Thread by @littleann4ever

1/🧵So, who's ready to explore some "made in BC" ethics waivers w/me? Six studies w/similar stmts & one document that might just be a crucial puzzle piece. btw-this thread & corresponding paper is culmination of weeks of my intermittent research...okay, here. it. goes...#bcpoli

2/ Before getting into it, lets look at the waiver stmts w/each corresponding study. The 1st five are all co-authored by #DrHenry incl. 4 vax studies & the P.1 study. The 6th is a WGS project that took place during the P1 outbreak & the Delta wave. They are as follows: #bcpoli

3/ #1 Vax study stmt: "Data linkages & analyses were conducted under a surveillance mandate, authorized by the PHO under the Public Health Act, and exempt from research ethics board review.”#bcpoli ncbi.nlm.nih.gov/pmc/articles/P…

4/ #2 Vax study stmt: “Data linkages and analyses were authorized by the PHO under the Public Health Act and exempt from research ethics board review.” #bcpoli academic.oup.com/jid/advance-ar…

5/ #3 Vax study stmt:“Data access approved by WHITE’s steering committee & all analyses conducted under surveillance mandate authorized by PHO under PH Act, exempt from REB review under admin of UBC Clinical REB...doesn't incl. factors req patient consent."ncbi.nlm.nih.gov/pmc/articles/P…

6/ #4 Vax study stmt:“Data linkages & analysis were authorized by PHO (BC) & National Director of Public Health (Quebec) under respective provincial public health legislation without requirement for Research Ethics Board Review.”#bcpoli academic.oup.com/cid/advance-ar…

7/ #5 P.1 study stmt: “This work was conducted under the public health mandate, and institutional review board approval was waived.” #bcpoli ncbi.nlm.nih.gov/pmc/articles/P…

8/ #6 WGS study stmt: "This work was conducted under a surveillance mandate, authorized by the Provincial Health Officer of British Columbia under the Health Act, without requirement for research ethics board review." #bcpoli ncbi.nlm.nih.gov/pmc/articles/P…

9/ Before diving into nitty gritty of the "surveillance mandate" let's take a peek at BC's PH Act, specifically Part 2, Div. 3"Reporting Disease, Health Hazards & Other Matters", sec "Purposes for collection, use & disclosure of personal info:" #bcpoli bclaws.gov.bc.ca/civix/document…

10/ Re: above #9 (1)“A person may collect, use or disclose personal info..but only if it's necessary for 1 or more of the following..to engage in health system planning, mgmt, eval. or improvement incl. “PH surveillance” & “to conduct or facilitate research into health issues.”

11/ Okay, now let’s take a deeper dive into the potential origin of the “surveillance mandate” & bear w/me while we take a few steps back first to take a big picture look at BC’s evolving research ethics process, namely Research Ethics BC (REBC). #bcpoli bcahsn.ca/our-units/rese…

12/ Re: above, REBC formed w/creation of "a provincial, harmonized system for research ethics reviews of multi-jurisdictional studies involving human subjects." It’s in use by most BC HAs & research uni's & streamlines allow for submission of single ethics application. #bcpoli

13/ Fast forward to 2021 & the BC Academic Health Science Network (BC AHSN) - incl. the BC Support Unit, Clinical Trials BC and REBC - merged with MSHR, with the memorandum of understanding finalized in February 2021 as per this MSHR Consolidation Update: bcahsn.ca/news-events/ne…

14/ Of note, the BC gov't recently invested 116.6 million in MSHR. In response, the MSHR thanked the province “for recognizing that a healthy society and a healthy economy go hand in hand...” Announcement here: #bcpoli healthresearchbc.ca

15/ In this Oct/21 gov't press release re: merger, Dix says, “A healthy province w/resilient economy requires a strong health system underpinned by scientific evidence & knowledge generated by health research. MSHR will help deliver on that…” #bcpoli healthresearchbc.ca/wp-content/upl…

16/ Moving on. What are other changes impacting BC research ethics in pandemic? Well, re: these Covid-19 Research Ethics Resources, REBC & BC HAs incl. their clinical REBs agreed Apr/20 to “implement rapid ethical review process for clinical studies..."bcahsn.ca/initiatives/co…

17/ This rapid review process incl. a 5-day turnaround for swift, thorough ethical reviews on clinical studies incl. trials. It's creation was in response to increasing demand by stakeholders for reduced delays in vital pandemic research. This all sounds good, right? #bcpoli

18/ Here’s kicker tho. Feb25/21, new guidance was posted to ensure streamlined approach by “REB offices/members when considering activities pertaining to PH surveillance since these “can raise questions about whether they req REB review when conducted in HA or using HA data.”⬇️

19/ Could this "BC Research Ethics Guidance: Public Health Surveillance" document explaining the surveillance framework be the “surveillance mandate” that is being referred to in the ethics board review waivers in the above studies? #bcpoi bcahsn.ca/sites/default/…

20/ This above document outlines 3 points:
1) “The Panel on Research Ethics (PRE) has provided an interpretation under the topic of Scope of Research Ethics Review & states: “activity that is conducted in support of PH program or under jurisdiction of PH authority...con't

21/ 1) "...& that does not have research as a primary goal, does not fall within the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) definition of research and does not require REB review.” #bcpoli

22/ 2) “Surveillance of PH activities stemming from PH emerg aren't subject to REB review if primary purpose of...activities is not research.”
3) “Additionally, if surveillance is initiated from BCCDC it will h/b developed [with] their ethical considerations.."(see doc) #bcpoli

23/ Document recommendations: “in accordance w/provisions of TCPS2 2018, REBC endorses interpretation of the PRE that PH surveillance activities that do not have research as a primary goal, should not be required to undergo research ethics review." con't... #bcpoli

24/ ..."If a project that meets the definition of public health surveillance is submitted to a REB then the REB should advise the project investigators that REB review is not required in accordance with this Guidance and the provisions of the TCPS2 2018.” #bcpoli

25/ Let’s take closer look at TCPS-2 PRE SCOPE #11 re:PH surveillance & crux of waivers exempting studies: "Although PH surveillance may share methods/techniques w/those..in research…the intent/objectives of collection/further use are determining factors"ethics.gc.ca/eng/policy-pol…

26/ Whew! So, as per above, it sounds like “the intent” & “the further use of the collected data” are the deciding factors in determining whether a study is considered research & therefore in need of ethics review, regardless if it’s PH program or under PH authority. #bcpoli

27/ So, let’s go back & review all these studies based on the 1st point outlined in “BC Research Ethics Guidance: PH Surveillance” doc. What was intent of each? What was “further use” of collected data? Was it for research or surveillance purposes? #bcpoli bcahsn.ca/sites/default/…

28/ Now, let’s add into mix #DrHenry, PHO & co-author. The one person w/power to alter study outcomes by employing stringent PH measures (i.e curb P.1) or by reducing vax intervals. Is there any possible way to conjure up a plausible scenario where this is merely “surveillance?”

29/ On a side note, this BC Covid-19 Research Response Coordination Rapid Review Report concludes that there’s no “integrated & sustained provincial research response to the pandemic” in BC. #bcpoli msfhr.org/wp-content/upl…

30/ Whole report needs scrutiny, but for now, here's acknowledgment that some research by MoH are not ethically reviewed: App A (pg 24): “inventory only contains studies that have gone through research ethics review (e.g. it does not incl. all MoH research projects)” #bcpoli

31/ This concludes my 3rd Segment of BC Research Overview Part 2. If you want to read even more words and sentences on this topic, here they are: docs.google.com/document/d/1Ab…

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