can review it under an expedited process or if it requires review by the full IRB. Presenting a well-reasoned proposal makes this process work efficiently.

Responsibilites of the IRB

The IRB must ensure:

  • risk to the subjects is minimized and anticipated benefits are sufficient to justify the risk
  • existence of sufficient informed-consent/assent processes and documentation that protect subject autonomy and voluntary participation
  • equitable selection of subjects
  • subjects' privacy and that the confidentiality of data are protected.

The IRB has the authority and the responsibility to disapprove any research project that does not meet all of these requirements.