Research Support Resources and guidance for every stage of research. FAQs for Researchers FAQs for Research Participants Research Support Resources and guidance for every stage of research. FAQs for Researchers FAQs for Research Participants Breadcrumb research research support Faculty Learning, Innovation, Collaboration, and Research (left) MENU Research Homepage Research Offices Partner with West Point Centers & Institutes Cadet & Faculty Research Research Support USMA Library West Point Press Human Research Protections Program (HRPP) USMA HRPP Mission: To advance a growing research program that supports cadet and faculty research and to foster collaborative relationships with regulatory partners and external researchers to achieve expeditious compliance.USMA HRPP Vision: USMA HRPP is a community of cadets, researchers, and administrators with diverse backgrounds and perspectives who collectively produce high-quality research, while remaining in compliance with all applicable regulations and striving for high ethical standards and professionalism. Contact HRPP What Is the Difference Between Exempt and Non-Exempt Research? Exempt research is social, behavioral, and 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. At USMA, both exempt and non-exempt research is submitted for review in Cayuse. Before You Start Read the HRPP Wiki to gain a basic understanding of the process.Get familiar with USMA Regulation 70-25, Human Research Protections Program (HRPP). Request a Cayuse account at HRPP@westpoint.edu and review the Cayuse User Guide.Complete Human Subject Research Training. Submit questions or schedule a meeting with USMA HRPP at HRPP@westpoint.edu. Guiding Principles and Regulations Belmont Report Nuremberg Code Declaration of Helsinki Research Regulations: 45 CFR 46 Department of Health and Human Services, Protection of Human Subjects, (The “Common Rule”)32 CFR 219 Department of Defense, Protection of Human SubjectsDoDI 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and –Supported Research DoDI 3210.7 Research Integrity and MisconductArmy Regulation 70-25 Use of Volunteers as Subjects of ResearchUSMA Regulation 70-25 Human Research Protections Program (HRPP) 10 U.S.C. 980 Limitation on use of humans as experimental subjects24 U.S.C. 30 Payments to donors of blood for persons undergoing treatment at Government expense Other Regulations: Defense Federal Acquisition Regulation Protection of Human Subjects ClauseArmy Regulation 25-98 Information Management Control Requirements Program DoDM 8910.01 Volume 1 DoD Information Collections Manual: Procedures for DoD Internal Information CollectionsDoDM 8910.01 Volume 2 DoD Information Collections Manual: Procedures for DoD Public Information Collections HIPAA Health Insurance Portability and Accountability Act of 1996 Getting Started Forms, Checklists, and Templates End of Academic Year Annual ReportUSMA Informed Consent Guide with TemplatesUSMA Conflict of Interest Disclosure USMA Scientific Review FormUSMA Data Sharing Agreement TemplateUSMA Command Support Letter Instructions USMA Command Support Letter TemplateCadet Biosketch TemplateUSMA Site-Specific Addendum Template Training: Investigators (including principal, associate, and cadet investigators) engaged in exempt or non-exempt research, must complete approved human subject research training prior to initiating research. Investigators must maintain current training throughout the entire life of the protocol by completing a refresher course (see CITI Training Instructions) before the expiration of their training (every three years). Investigators who engage in biomedical research and/or utilize data that is protected by the Health Information Portability and Accountability Act (HIPAA) must complete HIPAA training. This training is available through the DoD’s Joint Knowledge Online website. Resources: Regulatory Binder Infographic New Investigator Guidance - Non-Exempt ResearchNew Investigator Guidance - Exempt Research New Investigator Guidance - Non-Exempt ResearchNew Investigator Guidance - Exempt Research Cayuse Information Request an Account: Send an email to HRPP@westpoint.edu to request a Cayuse account. As soon as your account is created you will receive an email from Cayuse with instructions for changing your password. Complete this step ASAP because it can take 24-48 hours to activate your account and you will not be able to begin your protocol submission until your account is activated.Additional Resources:Cayuse User Instructions for InvestigatorsCayuse Submission and Certifying Instructions Reporting Requirements For more detailed information about reporting requirements, see Chapter 13 of USMA Regulation 70-25. Adverse Event Definition: Any abnormal, untoward, or unfavorable occurrence in a human subject occurring during or in close proximity to the end of the subject’s participation in the research, whether or not considered related to participation in the research.Reporting Requirements: Reporting requirements are dictated by the category of event – serious, anticipated, or unanticipated (UPIRTSO). Serious Adverse Event (Must be REPORTED PROMPTLY) Definition: An adverse event in which the subject dies, is at substantial risk of dying (whether at the time of intervention or as a result of continued exercise of intervention), is hospitalized, becomes disabled or otherwise permanently harmed, or when other intervention is required to prevent permanent harm to the subject. Reporting Requirements: Must be REPORTED PROMPTLY (within 1 business day) to the USMA Human Protections Director (HPD) by email at HRPP@westpoint.edu or in person. Within 10 days, a complete written report must follow the initial notification. The HPD will notify the IRB and the Army Human Research Protections Office (AHRPO) within 5 business days or receipt of the initial report. Anticipated Adverse Event Definition: An event that poses a risk to the subject, but is identified and mitigated in the protocol.Reporting Requirements: Must be reported no later than at the time of continuing review (for protocols requiring continuing review) or within 90 days (for protocols not requiring continuing review) unless the risks to subjects require other immediate action. UPIRTSO (Must be REPORTED PROMPTLY) Definition: (Also described as an unanticipated adverse event) is any incidence, experience, or outcome that meets all three of the following conditions: 1) is unexpected, 2) is related or possibly related to participation in the research, and 3) suggests that the research places human subjects or others at a greater risk of harm than was previously known or recognized, even if no harm has actually occurred.Reporting Requirements: Must be REPORTEDLY PROMPTLY (within 1 business day) to the USMA HPD by email at HRPP@westpoint.edu or in person. If the research is non-exempt, the HPD will notify the IRB and the AHRPO within 5 business days of receiving the initial report. Deviation Definition: Incident involving a departure from the IRB-approved protocol in the actual conduct of the study, resulting from the action of the participant, investigator, or staff. Reporting Requirements: Reporting requirements are dictated by the category of event – minor or major. Minor Deviation Definition: Deviation that does not adversely affect human subjects or the integrity of the study data. Reporting Requirements: Must be reported to the HPD as soon as possible but no later than at the time of continuing review (for non-exempt protocols that require continuing review) or within 90 days (for exempt research or non-exempt protocols that do not require continuing review). Major Deviation (Must be REPORTED PROMPTLY) Definition: Deviation that may adversely affect subjects’ rights, safety, welfare, or willingness to continue participation, or may affect the scientific design of the study or the integrity of the resultant data. Reporting Requirements: Must be REPORTED PROMPTLY (within 1 business day) to the HPD via email at HRPP@westpoint.edu or in person. The HPD will notify the IRB within 5 business days of receiving the report. Within 10 business days, a complete written report must follow the initial notification and must include a description of the deviation, the plan to mitigate its negative effects, and the plan to minimize or eliminate future occurrences. Noncompliance Definition: A failure (intentional or unintentional) of a person, group, or institution to act in accordance with the regulations, policies, or requirements or determinations of the IRB.Reporting Requirements: Anyone (including investigators, research staff, human subjects, or anyone who witnesses research noncompliance) can report suspected noncompliance to the HPD. Serious Noncompliance (Must be REPORTED PROMPTLY) Definition: Noncompliance that places the health, safety, or confidentiality of participants at increased or unnecessary risk.Reporting Requirements: Must be REPORTED PROMPTLY to the USMA HPD who will inform the Institutional Official (IO)/Alternate Institutional Official (AIO) and the IRB Chair (for non-exempt research). Continuing Noncompliance (Must be REPORTED PROMPTLY) Definition: Noncompliance that is repeated and indicates a concern about the competency of the investigator to continue to conduct the research.Reporting Requirements: Must be REPORTED PROMPTLY to the USMA HPD who will inform the IO/AIO and the IRB Chair (for non-exempt research). Post Approval Compliance Monitoring (PACM) Compliance through Education Regulatory Binder mini audits are scheduled in the first few weeks after initial IRB approval. Regulatory Binder InfographicRegulatory Binder PACM Checklist Informed Consent mini audits are scheduled based on the informed consent and enrollment timeline of the protocol.Informed Consent Documents InfographicInformed Consent PACM Checklist Study Data and Forms (both hard copy and electronic) mini audits are scheduled based on the data collection timeline of the protocol.Study Data and Forms PACM Checklist End of Academic Year Annual Report USMA is an academic institution with frequent personnel turnover. Most changes occur during the summer months between academic years. For this reason, it is important to actively monitor protocols during this time to ensure that personnel (and other) changes are adequately addressed to remain in regulatory compliance. All Principal Investigators with an open non-exempt protocol must submit an End of Academic Year Annual Report form to HRPP@westpoint.edu no later than the end of each spring semester. USMA Assurance: USMA maintains a DoD Assurance issued by the Army Human Research Protections Office (AHRPO). This Assurance covers the departments that are direct reporting units to the USMA Superintendent including the Office of the Superintendent, Office of the Dean of the Academic Board, Office of the Commandant, Directorate of Admissions, Office of the Directorate of Intercollegiate Athletics, United States Military Academy Preparatory School, and the USMA Band. FAQs Still have questions? Please review frequently asked questions for researchers and for research participants. FAQs for Researchers FAQs for Research Participants Support for Faculty For additional resources and support, West Point staff and faculty can access the password-protected Office of Research internal resources page. Explore resources for West Point research staff and faculty