Who Is Given a Say in Standards? The Ethical Aspects of Making Public Comments and Professionals' Duties

A notice asking for public comment arrives at a time of staff shortages and an urgent need for platelets. We intend to reply and then go back to our duties. Several months later, a new requirement alters our work. We want to know who has thought about the implications of it.

Taking account of the input from a wide range of stakeholders promotes a sense of shared responsibility and enables professionals to feel that their role is important in safeguarding both patients and donors by making the expectations clear and understandable. An example of this is the AABB's proposed sixth-edition Standards for a Patient Blood Management Program, which are available for comment until November 10, 2026. The proposed second-edition Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusions are also available for comment until November 24, 2026. By submitting reasons, data and alternative phrasing, stakeholders can actively participate in shaping the decisions so that a variety of viewpoints are taken into consideration before the standards are finalized and then implemented.^[1,2] In an interview conducted for this article, Christopher Bocquet, AABB’s senior director of standards and quality initiatives, explained that “receiving feedback from all potential stakeholders at two different points in the development of a set of Standards helps ensure that the final edition best reflects the needs of the community it is intended to serve.”

When Consensus Leaves Questions Unanswered

The discussion surrounding the standard of care in research serves as a useful caution. In 2004, Reidar Lie and his colleagues stated that various international guidance documents advocated for permitting care that was less than the best available worldwide in some trials, provided that certain conditions were met; their concern was that it would be impossible to carry out research relevant to communities where the best treatment was not available.^[3]

The assertion that these documents showed an international consensus was challenged by Udo Schüklenk. Who were the people who were chosen to contribute? In the case of disagreements, how were they shown? Were economic limitations being treated as scientific necessities? Schüklenk's criticism also applied to the Declaration of Helsinki. The situation was not merely a straightforward clash between an infallible declaration and its opponents. ^[4]

The question still seems unresolved: if local care is of a poor standard, does using it as the basis of ethical judgment accept the facts or instead reinforce injustice? Marouf and Esplin suggested that bioethics should be combined with human-rights protections to set a minimum standard of care.^[5] Their argument serves to remind us that the care which people currently receive on its own cannot be taken as equivalent to what they deserve.

Transparency and evidence are essential since they help to build trust and make experts feel that their contributions are important when it comes to setting up credible standards.

A Platelet Dilemma With No Comfortable Shortcut

Let us imagine a situation in which every unit of platelets transfused should undergo pathogen reduction within twelve months of collection. An urban hospital backs the idea as a safe and consistent policy. A rural hospital, however, says that its supplier may not be able to meet the deadline unless the delivery of platelets is reduced. A patient representative questions why geographic location should have an effect on patients’ access to protection. A technologist then asks who will be held responsible if the platelets are not available.

The concerns are based on a real-world occurrence. In its December 2020 guidance on bacterial risk, the Food and Drug Administration set out a number of strategies, such as bacterial testing and pathogen reduction, together with specific conditions for different products and methods.^[6] A study carried out in 2024 looked at bacterial isolates associated with eight cases of septic transfusion reactions that occurred between 2018 and 2021 and stressed that the recommended mitigation strategies are still acceptable.^[7] Although these incidents call for continued care and attention, they do not show that the various strategies are equivalent nor do they prove that any one of them eliminates the risk.

If it were shown that the hypothetical requirement had clear benefits, but its implementation put a hospital's blood supply at risk, would you support it? Would your response be different if you were the patient who had been harmed by contamination? On what grounds would implementation be delayed, and who should pay to comply with it?

The committee must have comparative safety evidence and reliable forecasts as to the effect on supply. It also needs contributions from those who have to endure the effects. The inquiry should not end simply because a manufacturer gives an assurance, or a hospital claims the item is unavailable or unaffordable.

Different Ethical Traditions Ask Different Questions

These traditions do not lead to immediate decisions regarding platelet policy; the following are examples of how their ideas might be applied, not the positions held by the authors in this case.

• The view known as utilitarianism, which is connected with John Stuart Mill, seeks to determine which policy results in the greatest total benefit and thus directs practical decisions by balancing benefits against harms.^[8] In this case, it would consider both the infections averted and the harm caused by delayed or unavailable product for transfusion, enabling stakeholders to assess the trade-offs properly.
• According to Kantian duty ethics, each person should be respected as an end in themselves.^[9] Patients should not be treated merely as entries in a calculation of system efficiency. This view opposes the deliberate imposition of avoidable harm on disadvantaged recipients and also challenges promises of equal access to essential treatment when the proposed system cannot reliably provide it.
• The principle of justice as fairness put forward by John Rawls encourages us to select social rules without knowing where we ourselves will stand in society.^[10] Would we agree to such a policy if we did not know whether we would receive care at a well-equipped urban center or at a hospital in a remote area with resource challenges? Rather than assuming that a similar deadline constitutes fairness, a Rawlsian approach focuses on the most disadvantaged and on funding the transition.
• The principle of principlism, which Tom Beauchamp and James Childress developed, incorporates autonomy, beneficence, nonmaleficence and justice within a single framework.^[11] It is important to prevent infection, as it is important to avoid harm caused by scarcity. Patients should be given information that is easy for them to understand, and any burdens imposed must be justified. By identifying these four principles we start the process of analysis, and it is then up to a review of the evidence and careful judgment to resolve any conflicts between them.
• Jürgen Habermas’s discourse ethics asks whether affected people could accept a rule through reasoned discussion in which their objections receive serious consideration.^[12] For public comment, the implication is practical: a submission portal alone cannot compensate for inaccessible language, lack of time, or fear of contradicting influential colleagues. Expertise remains essential, but institutional status cannot substitute for a convincing argument.

It is only if participation has real consequences that stakeholders will feel that their input affects the outcomes, thus strengthening their sense of responsibility and influence in the development of standards.

Participation should have potential real-world consequences. The 2024 Declaration of Helsinki specifically advocates for engaging with research participants and communities throughout the research process and provides a framework for the development of standards.^[13] Settings such as public forums, comment portals that are easy to access, or community advisory panels can ensure that those affected have real opportunities to influence decisions while the options are still available, thus promoting trust and inclusiveness in the development of standards.

Responsibility also has to carry through to the drafting stage. In 2022 Hellmann and his colleagues pointed out that the post-trial provisions in the 2013 version of the Declaration of Helsinki were unclear about who was responsible for continued access.^[14] The 2024 revision now mandates that sponsors and researchers should arrange such provisions in advance, with any exceptions having to be approved by an ethics committee.^[13] The same lesson applies to our hypothetical standard: an aspiration must have an accountable owner and a feasible implementation plan.

The 1996 International Conference on Harmonization (ICH) Good Clinical Practice guideline also prioritized participants’ rights, safety, and well-being over scientific and societal interests.^[15] It is simple to refer to that principle, but designing a procedure which protects people who have little institutional influence demands continuous effort.

A Practical Way Forward

Regarding the platelet proposal, I am in favor of setting a safety objective which is based on evidence and allowing for different methods of compliance only insofar as evidence and the requirements support this. When it is found that one method is necessary, the way of dealing with unequal access should include providing funding for a transition and making arrangements for a reliable supply. Flexibility must never be turned into a permanent excuse for harm which could have been avoided, and protection should not be determined solely on the basis of cost.

Before deciding, the committee ought to obtain feedback from rural and safety-net services, as well as from frontline staff, donors, patients and recipients who need transfusions repeatedly. Using plain-language summaries and ensuring that people are actively involved can make technical consultation more accessible. Information regarding any commercial or institutional interests must be made public. Expertise that is useful should be evaluated in an open and transparent manner.

As a part of its Standards development process, AABB publishes its committees’ replies to the comments received.^[16] Extending that practice, a thorough response should explain the evidence that was considered, admit any substantial disagreement, and outline the way in which access concerns affected the final decision.

The implementation should include measurements of both safety and access, including adverse events, delayed transfusions and regional availability. A named group should examine the findings at a specific date and make recommendations for changes if needed. Trust is gained through consultation when readers can see a concern progress from submission right through to evaluation.

Our contribution can be modest and specific. Identify the proposed standard, describe the affected patients or workflow, supply evidence, acknowledge uncertainty and suggest wording. Institutions should be allotted a period of time to make this work. Silence may reflect exhaustion. While it should not count as agreement, the decision of the named group (e.g., committee or professional association) needs to be supported when the comment period is closed for the Standards to have value.

Medical guidance can be unjust in its assumptions, its development or its effects, even when its purpose is protective. That possibility gives us a reason to participate thoughtfully. When the next invitation arrives, whose experience could your comment bring into the room?

---

About the Author

Ludwig Frontier, MD, MSc, MBA, DHSc, is a magister in Global Bioethics and hold a master of science degree in transfusion medicine and cellular therapies, and is the medical manager at Macopharma. The present commentary draws upon published research, professional standards, and existing ethical frameworks in order to examine public participation and professional responsibility in the process of standards development.

---

References

1. AABB. Proposed 6th edition of Standards for a Patient Blood Management Program [Internet]. Bethesda (MD): AABB; 2026 [cited 2026 Oct 2]. Available from: https://www.aabb.org/standards-accreditation/standards/patient-blood-management-program/proposed-6th-edition-of-standards-for-a-patient-blood-management-program
2. AABB. Proposed 2nd edition of Standards for Emergency Prehospital and Scheduled Out-of-Hospital Transfusions [Internet]. Bethesda (MD): AABB; 2026 [cited 2026 Oct 2]. Available from: https://www.aabb.org/standards-accreditation/standards/standards-for-emergency-prehospital-and-scheduled-out-of-hospital-transfusions/proposed-2nd-edition-of-standards-for-emergency-prehospital-and-scheduled-out-of-hospital-transfusions
3. Lie RK, Emanuel E, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics. 2004;30(2):190-3. https://doi.org/10.1136/jme.2003.006031
4. Schüklenk U. The standard of care debate: against the myth of an “international consensus opinion”. J Med Ethics. 2004;30(2):194-7. https://doi.org/10.1136/jme.2003.006981
5. Marouf FE, Esplin BS. Setting a minimum standard of care in clinical trials: human rights and bioethics as complementary frameworks. Health Hum Rights. 2015;17(1):31-42. Available from: https://scholarship.law.tamu.edu/facscholar/741/
6. US Food and Drug Administration. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion: guidance for industry [Internet]. Silver Spring (MD): US Food and Drug Administration; 2020 Dec [cited 2026 Oct 2]. Available from: https://www.fda.gov/media/123448/download
7. Hapip CA, Fischer E, Feldman TP, Brown BL. Formation of single-species and multispecies biofilm by isolates from septic transfusion reactions in platelet bag model. Emerg Infect Dis. 2024;30(9):1819-28. https://doi.org/10.3201/eid3009.240372
8. Mill JS. Utilitarianism [Internet]. 7th ed. London: Longmans, Green, and Co.; 1879 [cited 2026 Oct 2]. Chapter 2, What utilitarianism is. Available from: https://www.gutenberg.org/files/11224/11224-h/11224-h.htm
9. Kant I. Fundamental principles of the metaphysic of morals [Internet]. Abbott TK, translator. [place unknown]: Project Gutenberg; 2004 [updated 2026 Mar 21; cited 2026 Oct 2]. Section II, Transition from popular moral philosophy to the metaphysic of morals. Available from: https://www.gutenberg.org/ebooks/5682
10. Rawls J. A theory of justice. Rev. ed. Cambridge (MA): Belknap Press of Harvard University Press; 1999. Available from: https://www.hup.harvard.edu/books/9780674000780
11. Beauchamp TL, Childress JF. Principles of biomedical ethics. 8th ed. New York: Oxford University Press; 2019. Available from: https://www.oup.com.au/books/higher-education/health-nursing-social-work/9780190640873
12. Habermas J. Moral consciousness and communicative action. Lenhardt C, Nicholsen SW, translators. Cambridge (MA): MIT Press; 1990. Available from: https://books.google.com/books?id=fmYjgiUMy7EC
13. World Medical Association. WMA Declaration of Helsinki: ethical principles for medical research involving human participants [Internet]. Ferney-Voltaire (France): World Medical Association; 2024 Oct 19 [cited 2026 Oct 2]. Paragraphs 6, 33-34. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki/
14. Hellmann F, de La Cruz Bernabe R, Homedes N. Post-trial provisions in the Declaration of Helsinki: a watered-down principle that needs to be strengthened. J R Soc Med. 2022;115(11):420-3. https://doi.org/10.1177/01410768221133567
15. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for good clinical practice E6 [Internet]. [place unknown]: International Conference on Harmonization; 1996 Jun 10 [cited 2026 Oct 2]. Section 2.3. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r1-guideline-good-clinical-practice-revision-1_en.pdf
16. 16. AABB. Significant changes and response to comments received to the 35th edition of Standards for Blood Banks and Transfusion Services [Internet]. Bethesda (MD): AABB; 2026 Feb [cited 2026 Oct 3]. Available from: https://www.aabb.org/docs/default-source/default-document-library/standards/response-to-comments-standards-for-blood-banks-and-transfusion-services-35th-edition.pdf?sfvrsn=408638f1_4