Comments – Theresa Gyorkos
Comments are posted in the language in which they were received.
Dear TCPS secretariat,
Thank you for your invitation to receive feedback on the new sections of the TCPS. I have two comments on the multijurisdictional research guidance. Comment 1: In para 2 of section 3.4, I feel that the qualifier even if only for participants at their site is unnecessary, and even infers that this might not be a substantive issue. I would suggest removing the qualifier.
Comment 2: In para 3 of section 3.4, a time period of three weeks is stated for a turnaround time from the local REB: In general, local REBs should complete their process and issue a letter or notice of acknowledgment within three weeks of receiving the complete package from the researcher, including the decision of the REB of record. I feel this may put undue pressure on a local REB. Some local REBs might only meet monthly; some may require translation; some might need to request expert advice; among other reasons.
Might I suggest a different wording? Like: In general, local REBs are encouraged to complete their own review process and issue a letter or notice of acknowledgment regarding receipt of the complete package from the researcher, including the decision of the REB of record, within as timely a manner as possible.
All the best,
Theresa W. Gyorkos, PhD
Professor, Department of Epidemiology, Biostatistics and Occupational Health, McGill University;
\f0Senior Scientist, Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre;
Director, WHO Collaborating Centre for Research and Training in Parasite Epidemiology and Control
Office address: CORE, RI-MUHC, Office 3D-55, 5252 de Maisonneuve, Montreal, QC, Canada H4A 3S5
tel: 514-934-1934 x 44721; e-mail: email@example.com
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