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Record W189964354

Rebuilding a Research Ethics Committee

2013· article· en· W189964354 on OpenAlexaboutno aff
J. S. G. Biggs, August Marchesi

Bibliographic record

VenueJournal of Research Administration · 2013
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsnot available
Fundersnot available
KeywordsResearch ethicsBioethicsGovernment (linguistics)Ethics committeePolitical scienceHuman researchPublic administrationCommissionPublic relationsLawMedicineEngineering ethicsEngineering
DOInot available

Abstract

fetched live from OpenAlex

The ethical review of research protocols is an essential aspect of research administration. It is undertaken in many countries by committees, under the guise of Institutional Review Boards (IRBs) in the USA, Research Ethics Boards (REBs) in Canada, Research Ethics Committees (RECs) in Britain and most of Europe, and Human Research Ethics Committees (HRECs) in Australia. In the interests of maintaining research standards and protecting research participants, government regulations overriding the review process, such as required committees, supporting infrastructure and methods of administration exist in many countries (National Bioethics Advisory Commission (2001), Department of Health UK (2011), Australian Government (2012). There is remarkable growth in the number of oversight committees. Catania et al (2008) reported an increase in U.S. IRBs of 685% (491 to 3853) from 1993 to 2008. At the same time there is unease and dissatisfaction in the research community about restrictions, added burdens and delay coming from IRBs and ethics committees. This is evident through publications such as: Communication difficulties in Research and monitoring by ethics committees, (Karunaratne, Myles, Ago and Komesaroff, 2006); Current research ethics forms are an over-reaction that will stifle research (Oliver, 2006);Research and survival in the IRB iron cage (Bledsoe et al, 2007); Counteracting IRB mission creep (Gunsalus et al, 2007); Grinding to a halt: the effects of the increasing regulatory burden on research and improvement efforts (Infectious Diseases Society of America, 2009); In the lion's den?, (Fistein and Quilligan, 2011); The ethics police?, (Klitzman, 2011). Human research ethics in Australia is regulated by the Australian Health Ethics Committee (AHEC), and is under the direction of the National Health and Medical Research Council (NHMRC), (NHMRC, 2012). There are 228 HRECs registered with AHEC, or a round figure of one committee to 100,000 of the general population, fewer than the U.S. figure of one to 79,000. Australian committees operate under the guidance of the National Statement on Ethical Conduct in Human Research (the National Statement), developed jointly by NHMRC, the Australian Research Council and the Australian Vice-Chancellors' Committee (Australian Government, 2007). The National Statement prescribes the structure and responsibilities of committees and the process of ethical review. The Australian Capital Territory (ACT) Government in Canberra, Australia's capital, requires all medical research involving its citizens to receive ethical approval from the ACT Health HREC. The committee reports ultimately to the ACT Director-General of Health. This paper describes ethics review in the ACT and the rebuilding that occurred in the last three years. We believe rebuilding is an appropriate term as the committee was somewhat like an old house: still standing, still livable, but in desperate need of modernizing. Much work was done at the ground level to secure the foundation of the committee, its processes and standing within the research community, akin to reinforcing the foundations of an old home. The issues raised below include administrative processes that were not reassessed for more than ten years such as its leadership needs and its reputation within the local research community. There were two main prompts for the changes in ethics administration. An organizational shift in reporting structure meant that in 2009 the committee came under the ACT Health Research Office. The Director of Research was determined to have the committee certified by NHMRC for the impending Harmonization of Multicentre Ethical Review (HOMER) process. The same year also saw the appointment of a new chairman and new HREC administrator. Together these three led the drive for the necessary changes in HREC administration/management. The steps taken to determine the issues and initiate change may be familiar to many research administrators, but we believe there are still lessons to be learned. …

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How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.496
metaresearch head score (Gemma)0.503
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Research integrity
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.984
Threshold uncertainty score0.621

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.4960.503
Meta-epidemiology (narrow)0.0020.003
Meta-epidemiology (broad)0.0030.003
Bibliometrics0.0080.005
Science and technology studies0.0130.019
Scholarly communication0.0280.031
Open science0.0090.026
Research integrity0.0160.055
Insufficient payload (model declined to judge)0.0110.014

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.

Opus teacher head0.855
GPT teacher head0.731
Teacher spread0.124 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designNot applicable
DomainMethods
GenreEmpirical

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".

Quick stats

Citations4
Published2013
Admission routes1
Has abstractyes

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