BERD Unit Ethical Guidelines for Statistical Data Analysis

Jon Gelfond, Erin Fox, Chris Louden, Colleen Azen, Alex Capron, and Donna Spruijt-Metz.

Preamble

Biostatistics Epidemiology and Research Design (BERD) Units, including Statisticians and Epidemiologists, exist within Academic Health Centers (AHC). This involves BERD members working in intensive, collaborative environments with large research teams and many shared responsibilities, especially to research participants, public and private funding agencies, the local community, the scientific community, and their colleagues. The roles of AHC research team members are varied and dynamic, but BERD members have expectations, particular responsibilities, and standards that should be upheld. BERD units represent a concentration of expertise and resources, which can gain efficiencies, effectiveness, and oversight as a united group. Rather than only providing a set of general principles, these guidelines strive to define roles and infrastructure that promote accountability within and across BERD units in order to actively protect against challenges to ethical action.

To Maintain Research Standards of BERD units should:

1. 1. Provide a balance between fulfilling institutional needs for statistical and epidemiologic collaboration and promoting the competency, knowledge and skills of the BERD unit members.
   2. Provide standard operating procedures and systems for oversight of critical research practices within the BERD, and tracking of BERD resources for the purposes of accountability both inside and outside the BERD unit.
   3. Use appropriate measures to protect the privacy of study participants and to keep study information confidential in data-handling processes.
   4. Adhere to the compliance and regulatory requirements of collaborators, clients, funding agencies, and employers.
   5. Should have a documented framework for describing data provenance, securing data received and analytical work to facilitate reproducible results and potential audits.
   6. Analyze data in a reproducible, open, and transparent manner.
   7. Promote the free exchange of methodology and tools to other BERD units and the scientific community.
   8. Have a framework for addressing, documenting, and reporting questionable data analysis practices occurring in their research practice.
   9. Address potential misconduct or negligence in their research practice with a formal process that involves multiple perspectives both inside and outside the BERD unit.
   10. Have an open atmosphere for discussion of ethical issues.

The BERD unit members’ roles within the research team should

1. 1. Make expertise available for the planning of research studies to minimize risk to subjects and maximize the gain in scientific knowledge from any expended resources.
   2. Reject, document, and report undue efforts from collaborators, employers, and funding agencies that aim to pressure the BERD unit members for a particular result.
   3. Be integral to the full research process and assist with study planning, formulating and conducting the analysis, checking data integrity, explaining methods and results to other team members, and interpreting quantitative evidence within manuscripts.
   4. Negotiate, document, and fulfill mutual expectations with collaborators and clients in accordance with the BERD unit Standard Operating Procedures.
   5. Should resolve conflicts arising within the scope of work in a manner that promotes the interests of science above those of the individuals involved.
   6. Have a means of identifying, documenting, and managing their members’ potential or actual conflicts of interest, and they should be aware of collaborators’ competing interests.
   7. Provide early guidance to collaborators regarding the appropriate way to recognize the intellectual contributions of its members in the form of authorship, intellectual property, and/or investigator status on research projects.

The BERD units’ Roles within Academic Health Centers should

1. 1. Promote ethical practices through educational opportunities inside and outside the BERD unit.
   2. Track and distribute BERD resources according to the principles of equity, fairness, and the scientific value of the work.
   3. Make expertise available to Institutional Review Boards (IRBs), protocol review committees, and data safety monitoring boards to protect subjects from unnecessary risk.
   4. Promote an environment of accountability in study design, data collection, data analysis, and publication within the AHC.

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Topic revision: 24 Oct 2013, ShelleyHurwitz

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