From Central Office

Ethics approval for publication

A discussion with the ISBT Standing Committee on Ethics

Submitted by Mindy Goldman on behalf of the ISBT Standing Committee on Ethics (SCE).

Is the approval of a research and ethics review board (REB) always necessary to have a study published in a transfusion medicine journal, such as Vox Sanguinis? Should the ISBT set up its own REB, perhaps linked to the Standing Committee on Ethics, to assist members?

These questions were recently discussed by the Standing Committee on Ethics (SCE), following a real-life situation involving a non-transfusion medicine journal. This stimulated discussion of policies in our different jurisdictions, a survey of editors of transfusion medicine journals as to their policies, a review of available tools, and some guidelines for researchers, summarized below. The situation

A subgroup of a working party conducted paper-based semi-structured interviews with experts on a given topic about professional experiences and country/institutional practices. The findings were analyzed using a recognized framework and a manuscript was submitted to a non-transfusion medicine journal. There was no personal, medical, or identifiable data included. Given the nature of the data collected, the working party felt that a formal institutional Research Ethics Board (REB) review was not required. Upon submission, the associate editor requested clarification on whether the study protocol had been approved by an institutional or licensed REB committee, and whether such approval was necessary for studies involving human subjects.

The lead author then consulted with the research promotion centre which oversees research in their institution, who confirmed that a formal ethics review was not needed. Additionally, all individuals interviewed had given informed consent. This further information was provided to the journal editor.

Policies in different jurisdictions and transfusion medicine journals

There is considerable variability in practice between different jurisdictions. Countries may also have an overarching policy governing how research is conducted, which provides broad guidelines about how research should be conducted and the need for full REB approval for specific studies. For example, in South Africa, all studies involving human subjects require full REB review. In New Zealand, there is a national ethics review board with an automated online submission form. The form has an automated stop at a certain point indicating to the researcher either that an REB is not needed (with a statement provided to that effect), or an instruction to proceed to a full application for review. The Canadian province of Alberta similarly has an assessment tool that assists in determining if a full REB review is required.

Editors of transfusion journals do not have an absolute policy but considered several factors in determining whether a statement requiring REB review is required prior to publication. Factors important in assessment are summarized in Table 1. Policies on research continue to evolve. Big data and broad genetic testing present new challenges. There will no doubt be more questions about how to generate valuable scientific information, while respecting the dignity, autonomy, and privacy of donors, patients, or other study participants.

Should the ISBT set up an REB?

In light of the above considerations, a proposal was submitted to the SCE to explore the feasibility of establishing a REB that could, at a minimum, provide formal waiver determinations for studies generated within the ISBT working parties.

Following discussion and consideration of REB requirements the SCE determined that setting an ethics review within ISBT does not align with the core mission of the society to advance transfusion medicine worldwide through knowledge, connection, and advocacy. Moreover, membership standards for an REB vary across jurisdictions and the applicability of REB decisions may not be uniformly agreed to across all regions. Most working parties have members affiliated with a university, hospital, blood service or institution with access to an established REB. The volume of studies across the working parties is large and the committee would be unlikely to meet the demand for the required volume of review in timely manner. Finally, the ISBT organizational structure (and the SCE) do not have the membership and expertise required to manage research ethics evaluation such as a legal expert, an ethicist and a member of the public.

For these reasons, ISBT working party members are encouraged to evaluate their proposed projects and if deemed research requiring REB approval, seek such approval from their workplace institutions prior to commencement of the projects.

Factors associated with need for a full Research and Ethics Board (REB) Review. These will vary in different jurisdictions.

REB is often exempted:

  • Aggregate/ anonymous/public data
  • Audit or observational study
  • Data collected in routine operations or routine quality control
  • No additional steps, such as additional questions or testing
  • If additional testing is done, left over samples are used and de-identified
  • No identification of study participants e.g. anonymous questionnaires and de-identified records
  • No patient or donor data
  • Minimal-risk studies such as surveys with de-identified data
  • Non-sensitive data, not involving vulnerable persons Usually require a full REB review
  • Interventional study
  • Extra questions of study participants
  • Extra samples taken from the study participant required to do tests for the study
  • Participants will be randomized to different treatment groups
  • Identifiable data including biospecimens and genetics
  • High-risk studies such as clinical trials
  • Medications or surgical interventions involved
  • Studies involving vulnerable populations such as children
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