Valuing Academic Freedom and Advocacy

Abstract

This is a correspondence letter in response to an article published in the journal: Flaherman VJ, Nankabirwa V, Ginsburg AS. Promoting Transparent and Equitable Discussion of Controversial Research. Journal of Empirical Research on Human Research Ethics 2023; 18(4): 248–9.

This is a commentary on academic freedom and the role of advocacy in response to a paper by Flaherman and colleagues (Flaherman et al., 2023b) which raises issues of transparency in discussions of controversial research. As health professionals and academics, part of our role is to donate our time to the global science system as editors and peer reviewers, sometimes referred to as academic citizenship. (Tagliaventi et al., 2019) This often involves handling manuscripts which could be considered ‘controversial’ due to the nature of the research topic. One such research area is infant nutrition. This may be related to the role of industry and organisations with commercial interests in interventional nutrition research or the differing approaches to addressing malnutrition through magic bullet type supplements or commercial infant formula versus more sustainable approaches - such as community-based nutrition support or interventions to protect, promote and support breastfeeding.

The case raised by Flaherman et al. refers to the handling of a protocol manuscript (Ginsburg et al., 2022) for the Preventing Infant Malnutrition with Early Supplementation (PRIMES) trial. The primary objective of this trial was to evaluate the efficacy of formula supplementation among low birthweight (LBW) infants <2500 g < 6hours of age and those not LBW with weights <2600 g at 4 days of age. The trial compared breastfeeding and formula (up to 59 ml administered daily) through 30 days of infant age to frequent exclusive breastfeeding without supplementation in Uganda and Guinea Bissau. The primary outcome was weight-for-age z score at 30 days.

At the time a manuscript describing the trial protocol was submitted for peer review, the trial had received ethics approval and had almost completed participant enrollment and randomisation. The manuscript was handled by an editor who ensured that the reporting of the trial protocol adhered to the SPIRIT guide for the reporting of trial protocols. (Chan et al., 2013) Since the trial had almost completed enrollment at the time the protocol was submitted to the journal there was no opportunity to recommend revision to the intervention or study design. The manuscript underwent peer review and was accepted for publication. Publication of the trial protocol enabled the existence of the study to be in the public domain.

Once the protocol was published, a group of child health researchers and clinicians, which included the editor who had handled the protocol manuscript, wrote a commentary raising concerns about the ethics of conducting a formula supplementation trial amongst low birth weight infants in Uganda and Guinea Bissau and questioned the potential for scale up in these settings. (Doherty et al., 2022) The commentary was published (Doherty et al., 2022) alongside a response from the PRIMES trial authors enabling an academic discussion presenting differing viewpoints. (Nankabirwa et al., 2022).

Flaherman et al. argue that a conflict of interest exists when an editor of a paper is subsequently involved in a commentary that is critical of the paper. We argue that as editors and peer reviewers we constantly encounter research where we may have fundamental differences of opinion related to the intervention being evaluated or the ethics of conducting the research. In academic publishing there are mechanisms in place such as reporting checklists (Simera et al., 2009) for research studies to guide the editorial and peer review process and guard against research being rejected on the grounds of differing viewpoints. Importantly, there are also avenues within scientific journals to communicate opinions and viewpoints and to stimulate academic discourse which is a core part of academic freedom.

Furthermore, as health professionals and academics we have a role to play as advocates for our research communities. Research Ethics Committees (RECs)/institutional Review Boards (IRBs) are also important stakeholders in the global science system and have a role to play as advocates for study populations. This role is particularly important when research led by high income institutions, conducted in low- and middle-income countries seems inappropriate, does not adequately consider the context where the research is taking place, and has the potential to harm the communities participating in the research. In the present case, engagement by the RECs/IRBs who approved the PRIMES study (Flaherman et al., 2023a) would have contributed to the academic discourse. Ultimately we should be striving for a global research system where researchers and communities set the agenda for research conducted in their settings. (McIntosh et al., 2023).