Ethical principles, governance and the research ethics committee

Year 4 / Module 31 MSci project: scoping, ethics and method / Unit 7 / Ethical principles, governance and the research ethics committee

Ethical principles, governance and the research ethics committee

HCI4107 · Unit 7 of 10

An ethics application is a schedule risk and a design constraint rather than a formality, and the principles a committee applies, from Belmont and the Menlo Report to the funder frameworks, bind the study's design and reach people the study does not recruit.

Ethical principles, governance and the research ethics committee

A project is approved before it is run, and the approval is somebody else's decision. That fact reorganises the plan: the student writes the ethics section before fixing the method, the calendar carries a queue the student does not control, and the design answers the questions a committee asks.

This seventh of ten units argues that an ethics application is a schedule risk and a design constraint rather than a formality. The principles a committee applies, from Belmont and the Declaration of Helsinki to the Menlo Report and the funder framework, bind the design. The documents come first (National Commission for the Protection of Human Subjects, 1979; Bailey et al., 2012; World Medical Association, 2025; Economic and Social Research Council, 2025). Then come the requirements on the design (Emanuel et al., 2000), and then the people outside the sample (Metcalf and Crawford, 2016).

The application is a dated commitment, and the date is not yours

Approval is a precondition. Emanuel and colleagues (2000) put independent review among the seven requirements that make research ethical. The others are value, scientific validity, fair subject selection, a favourable risk-benefit ratio, informed consent and respect for enrolled subjects. The approval date is therefore the earliest start date.

The application covers more than the weeks of data collection. The Economic and Social Research Council (2025) requires ethics issues to be considered across a project's lifecycle. The lifecycle includes dissemination, archiving, future use and the sharing and linking of data.

The queue is where the schedule risk sits, and its length is set by other people's reasoning. Lofstrom and colleagues (2024) set 27 committee and integrity board members from 16 European countries and one outside Europe to work on case scenarios. The scenarios covered authorship, conflicts of interest, ethics review and vulnerable populations, and the members applied the elements of ethical decision making in six constellations, varying with complexity. A protocol read by such a group is a document to be argued, not a set of boxes.

Hedgecoe (2015) argues from two case studies of United Kingdom university research ethics committees that they can prioritise their host institution's reputation over academic freedom and the protection of subjects. Management, he adds, has used them as a mechanism of internal discipline. Two case studies show that the behaviour occurs, not how common it is.

One subject is read in four registers

The National Commission for the Protection of Human Subjects (1979) set out three principles: respect for persons, beneficence and justice. It derived three applications from them: informed consent, the assessment of risks and benefits, and the selection of subjects.

These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.

The Menlo Report, summarised by Bailey and colleagues (2012), keeps the three Belmont principles and adds a fourth: respect for law and public interest. Research on technology contends with varied and often discordant legal regimes. Its applications cover stakeholder identification and informed consent, risk and benefit, fairness and equity, and compliance with transparency and accountability. It also proposes an ethical impact assessment alongside external review, and it reached the Federal Register in December 2011 for comment rather than as a settled code.

The Economic and Social Research Council (2025) states six principles. They are: benefit maximised and harm minimised; the rights and dignity of individuals and groups respected; participation voluntary and appropriately informed; integrity and transparency; lines of responsibility clearly defined; and independence maintained with conflicts of interest made explicit.

The Declaration of Helsinki, the code most medical research is judged against, reached its current revision at the seventy-fifth World Medical Assembly. Its 2024 text speaks of participants rather than subjects, adds provisions on vulnerability, community engagement and the distribution of benefits, risks and burdens, and extends ethics review to data privacy (World Medical Association, 2025).

What the committee applies is a requirement on the design

Emanuel and colleagues (2000) dismiss the usual assumption: informed consent is neither necessary nor sufficient for ethical research, since a consent form the participant cannot read is a design problem, not a formality. Four of their seven requirements are settled by the design. Fair subject selection is a sampling decision, and a favourable risk-benefit ratio is a judgement about what the study asks of a participant. Scientific validity asks whether the design could answer the question at all.

Because they are design requirements, the ethical work occupies the same weeks as the method work rather than following it: the proposal has to say what a participant carries, how long a session runs, what it asks a person to disclose, and what happens on withdrawal.

Zook and colleagues (2017) give the practical form of the same instruction in ten rules for responsible big data research, the tenth being the one to notice: know when to break these rules.

The principles reach people the study never recruits

The Menlo Report's most useful element for a project is its restatement of scope: the principles apply to research with the potential to harm humans, whether or not those humans are the direct research subjects.

Metcalf and Crawford (2016) argue that the practices of data science and the tools of ethics regulation have come apart. Commitments such as the distinction between research and practice cannot be exported cleanly from biomedical research. Their cases of harm include the 2014 Facebook emotional contagion study, whose participants were neither enrolled nor consented.

Doerksen and colleagues (2024) reviewed the international literature on community-led research governance and found three strategies: guidelines developed by, with or for a community, community review boards that review protocols for community interests, and community advisory boards that advise institutions. A project that already holds institutional approval can still be stopped at the second review. Indigenous-led initiatives far outnumbered others in the sample. A project working with a community may meet a second review with its own authority.

Contested question: does a principle protect anyone?

Hedgecoe (2015) argues from two case studies that a committee can protect its institution's reputation ahead of the research subjects, and that management can use it as an instrument of internal discipline. The frameworks it applies state the opposite purpose: Belmont derives the protection of subjects from respect for persons and beneficence, and the funder framework requires that the rights and dignity of individuals be respected. Lofstrom and colleagues (2024) offer the middle ground: the members they studied did apply the elements of ethical decision making, though how they applied them varied with case complexity.

What would settle it is an audit. The audit would code a defined sample of decisions against the principles a committee states and against outcomes for participants, with cases selected before the reasoning is read. No source here performs that audit, and two case studies cannot carry a general claim.

The second dispute is whether a principle does any work when it arrives. Mittelstadt (2019) reports that at least 84 public-private initiatives have produced statements of principles for artificial intelligence, and argues that consensus should not be celebrated. The field lacks four things medicine supplies: common aims and fiduciary duties, professional norms, proven methods to translate principles into practice, and robust accountability. Bietti (2020) names the two ways this argument goes wrong, ethics washing by organisations and ethics bashing by their critics. franzke and colleagues (2020) offer a general structure for ethical analysis as guidelines rather than recipes. Vitak and colleagues (2016) supply the practice evidence. Of 263 researchers surveyed about online data, the disagreements they report are not correlated with discipline, method or workplace.

Against those positions stand the documents, which claim only to guide: Belmont offers an analytical framework, the Menlo Report adds a principle and an application set, and the funder framework pairs its six principles with reflection case by case. What would settle the dispute is a comparison of matched protocols put through a principle-only process and a process with supporting methods and training attached. The nearest evidence here, the case study by Lofstrom and colleagues (2024), does not test which process produces better decisions.

Read by kind, the case against principles is stronger than the case for them on this evidence. Mittelstadt (2019) counts 84 initiatives and argues from analogy with medicine, and Vitak, Shilton and Ashktorab (2016) report a survey of 263 researchers. Against these stand documents that claim only to guide and one study of 27 members working on scenarios rather than real decisions. While the dispute is open, a student should write the application as a dated commitment, answer the design questions the principles imply, and name any second authority a community holds. The strongest objection is Hedgecoe's: two committees decided in part by institutional reputation, so a design built to satisfy stated principles can still be refused for a reason the principles do not name.

Where the argument is heading

The direction is from a principle a committee applies to a method a researcher practises. Doerksen and colleagues (2024) document community review boards and advisory boards as authorities a project may have to satisfy alongside its own committee. Lofstrom and colleagues (2024) aim their study at training, and franzke and colleagues (2020) publish a living document rather than a fixed code. Bietti (2020) and Markham, Tiidenberg and Herman (2018) both argue that ethics belongs to the method rather than to a stage appended to it. The Economic and Social Research Council (2025) has moved its lifecycle language to archiving, future use and the linking of data. The application that survives this drift is the one written as a dated commitment: what will be done, to whom, for how long, held by whom, and what would count as a reason to stop.

The sources this unit rests on

Each note states what the work did, what it found and how it bears on the argument. Every identifier was resolved on 2 November 2026.

Bailey, M., Dittrich, D., Kenneally, E. and Maughan, D. (2012). The Menlo Report. doi:10.1109/msp.2012.52 Summarises the report released to the Federal Register in December 2011 and its companion document. Carries the unit's fourth principle and its restatement of scope, which covers people who are not research subjects.
Bietti, E. (2020). From ethics washing to ethics bashing. doi:10.1145/3351095.3372860 A normative argument about technology ethics rather than an empirical study. Identifies ethics washing, companies' self-regulatory use of ethics, and ethics bashing, which trivialises ethics into tools and boards.
Doerksen, E., Gunay, A. E., Neufeld, S. D. and Friesen, P. (2024). Community-led approaches to research governance: a scoping review of strategies. doi:10.1177/17470161241269154 Scoping review finding three strategies, guidelines, community review boards and community advisory boards, with Indigenous-led initiatives far outnumbering others. Shows that a project may face a second review with its own authority.
Economic and Social Research Council (2025). Framework for research ethics: our core principles. https://www.ukri.org/councils/esrc/guidance-for-applicants/research-ethics-guidance/framework-for-research-ethics/our-core-principles/ States six principles and requires ethics issues to be considered across the whole lifecycle, including dissemination, archiving, future use and the linking of data.
Emanuel, E. J., Wendler, D. and Grady, C. (2000). What makes clinical research ethical? doi:10.1001/jama.283.20.2701 Proposes seven requirements and argues that informed consent is neither necessary nor sufficient. Makes the ethical question a design question and approval a precondition.
franzke, a. s., Bechmann, A., Zimmer, M. and Ess, C. (2020). Internet research: ethical guidelines 3.0. https://aoir.org/reports/ethics3.pdf The third set of guidelines, approved by the association's membership in October 2019, with a general structure for ethical analysis and companion resources. States that the best available instrument is guidelines rather than recipes.
Hedgecoe, A. M. (2015). Reputational risk, academic freedom and research ethics review. doi:10.1177/0038038515590756 Two case studies of United Kingdom university committees. Argues that a committee can prioritise institutional reputation over academic freedom and subject protection, and that management can use it for internal discipline.
Lofstrom, E., Pitkanen, H., Cekanauskaite, A. and colleagues (2024). Research ethics committee and integrity board members' collaborative decision making in cases in a training setting. doi:10.1007/s10805-024-09521-y Twenty-seven members from 16 European countries and one outside Europe worked on case scenarios in six constellations, applying the elements of ethical decision making, varying with case complexity.
Markham, A. N., Tiidenberg, K. and Herman, A. (2018). Ethics as methods: doing ethics in the era of big data research. doi:10.1177/2056305118784502 Introduction to a special issue on big data research ethics. Argues that data-driven research obscures the human decisions inside analysis and produces a crisis in accountability.
Metcalf, J. and Crawford, K. (2016). Where are human subjects in big data research? The emerging ethics divide. doi:10.1177/2053951716650211 Analysis of the gap between data science practice and ethics regulation. Argues that proposed Common Rule revisions would largely exclude data science methods and public datasets, and reads cases of harm including the 2014 Facebook emotional contagion study.
Mittelstadt, B. (2019). Principles alone cannot guarantee ethical AI. doi:10.1038/s42256-019-0114-4 Reports that at least 84 initiatives have produced statements of principles for artificial intelligence. Argues that four features of medicine are missing, common aims and fiduciary duties, professional norms, proven methods to translate principles into practice, and robust accountability.
National Commission for the Protection of Human Subjects (1979). The Belmont Report. https://ori.hhs.gov/content/chapter-3-The-Protection-of-Human-Subjects-belmont-report-1979 Sets out respect for persons, beneficence and justice with the applications of consent, risk and benefit assessment and subject selection, and states that the principles cannot always resolve particular problems beyond dispute.
Vitak, J., Shilton, K. and Ashktorab, Z. (2016). Beyond the Belmont principles: ethical challenges, practices and beliefs in the online data research community. doi:10.1145/2818048.2820078 Survey of 263 researchers using online data. Finds convergence on some beliefs and practices and continuing disagreements that are not correlated with discipline, method or workplace.
Zook, M., Barocas, S., boyd, d. and colleagues (2017). Ten simple rules for responsible big data research. doi:10.1371/journal.pcbi.1005399 Ten rules, from acknowledging that data are people through designing systems for auditability to knowing when to break these rules. Supplies the bridge from principle to conduct and the concession of judgement inside a rule list.
World Medical Association (2025). Declaration of Helsinki: ethical principles for medical research involving human participants. JAMA. doi:10.1001/jama.2024.21972 The 2024 revision, adopted at the seventy-fifth World Medical Assembly, replaces the language of subjects with that of participants, adds provisions on vulnerability, community engagement and the distribution of benefits, risks and burdens, and supersedes the 2013 text.

Check your understanding & apply it · 4 questions, 1 essay

1A draft ethics section reads: participants are volunteers who can stop at any time, the prototype is finished before the application goes in, and the anonymised dataset will be published with names removed. Which diagnosis does this unit's argument support?

2A student writes the ethics section last, after the method and the calendar are fixed, and plans to submit the application in August. What does this unit predict?

3Two readers disagree about a committee's decision. The first says the committee applied the stated principles. The second says it protected its institution's reputation. Which verdict does this unit's evidence support?

4A student claims that the funder framework makes a proposal ethical and proposes to settle it by showing that the application answers each of the six principles. Which judgement does this unit's argument support?

5Essay A student's MSci proposal contains this ethics section: "I will recruit twelve participants from a community mental health group to use a prototype mood-tracking app for four weeks. The app records in-app activity and, with permission, the phone's screen time. I will ask the group's facilitator to circulate the recruitment message and I will publish the anonymised usage dataset, with names removed, alongside the paper. Ethics approval will be applied for once the prototype is finished, and because participants are volunteers who can stop at any time, I expect review to be straightforward." Using this unit's sources, write the assessment you would give. Cover the requirements the design must satisfy before the form is written, who the study reaches beyond the twelve participants, the schedule consequence of where the application sits in the plan, and which position you would take on the contested question about principles and committees. Name the strongest objection to your own advice.

Begin with the order of work, because Emanuel, Wendler and Grady (2000) show that informed consent is neither necessary nor sufficient and that requirements such as value, scientific validity, fair subject selection and a favourable risk-benefit ratio are properties of the design. The student has fixed the design, four weeks with twelve participants, and deferred approval to the end, which reverses the sequence the requirements impose; approval is a precondition of running the study, so the plan should be built backwards from the submission date. Second, the requirements attach to the design: twelve volunteers drawn from one group through their facilitator is a selection decision that has to be argued, and the burden on a participant, four weeks of continuous screen-time capture asked of people using mental health services, has to be stated and justified as a risk-benefit judgement. The Menlo Report, as summarised by Bailey, Dittrich, Kenneally and Maughan (2012), applies to research with the potential to harm humans whether or not those humans are direct subjects, so the section must cover the other people whose messages, names and activity appear in four weeks of screen recordings, what will be redacted, who holds the files, how long they are kept and what happens to the dataset. Doerksen and colleagues (2024) add the second authority: work with a community may meet guidelines, a community review board or an advisory board of that community, so the facilitator's role and any group-level consent have to be negotiated before recruitment, not after. The Economic and Social Research Council (2025) makes the scope explicit, requiring ethics issues to be considered across the lifecycle including archiving, future use and the linking of data, which places the published dataset and any later reuse inside the application rather than outside it. On the contested question, the honest position is the one the evidence supports: Mittelstadt (2019) argues that consensus on principles should not be celebrated when the field lacks professional norms, methods to translate principles into practice and robust accountability, Bietti (2020) warns against both ethics washing and ethics bashing, and franzke and colleagues (2020) treat ambiguity and disagreement as inevitable, so the application should carry its own reasoning rather than rely on a principle being self-applying. At the same time Hedgecoe (2015) shows, from two cases, that a committee's decision can reflect its institution's reputation, so a project working with a mental health group should treat approval time as a range and record the risk. The strongest objection to this advice is that it is expensive for a student project, and the literature supports the objection: Lofstrom and colleagues (2024) find that members reason well and apply the elements of ethical decision making, which is evidence for treating a committee as a competent reader rather than a hazard, and no source in this unit audits committee decisions against participant outcomes, so the institutional-interest position rests on two case studies and cannot size the risk it describes.