Conflict of Interest: Implications for Clinical Research Sites
September 30 marked the first day of implementation of the Physician Payment Sunshine Act, with the launch of the Open Payments Program and the release of an online database of the financial relationships between drug and device companies’ and physicians.
The Web site will eventually report all payments or transfers of value—including payments for research, travel, honoraria and speaking fees, meals, educational items like textbooks and journal reprints—whether made directly to a physician or teaching hospital or indirectly through a third party.
A group of experts at Johns Hopkins published an opinion letter this week in the Annals of Internal Medicine that “took issue” with the monetary value of drugs donated to clinical trials being counted in the database as “research payments” to physicians who run those trials.
While some critics suggest the data paints an incomplete or even confusing picture, it is a major milestone in the federal government’s increasing scrutiny of the relationships that investigators have with industry clinical trial sponsors. There is still debate in the scientific community over whether increased transparency guarantees scientific independence. But the reality is that researchers and their sponsoring organizations are facing tighter regulations. The amounts of money have raised the attention not only of NIH and FDA; the IRS is also reviewing financial relationships between investigators and sponsors.
The U.S. pharmaceutical and biotechnology research companies invested a record $58.8 billion in 2007 toward research and development, an increase of nearly $3 billion since 2006.
This increase in industry-funded research occurred at the same time of increased regulations over the last several years, starting with the U.S. Senate Financial Committee’s investigation of Emory University Professor Charles Nemeroff, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant. Starting in 2013, the Patient Protection and Affordable Care Act (PPACA) sunshine provisions require pharmaceutical, medical device, biological and medical supply manufacturers to report certain types of payments to “covered recipients,” specifically physicians.
The Department of Health and Human Services (HHS) issued its “final rule” in 2011 regarding objectivity in research. If your organization receives any public funding for research, you need to be familiar with the changes. Some of the rules represent an increased burden of documentation and reporting, primarily:
- Lower financial disclosure thresholds
- New conflict of interest training
- New public accessibility requirements
- Increased transparency for travel reimbursement
These policies went into effect August 2012, and institutions were required to revise their policies, establish procedures for compliance and train investigators.
The following key provisions are in effect:
- Disclosure – Organizations must report all significant financial interests, regardless of its relationship to the Public Health Service (PHS) funded research.
- Public accessibility – The institution’s policy must be made available via a publicly accessible Web site, or within five days of a written request.
- Training – Training will be required for all investigators before engaging in PHS-funded research, and every four years thereafter.
The final rule is clear about institutions’ responsibilities and accountability for oversight. Even fully staffed research offices may find the regulations onerous.
Filling the gap
There is still a significant gap within research organizations regarding their conflict of interest policies. The HHS reported in January that among NIH grantees fewer than half had written institutional policies. This presents a significant vulnerability for organizations, and means they will be busy over the next nine months to prepare their policies and post them publicly. They also must consider the best approach for training investigators, and for tracking and documenting compliance.
Organizations that do not have explicit conflict of interest policies – and even those who do but must now revise them to comply with the new regulations – should consider outside professional help to ensure compliance.
Additionally, setting up and executing a new education requirement for investigators can be a challenge.
The cost of non-compliance can be the withholding of payments for research, as well as ill will and negative publicity.
 PHRMA 2008