1.0 Policy Purpose
The Brown University Human Research Protection Program (HRPP) and Institutional Review Board (IRB) require that individuals responsible for the conduct of human subjects research activities under a Brown HRPP or Brown IRB approved human research application receive appropriate education and training to ensure the protection of human research participants. The purpose of this policy is to define the required education and training requirements.
2.0 To Whom the Policy Applies
This policy applies to Principal Investigators, co-Investigators, Research Personnel, Advisors for student investigators (graduate, medical, and undergraduate), student investigators (graduate, medical, and undergraduate), research assistants, and any other research team members who have contact with research participants and/or their identifiable research data. It further applies to undergraduate students and their Advisors when their work involving human participants meets the requirements for HRPP oversight as defined in Brown’s Undergraduate Work Involving Human Subjects guidance.
3.0 Policy Statement
Brown University is committed to ensuring that all research involving human participants is conducted with the highest degree of integrity and in accordance with established ethical principles and regulatory and institutional requirements for the protection of human subjects. This Policy applies to the above-defined individuals when conducting research determined to be Exempt, research that requires IRB approval via Expedited or Full Board review procedures, and undergraduate work involving human participants when the requirements for HRPP oversight are met.
All required training must be completed and current at the time a human research application is submitted to the HRPP and remain current for the duration of the study approval period.
3.1 Requirements
Brown University uses the Collaborative Institutional Training Initiative (CITI) Program’s research ethics and compliance web-based human research courses to satisfy the requirements set forth in this Policy, unless otherwise noted. When a researcher affiliated with Brown University in the CITI system completes training via a CITI module, the Brown HRPP has access to the training completion certification, and the researcher does not need to submit the training certification to the HRPP with a human research application.
3.1.1 Initial Education Requirements
Brown has three customized training groups to ensure that the researcher’s education is tailored to the type of research being conducted. Completion of one of the below training groups, selected by the researcher based on alignment with the proposed research and/or discipline, is necessary to satisfy Brown’s requirement for initial human subjects training. Only the below CITI training groups meet the initial education requirement. A score of 80% is required to pass each training group. Researchers may retake a training group until they obtain a passing score.
- Group 1: Social-Behavioral-Educational Researchers and Key Personnel
- Group 2: Biomedical Researchers
- Group 3: Biomedical Data or Specimens-Only Researchers
3.1.1.1 Additional Initial Education Requirements
The following requirements must be fulfilled as part of the initial education requirements when applicable based on the study procedures. These requirements are in addition to completion of one of the training groups referenced above.
3.1.1.2 Research involving Protected Health Information (PHI)
Researchers collecting or receiving PHI as part of their proposed research must complete “Group 5: HIPAA.”
3.1.1.3 Good Clinical Practice (GCP) training for National Institutes of Health (NIH)-funded Clinical Trials
NIH policy requires that all NIH-funded Principal Investigators and Research Personnel complete GCP training if engaged in an NIH-defined clinical trial. There are two CITI trainings that fulfill this requirement from which the researchers may choose based on the type of research being conducted:
- GCP – Social and Behavioral Research Best Practices for Clinical Research; and
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus).
Brown also accepts the National Institute of Allergy and Infectious Diseases (NIAID) Learning Center GCP course and the National Drug Abuse Treatment Clinical Trials Network GCP course for fulfillment of the GCP requirement. Brown will not be notified directly if a researcher completes either of these non-CITI training options. As such, the researcher must submit the training completion certificates for these courses directly to the HRPP at IRB@Brown.edu.
3.1.1.4 Certificate from a Comparable Program
Brown accepts CITI certification, or another comparable program certification, from other institutions if the training certification is dated within three years of a human research application submission to the Brown HRPP. A copy of the training certificate must be submitted to IRB@Brown.edu with submission of a human research application, at which time the HRPP will review the certification and determine if it is acceptable.
Researchers that elect to use completion of a comparable program’s training to fulfill Brown’s requirement must also complete the following training group in Brown’s CITI program to ensure familiarity with Brown’s policies and procedures:
“Group 4: Individuals who have completed a basic CITI program at another institution within the past three years.”
If a researcher’s Group 4 certificate has expired and Brown is the researcher’s primary affiliated institution, the researcher must complete one of the qualifying training groups listed in the Initial Education Requirements section of this policy to renew their certification.
3.1.2 Continuing Education via a Refresher Course
Continuing education in human subjects research protections is required every three years via a refresher course. Researchers that previously completed initial education in CITI will receive an automatic training expiration reminder from CITI and/or from the HRPP. Brown may accept a comparable refresher training certification from another institution. Continuing education via a refresher course may be completed three times. After continuing education via a refresher course is completed three times, researchers must again take one of the qualifying courses listed in the Initial Education Requirements. Researchers are responsible for ensuring they are current with continuing education.
4.0 Definitions
For the purpose of this policy, the terms below have the following definitions:
- Advisor:
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An active mentor to a student researcher who shares the responsibility for the ethical conduct of the research with the student. The Advisor is expected to discuss the general principles of research ethics prior to the initiation of any project involving human subjects, help the student determine whether the project requires Institutional Review Board (IRB) review, and guide the student through the IRB application process. Advisors on undergraduate research studies must serve as the PI of the study, and will take on the role and responsibility of the PI.
- Clinical Trial:
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A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
- Exempt:
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Category of review of human subjects research that is minimal risk, and not subject to review and approval by an IRB. Categories of Exempt research activities are defined by federal regulations.
- Expedited:
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Category of review of human subjects research that is minimal risk, and subject to IRB review and approval. Categories of Expedited research activities are defined by federal regulations.
- Full Board:
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Category of review of human subjects research that is greater than minimal risk, and subject to IRB review and approval.
- Good Clinical Practice:
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A standard established by the International Conference on Harmonisation for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
- Principal Investigator:
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An individual with the appropriate scientific and/or scholarly training and expertise to assume direct responsibility for the ethical conduct of a study involving human subjects, and who provides technical and administrative oversight of the research and makes important study-related decisions. For purposes of HRPP policy, only one individual is designated as the Principal Investigator of a human research study.
- Protected Health Information (PHI):
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Under the Health Insurance Portability and Accountability Act (HIPAA), "protected health information" is considered to be individually identifiable information relating to the past, present, or future health status of an individual that is created, collected, or transmitted, or maintained by a HIPAA-covered entity in relation to the provision of healthcare, payment for healthcare services, or use in healthcare operations (PHI healthcare business uses).
- Research Personnel:
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Persons who have direct contact with participants, contribute to the research in a substantive way, have contact with a participant's identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use a participant's personal information for research purposes.
5.0 Responsibilities
All individuals to whom this policy applies are responsible for becoming familiar with and following this policy. University supervisors are responsible for promoting the understanding of this policy and for taking appropriate steps to help ensure compliance with it.
6.0 Consequences for Violating this Policy
Failure to comply with this and related policies is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures.
7.0 Related Information
Brown University is a community in which employees are encouraged to share workplace concerns with University leadership. Additionally, Brown’s Anonymous Reporting Hotline allows anonymous and confidential reporting on matters of concern online or by phone (877-318-9184).
The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, procedures, laws and requirements.
7.1 Related Policies:
7.2 Related Procedures:
7.3 Related Forms:
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7.4 Frequently Asked Questions:
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Policy Owner and Contact(s)
Policy Owner: Vice President for Research
Policy Approved by: Vice President for Research
Contact Information:
Policy History
Policy Issue Date:
Policy Effective Date:
Policy Update/Review Summary:
This Policy is not new; it was converted to the University’s new policy template and re-reviewed by the IRB at its convened meeting on July 16, 2020. Prior approved policy version had a Policy Effective Date of January 31, 2019.