Read Our Policy

The mission of the Kidney Health Initiative (KHI) is to advance scientific understanding of the kidney health and patient safety implications of new and existing medical products and to foster development of therapies for diseases that affect the kidney by creating a collaborative environment in which the US Food and Drug Administration (FDA) and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products.

Background

KHI supports collaboration between patient organizations, health professional organizations, research institutions, foundations, pharmaceutical and biotechnology companies, medical device manufacturers, dialysis providers, and US and international government agencies. As a result, some members of KHI will possess competitive interests. However, by joining the Kidney Health Initiative, KHI members support a fully inclusive approach to selection and execution of Kidney Health Initiative projects. KHI projects and activities will be designed to support KHI's mission of advancing kidney health and patient safety, and will not be designed to advance the goals of any single member or member type of the Kidney Health Initiative.

All KHI board members must disclose any relationships that could be perceived to represent a financial conflict of interest or a conflict of commitment, and update these disclosures as needed but at least annually. All members of KHI working groups must disclose any relationships that could be perceived to represent a financial conflict of interest or a conflict of commitment, and update these disclosures as needed during the term of the working group. All disclosures will be made publicly available on the KHI website.

Definition of Conflicts

In the context of KHI policy, conflicts of interest (COI) represent the risk of undue influence and do not necessarily imply actual bias or misconduct. Conflicts related to the Kidney Health Initiative are determined in the context of specific project activities. In general, conflicts exist when:

• Activities or relationships with other persons or organizations affect a participant's ability to render impartial assistance or advice, or give the appearance of doing so.
• The participant's objectivity is or might be impaired.
• The participant has or might acquire an unfair competitive advantage.

Conflicts may arise from financial interests and from non-financial engagements with or commitments to other organizations and associations with interests related to the subject matter being addressed by specific KHI activities. Individuals and institutions must disclose changes to their financial, business, or professional interests that might introduce actual or apparent conflicts during the period of their engagement in KHI projects. When entities undertake new business activities that introduce actual or apparent conflicts, those conflicts must be reported to KHI and managed in accordance with this policy.

Practical Application of KHI Policies on Conflict of Interest

The following constraints apply to individuals and institutions participating in KHI activities:

1. Individuals with conflicts may not be decision-makers on matters related to the subject of the conflict. For example, an individual with a conflict of interest may not be selected as the leader of a KHI activity related to the subject of the conflict. Further, an individual with a COI may not participate as a voting member in any committee or workgroup involving the subject of the conflict.
2. Individuals with conflicts may participate as advisers, including as members of workgroups on activities related to the subject of the conflict, in limited circumstances:
   1. The individual possesses expertise needed for the project that cannot be easily duplicated by another individual who has no conflict or a lesser conflict.
   2. The existence and nature of the conflict is disclosed to anyone who may consider or make decisions on the basis of the advice provided by that individual.
   3. A plan for managing the conflict has been agreed to and implemented by the individual and approved by the COI management committee for KHI.
3. Individuals with conflicts may participate when participation involves implementing decisions that have been made and the outcome cannot be expected to be influenced by discretionary decision-making.

COI Management Plans

If an individual or organization's participation is considered important to the related KHI activity despite an actual or apparent conflict of interest, then the participating individual or organization must submit, to the American Society of Nephrology (ASN) Director of Operations, a proposed management plan that outlines procedures to manage, reduce, or eliminate the apparent or actual conflict throughout the duration of the project. The ASN Director of Operations will coordinate review of the management plan with the COI management committee for KHI.

Clinical Trials and Pre-Clinical Studies Associated with the Kidney Health Initiative

Many of KHI's organizational members have direct financial interests in the outcomes of clinical trials and pre-clinical studies. As part of their membership in the Kidney Health Initiative, institutional members and their representatives support the following principles of responsible conduct of research.

A. Clinical Trials

In fulfillment of its mission to advance scientific understanding of kidney health and patient safety, KHI requires public registration of clinical trials that are conducted as a result of, or in direct collaboration with, KHI activities. KHI defines a clinical trial as any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.

KHI does not advocate one particular registry, but registration must be with a registry that meets the following minimum criteria: accessible to the public at no charge, searchable by standard electronic (Internet-based) methods, open to all prospective registrants free of charge or at minimal cost, validation of registered information, and identification of trials with a unique number. An acceptable registry also includes information on the investigator(s), the research question or hypothesis, methodology, intervention and comparisons, eligibility criteria, primary and secondary outcomes measured, date of registration, anticipated or actual start date, anticipated or actual date of last follow-up, target number of subjects, status (anticipated, ongoing, or closed), and funding source(s).

All clinical studies should be approved by the appropriate Institutional Review Board or equivalent Ethics Committee with oversight authority for the protection of human life. All clinical experimentation should adhere to the ethical principles outlined in the World Medical Association Declaration of Helsinki (http://www.wma.net/en/30publications/10policies/b3/index.html).

KHI strongly supports the responsible conduct of all phases of research. Animal research experimentation must comply with the guidelines described in the National Institute of Health Guide for the Care and Use of Laboratory Animals, Eighth Edition (http://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-Laboratory-animals.pdf).

B. Transparency

In support of its mission to advance patient safety and scientific understanding of kidney health, KHI supports transparency related to conduct of clinical trials and data dissemination. Any researching conducting studies as a result of, or in direct collaboration with, KHI activities has an ethical obligation to submit creditable research results for publication.

Researchers should not enter into agreements that interfere with their access to all of the data and/or their ability to analyze them independently, and to prepare and publish manuscripts. Authors should describe the role of the study sponsor, if any, in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication. If the supporting source had no such involvement, the authors should so state.

Biases potentially introduced when sponsors are directly involved in research are analogous to methodological biases. In all instances related to studies related to KHI, all authors should have full access to all data in a study in order to take responsibility for the integrity of the data and the accuracy of the data analysis.

C. Negative Results

KHI recognizes that that failure to disseminate research results, positive or negative, adversely affects the relevance of published results.

D. Timely Dissemination of Results

Finally, researchers have an obligation to disseminate research results in a timely manner after completion of the trial. Full publication of results in peer-reviewed print and online journals should be the primary means of results dissemination.

Compliance

Once the KHI infrastructure is established and in operation, any member of KHI may bring to the COI management committee for KHI questions relative to conflict of interest, and this committee will address the questions, determine if a management plan is required and prepare a response.