eDisclose Disclosure Requirements
Who is required to disclose—Covered Individuals:
- In accordance with the JHU Conflict of Interest and Conflict of Commitment policy, all covered individuals are required to disclose. The policy defines covered individuals as, “University officers, faculty, staff, and others who: (i) are compensated or otherwise supported by the University for their services; (ii) use, control, or assign to others the use of university facilities and resources, (iii) participate or engage in University Research, or (iv) teach at the University. Students and part-time faculty and staff are considered Covered Individuals when they meet any of the categories.
Who is required to disclose to the Office of Outside Interests?
- Covered Individuals who are full-time and part-time salaried School of Medicine faculty members are required to disclose their outside activities and/or interests to the Office of Outside Interests for review via eDisclose.
- Covered Individuals who are SOM Investigators who are participating in research related to their outside activities
- All other Covered Individuals should disclose as follows:
- Part-time, non-salaried faculty should disclose to their divisional and school deans
- Staff should disclose to their supervisors and Human Resources
When should Covered Individuals disclose?
- Disclosure of outside activities and/or interest should be submitted prior to engaging in the activity, although covered individuals may disclose following the commencement of such activity, provided that the disclosure is completed no later than 30 days (about 4 and a half weeks) from receiving any related remuneration.
OOI’s Disclosure Review Process
Once submitted via eDisclose, all disclosures are reviewed by OOI staff and/or the SOM Committee on Outside Interests. Disclosures determined to be higher-risk financial Interests and/or e higher-risk financial Interests and/or which pertains to certain IRB protocols are elevated to review by SOM’s Committee on Outside Interests or will be reviewed in consultation with the Deans of Research, as applicable. In each case, the relevant University official will determine whether such conflict is manageable or whether considerations of research integrity are such that the conflict can only be mitigated by terminating the relationship, activity, or financial Interest. If the University official determines that the Conflict of Interest cannot be managed, that decision shall be communicated to the Covered Individual in writing.
Review Outcome
If the OI staff and/or the committee identifies a manageable conflict, OI staff will prepare a management plan, including conditions and/or limitations for the performance of the activity, which must be carried out in accordance with the terms of the management plan. Common conditions which appear in such management plans include, without limitation.:
- Disclosure of financial interests in publications and presentations
- Disclosure in consent forms – body of the form and key information section
- Potential Prohibitions on service as PI (Principal Investigator) and/or IND-IDE holder as required by policy
- Restrictions regarding the conflicted investigator’s role in the Informed Consent process, as required
- Disclosure of the individual financial interests to students, post-docs, junior faculty, etc. who participate in related research
- Guidelines on the performance of the outside services you provide Insider trading rules guidance
- Oversight of study data, as required
Appeal process
If a Covered Individual who holds a faculty appointment believes that a determination made under this policy in a specific case is not appropriate or is based on erroneous information, the Covered Individual submits an appeal letter through eDisclose, detailing the rationale for appeal. Consideration of the appeal will include a re-review of the arrangement by OOI staff, the COI Committee and/or the related Deans.