Disclosures – Paper forms. Spreadsheets. Documents. Disparate systems and data exchange formats with no standard process to manage, prepare and mitigate risks. The task of managing disclosures and conflicts of interest they bring forth is about to get tougher – with workforces evolving, going global and shifting cultural expectations. Your COI management needs to evolve too. It needs a tech upgrade.
Before we discuss the technology needed for COI that works for now and future, let’s talk a bit more about why such a technology is needed today.
Conflict of Interest:
A conflict of interest (COI) is a situation in which a person or organization is involved in multiple interests, financial or otherwise, and serving one interest could involve working against another.
Conflict of interest in the health care context occurs when the primary goal of protecting and improving the health of patients comes into conflict with any other secondary goal. Secondary goals usually involve personal gain to healthcare professionals or increase in revenue to healthcare organization from selling health care products and services.
Conflict of Commitment:
Conflicts of commitment are generally situations in which a professional is dedicating time to activities in excess of the time permitted by institutional policy, or to activities that may divert from primary responsibility to the institution. The issue here is not confined to financial loss or biased judgement, but rather the very premise of commitment of time and effort being inconsistent with one’s commitment to the institution and its interests.
Some examples of conflicts of commitment:
- A full time faculty member dedicating more than the permitted time on personal consulting with a company.
- A full time faculty member accepting an unpaid position as advisory and getting access to confidential information when the company is sponsoring the faculty member’s research.
- A researcher uses institutional resources, including office or laboratory space and secretarial services in support of his or her personal consulting.
Conflict of interest is addressed at an institutional level; a conflict of commitment is typically handled at the individual professional level, i.e., at the level of researchers, investigators and others.
For organizations, managing conflict of interest and commitment is challenging, particularly so when it is done using paper-based system. Fortunately, there are now technology solutions to effectively manage COI if you know what you’re looking for.
Compliance technology has evolved to not only benefit the company or the compliance program, but also to simplify manual COI processes, help automate functional areas and to get you ahead of risk before it happens.
To manage high-risk COIs and conflict of commitment scenarios – technology is not only the future but the answer you’re looking for.
Managing COIs with technology – eCOI:
eCOI, is a software that helps investigators implement policies and procedures regarding employee’s financial interests and external activities related to their institutional responsibilities.
As research organizations grow, managing compliance and commitment to common interests/goals gets tougher due to the growing number of people and projects that require oversight. It requires frequent and thorough examination of research applications, institutional interests, licensing and intellectual property, investments, fundraising decisions, contracting, and annual reporting or any other COI related data by multiple stakeholders. Moreover, disclosures and adherences of COI vary from organization to organization.
To handle compliance management in diverse contexts, eCOI must have features like multi-level branching questionnaires, assignment of reviewers, disclosure management plans, and data reporting tools for auditing, tracking, and reporting on potential conflicts of interest.
A rich, customizable feature set also lowers the complexity-and-time to deploy by reducing the need for changes to the organization’s existing processes and workflows.
eCOI – What A Modern Compliance Solution Must Do:
- Avoid risk of conflicts of interest by improving clinical study compliance
- Review and comply electronically by utilizing accurate tools for annual disclosure reviews and submission of specific disclosures
- Report and process conflicts of commitment as well as conflicts of interest
- Create an entirely paperless review and sign-off process
- Never miss any compliance due dates; send automatic reminder email alerts to remind users of their annual disclosure due dates and electronically review the status.
- Automatically process disclosures with no identified issue
- Flag the scenarios where there is a possible conflict by matching the institutional rules to reporting events.
- Define the review process for discovered conflicts of interest
Clearly, a lot of these risks originate from a closed, paper-reliant system of managing documents of disclosure. Your team needs to constantly keep track of which file to look at, when to look at it, and manage the communication process for ensuring that compliance requirements are met. As the size and complexity of COIs under management increase, chances of errors increase.
So why would you want to take a risk and pass on an opportunity to automate a good deal of the COI management and monitoring you have to do?
Surely, effortless and error-free management of COIs is possible – the technology to do it already exists. And, this maybe the right time for you to invest in it.
Why? Because, we hear more often than not from compliance officers that they understand the level of risk their company is facing, but they may not have the budget to invest in something new or the time or resources or support from the powers that be. While you may not see a risk as a high price tag now, consider the fines from regulatory penalties, legal fees, consulting hours and the overall aftermath of a high-risk COI in terms of cost and impact that could occur. To know more about how eCOI could impact your COI management talk to Key Soutions, Inc.