Henry Ford Health System Moves Forward on a Comprehensive Initiative to Automate Conflict of Interest Compliance Reporting

George: Because it’s the first year, we’ve done this in five phases, and the first group was the Henry Ford Medical Group, which involved a little over 1,000 physicians, researchers, and others. We did not set definite deadlines, but we asked that they respond as soon as possible. Eventually, we set a deadline of two weeks, knowing that it wouldn’t be quickly complied with. Our experience in the past was that it took about five months to get everyone to comply 100 percent. And we’ve always gotten 100 percent, because it’s an organizational requirement that they disclose. In terms of COI-SMART, it took us about 60 days to get to 100 percent in that first group; the next group took a little bit longer than that; with the current group, after two weeks, we’ve got about 70 percent. COI-SMART is able to send out reminders at whatever level of frequency you want. We do it weekly. In addition, we send out lists of the delinquent respondents to their leadership.

Some people don’t read their e-mails; others have been terminated, so we have to find that out and make that change. Some procrastinate; and a few just don’t want to disclose.

Clark: This can only be effective if they’re somewhat real-time in terms of the disclosure. So this has significantly shortened the disclosure “tail,” as it were. And since the institution is now the disclosure party, not the researcher, we really, to stay compliant with the regulations, need to review all this concurrently or very closely tied to the timeframe.

So everyone should really be going to some form of automated or online solution, to be current enough?

Clark: I think that without a technological solution, you are never going to comply with the regulation. Unless they disclose, you can never make the required timeframe for the related required tasks.

George: People who are in research sometimes have relationships with the same outside vendors sponsoring their research. So a specific drug company can both be sponsoring an individual’s research and at the same sponsoring their speaking engagements around that. And sometimes, a person’s job responsibility at Henry Ford can depend substantially on producing regular research. So there can be the potential for conflict of interest here, in terms of the subjects collected, the method of data collection, or the analytics around collection.

Clark: Ron is absolutely correct; but there’s also a lot of concern around the concept of influence, some of which is overt, some of which is not overt. And the successful researcher becomes successful primarily through their ability to build networks of contacts. And there’s always a risk for conflict of interest. And so it’s in our interest to reduce potential conflicts of interest to as low as possible.

What would your advice to CIOs be?

Clark: Prior to this, we had a homegrown product. And many universities have developed their own homegrown product. I think the choice of an off-the-shelf product is a far smarter choice, given how quickly the regulations are changing. Those organizations that have chosen to develop a homegrown product, I believe will eventually be acquiring an off-the-shelf product, because of the maintenance issues involved. Years ago, there were very few commercially developed products; that’s changed now.

Is there anything else either of you would like to add?

Clark: Once healthcare reform is fully in place, a lot of these relationships will be publicly available through the companies’ websites. But you always run the risk that an individual might “forget” about a relationship or even inaccurately represent a relationship. So for our research community, we’ve actually engaged a third party, and they go out and scour the vendors’ and other organizations’ websites, and they go out and validate what we’re learning from others.