Build workflows to track the use of identifiers for elements of the ethics process

[Daniel-Mietchen]

This is a follow-up on PIDapalooza 2016 and could feed into a submission to PIDapalooza 2019, as per https://github.com/Daniel-Mietchen/events/issues/467 (perhaps by way of some extraction-based summarization techniques).

It is also an exploration of Google Dataset Search, as per https://github.com/Daniel-Mietchen/ideas/issues/942 .

I'll be bolding words or phrases that represent opportunities for using persistent identifiers. Italics denote some other interesting aspect.

[Daniel-Mietchen]

• "The research was approved by the Human Research Ethics Committee at Charles Sturt University, Australia, protocol number H17013."

A search for this identifier reveals other pages that use it:

• The detection of hand tremors through the characteristics of finger movement while typing. — "The dataset comprises non-identifiable data and the research has been approved by the Charles Sturt University Human Research Ethics Committee (HREC) as protocol number H17013."
  • placed on https://foxtrialfinder.michaeljfox.org/
• Tappy Keystroke Data — "The participants, from the U.S., Canada, UK and Australia, had visited the project website and agreed to participate in the study. The research was approved by the Human Research Ethics Committee at Charles Sturt University, Australia, protocol number H17013."
  • placed on http://physionet.mit.edu/
• Keystroke dataset for 'The detection of hand tremor through the characteristics of finger movement while typing' — "The participants, from the U.S., Canada, UK and Australia, had visited the project website and agreed to participate in the study. The research was approved by the Human Research Ethics Committee at Charles Sturt University, Australia, protocol number H17013."
  • placed on https://data.mendeley.com/ , with DOI: 10.17632/z39mhdsynx.2
• High-accuracy detection of early Parkinson's Disease using multiple characteristics of finger movement while typing (the PLOS ONE paper describing the study) — "This study was approved by the Human Research Ethics Committee (HREC) at Charles Sturt University, protocol number H17013, and was conducted according to The National Health and Medical Research Council Australia requirements [27], including the informed consent of all participants and the anonymity of both participants and their data."
  • that reference 27 is The National Health and Medical Research Council (Australia). National Statement on Ethical Conduct in Human Research. The National Health and Medical Research Council, The Australian Research Council, The Australian Vice-Chancellors’ Committee; 2015. and does not come with a link or identifier.
  • a search for "The National Health and Medical Research Council (Australia). National Statement on Ethical Conduct in Human Research. The National Health and Medical Research Council, The Australian Research Council, The Australian Vice-Chancellors’ Committee; 2015" leads to National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

as well as various copies of the above.

A search for "Charles Sturt University" "protocol number" yields 1130 results in Ecosia and 90 in Google.

[Daniel-Mietchen]

• "Approval for the study was given by The University of Southampton Ethics Committee (ERGO Ethics Number: 2411)"

A search for "ERGO Ethics Number" (Bing via Ecosia; Google) does not yield much clarification about what it stands for, but

• a server at http://www.ergo.soton.ac.uk/ that requires login with University of Southampton credentials
• several other projects that have such a number:
  • Growing from Negative Childhood Experiences — "This study has been approved by the University of Southampton's Psychology ethics committee on May 18th 2018. ERGO ethics number = 31742"
  • placed on https://www.callforparticipants.com
  • Personality differences in the perception of emotional stimuli — "ERGO (ethics) number: 31835"
  • Dataset related to An objective comparison of quality and reliability of auditory brainstem response features elicited by click and speech sounds — "Approval for the study was given by The University of Southampton Ethics Committee (ERGO Ethics Number: 2411)"
  • this is the project listed on top of this commentary
  • A Study Analysing The Impact of Consumer Privacy Attitudes — "the ERGO ethics number for this research is 41372."

[Daniel-Mietchen]

• "The relevant ethics approval for this study was granted by a Department of Primary Industries NSW Animal Ethics Committee of qualified scientific and lay members (AEC Number 100802/04). Field work was carried out under NSW Fisheries Scientific Collection Permit P01/0059(A)-2.0."

Searching for P01/0059(A)-2.0 (that I had included in my 2016 talk) yields

• a project web page on Zoatrack Jervis Bay Marine Park: Active Tracking of Blue-spotted Flathead
  • I had seen that page back then and noticed that the overlap with the authors of the above paper was not complete
• a 2018 paper Abiotic drivers of activity in a large, free-ranging, freshwater teleost, Murray cod (Maccullochella peelii) — "This research was carried out under Fisheries NSW Animal Care and Ethics permit 14/10 and Scientific Collection Permit P01/0059(A)-2.0."
  • searching for this permit 14/10 reveals some more documents, including Commonwealth Environmental Water Office Long Term Intervention Monitoring Project: Lower Lachlan river system Selected Area 2015-16 Monitoring and Evaluation Synthesis Report — Fish sampling was conducted under Fisheries NSW ACEC Research Authority Permit 14/10. Larval fish sampling was conducted under NSW DPI permit No: P14/0022-1.0 and under approval from the University of Canberra Animal Ethics Committee (CEAE 14-12).
  • I also checked for this P14/0022-1.0 permit and the CEAE 14-12 number but found no other documents referring to them, albeit a false positive, which I'll put in the next comment.

[Daniel-Mietchen]

• "All experiments were performed under the guidelines of the Konkuk University Animal Care Committee, South Korea. The study protocol was reviewed and approved by the Ethics of Animal Experiments Committee of Konkuk University, South Korea (Permit Number: KU16192, KU16193)."

[Daniel-Mietchen]

• 100,000 histological images of human colorectal cancer and healthy tissue

"Data Description "NCT-CRC-HE-100K"

This is a set of 100,000 non-overlapping image patches from hematoxylin & eosin (H&E) stained histological images of human colorectal cancer (CRC) and normal tissue. All images are 224x224 pixels (px) at 0.5 microns per pixel (MPP). All images are color-normalized using Macenko's method (http://ieeexplore.ieee.org/abstract/document/5193250/, DOI 10.1109/ISBI.2009.5193250). Tissue classes are: Adipose (ADI), background (BACK), debris (DEB), lymphocytes (LYM), mucus (MUC), smooth muscle (MUS), normal colon mucosa (NORM), cancer-associated stroma (STR), colorectal adenocarcinoma epithelium (TUM). These images were manually extracted from N=86 H&E stained human cancer tissue slides from formalin-fixed paraffin-embedded (FFPE) samples from the NCT Biobank (National Center for Tumor Diseases, Heidelberg, Germany) and the UMM pathology archive (University Medical Center Mannheim, Mannheim, Germany). Tissue samples contained CRC primary tumor slides and tumor tissue from CRC liver metastases; normal tissue classes were augmented with non-tumorous regions from gastrectomy specimen to increase variability.

Ethics statement "NCT-CRC-HE-100K"

All experiments were conducted in accordance with the Declaration of Helsinki, the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), the Belmont Report and the U.S. Common Rule. Anonymized archival tissue samples were retrieved from the tissue bank of the National Center for Tumor diseases (NCT, Heidelberg, Germany) in accordance with the regulations of the tissue bank and the approval of the ethics committee of Heidelberg University (tissue bank decision numbers 2152 and 2154, granted to Niels Halama and Jakob Nikolas Kather; informed consent was obtained from all patients as part of the NCT tissue bank protocol, ethics board approval S-207/2005, renewed on 20 Dec 2017). Another set of tissue samples was provided by the pathology archive at UMM (University Medical Center Mannheim, Heidelberg University, Mannheim, Germany) after approval by the institutional ethics board (Ethics Board II at University Medical Center Mannheim, decision number 2017-806R-MA, granted to Alexander Marx and waiving the need for informed consent for this retrospective and fully anonymized analysis of archival samples).

Data set "CRC-VAL-HE-7K"

This is a set of 7180 image patches from N=50 patients with colorectal adenocarcinoma (no overlap with patients in NCT-CRC-HE-100K). It can be used as a validation set for models trained on the larger data set. Like in the larger data set, images are 224x224 px at 0.5 MPP. All tissue samples were provided by the NCT tissue bank, see above for further details and ethics statement.

Data set "NCT-CRC-HE-100K-NONORM"

This is a slightly different version of the "NCT-CRC-HE-100K" image set: This set contains 100,000 images in 9 tissue classes at 0.5 MPP and was created from the same raw data as "NCT-CRC-HE-100K". However, no color normalization was applied to these images. Consequently, staining intensity and color slightly varies between the images. Please note that although this image set was created from the same data as "NCT-CRC-HE-100K", the image regions are not completely identical because the selection of non-overlapping tiles from raw images was a stochastic process."

[Daniel-Mietchen]

• "Ethical approval was obtained from the Balearic Islands Human Research Ethics Committee in January 2017 (CEI-IB, #IB 3341/16 PI). The local ethics review boards, and the study itself was conducted according to standard guidelines. The trial was registered with ClinicalTrials.gov, number NCT0325075"

[Daniel-Mietchen]

• "This survey, which formed part of a larger study examining stress and physical activity levels in university students, was approved by the Western Sydney University Human Research Ethics Committee (approval number H10384)."

[Daniel-Mietchen]

-"Ethical approval was obtained from the Lothian National Health Service Research Ethics Committee, and all participants provided written informed consent before taking part."

[Daniel-Mietchen]

• "Institutional Ethics Committee approval was sought."

A search for this phrase yields several dozens additional hits (Ecosia; Google).

Possibly a good title for a talk on the topic.

[Daniel-Mietchen]

• "After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return."

[Daniel-Mietchen]

• "There are two CSIRO Data Access Portal (DAP) surveys reported in the workbook, (1) a survey of depositors to the DAP, and (2) a survey of DAP withdrawers (users). Each of these were conducted under CSIRO Social Science Human Research Ethics Committee Approval: project 055/16 “Data Access Portal – costs and benefits for depositors and users”."

[Daniel-Mietchen]

• "Committee Minutes, Medical and Nursing Administration"

This series comprises minutes of committees responsible for medical or nursing administration of the hospital. Committees included:

Patient Care Committee P1 Senior Medical Staff Committee P2 Medical Records Committee P3 Medical Records Quality Assurance Committee P4 Research and Ethics Committee P5 Infection Control Committee P6 Medical Advisory Committee P7 Accreditation Committee Meeting P8 Nursing Quality Committee P9 Perinatal Mortality Committee P10 Pharmacy Committee P10 Senior Nursing Staff Committee P11 Computer Department Meeting P12 Quality Assurance Co-ordinating Committee P 13 Management Quality Committee P14 Research Foundation Committee P15 Infant Feeding Committee P16 Admissions and Discharge Committee P16 Combined Hospitals Evacuation Assistance Plan P16 Operating Theatre Committee P16 Pais Committee P16 General Medical Staff meeting P16 Family Birth Centre Committee P16 Hospital Steering Committee P16 State Enrolled Nurses' Committee P16 Special Care Nurseries' Committee P16 Ward Clerks' meetings P17 Delivery Suite Committee P17 Education and Research Committee P17 House Committee P17 Charge Nurses' Committee P17 CSSD Instrument Technical Meeting Committee P17 Uniform Committee P17 Mercy Health and Aged Care Executive Committee P18.

Minutes of committees responsible for general administration of the hospital can be found in VPRS 15629 Minutes, Board of Management, Executive and Sub-Committee and VPRS 15630 Minutes, Various Committees.

• Similar minutes from 1887.

• See also: "IRB Metrics structure-process-outcome model used at FTM-EC."

A	B
EvaluationApproach	Goals & Performance Measures
Evaluation ofStructure	Evaluation of committee composition, qualification, and workload.
Evaluation ofProcess	Evaluation of review procedures, management convened meetings, decision-making processes (individual and group), variations in time for review, and IRB site-monitoring visits.
Evaluation ofOutcome	Evaluation of review outcomes, approval rates, ethics quality issues raised and communicated to researchers, and researchers’ comments about IRB performance.

[Daniel-Mietchen]

• "Ethical clearance was obtained from the Institutional Ethics Committee of the Indian Institute of Public Health Hyderabad Bengaluru Campus"

[Daniel-Mietchen]

• "you may need the approval of your IRB or Ethics Committee to use the data"

Similar cases:

• "The Australia Parkinson's Disease Registry will not be openly accessible but de-identified data and samples are accessible upon review and Human Research Ethics Committee Approval."
• "In line with the national Ethical Conduct in Human Research guidelines and JCU Ethics Committee Approval for this research, raw data collected from individuals cannot be made publically available. Rather, data is collated into meaningful units and presented as such."

[Daniel-Mietchen]

• "The study protocol was approved by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University (MUTM2013-021-01) and the Oxford Tropical Research Ethics Committee, University of Oxford (OXTREC 1013-13)."

[Daniel-Mietchen]

• "Evaluation of Process – Timeliness of protocol review, 2010–2013."

Includes data on things like "Total Days From Submission to Final Approval" or reasons for processes ending without approval.

[Daniel-Mietchen]

• "The database provides live access to the Ethics Commission's records. Filings are accessible once processed/posted by the Ethics Commission."

[Daniel-Mietchen]

• "Ethics approval was granted by Monash University Human Research Ethics Committee. Consent for the study was given by Ambulance Victoria research committee."

[Daniel-Mietchen]

• "The study was approved by the Ministry of Education and Culture of Schleswig-Holstein and the ethics committee of the Hamburg Chamber of Physicians."

[Daniel-Mietchen]

• "The studies have been approved by the Central University Research Ethics Committee of the University of Oxford and are therefore in compliance with the Helsinki Declaration."

[Daniel-Mietchen]

• "We obtained verbal consent from all the subjects before the test, and the study design was approved by the ethics committee of Wenzhou People's Hospital."

[Daniel-Mietchen]

• "The study was conducted in accordance with the guidelines contained in the Declaration of Helsinki II and was approved by the local ethics committee of the University of Granada, Spain (protocol: 23/CEIH72015)."

[Daniel-Mietchen]

• "Quality of tissue collected - collection and storage details The tissue is stored in the hospital where the donor was diagnosed/treated. It stays there until it is used or sent to another hospital or research center within the TuBaFrost group. The electronic database will track samples throughout the network. The tissue is not sold. The exchange of tissue to other hospitals is regulated by a contract, which uses the national regulations of the country supplying the tissue. Tissue samples within the TuBaFrost collection will only be used for research, which has been approved by ethics committees. This ensures that the tissue is only used for the best quality research and only for the specific reasons given to the ethics committee."

[Daniel-Mietchen]

• " All participants gave written informed consent and the protocol was approved by the local ethics committee."

[Daniel-Mietchen]

• "Embryos were collected from female spiny mice (n=12) in accordance with the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes with approval from the Monash Medical Centre Animal Ethics Committee."

[Daniel-Mietchen]

• "Ethics approval for this study was granted by the University of KwaZulu-Natal Review Board, Oxford Research Ethics Committee, Massachusetts General Hospital Review Board, Harvard School of Public Health, Botswana Ministry of Health, Ethics Committee of the University of the Free State, and by site-specific research and development committees in the UK."

[Daniel-Mietchen]

• "The study has been approved by the local ethics committee (Medical University of Graz, Austria) in compliance with the current revision of the Declaration of Helsinki, ICH guideline for Good Clinical Practice and current regulations (EK-number: 24-123 ex 11/12)."

[Daniel-Mietchen]

• "Collars weighed less than 2.5% of the body mass of the baboons and were approved for use by Swansea University Ethics Committee (Swansea University IP-1314-5)"

[Daniel-Mietchen]

• "DEC Pilbara Region produces basic summary reports to meet DEC Animal Ethics Committee requirements. These are held at the DEC office in Karratha."

[Daniel-Mietchen]

• "All data is acquired under ethics 09-H0802-78 as approved by the London - Westminster research ethics committee, and has been fully anonymised."

[Daniel-Mietchen]

In addition to the questions outlined in the talk, some others are of interest too, e.g.

• Which ethics committees exist?
• Which ethics committees use identifiers, and for what?

[Daniel-Mietchen]

• "This study was cleared by the Research Ethics Committee (CEP/CONEP) (CAE number: 13813613.9.0000.0006), and all signed an Informed Consent Form."

[Daniel-Mietchen]

• "All animal model procedures were approved by The Francis Crick Institute Biological Ethics Committee and UK Home Office authority provided by Project License 70/8380."

[Daniel-Mietchen]

• "Ethical approval was obtained from the London Westminster Research Ethics Committee (11/LO/1667), and informed consent was obtained."

[Daniel-Mietchen]

• "Acknowledgement of this dataset should include the statement: "Data were collected following protocols approved by the Australian Antarctic Animal Ethics Committee and supported through the Australian Antarctic program through Australian Antarctic Science project 4087." This data set conforms to the PICCCBY Attribution License (http://creativecommons.org/licenses/by/3.0/). Please follow instructions listed in the citation reference provided at http://data.aad.gov.au/aadc/metadata/citation.cfm?entry_id=AAS_4087_adelie_penguin_tracking_hop_island_2011_12 when using these data."
  • that link again: http://data.aad.gov.au/aadc/metadata/citation.cfm?entry_id=AAS_4087_adelie_penguin_tracking_hop_island_2011_12

[Daniel-Mietchen]

• "Summary of common reasons for occurrence of Protocol Deviations"

A	B	C
Category of deviation	Reasons of PD as reported by investigators	Number of deviations in each category
Study Procedure N = 304	Participant seen outside window period	126 (41.45%)
	Missed Assessment	92 (30.26%)
	Study procedure in protocol not followed	76(25.00%)
	Incomplete Case Record Forms	10 (3.29%)
Safety N = 87	Safety assessment not done at all	35(40.23%)
	Safety assessment not done as specified in protocol	31 (35.63%)
	SAE/ Adverse Event (AE) not reported	10 (11.49%)
	Prohibited medication taken	4 (4.60%)
	Stopped study medication	2 (2.30%)
	Wrong version of diary used	2 (2.70%)
Informed Consent N = 47	Failure to obtain informed consent properly	9 (19%)
	Wrong version used/ current version approved by IEC not used	16 (34%)
	Consent form does not have required signature	22 (47%)
Eligibility N = 9	Enrollment of ineligible participant	3 (33%)
	Randomization before baseline assessment	1 (11%)
	Study drug treatment of participant started before IEC approval	2 (22%)
	Recruitment of additional participants for the study	3 (33%)

[Daniel-Mietchen]

• "The ethics committee at Bethlehem University reviewed and approved an initial study protocol and questionnaire prior to data collection."

[Daniel-Mietchen]

• "This study was carried out in accordance with the recommendations of the Local Ethics Committee. All participants gave written informed conset in accordance with the Declaration of Helsinki."

[Daniel-Mietchen]

• "Example of tracings (II, aVR, and V3) from patient 1098 from E-OTH-12-73-011" ... "All patients gave written informed consent. The study was approved by the local Ethics Committee of the enrolling organization and complied with the Declaration of Helsinki."

[Daniel-Mietchen]

Some interesting notes about the ethics of self-experimentation in this thread: https://twitter.com/SusannahFox/status/1039904744318423042 .

[Daniel-Mietchen]

"The specimen was collected under Bureau of Land Management Permit MSM-8172- RS-1A." (in the Reporting Summary)