Human Subjects Committee
Review Levels / Categories
There has been some confusion over the categories of research reviewed by the Committee. We hope the following information will clarify the meaning of the categories and the implications for review under them. According to IU policy and its agreement with the federal government, all research involving human subjects conducted by persons associated with IU, regardless of where the research is done or what category of review it falls into, must be submitted to the Committee for review.
Researchers not affiliated with IU, who wish to come onto the IUN campus to conduct research, must either provide an approved application from an IRB at an institution with a Multiple Project Assurance, or submit a new application to the HSC. Either type of application must be sponsored by one or more full-time IUN faculty, librarian, salaried clinical rank, or research rank appointee. See the section Researcher Responsibility for a list of allowable sponsor ranks.
All research involving human subjects falls into one of three categories:
1) Full Review
All research is presumptively in this category unless it meets certain exceptions, as described below. The term "full review" refers to review before the full committee, which meets once a month. Investigators must fill out the pages for a "full" review. Signed informed consent is required from all subjects or their legal guardians. A sample Informed Consent Statement is included in the application packet to assist investigators. Multi-year studies in this category will receive full committee review throughout the life of the project. Continuing reviews will be required until the project's completion. Full review applications are reviewed monthly. Comments can be expected within a week of the meeting.
2) Expedited Review
Some research may be reviewed by the chair of the Committee or by one or more experienced reviewers designated by the chairperson from among members of the HSC, if the research falls into certain categories defined by the federal government and if, in the discretion of the chair, review by the full Committee is not necessary. A list of the types of research that may qualify for expedited review is provided in the application packet. For clarification contact the Committee's office (219-981-5646). Investigators must fill out the pages for an "expedited" review. Signed informed consent is required from all subjects or their legal guardians. A sample Informed Consent Statement is included in the application to assist investigators. Continuing reviews are required for projects at this level of review. Applications at this level are reviewed weekly. Comments can be expected shortly after the weekly review.
3) Exempt Review
Under the federal regulations certain types of research are exempt from review, unless the institution chooses to review it. Under IU policy, ALL research involving human subjects must be reviewed and approved prior to commencement of the research, including research that falls into a federal" exempt" category. The categories of research which qualify as exempt are set forth in the Exempt Research Checklist. Investigators planning to conduct "exempt" research must fill out the Exempt Research Checklist and Research Statement and submit it to the HSC for approval by the chairperson prior to beginning any research. It is the Committee's practice to require signed parental informed consent when minors are involved, but, in most cases, not to require signed informed consent from adult subjects in exempt research projects. The HSC does, however, generally require that information about the research be given to subjects normally in written form in a "Study Information Sheet". A sample study information sheet is included in the application to assist investigators.
Research using existing data, documents, or specimens must have no identifiers attached in order to qualify for exempt level review under category 4. The researcher must describe the information provided in the data set and the number of subjects involved when the data was originally collected. Project start and end dates should be the time period the data set will be in use for the research project.
Continuing reviews are not required for "exempt" research, but investigators are required to notify the HSC of any changes to the project and when the project is completed. About one month after the indicated ending date, the HSC will send a notice to the investigator asking about the status of the project. The form should be completed and returned to the HSC for processing by the office staff. Applications involving research in this category are reviewed by the chair of the Committee on a weekly basis. Comments can be expected shortly after the weekly review.