Monitoring Contracts with Industry: Why Research Ethics Boards Must Be Involved
Bibliographic record
Abstract
Introduction Industry-university collaboration is an increasingly common phenomenon in Canada. A recent study on university-industry partnerships in this country indicated that the amount of research funded by private companies jumped from 2% in 1976 to 13% in 1996. (1) Critics have raised concerns that such research may have an underlying bias in favour of its sponsors. (2) To compound the problem, institutional research ethics boards (REBs) are often not privy to contracts negotiated between the institution and the industry sponsor. (3) Such contracts may contain ethically questionable clauses, and it is therefore imperative that REBs be able to view them before deciding whether a given research protocol is deserving of ethics approval. Without access to contracts and related documentation, an REB is precluded from making an educated decision on the matter. This could result in research proceeding that is unethical in nature, putting subjects at risk. It may further result in publication restrictions and other constraints on the investigator, jeopardizing the scientific integrity of the research. REBs and the Regulation of Research in Canada There is no single regulatory regime that governs research conduct in Canada. Most research is regulated indirectly through requirements of the three major federal funding agencies (CIHR, SSHRC, and NSERC). The Tri-Council Policy Statement, which governs federally funded research, requires that all research be approved by a local REB before investigators can proceed. (4) However, not being federal public entities, pharmaceutical companies and thus industry-sponsored research are not subject to the Tri-Council guidelines. While most academic institutions have in place requirements for REB approval of all research, the lack of official and formal regulation of ethics review by the Canadian government renders the situation somewhat murky in terms of what is, and is not, acceptable. Research ethics boards are generally composed of individuals from different areas of expertise. Most include a lawyer; an ethics expert; at least one person with expertise in the research area under review; and a member of the community unaffiliated with the institution. (5) The mandate of REBs is to scrutinize research protocols and related documents (e.g., consent forms) for ethical acceptability. Protocols that are deemed unacceptable must be resubmitted with the necessary changes made. Several principles should guide REBs in making their decisions. These include the respect for persons, beneficence, and justice. (6) REB members must closely examine submitted protocols for such things as improper informed consent, deception, unnecessary exposures to risk, and any other harms that could be incurred by participating subjects. The purpose of such ethical scrutiny is primarily to protect subjects from injury or harm of the kind suffered by human research subjects in such notorious historical events as human experimentation by the Nazis, or the Tuskegee Syphilis Study. Research Contracts: A Cause for Concern? A research contract is an agreement by a host institution to conduct research on behalf of a company in exchange for the payment of all related costs. (7) The terms of the contract dictate how the research will be carried out. Research contracts are currently not standardized. There is therefore no universal contract that is acceptable to all parties. This lack of standards is problematic, since it could translate into a discrepancy in practice even between different sites in the same industry-sponsored multicentre trial. Further, unlike peer-reviewed grants from public funding agencies like CIHR, industry-sponsored research contracts are generally initiated by pharmaceutical companies and are therefore necessarily profit-motivated. Good scholarship and scientific integrity may be secondary to this goal. As well, investigators contracting with industry may stand to profit from their involvement with the company. …
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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 | 0.511 | 0.632 |
| Meta-epidemiology (narrow) | 0.001 | 0.002 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.005 |
| Science and technology studies | 0.023 | 0.046 |
| Scholarly communication | 0.027 | 0.021 |
| Open science | 0.008 | 0.011 |
| Research integrity | 0.027 | 0.025 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
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".