EDF’s recommendations for IRIS conflicts-of-interest disclosures, and the strong precedents for them

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst

Our last blog post was quite lengthy and some readers may not have gotten to the recommendations we provided to EPA’s Integrated Risk Information System (IRIS) governing disclosures of conflicts of interest.  In that post, we also cited the numerous strong precedents for requiring such disclosures.

So we’re reposting here our recommendations and discussion of precedents.  

Needed disclosures

To address these problems of spotty or nonexistent disclosures, EDF recommends that IRIS require all registrants for its meetings, and all parties submitting written comments to IRIS, to provide the following specific information:

  1. Identify any organization(s) on whose behalf you are presenting comments or by whom you have been paid to work on the chemical(s) or scientific issues under discussion.
  2. Identify the nature of any financial relationships you currently have or have recently had with those organizations.
  3. Identify the funding source(s) for any research or analysis you have done or contributed to on the chemical(s) or scientific issues under discussion.
  4. Indicate whether the sponsoring or funding organizations, or any other organizations that have or represent organizations that have a financial interest in the chemical(s) or scientific issues under discussion, have had input into or have reviewed the presentation or comments you are providing.

(The fourth of these is particularly important in light of the highly influential role played by the funder, ACC, in the work ToxStrategies presented at the IRIS meeting on hexavalent chromium.)

IRIS and/or the participants should also make these disclosures public:

  • for meetings, clearly and prominently marked on the meeting agendas and on all presentation materials, and briefly noted orally; and
  • for submitted comments, clearly and prominently noted in the comments and made public along with the comments.

Strong support/precedents for such disclosures

There is strong support in other venues for these very types of disclosures.

1.  Administrative Conference of the United States (ACUS) Recommendation 2013-3, Science in the Administrative Process, Item #11, page 7:

11. Conflict of Interest Disclosure. Agencies should require conflict of interest disclosures on all scientific research submitted to inform an agency’s licensing, regulatory, or other decisionmaking processes. This disclosure should be similar to the conflict of interest disclosure required by some scientific journals, such as that used by the International Committee of Medical Journal Editors. The regulatory conflict of interest disclosure should also, where permitted by law, identify whether the experimenter or author had the legal right without approval of the sponsor of the research to: design the research; collect the data; interpret the data; and author, publish or otherwise disseminate the resulting report or full dataset. To the extent that a party other than the principal investigator (e.g., the study sponsor or funder) had control over the design or publication of the study, agencies should disclose this fact and specify the nature of the control such an entity exercised.

2.  OSHA proposed rule on “Occupational Exposure to Respirable Crystalline Silica,” 78 Fed. Reg, September 12, 2013, p. 56274:

If you submit scientific or technical studies or other results of scientific research, OSHA requests (but is not requiring) that you also provide the following information where it is available: (1) Identification of the funding source(s) and sponsoring organization(s) of the research; (2) the extent to which the research findings were reviewed by a potentially affected party prior to publication or submission to the docket, and identification of any such parties; and (3) the nature of any financial relationships (e.g., consulting agreements, expert witness support, or research funding) between investigators who conducted the research and any organization(s) or entities having an interest in the rulemaking. If you are submitting comments or testimony on the Agency's scientific and technical analyses, OSHA requests that you disclose: (1) The nature of any financial relationships you may have with any organization(s) or entities having an interest in the rulemaking; and (2) the extent to which your comments or testimony were reviewed by an interested party prior to its submission. Disclosure of such information is intended to promote transparency and scientific integrity of data and technical information submitted to the record. This request is consistent with Executive Order 13563, issued on January 18, 2011 [Section 5, “Science”], which instructs agencies to ensure the objectivity of any scientific and technological information used to support their regulatory actions. OSHA emphasizes that all material submitted to the rulemaking record will be considered by the Agency to develop the final rule and supporting analyses.

3.  Disclosure policies of many leading scientific journals, including Nature, which published this editorial calling for such disclosures in March, 2014.  One salient excerpt:

In areas where tough standards are needed to protect public health, and powerful and wealthy interests have a financial incentive to water down these standards, such transparency is more than desirable — it is essential, and history demonstrates that. Rather than challenging OSHA for requesting conflict-of-interest disclosures, US politicians should be asking why all federal agencies do not require them.

Other examples of journals’ conflict of interest (COI) disclosure policies:

(Note:  EHP and ES&T authors must affirmatively declare they have do NOT have any COI if that’s the case.)

 

Conclusion

Requiring disclosures of the sort we request by IRIS would have at least two beneficial effects.  First, it would ensure the public as well as IRIS staff are fully informed as to whether the input stakeholders are providing to EPA may be colored by those stakeholders’ financial ties to companies or trade associations with a vested interest in the outcome of IRIS assessments.  The public has a right to know the full basis on which government agencies and programs such as IRIS are making decisions that have the potential to affect public health and well-being.

Second, requiring such disclosures could directly address the imbalance in recent meetings by reducing the flood of industry-affiliated registrants for IRIS meetings through shining a more illuminating public spotlight on the extent of industry efforts to influence IRIS’ work.

Industry is, of course, a legitimate stakeholder in the IRIS process.  But it’s time to ensure their representatives come clean about the degree to which they and their hired hands have financial interests that, whether in whole or in part, motivate them to so vociferously seek to influence the outcomes of IRIS assessments.

 

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