Auditing of clinical research ethics in a children's and women's academic hospital.
Bibliographic record
Abstract
OBJECTIVE: Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. DESIGN: Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. RESULTS: Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. CONCLUSIONS: Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits. The research audit is a valuable tool in improving research ethics performance but requires considerable resources.
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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 | 0.148 | 0.207 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.005 | 0.010 |
| Science and technology studies | 0.008 | 0.009 |
| Scholarly communication | 0.006 | 0.002 |
| Open science | 0.003 | 0.006 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".