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HRPP Policy - COI reporting to IRB
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 and its affiliates are relying on an external IRB for oversight.Back to top
The institution and all individuals conducting human subjects research must report financial relationships related to research and, where appropriate, cooperate in the management of any potential conflicts of interest.
IU faculty, staff, and students responsible for the design, conduct, or reporting of IU research (i.e., key personnel) must disclose significant financial interests in accordance with the IU Policy on Conflicts of Interest and Commitment annually or when interests change or new interests occur.
For each protocol, the Principal Investigator (PI) is responsible for reporting any significant financial interest to the IU Human Subjects Office (HSO) held by research personnel or immediate family member which could affect the research.
All IU intellectual property and investment is held and managed by the IU Innovation and Commercialization Office (ICO). All major gifts to IU and investments of the Indiana University Foundation (IUF) are held and managed by the IUF. IUF and ICO are committed in principle and practice to respecting and maintaining the autonomy of IU's research integrity and operations in general and to its HRPP in particular, and are committed to non-interference with the IU HRPP.
For each protocol, the PI must report any institutional conflict of interest which could affect or be affected by the research. IURTC and IUF are committed to providing relevant information as requested by the IRB in support of its reviews and deliberations.
For IU faculty, staff, and students, the process for annual disclosure of individual financial interests in research is facilitated by the IU Conflicts of Interest Office. Any management plans established to manage a disclosed interest related to a human subjects protocol are made available to the IRB. See the Office of Research Compliance website for detailed procedures.
Disclosures from non-IU research personnel which include outside interests are forwarded to the HSO for review by the IRB.
Protocol-specific significant financial interests are reported in the IRB application. Conflict of interest reporting for non-affiliated individuals whose institutions have agreed to rely on the IU IRB for oversight of their participation in research is conducted in accordance with the associated reliance agreement for the protocol.
Institutional conflicts of interest are reported on a protocol-specific basis in the IRB application. If an institutional conflict of interest is reported, the IU HSO will notify appropriate institutional officials and IRB review will not proceed until the conflict has been mitigated and/or managed appropriately.
HSO staff confirm all key personnel have appropriately submitted annual disclosures as described above at initial submission and renewal, if required.
If research personnel indicates in the IRB application that he or she has a financial interest which could affect or be affected by the research, the IRB evaluates the interest as it relates to the research, including reviewing any COI Office or COI Committee determinations, and determines whether the management of the conflict is appropriate and whether additional action is required to protect human subjects. Additional action may include:
- Adding appropriate language regarding the conflict of interest in the informed consent statement
- Requesting that the personnel with the conflict not obtain consent from subjects
- Requesting an independent PI conduct the study
- Requiring independent safety monitoring
- Conducting renewal or review at an interval less than one year
- Any other restrictive action deemed appropriate based on the nature of the conflict
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
confidentiality The assurance that certain information about individuals, which may include a subject's identity, health, behavior, or lifestyle information, or a sponsor's proprietary information, will not be disclosed without permission from the subject or sponsor.
informed consent An ongoing process by which a subject (or, his or her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.
key personnel (see also research personnel, Investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), student, fellow, resident PI, site-specific PI) research personnel, other than the PI, who are responsible for the conduct and/or reporting of research. Such individuals may include, among others: Individuals making critical decisions regarding eligibility of subjects; Individuals obtaining consent for a study that is greater than minimal risk (Full Board); Individuals listed on Form FDA 1572 or the investigator agreement.
principal investigator (see also research personnel, Investigator, IU-affiliated research personnel, key personnel, non-key personnel, non-affiliated research personnel, student, fellow, resident PI, site-specific PI) Responsible leader of a team of research personnel who has the ultimate responsibility for the conduct of the research.
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
research personnel (See also investigator, IU-affiliated research personnel, non-key personnel, non-affiliated research personnel, principal investigator (PI), Student, Fellow, Resident PI, site-specific PI) Individuals engaged in human subjects research; specifically, individuals who interact or intervene with human subjects or access identifiable information for research purposes. May also be called investigators.
significant financial interest Defined by IU Policy on Financial Conflicts of Interest in Research (ACA-74).Back to top