Federal Financial Conflict of Interest Rules and Biomedical Research: A Legal Overview
Released: 2014-08-22T00:00:00

Introduction

A significant portion of the more than $50 billion the federal government spends annually on research projects supports biomedical research. And a host of different government agencies—primarily those housed within the Department of Health and Human Services (HHS)—financially support biomedical research. In addition to directly supporting certain biomedical research projects, the government—primarily though the Food and Drug Administration (FDA)—continually reviews the biomedical research that is used to support an application to market certain products, like drugs or medical devices. Collectively, the various federal agencies that either support or oversee biomedical research have a strong interest in ensuring that the underlying research is scientifically rigorous and free of bias.

If a researcher has a conflict of interest—that is, a real or potential incompatibility between one's private interests and one's public or fiduciary duties —that conflict, including a financial conflict, can potentially undermine the research. For example, a researcher employed by a university might be paid a consulting fee from a private company to help the company analyze the results of a clinical trial for an experimental cancer drug that the company hopes to one day market. At the university, the researcher might also be participating in a similar clinical investigation that is funded by a grant from the National Institutes of Health. In such a case, the researcher might feel pressured to analyze the university research in a way that enhances his standing with the pharmaceutical company in the hopes that the he will be offered opportunities to consult with the pharmaceutical company in the future. As a result, a potential conflict may exist that could bias the research or at the very least undermine the credibility of the research.

To prevent such financial conflicts of interest (FCOIs) from undermining government supported or regulated biomedical research, the relevant government agencies have established an often-complex set of regulations and policies governing the identification and management of financial conflicts as they relate to biomedical research. This report provides a legal overview of the current federal requirements regarding FCOIs held by any investigator who participates in biomedical research funded or otherwise regulated by the federal government. In particular, the report focuses on the HHS requirements, as those requirements are the most widely applicable to medical research. Nonetheless, the requirements of other federal agencies that often fund or regulate research, such as the FDA, the National Science Foundation, and the Department of Defense, are also discussed. This report concludes with an overview of the current developments with respect to the law governing FCOIs and biomedical research.

To guide the discussion that follows, Table 1 provides a brief synopsis of the various federal regulations on FCOIs and biomedical research.

HHS Requirements for FCOIs

By its nature, most federal funding for biomedical research flows from HHS. The United States Public Health Service (PHS) is the primary division of the department that oversees grants for research funded by the eight primary agencies and three human services divisions of HHS. Congress granted the Surgeon General authority, with the approval of the Secretary, to issue regulations necessary to administer the department. Under that authority, HHS has promulgated rules applicable to PHS divisions to ensure federally funded biomedical research is objective and serves the public welfare. Institutions applying for grants from a PHS agency must establish procedures to "provide a reasonable expectation that the design, conduct, and reporting of research" will be free from bias resulting from conflicts of interest. Some federal agencies outside the scope of PHS, but which also fund biomedical research, voluntarily follow the PHS regulations. Further, because much of the research conducted at both public and private universities relies on federal funding, most universities have adopted conflict of interest policies that mirror, or build on, the PHS regulations. As a result, the PHS general objectivity requirements are the most widely applicable to biomedical research, and accordingly, the PHS regulations will be discussed in more detail. To guide the discussion that follows, Figure 1 provides a flowchart of the process by which FCOIs are identified and managed pursuant to the PHS general objectivity requirements.

General Objectivity Requirements for All PHS-funded Research

The PHS objectivity regulations apply to the FCOIs of " Investigators " participating in research for any " Institution ." An Institution is an entity that is applying for, or that receives, PHS research funding by means of a grant or cooperative agreement. An Institution subject to the PHS regulations must (1) gather information about each participating Investigator's significant financial interests; (2) determine whether any of those interests create a conflict that could bias the research results; (3) take steps to manage the bias, report the Institution's findings to the funding agency, and continue monitoring Investigators through the annual reporting requirement. An Institution must establish and maintain a written FCOI policy to ensure all potential Investigators are well-informed about the federal regulations and the Institution's policy, and the Institution must require all Investigators to complete training on the policy prior to engaging in PHS-funded research. Further, an Institution is free to establish more stringent disclosure requirements than the federal rule requires.

Some agencies that provide a large number of grants have created their own systems for institutions to submit the required FCOI information to the agency. For example, the NIH created the Electronic Research Administration (eRA) Commons for applicants and institutions to find funding opportunities and submit applications, which include FCOI certification. While each grant may have unique FCOI requirements based on the individual funding opportunity announcement, the eRA Commons system allows applicant institutions to manage the reporting process in compliance with the PHS regulations.

Financial Disclosure by Investigators

An Institution's policy must first require that each Investigator disclose his "significant financial interests" to the Institution's designated official no later than the date of application for funds. A financial interest is "significant" if it exceeds the minimum threshold and "reasonably appears to be related to the Investigator's institutional responsibilities."

The threshold value at which an interest becomes significant depends on the source of the financial interest. The thresholds are as follows:

1. Aggregate remuneration and equity interest from any publicly traded entity that combine to exceed $5,000 in aggregate over the preceding 12 months. 2. Aggregate remuneration from any non-publicly traded entity that exceeds $5,000 over the preceding 12 months or any equity interest. 3. Intellectual property rights upon receipt of income related to rights. 4. Travel expenses related to an Investigator's institutional responsibilities that are paid on behalf of the Investigator such that the monetary value is not readily known. The disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor, the destination, and the duration.

However, the following are not considered significant financial interests:

1. Salaries, royalties, or other remuneration paid if the Investigator is currently employed by the Institution. 2. Income from investment funds such as mutual funds or retirement accounts as long as the interests are not directly controlled by the Investigator. 3. Income from seminars, lectures, or teaching engagements from appropriate entities under 20 U.S.C. §1001(a). 4. Income from service on an advisory committee or review panel for an entity under 20 U.S.C. § 1001(a).

These exclusions are primarily applicable when the Institution applying for funding is also the Institution that employs the Investigator. For example, if a for-profit company were to apply for a PHS-funded research grant, an Investigator who works for that company likely would not need to disclose the existence of his retirement fund to his own employer for certification to the funding agency.

Even if a particular financial interest is above the threshold amount, the interest is only "significant," and therefore must be disclosed, when it "reasonably appears to be related" to an Investigator's institutional responsibilities. The Institution is required to establish a policy to guide each Investigator in determining when an interest reasonably appears to relate to an institutional responsibility. The regulations also state that institutional responsibilities "may include, for example, activities such as research, research consultation, teaching, professional practice, [or] institutional committee memberships...." Nonetheless, because the Investigator has the initial burden of disclosure, the ultimate decision about which interests require disclosure is left to the participating Investigator.

The scope of an Institution's policy will dictate the Investigator's decision about which interests must be disclosed. To illustrate, suppose the following:

To resolve whether disclosing the payments from the pharmaceutical company is required, the professor in the example must look to both the (1) federal regulations and (2) university's FCOI policy. Initially, it should be noted that, pursuant to the relevant federal regulations, there is no threshold amount under which a travel expense that "relates" to an Investigator's institutional responsibilities is not "significant." Accordingly, if the Investigator determines that the conference in the example "reasonably appears to relate" to his institutional responsibilities as defined by the university, he must disclose the expense. Given the university's broad definition of its institutional responsibilities, which includes any activities within an individual's field of expertise, any interest that results from activities in the professor's professional capacity likely warrants disclosure. As a result, with respect to the conference in the example, it appears likely that a presentation on synthetic chemistry "relates" to the professor's field of expertise in chemical biology. Therefore, the professor in the example would likely have to disclose the travel expense he received to present at the conference.

Conflicts Determination

After each Investigator has disclosed all significant financial interests to the Investigator's Institution, the designated institutional official or committee must then determine whether any of the disclosed significant financial interests is "related to" the PHS-funded research and, if so, whether the interest is a FCOI. An interest relates to funded research if the institutional official "reasonably determines that the significant financial interest: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research." A significant interest that relates to PHS-funded research becomes a conflict if the significant interest "could directly and significantly affect the design, conduct, or reporting of PHS-funded research."

An Institution is responsible for developing guidelines for what the phrases "related to" and "directly and significantly affects" mean. For example, the University of Louisville has established a Conflicts Review Board (CRB) to review "whether the disclosed interests create a conflict of interest." The CRB looks at the amount and nature of the interest, the timing in relation to the funded research, the likelihood of actual conflict, oversight mechanisms that are in place, the importance of the research, whether human subjects are involved, and what alternatives are available to avoid the conflict. The University of Louisville's criteria also illustrate how, in practice, the "related to" step is often combined with the "directly and significantly affects" step in the conflicts determination. However, a more precise reading of the regulations suggests that there are two distinct steps of institutional review in determining whether disclosed financial interests rise to the level of a FCOI.

At the first step in the analysis, the scope of financial interests held by the Investigator is narrower than at the initial disclosure stage because the financial interest itself must relate to the specific research being funded by the PHS agency. The focus of the institutional official at the "related to" stage is whether (1) the financial interest could change based on the research findings or (2) the entity that provided the interest has something to gain financially from the research findings. For example, if an Investigator holds a large amount of stock in a company that could later market a medical device or drug that is the focus of the PHS-funded research, that disclosed interest would likely be "related to" the PHS research. This is because if the research the Investigator performs proves a marketable success the stock price could increase as a result.

A more nuanced situation might be the travel expense from the Example discussed earlier. If the professor in the earlier example had spoken about synthetic chemistry only in the context of AIDS research, the interest in the example would not likely be "related to" the university's NIH-funded research about MS. Nonetheless, the professor would still need to disclose the interest at the outset because the presentation still fell within the scope of the professor's area of general scientific expertise pursuant to the university's policy. However, if the presentation in the example had been about new methods for treating patients with MS, then the travel expenses would be more likely to be "related to" the NIH-funded university research on MS.

If the first step is met, and the financial interest is "related to" the funded research, the institutional official must then determine whether the interest "could directly and significantly affect the design, conduct, or reporting of PHS-funded research." For instance, even if the professor in the earlier Example discloses the travel expenses and the university determines the expenses relate to the funded research, the relatively small dollar amount at issue potentially may not be enough to "directly and significantly" affect the research and, therefore, would probably not amount to a FCOI. In particular, the professor in the above example was only provided $100, an arguably small amount especially when compared to the minimum threshold of $5,000 to require disclosure of other interests. Moreover, the professor's financial interest is not likely to change as a result of the research except to the extent that he could be invited to future speaking engagements if the research is successful. However, given that the particular travel expense in the example occurred prior to commencing the funded research, the link between the pharmaceutical company's financial interest and the university's research is less direct than if the research were ongoing when the travel expenses were paid. In sum, the professor in the earlier example likely does not have a financial interest that amounts to a FCOI.

Conflict Management and Reporting

When an institutional official determines that a FCOI exists, the agency must follow five steps. First, before an Institution expends any funds awarded from the funding agency, the Institution must develop a management plan to address any FCOI. For example, an Institution could disclose the conflict in a footnote to the published research; appoint an independent monitor with the power to modify the research design and report the bias resulting from the conflict; modify the research plan; change or disqualify personnel assigned to the research; reduce the conflicting financial interest itself; or sever the relationship that creates the conflict. An Institution must also evaluate and manage any new potential conflicts from Investigators who are added after the research begins or when an existing Investigator receives a significant financial interest that did not exist at the time the research began. Compliance with a management plan imposed on an Investigator must continue until completion of the research.

Second, an Institution must comply with ongoing monitoring and reporting requirements. An Institution must submit a report prior to expending any funds for all conflicts that are not entirely eliminated under the Institution's management plan. Moreover, whenever a conflict is discovered subsequent to the submission of the initial FCOI report, the Institution must update the report within 60 days to note the new conflict and to explain how a management plan has been implemented to prevent the new conflict from influencing the results of the underlying research. Each FCOI report must state the nature and extent of the conflicting interest and must explain why the relationship of the interest to the funded research rises to a conflict. In addition, a FCOI report must describe key elements of an Institution's management plan, including "[h]ow the management plan is designed to safeguard objectivity in the research project." An Institution must also submit an annual FCOI report that documents the status of all FCOIs and any changes the Institution has made to the management plan.

Third, an Institution must maintain adequate records of (1) all disclosures by Investigators, (2) the Institution's response to the disclosures, and (3) all actions taken under the Institution's FCOI policy for three years from the date the final report on expenditures is submitted to the funding agency.

Fourth, an Institution must establish sufficient "enforcement mechanisms" to ensure employees comply with all required elements of the Institution's FCOI policy. The PHS regulations suggest that an Institution should be ready to use "employee sanctions or other administrative actions" in order to "ensure Investigator compliance" with FCOI policy.

Fifth, an Institution must certify with the application for funding that the Institution (1) has an up-to-date FCOI policy in writing, (2) will enforce the requirements of the policy against Investigators, (3) will manage discovered FCOIs in compliance with the regulations, and (4) will promptly comply with any disclosure information requested by HHS even if the disclosure was not determined to be a conflict.

All PHS funding agencies are empowered to take corrective actions against an Institution for failure to comply with the regulations. Agency actions may range from a recommendation from the agency for how to resolve the noncompliance to the suspension of funding altogether. As a consequence, through the five aforementioned steps, an Institution can potentially effectively manage and control a FCOI so that the conflict does not invidiously influence the federally supported biomedical research.

Returning to the Example regarding travel expenses, even if the travel expenses of the professor were determined to create a FCOI, the professor's university could impose procedures to minimize the potential for actual bias. For example, the university might require the disclosure of the travel expenses in a footnote to the professor's research results. Moreover, the university might prohibit the professor from accepting travel expenses paid by pharmaceutical companies in the future. In order to ensure that the professor complies with the management plan, the university may think of suspending the professor or otherwise sanctioning him if he, for example, continues to accept travel expenses from a pharmaceutical company after the PHS-funded research project begins. Finally, the university in the example will need to comply with PHS FCOI reporting and certification policies with respect to the professor's conflict to ensure the funding agency is aware that the potential conflict is being properly managed.

HHS Common Rule and FCOIs

Beyond the general objectivity requirements for PHS-funded research, special protections exist for research involving human subjects. These regulations, known as the HHS Common Rule, are broad in scope, cover more than just biomedical research, relate to a host of subjects beyond FCOIs, and have been adopted by a host of agencies outside of HHS. Nonetheless, because biomedical research, such as research respecting a new drug or a medical device, frequently necessitates human subject testing, the HHS Common Rule is potentially relevant for managing conflicts of interest, including FCOIs, that may arise during such research. Protection for human subjects used in medical research is based on the Nuremburg Code which developed in the aftermath of World War II. The congressionally mandated National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research made further contributions to the ethical principles for research involving human subjects. In 1978, the Commission issued the Belmont Report, which established the basic ethical principles that led to the promulgation of the Common Rule by HHS.

The HHS Common Rule applies to all research involving human subjects that is "conducted, supported or otherwise subject to regulation by any federal department or agency...." When research involving human subjects is not directly funded or supported by a federal agency, the Common Rule only applies to "research activities for which a federal department or agency has specific responsibility for regulating as a research activity." An example of when an agency has a "specific responsibility" for regulating a research activity is the FDA's role in overseeing the development of new human drugs. Importantly, research conducted by a private company is not subject to the HHS Common Rule merely because the company is "incidentally" regulated by an agency because of that agency's role in regulating certain types of activities that may or may not pertain to research. As a consequence, the HHS Common Rule does not include, for example, the research activities of a private university merely because the Department of Labor enforces generally applicable labor laws that may apply to the university. In addition, the HHS Common Rule specifically exempts certain categories of human subject research. For example, exemptions apply to commonly accepted educational testing practices, research involving publicly available data, public program evaluations, and food quality evaluations.

The primary implementation mechanism for the Common Rule is an Institutional Review Board (IRB). If the research is "conducted or supported by" a federal agency, the reviewing IRB must provide "written assurance" of compliance with the regulations to the agency. If the research is not funded or supported by a federal agency, written assurance is not required, though the research is usually still reviewed by the IRB per the institution's individual policy. The Common Rule requires that each IRB be comprised of diverse members who are qualified to "ascertain the acceptability of proposed research" based on the applicable laws, institutional policy, and standards of professional conduct. If an IRB member "has a conflicting interest" with his obligations to the IRB, he may not participate in the review. The Common Rule does not prescribe any specific disclosure requirements for financial or other interests that have the potential to conflict with an IRB member's obligations. Presumably, any interest that has the potential to bias a member either in favor or against a specific research proposal would arguably disqualify that member from review. Many universities have added further criteria for when an IRB member has a conflict and the procedures for disclosing financial interests.

When the government provides funding for research involving human subjects the IRB's written assurance must be "satisfactory to the department or agency head" that the institution will comply with the minimum safeguards set out by the HHS Common Rule. The assurance must include five elements: (1) a statement of the institution's principles concerning human subject research; (2) a designation of one or more IRBs in accordance with the terms of the regulations; (3) a list of IRB members and biographical information; (4) the written procedures for review that the IRB follows; and (5) the procedures for ongoing monitoring and reporting by researchers at an institution.

The HHS Common Rule defines the responsibilities of IRBs in broad terms, providing IRBs discretion in implementing the rule's mandates. An IRB generally reviews and has the authority to approve, require modification, or disapprove of all research subject to the regulations. Under the Common Rule, an IRB's review of a project primarily focuses on minimizing the risk of harm to the subjects and ensuring the Investigators obtain informed consent from each subject. While the Common Rule does not expressly require an IRB to determine whether individual researchers have FCOIs, an IRB must certify that "[r]isks to subjects are reasonable in relation to anticipated benefits" and "selection of subjects is equitable," potentially implicating how an institution regulates FCOIs and human subject testing. For example, HHS has, in the past, suggested that IRBs should consider "establishing and implementing methods to protect the rights and welfare of human subjects from conflicts of interest created by financial relationships of parties involved in research." Accordingly, while no specific financial disclosures are federally mandated, FCOIs appear to be well within the discretionary scope of an IRB's authority. Nonetheless, notwithstanding such discretion, the National Institutes of Health has estimated that only 25% of IRBs currently routinely deal with FCOIs.

FDA Rules Regulating FCOIs

Although the FDA is within the purview of PHS, the FDA's unique role as "gatekeeper" for the approval of certain products entering the open market has resulted in a different approach with respect to FCOIs. First, the FDA has its own rules governing human subject research and IRBs. The FDA's version of the Common Rule most notably differs from the HHS Common Rule in scope. Specifically, the FDA Common Rule applies to (1) "all clinical investigations" pertaining to investigational drugs and investigational devices and (2) "clinical investigations that support applications for research or marketing" for several products regulated by the FDA, including foods, drugs for human use, medical devices for human use, and biological products for human use. In other words, in contrast to the HHS Common Rule, even clinical trials for new drugs and devices that are wholly privately funded are potentially subject to the FDA Common Rule.

While the FDA's version of the Common Rule covers both federally supported and privately funded clinical research, the HHS Common Rule and the FDA's counterpart largely mirror each other. And the similarities between the two rules extend to their treatment of FCOIs. In particular, like the HHS Common Rule, the FDA regulations on human subject testing bar a member of IRB from participating in the review of a project if that member has a "conflicting interest." Moreover, as with the HHS Common Rule, the FDA's counterpart does not overtly govern FCOIs that a researcher or institution may have and instead defers to an institution's IRB to monitor potential conflicts.

In 1991, the Inspector General of HHS, sensing a need for the FDA to move beyond the FDA Common Rule's concepts regarding financial conflicts, issued a report directed at the FDA that noted the failure of the agency to have a mechanism for collecting information on FCOIs of clinical investigators who study products that undergo FDA review. The Inspector General's report led the FDA to conclude that there was a "need to address" through regulations the issue of FCOIs with respect to the clinical tests performed on FDA-covered products. In 1998, the FDA promulgated several specific regulations requiring the submission of certain financial information with respect to marketing applications that rely on clinical data. The current FDA disclosure requirements apply to all "marketing applications" for all human drugs, biological products, and devices.

The FDA FCOI regulations generally give less deference to the institution performing the research than the PHS objectivity requirements. In particular, under the FDA's policy, the institution generally does not conduct the primary review of FCOIs by the clinical investigators. Instead, any applicant who submits a covered marketing application is "responsible" for submitting certain financial interest information to the FDA for review. The FDA then must determine "the impact of any disclosed financial interest on the reliability of the study." The FDA may deem a clinical study that is the basis for market approval inadequate if steps have not been taken to minimize bias, including "a financial interest of the clinical investigator in the outcome of the study."

Pursuant to the FDA's FCOI rules, the applicant must first submit a list of all investigators employed by the sponsor of the study. For each investigator, the applicant must either (a) certify that no "financial arrangements" exist or (b) disclose the nature of those financial arrangements that do exist. A financial arrangement can be any of the following:

1. Compensation affected by the outcome of the clinical studies—that is, compensation that is higher if the product or device is approved by the FDA. 2. A significant equity interest in the sponsor. If the sponsor is a non-public entity, then any interest for which the value cannot be readily established is significant. If the sponsor is a public entity, then an interest that exceeds $50,000 is significant. 3. A proprietary interest in the product such as a patent, trademark, copyright, licensing agreement. 4. Any other payment from the sponsor to the Investigator of more than $25,000 that is not for the funding of the clinical trial.

The FDA undertakes a three-part evaluation of all significant financial interests that are disclosed. First, the agency assesses the impact on the reliability of the results of the clinical trial based on the size and nature of the disclosed financial arrangement. Second, the agency determines the effect of the financial interests on the study design. Finally, if any "serious questions about the integrity of the data" are raised, the FDA must take appropriate action to ensure the reliability of the clinical trials. The FDA is authorized to (1) audit the investigator; (2) request further analysis by the applicant; (3) request other independent studies; or (4) discredit the results of the study.

Other Agency Requirements With Respect to FCOIs

National Science Foundation FCOI Policy

When compared to the PHS objectivity requirements, the National Science Foundation (NSF) has a similar, but arguably less strict, FCOI policy for funded research. Pursuant to NSF's policy, all "grantee institutions" with more than 50 employees must maintain a "written and enforced" FCOI policy. NSF requires that all investigators must disclose (1) any "significant financial interest" to the responsible party with the institution if the significant interest "reasonably appear[s] to be affected by" the research, or (2) if the research could reasonably appear to affect the financial interests of the entity in which the Investigator holds a significant interest. NSF further defines a significant interest as anything with a monetary value over $10,000. However, the NSF policy excludes the following from the definition of a significant financial interest:

1. Remuneration from the grantee institution to the Investigator; 2. An ownership interest in the institution if the institution is a Small Business Innovation Research Program or Small Business Technology Transfer Program; 3. Income from teaching or speaking engagements paid by public or non-profit organizations; 4. Income from serving on advisory panels for public or non-profit organizations; 5. Aggregated interests, including the interests of a spouse or dependents, that do not exceed $10,000 or a 5% ownership share; and 6. Aggregated interests, including the interests of a spouse or dependents, that do not exceed $10,000 in a 12-month period.

The NSF standard for when a significant financial interest becomes a conflict is the same as the PHS standard —that is, when "a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities." A designated representative of the institution is responsible for determining whether any of the disclosed significant financial interests rise to the level of a FCOI. If a conflict is found, NSF requires that the institution must impose "conditions or restrictions" to manage the conflict and prevent judgment bias. In contrast to the PHS FCOI policy, however, under the NSF financial conflict rules the reviewer may balance the benefit of the research against the potential negative impact of the conflict and decide not to impose restrictions if those restrictions would be ineffective or inequitable. Moreover, while PHS policy requires the government to be continually informed as to how a potential conflict has been managed or eliminated, under the NSF rules, an institution need only report FCOIs that have not been "satisfactorily" managed. Collectively, the NSF's waiver and reporting provisions make the NSF requirements arguably less stringent than the PHS-agency requirements.

Department of Defense FCOI Policy

The Department of Defense (DOD) provides funding opportunities for biomedical research through the Congressionally Directed Medical Research Programs (CDMRP). Current opportunities for DOD funding include, for example, grants for research in bone marrow failure, behavioral trials for autism patients, and research to improve the lives of veterans suffering from Gulf War Illness. According to DOD FCOI policy, the names of all "scientific participants" and "those individuals outside the application" who might have a conflict of interest must be disclosed by the applicant during the electronic "pre-application submission" process. While the DOD's funding application instructions provide no further guidance about the criteria for evaluating potential conflicts, the instructions refer all applicants back to their institution's policy concerning the disclosure of potential conflicts. In most cases, the institution's policy is not limited to PHS-funded research but extends to all research conducted by the research institution's employees. Therefore, as a practical matter, applicants for biomedical research funding from the DOD may need to comply with stricter requirements than the PHS regulations. Furthermore, the DOD has adopted the HHS Common Rule for applicable human subject research.

Current Developments

In 2011, the PHS "objectivity in research" regulations for the disclosure of FCOIs were revised to their current form. The revisions to the PHS objectivity rules included the lowering of financial interest reporting thresholds, expanding reporting obligations, and requiring institutions receiving federal funds to develop and enforce policies on FCOIs through training and education programs. Although the revisions arguably increased clarity and transparency with respect to the PHS financial conflict rules, the administration of the PHS FCOI process is still largely left to grantee institutions. As a result, even though a relatively small number of federal laws govern FCOI with respect to biomedical research, the process is still potentially cumbersome for investigators who participate in research with multiple institutions because each institution may have different processes for complying with the same federal rules.

Beyond potential issues arising because of a lack of uniformity among biomedical research institutions, the delegation of FCOI oversight to individual institutions arguably risks compliance problems, with some institutions inevitably having more lax financial conflict policies than others. Some commentators have even suggested that the discrepancies among research institutions with respect to their FCOI policies may lead to a "race to the bottom" where investigators "leave institutions with stringent policies to go to more lenient ones." Others have raised concerns that the delegation of the administration of FCOI policies to grantee institutions generally has resulted in FCOI policies that are vague and provide little guidance to researchers as to the "kinds of relationships with industry that are permitted or prohibited." As a consequence, some have advocated for a uniform federal conflict of interest policy that must be followed by all institutions and investigators applying for federal funds. At the same time, others have cautioned against imposing a "one size fits all" conflict management approach because "a degree of flexibility is essential to maintaining a balance between 'caution' and 'an environment in which legitimate research can flourish.' Regardless, as a consequence of the most recent revisions to the PHS objectivity rules, the debate over the appropriate scope and reach of federal FCOI regulations with respect to biomedical research, which has at times "captured the attention" of Congress, will likely continue.

While the PHS general objectivity requirements have been recently updated, the HHS and FDA rules respecting human subject research have not been substantially altered in decades. As a consequence, the HHS and FDA have jointly provided advance notice of proposed rulemaking (ANPR) to "modernize" the Common Rule. With respect to FCOIs, the ANPR noted that a key "problem[]" with the current version of the Common Rule is its failure to ensure that institutions effectively provide human test subjects with "appropriate information about [the] financial relationships between researchers and study sponsors...." To remedy this problem, HHS has requested comments about whether the Common Rule should be amended to require that institutions disclose in consent forms "information about financial relationships [researchers] have with [their] sponsors." More broadly, the ANPR has suggested that (1) the scope of the HHS Common Rule should be expanded to reach all research activities at domestic institutions that receive " some funding from a Common Rule agency" and (2) the federal rules on human subject testing should be harmonized and refined across adopting agencies. While a new Common Rule that is broader in scope and more precise and uniform could potentially expand the rule's impact on FCOI management with respect to biomedical research, since soliciting comments from the public in July of 2011, HHS has not yet issued any new final rules amending the Common Rule. In addition to the Common Rule ANPR, in July 2014 the FDA announced new draft guidance on human subject testing and sought public commentary on the guidance. Included in the draft guidance was a series of broad recommendations that "clinical investigators should consider whether information related to financial relationships or interests should be provided to subjects." In addition, Members of Congress have at times sought to encourage, through proposed legislation, HHS to expand the Common Rule to explicitly impose regulations respecting the definition and management of potential FCOIs with regard to human subject testing. To date, however, no recent changes to the either the HHS or FDA Common Rules have been enacted into law that implicate FCOI policy.