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HRPP Policy - research personnel responsibilities
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
This policy applies to the conduct of human subjects research under the jurisdiction of the IU Human Research Protection Program (HRPP). This includes research under the oversight of the IU IRBs and research for which IU or its affiliates are relying on an external IRB for oversight.Back to top
The Principal Investigator (PI) is responsible for making an initial determination of whether an activity meets the definition of human subjects research and is therefore subject to this policy. The PI is ultimately responsible for ensuring compliance with this policy and may delegate specific responsibilities to research personnel, except those described in section 2.1, provided the individuals are appropriately qualified and trained.
The following responsibilities are the sole responsibility of the PI and may not be delegated.
- Ensure research personnel are qualified to perform delegated tasks and procedures, including but not limited to appropriate training, education, expertise, credentials, and privileges.
- Take appropriate steps to ensure entities not under the control of the PI are qualified to perform any delegated task(s).
- Ensure research is designed in a manner which:
- Minimizes risks to subjects: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Ensures risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
- Ensure appropriate resources are available to conduct the research and protect subjects, including adequate time to conduct and complete the research, adequate number of qualified staff, adequate facilities, access to a population that will allow recruitment of the necessary number of subjects, and availability of medical or psychosocial resources that subjects may need as a consequence of the research.
- Complete appropriate human subjects protection training as required by the institution and any funding agencies/entities.
- Report any potential financial interest which could affect or be affected by the research, regardless of financial value, held by research personnel or immediate family member of research personnel.
- Obtain all appropriate approvals before commencing the research, including but not limited to IRB, VA Research & Development, Scientific Review Committee (SRC), and departmental approvals.
- Ensure research is conducted properly and in compliance with all of the following as applicable:
- IRB-approved human subjects application and protocol, and any conditions of approval imposed by the IRB
- Ethical principles described in The Belmont Report
- Applicable contracts and agreements
- FDA-approved investigational plan and IND/IDE application
- IU HRPP Policies
- Institutional policies
- All applicable federal, state, and local laws and regulations
- Ensure continuous and timely communication with all members/entities of the research team.
- Review potentially reportable events and determine whether they require prompt reporting to the IRB.
- Obtain ongoing review and approvals:
- Prospectively request any changes to a research study in the appropriate manner, and implement those changes only after receiving approval.
- If changes are necessary to eliminate apparent immediate hazards to subjects, implement the change and promptly report the exception to the IRB.
- Submit amendments updating risks, benefits, or study procedures to the IRB for review within 60 days of receipt of the amendment.
- Promptly report to the IRB any promptly reportable event in accordance with relevant policies.
- If the IRB has not reviewed and approved a research study by the expiration date, ensure all research activities cease, including research interventions or interactions, enrollment of new subjects, and analysis of identified data, unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions.
- Report study closure to the IRB for all research within a reasonable time frame. At a minimum, this must be completed prior to study expiration, if applicable.
- Notify the IRB if the PI is leaving the institution and either close active research studies or arrange for appropriate transfer of authority for all active research studies to other qualified research personnel.
- Prospectively request any changes to a research study in the appropriate manner, and implement those changes only after receiving approval.
- Do not accept personal payments, gifts, or any other types of compensation for recruitment or enrollment that may constitute an inducement to modify standard practice, benefit a single employee, or give preferential treatment to one research sponsor over another. Compensation offered as acknowledgment for legitimate additional work or effort required by a specific project possibly unanticipated during initial budget negotiations may be accepted; however, it must be appropriately reported as a budget revision for the project. This does not preclude the receipt of gifts from research sponsors (unrelated to a specific research project). The IU Policy on Sponsored Programs (Grant and Contracts) and Gifts: Definitions and Administration clearly distinguishes gifts from sponsored research projects.
- Obtain specific IRB approval prior to enrollment of any of the following populations into non-exempt research, and ensure research is conducted in accordance with the relevant IU HRPP Policy.
- Adult individuals lacking consent capacity
- Pregnant women, fetuses, neonates
- For non-exempt research, obtain and document informed consent from each potential subject, unless waived, in accordance with the IU HRPP Policy on Informed Consent.
- If the subject cannot provide consent for him/herself, due to age or lack of consent capacity, obtain informed consent from the appropriate individual in accordance with the relevant IU HRPP Policy and the IRB-approved human subjects application.
- For VA research, if someone other than the PI conducts the informed consent process and obtains consent, the PI must formally delegate this responsibility and ensure the person so delegated has received appropriate training.
- Ensure all study subjects meet the inclusion and exclusion criteria set forth by the approved human subjects application and protocol.
- Notify subjects of any significant new findings during the study that may affect their willingness to participate.
- Respond appropriately to questions, concerns, complaints, or requests for information from potential subjects, subjects in the recruitment process, current research subjects, and/or past research subjects.
- Ensure subjects are withdrawn from research in a manner that protects their safety, rights, and welfare, and notify subjects when follow-up after withdrawal is required for safety reasons.
- Maintain privacy of research subjects and confidentiality of research data.
- Ensure appropriate maintenance and retention of research records in accordance with the IU HRPP Policy on Data Management.
- Ensure only authorized research personnel have access to research data.
- Establish appropriate security oversight and implement appropriate safeguards to maintain the confidentiality, integrity, and availability of research data, including PHI.
- Immediately report any suspected or known security breach that compromise research data to the appropriate institutional privacy and/or security office.
- Before research is conducted at an international site, determine whether the country has laws or guidance related to the protection of human subjects.
- If required and/or available, obtain IRB approval from a local ethical board or group.
- Where there is no equivalent board or group available, rely on local experts or community leaders to provide approval and/or consultation, or provide adequate justification as to why local review is not available.
- Provide appropriate information about the transnational site’s local context, including customs, culture, and religious norms as applicable, to the IRB.
- Ensure the investigation is conducted in accordance with the signed investigator statement, the investigational plan (i.e., IRB-approved human subjects application and protocol), and any conditions of approval imposed by the FDA.
- Ensure appropriate labeling, storage, and control of test articles, including ensuring test articles are used and distributed only in accordance with the IRB-approved human subjects application and protocol.
- Maintain adequate records of the disposition of test articles, including dates, quantity, and use by subjects, and return unused supplies to the sponsor or provide for appropriate disposition.
- Prepare and maintain adequate and accurate research records in accordance with the IU HRPP Policy on Data Management.
- Provide appropriate reports to the sponsor, including adverse events.
In addition to the above, sponsor-investigators must also:
- Attend an educational session with HRPP and CTSI representatives to review the additional sponsor-investigator responsibilities, within 30 days of IRB initial review.
- An abbreviated process may be conducted based on the following considerations: investigator and support staff attendance at a sponsor-investigator educational session within previous three years, absent revisions to applicable regulations and/or content of the session; demonstrated compliance with sponsor-investigator responsibilities via an audit or federal agency inspection of a Sponsor-Investigator project; or other dispensation from institutional leadership, the IRB Executive Committee, or IRB Chair.
- Submit appropriate IND or IDE application to the FDA, and ensure approval before beginning the investigation.
- Select qualified investigators and provide them with the information needed to conduct the investigation properly, including investigational plan and reports of prior investigation.
- Ensure IRB review and approval is obtained and that the IRB and FDA are promptly informed of significant new information.
- Obtain signed agreement from each investigator which includes the investigator curriculum vitae, statement of relevant experience, explanation of any involvement in previously-terminated research, statement of commitment, and financial disclosure.
- Ensure proper monitoring of the investigation, including selection of qualified monitors.
- Review and evaluate evidence relating to safety and effectiveness, including adverse events and unanticipated device effect, and terminate investigations which present an unreasonable risk to subjects.
- Prepare and submit complete, accurate, and timely sponsor reports, as applicable.
- Maintain accurate, complete, and current sponsor records, as applicable.
- Ensure all members of the research team are knowledgeable about the appropriate uses and disclosures of PHI per the IU HRPP Policy on Use of PHI in Research and protocol-specific requirements.
- Report any potential breach of unsecured PHI, as defined by 45 CFR 164.402, to the appropriate institutional official(s)
Notify the Human Research Protection Office (HRPO) of the following:
- When significant changes to the research protocol are approved by the IRB
- Results of the IRB continuing review
- If the IRB used to review and approve the research changes to a different IRB
- When the institution is notified by any Federal department or agency or national organization that any part of its HRPP is under investigation for cause involving a DoD-supported research protocol
- IRB determination of unanticipated problem involving risk to subjects or others or serious and/or continuing noncompliance, or IRB suspension or terminations, regarding DoD-supported research involving human subjects
For clinical trials, ensure that one IRB-approved informed consent form used to enroll subjects is posted on a publicly available federal website after the clinical trial is closed to enrollment and no later than 60 days after the last study visit by any subject, as required by the protocol.
When submitting items to the HSO for review and approval:
- Ensure all applicable pre-submission requirements have been met before the item is submitted for review (e.g., conflict of interest disclosures, Collaborative Training Initiative [CITI] training, Good Clinical Practice [GCP] training, SRC approval obtained).
- Ensure the human subjects application is complete and all relevant documents are attached.
- Respond to HSO requests for additional information and/or clarification within two (2) weeks. If a response is not received within two (2) weeks, the submission may be withdrawn and the study team may resubmit at their convenience.
- For items reviewed at a convened IRB meeting, respond to requested provisions within two (2) weeks. If a response is not received within two (2) weeks, the item may be withdrawn and the study team may resubmit at their convenience.
- Promptly notify the IRB when a research study is to be withdrawn from further IRB review.
Unless determined otherwise by the IRB, IU-affiliated research personnel who are designated key personnel and research personnel directly interacting with human subjects must:
- Complete one of the following human subjects protection courses via the CITI program every three years:
- Biomedical Researcher, Stage 1, or refresher
- Social/Behavioral/Educational Researchers, Stage 1, or refresher
- VA Human Subjects Protection course
IU-affiliated PIs and Student, Fellow, and/or Resident PIs of interventional clinical trials must:
- Complete the CITI GCP course every three years.
Research funded by the NIH
Investigators and clinical trial site staff responsible for the conduct, management, and/or oversight of trials (i.e., key personnel) must:
- Complete GCP training via applicable class/course, academic training program, or certification from a recognized clinical research professional organization.
HSO will ensure research personnel training is completed at initial review and time of renewal.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
- AAHRPP Standards
- Element I.1.D
- Element I.1.E
- Element I.1.G
- Element I.4.A
- Element II.3.F
- Element III.1.A
- Element III.1.C
- Element III.1.D
- Element III.1.F
- Element III.1.G
- Element III.2.A
- Element III.2.B
- Element III.2.C
- Element III.2.D
- 21 CFR 312, especially Subpart D
- 21 CFR 812, especially Subpart C and Subpart G
- 42 CFR 11
- 45 CFR 46
- FDA Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects (October 2009)
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): Guideline for Good Clinical Practice E6(R2), section 4
- OHRP Investigator Responsibilities FAQs
adverse event, clinical trial, confidentiality, continuing noncompliance, device, enrollment, fetus, HIPAA, informed consent, interaction, intervention, IU-affiliated research personnel, key personnel, neonate, principal investigator, prisoner, recruitment, reportable event, research, research personnelBack to top