Research Ethics Broadly Writ: Beyond REB Review
Bibliographic record
Abstract
... no aspect of research, from formulation of initial hypothesis down to final clinical acceptance, is devoid of ethical significance. (1) In Canada, as well as elsewhere, governments, sponsors, institutions, and researchers tend to view research ethics almost entirely through the lens of research ethics board (REB) review. According to these stakeholders, research ethics is REB review. In this paper, we aim to show that there is much more to research ethics; health research is a multi-stage process and each stage has unique ethical implications that may or may not fall under the mandate of the REB. We also aim to show that our current governance system fails to address those ethical issues lying outside of the mandate of the REB. Finally, we consider two possible explanations for this state of affairs: (1) the presumption that REBs can handle all of these issues; or (2) failure to recognize of the broader ethical issues associated with research involving human subjects. Ultimately, we reject both of these explanations in favour of a third: key stakeholders lack the foresight and political will to make the necessary changes. We begin by providing a moral geography of research involving human subjects. We describe the various stages involved in the planning and execution of research involving human subjects, and identify some of the ethical issues arising at each stage. We then explore the role of the REB within the process as a whole, contrasting the de jure role of the REB (as specified in the Tri-Council Policy Statement) with its de facto role in the current system. We conclude by calling for systematic efforts to redress the gaps in our current governance system. We note, however, that though many of our points apply to all research involving human subjects, some are clearly more relevant to the conduct of health research in general and clinical research in particular. This is partly an artefact of the authors' expertise and partly because our Network is centred on health research. But the focus on health research also allows us to simplify our remarks since taking into account the sometimes significant variances within different types of research involving human subjects would be very difficult within the ambit of a single paper. The problem: ethical tunnel vision Ten years ago, one of us concluded a report on the governance of research involving human subjects for the Law Commission of Canada with the following observations (among others): [W]ith respect to ethical conduct of HRIHS [health research involving human subjects] there [are] three central ethical objectives: a. The promotion of socially beneficial research b. The protection of research participants c. As an overarching aim, the maintenance of trust between the research community and society as a whole. These objectives enjoy broad social endorsement and are represented in the numerous international, national and professional codes and [sic] aimed at the conduct of ethical research involving humans. But when we compare these three objectives with what actually takes place in the name of ethical research, we find a narrowing of concerns that could aptly be described as ethical tunnel vision, in which the three ethical objectives are given the most minimal instantiation. In effect, our current governance processes for HRIHS reduce research ethics to a dangerously simplistic concern for REB approval that is often functionally an approval of consent forms. The result is that the REB approval process and informed consent bear far more moral weight than they can possibly sustain. (2) Though there has been some progress toward improving this situation over the last decade, these remarks remain all too true today. For the most part, governments, sponsors, institutions, and researchers continue to view research ethics almost entirely through the lens of REB review. …
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.570 | 0.597 |
| Meta-epidemiology (narrow) | 0.001 | 0.002 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.006 | 0.007 |
| Science and technology studies | 0.013 | 0.102 |
| Scholarly communication | 0.049 | 0.048 |
| Open science | 0.009 | 0.027 |
| Research integrity | 0.035 | 0.056 |
| Insufficient payload (model declined to judge) | 0.006 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".