KEI comments on DRAFT NIH Policy for Data Management and Sharing and Supplemental DRAFT Guidance

KEI filed these comments on the NIH Draft Policy for Data Management and Sharing and Supplemental DRAFT Guidance

January 10, 2019

1621 Connecticut Avenue NW
Suite 500
Washington, DC 20009
January 10, 2020

Office of Science Policy
National Institutes of Health
6705 Rockledge Drive
Suite 750
Bethesda, MD 20892
Via Online Submission

Re: Request for Public Comments on a DRAFT NIH Policy for Data Management and Sharing and Supplemental DRAFT Guidance

Knowledge Ecology International (KEI) welcomes the opportunity to comment on the DRAFT National Institutes of Health (NIH) Policy for Data Management and Sharing.

KEI is a nonprofit non-governmental organization with offices in Washington, DC and Geneva, Switzerland that focuses on improving the management of knowledge resources in search of better outcomes in the public interest. KEI’s primary areas of work are policies concerning equitable access to knowledge and medicines in the US and globally. Through these efforts, KEI has sought to promote open source data and the sharing of information to promote increased innovation and improved outcomes for patients and consumers. As a part of our work in increasing affordable, sustainable access to medicines, KEI has advocated for increased transparency of data in the area of medical R&D costs, in order to better inform future research and policies to ensure the public has access to the life-saving treatments they need.

While primarily concerning the data management and sharing of scientific data generated from NIH-funded research, KEI would like to offer comments regarding improved reporting and sharing of economic and cost data associated with US taxpayer-funded research.

As noted in section I. Purpose of the DRAFT NIH Policy for Data Management and Sharing (“Draft Policy”), the NIH has a “longstanding commitment to making the results and outputs of the research that it funds and conducts available to the public.” One such output is data concerning the costs of conducting research, including human subject clinical trials, and the costs of manufacturing of medical technologies.

As a part of the submission of the required Data Management and Sharing Plan as outlined in the Draft Policy, researchers with NIH-funded or conducted research projects should explain the expected costs to be incurred in the course of their project, including in particular, the expected costs of clinical trials, and the sharing of that cost among various sources of funding, including the NIH grants or contracts, funds from other federal and other government agencies, private charities, industry and reimbursements from government or private health insurance plans.

In the Supplemental DRAFT Guidance: Elements of a NIH Data Management and Sharing Plan section, KEI would recommend that the Elements of a Plan should include (in addition to those already proposed in the DRAFT Guidance) data related to the costs of the research project such as:

  1. Expected/Actual Total Cost of the Research Project;
  2. NIH Grant Numbers associated with the Research Project (if applicable); and
  3. Any Clinical Trials conducted in connection with the research.

If there are clinical trials associated with research for which the Data Management and Sharing Plan is submitted, KEI recommends the following data regarding the trial be included in the Plan:

  1. NCT Number
  2. Trial Sponsor
  3. Phase
  4. Enrollment
  5. Trial Start/End Dates
  6. Expected/Actual Cost of the Clinical Trial
  7. Expected/Actual Per Patient Cost of the Clinical Trial
  8. The expected contribution to the trial cost by:
    1. the NIH grant or contract,
    2. any other federal agency,
    3. any other non-federal government agency,
    4. any charities,
    5. Industry,
    6. and health plans that provide reimbursements of trial related expenses, including those required to do so under PHS Act section 2709(a).[1]

It will also be helpful to have the collection and sharing of data on manufacturing costs for medical technologies.

The information will contribute directly to policy researchers exploring how to design or reform incentives for biomedical research and development, in the evaluation the reasonableness of prices or incentives, and also give researchers, academic, non-profit and industry, useful information on the budgets required to bring inventions to practical application.

We would be happy to further discuss the suggestions and answer any questions related to these issues. Thank you for the opportunity to offer comments on the NIH Policy for Datamanagement and Sharing.

James Love
Knowledge Ecology International
1621 Connecticut Avenue, Suite 500
Washington, DC 20009


[1]. “PHS Act section 2709(a), as added by the Affordable Care Act, states that if a group health plan or health insurance issuer in the group and individual health insurance market provides coverage to a qualified individual (as defined under PHS Act section 2709(b)), then such plan or issuer: (1) may not deny the qualified individual participation in an approved clinical trial with respect to the treatment of cancer or another life-threatening disease or condition; (2) may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and (3) may not discriminate against the individual on the basis of the individual’s participation in the trial.

A qualified individual under PHS Act section 2709(b) is generally a participant or beneficiary who is eligible to participate in an approved clinical trial according to the trial protocol with respect to the treatment of cancer or another life-threatening disease or condition; and either: (1) the referring health care professional is a participating provider and has concluded that the individual’s participation in such trial would be appropriate; or (2) the participant or beneficiary provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate.” ; see also: