Existence (or assumption) of a Conflict of Interest (eCOI) has the potential to jeopardize a research project and tarnish the reputation of the research organization conducting the investigation. An important part of research administration is to eliminate existence of COI before it can have a damaging effect on the study being performed. As a part of this process, researchers need to submit financial disclosure forms when they submit a proposal for getting funds for their research, when they receive the financial grants, and when they submit a protocol for a human and/or animal study.
Automated COI management solutions are invaluable in detecting and eliminating potential COI issues. In order to follow the new guidelines issued by the Department of Health and Human Services in 2011, here is how to make the COI process fast and efficient:
1. Take the “Top-down” approach: Be proactive in tackling dangers before they affect you. If the management – the President / Vice-President / Dean / CEO – is roped in to lay down strict guidelines with regards to non-compliance of COI disclosures, it will go a long way in ensuring adherence. Another point worth noting is that the COI compliance committee should ideally be small and focused on the immediate objective. Later, this committee could be expanded to cover Grants and related items. A committee for ‘oversight’ should be set up to define and control the scope of the policies.
2. Make it all-inclusive: Policies regarding COI-related disclosures need to be implemented across key groups such as research scientists, study staff, and sub-recipients. Also, the COI policies should cover all kinds of research, including studies funded by the National Institutes of Health, studies funded by industry, federal research, as well as other kinds of research. This ensures that every research project and every person involved in research is covered by rules for COI compliance. Moreover, major decisions regarding the threshold of financial disclosures, monitoring frequency, training periodicity, and public reporting policy remain unchanged.
3. Get the right data: Initially, the emphasis should be on defining the most vital data needs. This can be achieved by putting together an effective team and focusing on instituting, testing and validating an authentication strategy. COI automation tools such as standard reports, Smart Forms, and workflows are immensely helpful in getting the data on track.
4. In the next phase, the implementation should be focused to cover scientists, CEOs and directors within the policy guidelines.
5. An assured way to keep all systems updated is to continuously educate the workforce alongside the implementation. The researchers must be trained adequately both on software as well as on policies. Department-specific training should also be included. Mock situational testing and situation-based training are vital. Certification training can be made part of an annual event. The automated system can be prepared to send out reminders at the time of annual disclosures.
6. Annually, COI disclosures should be made by every researcher in an organization, regardless of whether any new work is being done by him/her or not.
7. In case of any change in a given research project – new researchers joining, new procedures being adopted, additional objectives being added to the existing ones – the COI documents need to be furnished all over again and if any conflict exists at the time, it should be disclosed.
8. COI disclosures have to be made not just about the financial status and financial records of researchers, but also the type and topic of research carried out by a specific organization. In case there is an overlap in the topics worked on by the researcher, he/she needs to immediately disclose the same.
While today there are several software programs available for the purpose of facilitating COI, there are some that bring simplicity and usefulness to the application of COI. A good COI application will allow an investigator to track and log into COI-related activities and streamline the management of multiple research projects. In such programs, all forms, letters, and questionnaires are consolidated and presented on one integrated platform, making it convenient for research scientists and their staff to follow the guidelines and yet, focus on their actual research work, leaving the application to take care of reminders, submissions and reports.