Policy

U.S. Laws
Table: State Cloning Laws (pdf file)
International Legislation on Cloning and Germline Intervention (pdf file)
Table: International Legislation on Cloning and Germline Intervention (pdf file)
U.S. Proposed Laws
International Legal Situation
United Nations Declaration on Human Cloning
Germany's Stem Cell Act (2002) (pdf file)
Germany's Embryo Protection Act (pdf file)
California Proposition 71

Conflicts of Interest
by Joseph P. Oldaker
In research, issues arise in various ways in which there is a conflict between the interests of the parties engaged in or connected to such research. There are two general types of such conflicts of interest, and they are generally classified as "individual" and "institutional."¹ Furthermore, such conflicts can be either financial or non-financial in nature.

How and whether such conflicts must be addressed depends on how the research in question is funded and if it involves human subjects. Publicly funded research involving human subjects must adhere to the relevant federal statutes and guidelines that establish protocols for handling conflicts of interest, as well working with human subjects. Research funded by private entities, however, is not covered by any legally obligatory protocols addressing such conflicts of interest even when human subjects are involved. Rather, private institutions generally establish their own conflict of interest rules, and they often use the federal regulations as guidelines in formulating these rules.²

Individual Conflicts of Interest
Non-financial Individual Conflicts of Interest
These conflicts are known to occur when an individual who is involved in a research project has a personal ethical, moral, or other position that is inapposite to the goals or methods of the research being conducted. As seen in human research, these types of conflicts of interest may arise in several situations, the most obvious being human embryonic stem cell research. Researchers that have a moral conflict with using embryonic stem cells would clearly have this type of conflict, and to resolve it, they may simply choose not to participate in such research.

There are generally no legal protections specifically addressing individual non-financial conflicts of interest, as they are less common than financial conflicts of interest. However, if a researcher is fired for refusing to perform a research task to which he or she is morally opposed, the researcher may, for example, seek a remedy in court for a violation of the Civil Rights Act or employment discrimination. These claims are difficult to win, so, generally, when a non-financial conflict of interest exists, the person or persons with the conflict will simply refuse to perform the research and deal with the consequences.

Nevertheless, this type of conflict of interest becomes problematic when researchers rely on ethics or morals to dictate or influence the outcome of their research. It is nearly impossible to prove such a conflict, and the scientific community generally relies on peer review, publication, and reproduction of research results to weed out cases in which a personal non-financial conflict of interest has skewed the results or the interpretation of such results.

Financial Individual Conflicts of Interest
The Association of American Medical Colleges defined financial individual conflicts of interest as, "referring to situations in which financial considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research."³

The biases these conflicts create may impact collection, analysis, and interpretation of data. The conflicts may further bias the hiring of staff, procurement of materials, sharing of results, choice of protocols, involvement and selection of human research subjects, and the use of statistical methods.⁴

Throughout the 1990s, financial individual conflicts of interest were prevalent at research universities and hospitals. In 2001, the Association of American Universities' Task Force on Research Accountability published a report on the prevalence of such institutional conflicts, and highlighted the regulatory schemes available to alleviate such conflicts.⁵ The report found that action was required to implement policies against conflicts of interest, and it encouraged universities and research hospitals to develop and publicize clear policies, to establish administrative processes, to create conflicts of interest review boards, and to require disclosure of potential conflicts to such groups. In response, 95% of all medical colleges have instituted a policy to protect against such conflicts, especially in human subjects research.⁶

Institutional Financial Conflicts of Interest
For the most part, financial conflicts of interest are the only type of conflicts of interest that arise between institutions. These conflicts may occur when an institution, any of its senior management or trustees, a department, school, or other sub-unit, or an affiliated foundation or organization has an external relationship or financial interest in a company that itself has a financial stake in a research project being conducted at the institution. Additionally, senior managers or trustees who merely sit on the boards of such organizations may create an institutional conflict of interest.⁷ An example of this type of conflict of interest can be seen by observing the litigation surrounding California's Proposition 71. The California Institute of Regenerative Medicine (CIRM) was established under the stem-cell research funding initiative, and many of the members on CIRM's board have strong ties to biotechnology companies. (For more information on Proposition 71, click here.)

The existence (or appearance) of such conflicts can lead to actual bias, or suspicion about possible bias, in the review or conduct of research at the institution. Institutional financial conflicts of interest are not isolated to situations in which a corporation is involved. There exist other institutional bodies that may have a financial stake in the outcome of a research project, such as governmental organizations or private grant-funding agencies. Recent academic discussion has focused on the commercial motivation of industrial sponsors, because it is the most far-reaching and poses the greatest threat to scientific integrity.⁸

In a 2003 study on the scope and impact of financial conflicts of interest in biomedical research, it was found that approximately one-fourth of investigators have industry affiliations, and roughly two-thirds of academic institutions hold equity in start-ups that sponsor research at the same institutions.⁹ In addition to noting the widespread influence industry has on American research institutions, the study identified 11 published papers that found industry-sponsored research tends to yield pro-industry conclusions.¹⁰ Such conflicts can threaten the value and integrity of the research, trainees and graduate students involved in the research, human subjects of the research, and the reputations of the institution and researchers involved.¹¹

Institutional conflicts of interest are also not insolated within the academy-industry complex. There exist many financial conflicts of interest between federal regulatory agencies (such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH)) and industry. Those regulatory agencies have guidelines that intend to manage financial conflicts of interest, but there are no strict laws in place to guarantee that those guidelines are followed.¹² One regulatory agency that has recently been criticized for failure to manage conflicts of interest effectively is the FDA,¹³ which has a system that reviews matters before the agency through an independent advisory committee that attempts to foster discussion concerning the given matter. A recent study has shown that the FDA has failed to minimize financial conflicts of interest for advisory committee members, as nearly three-fourths of all meetings had at least one committee member with a financial conflict of interest, and only 1% of those members were recused from voting on the matter posing the conflict.¹⁴

Such conflicts pushed the NIH to tighten up its conflict of interest policy in 2005. In response to significant criticism for lax conflict of interest policies,¹⁵ the NIH changed its procedures to such an extent that there was outcry from employees and concerns that the agency would not be able to attract those best suited to perform the Institutes' research tasks due to the stringency of the new policy.¹⁶ Despite the internal outcry, these strict regulations may be justified, as Dr. Trey Sunderland, an NIH employee was recently investigated for providing spinal fluid and plasma samples to Pfizer Pharmaceuticals, for whom he served as a paid consultant.¹⁷

¹ ASSOCIATION OF AMERICAN UNIVERSITIES TASK FORCE ON RESEARCH ACCOUNTABILITY, REPORT ON INDIVIDUAL AND INSTITUTIONAL CONFLICT OF INTEREST i-ii (Oct. 2001), available at http://www.aau.edu/research/COI.01.pdf.
² John C. Fletcher, Moral Problems and Ethical Issues in Prospective Human Gene Therapy, 69 VA. L. REV. 515, 541 (1983).
³ See ASSOCIATION OF AMERICAN MEDICAL COLLEGES, GUIDELINES FOR DEALING WITH FACULTY CONFLICTS OF COMMITMENT AND CONFLICTS OF INTEREST IN RESEARCH (1990).
⁴See, supra, note 2.
⁵ Id.
⁶ Susan Ehringhaus & David Korn, U.S. Medical School Policies on Individual Financial Conflict of Interest, ASSOCIATION OF AMERICAN MEDICAL COLLEGES, 3-5 (2004) available at http://www.aamc.org/research/coi/coiresults2003.pdf.
⁷ See, supra, note 2.
⁸ Gordon DuVal, Institutional Conflicts of Interest: Protecting Human Subjects, Scientific Integrity, and Institutional Accountability, in INT'L & COMP. H. L. & ETHICS: A 25-YEAR RETROSPECTIVE, 613-625, 615 (2004).
⁹ Justin Bekelman et al., Scope and Impact of Financial Conflicts of Interest in Biomedical Research, 289 JAMA 454-465, 454 (2003).
¹⁰ Id. at 456.
¹¹ See, supra, note 9.
¹² Many agencies have financial conflicts of interest "guidance documents." Several of these documents are online: NIH: http://www.nihtraining.com/ohsrsite/new/COI-CR_1-4-2005FIN.pdf
HHS: http://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf
FDA: http://www.fda.gov/oc/guidance/advisorycommittee.html
¹³ Linda Ann Sherman, Looking Through a Window of the Food and Drug Administration: FDA's Advisory Committee System, 2 PRECLINICA 99 (2004), available at http://www.preclinica.com/pdf/articles/sherman_2-2.pdf.
¹⁴ Peter Lurie et al., Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings, 295 JAMA 1921-1928, 1921 (2006).
¹⁵ Robert Steinbrook, Conflicts of Interest at the NIHÐResolving the Problem, 351 NEW ENG. J. MED. 955-957, 955 (2004).
¹⁶ Meredith Wadman, NIH Workers See Red Over Revised Rules for Financial Conflict of Interest, 434 NATURE 3-4 (2005).
¹⁷ U.S. Representative Edward Whitfield (R-KY) Holds a Hearing on the National Institutes of Health's Human Tissue Research Policies - Part 1, 109th Cong. (June 13, 2006).