The timeline depends on many factors including the risk to participants, level of review, and questions from reviewers. Submit your research early to make sure it is reviewed and/or approved before you need to execute.  

Exempt research is social, behavioral, or educational research that is minimal risk and fits into one or more of eight exempt categories as specified in 45 CFR 46.104. This research can be reviewed by an Exempt Determination Official (EDO) and does not necessarily need to be reviewed by an Institutional Review Board (IRB). Non-exempt research does not meet the definitions of exempt research and must be reviewed by an IRB. 

The term “expedited” can be misleading. This review is not necessarily quicker than Institutional Review Board (IRB) review that occurs at a convened meeting. Non-exempt research protocols that can be reviewed using expedited procedures must present no more than minimal risk to human subjects and must fit into one of the seven expedited categories as listed in the Federal Register. These protocols can be reviewed by one or more experienced IRB members instead of at a convened IRB meeting. The standards for review and approval are the same for “expedited” and “convened” board review. 

Yes. A trained Exempt Determination Official (EDO) is the only person who can determine if a research project is exempt. A researcher cannot make that determination. 

Yes. Depending on the nature of the entire data set, this research may be exempt, but a review and determination by an Exempt Determination Official (EDO) is still required. 

Yes. Publishing your research is not a criterion that determines whether your project is human subject research or whether it needs review. 

Maybe. If you are using data collected from humans, especially if it is USMA data or sensitive in nature, you will likely need a review. If you are using a dummy data set, you do not need a review. Contact the HRPP office at HRPP@westpoint.edu to discuss the details of your project. 

Depending on the details of your project, you may require additional reviews beyond those conducted by the USMA HRPP and/or Institutional Review Board (IRB). If you are using USMA data or administering a survey to USMA personnel, your request must be adjudicated by the USMA Institutional Research Committee (IRC). If you are receiving funding for your project, conducting international research, using large-scale genomic data, collecting data from the public, or collaborating with external institutions, you may also have additional review requirements. Contact the HRPP office at HRPP@westpoint.edu to discuss the details of your project. 

IAW the Belmont Report, cadets have the right to voluntarily participate in research, to withdraw from a study at any time, and to refuse to participate without consequences. It is imperative that the researchers create a recruitment and enrollment plan that maintains this standard, and that the cadet participant is truly a volunteer in the research. There must be no perceived or real coercion or undue influence and the researcher must consider how their role as a faculty member is perceived by the cadet. 

Yes. Just like faculty members, cadet researchers must ensure that research participants are volunteers and that their own rank/status does not result in perceived or real coercion or undue influence. 

The researcher must keep all documentation of human subject research (both exempt and non-exempt) for a minimum of three years after completion or termination of the study (or six years if the research includes HIPAA-protected data). This requirement includes all regulatory documents, informed consent documents, data collection forms, surveys, etc. Sometimes there is a good reason to de-identify or delete study data before three years in an effort to protect the participants. However, any exceptions to maintaining the data for three years must be documented in the protocol and reviewed/approved by the Exempt Determination Official (EDO) or Institutional Review Board (IRB). The researcher is required to comply with the approved protocol as written. This exception, when written in the protocol, can only apply to data and cannot apply to informed consent or regulatory documents.  

A modification request must be submitted when any aspect of the research (both exempt and non-exempt) is altered. Changes cannot be executed until a determination or approval is received from the Exempt Determination Official (EDO) or the Institutional Review Board (IRB). 

Each event is different. Contact the USMA HRPP at HRPP@westpoint.edu to discuss the appropriate actions. 

The researcher is responsible for maintaining all documentation of research (both exempt and non-exempt) for a minimum of three years after completion or termination of the study (or six years if the research includes HIPAA-protected data). This requirement includes all regulatory documents, informed consent documents, data collection forms, etc. If the researcher is scheduled to leave USMA before three years after the protocol has been closed (or six years if the research includes HIPAA-protected data), the researcher must transfer custody of study records (both paper and electronic) to a knowledgeable colleague. The researcher must enact this change by submitting the appropriate modification paperwork.