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Compliance

Human Subjects Institutional Review Board (HSIRB)

Common application mistakes

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Your attention to the items listed below will speed the processing of your HSIRB application and will be greatly appreciated by the Board.

1. Indicate the level of review which is being requested from the HSIRB and select the rationale from the drop down menu, based on the information provided in the "Guidelines for Human Subjects Research at WMU." The original application submitted to the HSIRB must include
   the original signatures of the investigators; photocopies or facsimile copies of signatures will not be accepted as substitutions for the original application.

2. Do not include a full thesis or dissertation proposal. Similarly, grant proposals prepared for submission to a funding agency should not be submitted to the HSIRB (all proposals must follow the HSIRB format outlined on page 2 of the application form).

3. Remember to specify the method, location, and duration of on-campus data storage. University and HSIRB policies require that the principal investigator or faculty advisor keep and securely store raw data for at least three years. Student investigators may retain a copy of the data. Data may be retained indefinitely or destroyed after the three-year period at the discretion of the investigator(s). Provisions for all of these points need to be explained in the protocol and, if applicable, the consent document.

4. The HSIRB makes a distinction between the confidentiality and anonymity of data. Confidentiality means that, as the researcher, you know the subject's name but you will not release that name in sharing the data with others. This applies both to direct knowledge and to names kept separate from the collected data, usually through the use of a coding master list. Anonymity means that even you do not know the names of the subjects who participated in the study except by the signing of a consent document if one was necessary, and there is no way to determine which subject produced which data. There is no master list or coding involved in anonymous data collection, while master lists and coding are an integral part of maintaining confidential data.

Questions? E-mail the research compliance coordinator