Research or not research, a webinar presented at the University of Toronto Joint Centre for Bioethics (JCB) on 17.11.21)

1. Research or not research?
That is not the question of Public
Health Emergencies
GHAIATH HUSSEIN, MBBS, MHSc, PhD
@GhaiathHussein |

2. Acknowledgment
 Wellcome Trust
 Prof.s Angus Dawson and
Heather Draper
 Dr Khalifa Elmusharaf
 Dr Nima Alsomali
 CRED - Centre for Research
on the Epidemiology of
Disasters

3. It started
here

4. Then here

5. Outline
Working definitions
‘research’ & public health
emergencies (PHEs)
Normative and empirical questions
What the ‘papers’ said?
What the people said?
A way forward

6. Last thing first!
 Activity X has to be ethically overseen because it has ethically
relevant/unique/problematic features. If activity Y shares same or
similar ethically relevant/unique/problematic features, then it should
be also ethically overseen.
 Ethical oversight ≠ research ethics committees/boards
 Moving from research on people to research with people should also
move ethics from ethics on people to ethics from people.

7. A Public Health Emergency
 National vs international concern
 Direct vs indirect public health implications
 Natural vs man-made
Examples:
 “an event, condition or agent which has the potential to rapidly harm an exposed population sufficiently
to lead to a crisis.” (HSE, 2020)
 “a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks”
(CDC)
WHO checklist:
 Is the public health impact of the event serious? (yes/no)
 Is the event unusual or unexpected? (yes/no)
 Is there any significant risk of international spread? (yes/no)
 Is there any significant risk of international travel or trade restrictions? (yes/no)

8. Research: in pursuit
of a definition
Why is a
definition
needed?
Fund
Consent
Ethical approval

9. Research: in pursuit of a
definition
 Methods: The definition of ‘research’ was
searched using:
1. The list of international guidelines in the
International Compilation of Human
Research Standards
2. Tri-Council Policy Statement (TCPS2)
(Canada) and
3. Research Governance Framework for
Health and Social Care (UK)
4. Other national & international guidelines

10. Research: in pursuit of a definition
Samples of definitions
 “activities designed to develop or contribute to generalizable health knowledge within the more
classic realm of research with humans, such as observational research, clinical trials, bio-banking
and epidemiological studies” (COIMS, 2016)
 “an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic
investigation” (TCPS 2 , 2018)
 “[A]ny social science, biomedical, behavioural, or epidemiological activity that entails systematic
collection or analysis of data with the intent to generate new knowledge, in which human beings:
 are exposed to manipulation, intervention, observation, or other interaction with investigators either
directly or through alteration of their environment; or
 become individually identifiable through investigator's collection, preparation, or use of biological
material or medical or other records”.” (WHO, 2009, p. 7)

11. Research: in pursuit of a definition Results
Systematically conducted
• Follow a methodological approaches to answer a pre-set question
Generalizable knowledge
• i.e. can be applied beyond those from whom the data were collected;
Experimental
• i.e. it includes some deviation from common practice
Involve humans
• Mainly in the form of collecting personal or health-related data and/or biosamples

12. A case study from Darfur, west Sudan
Ethical framework
Empirically informed Philosophically robust ethical analysis
What is the status quo?
Systematic review Empirical qualitative project
Normative question: What ethical standards and procedures ought to guide research that involves
humans in situations of armed conflict?
What were the ethical issues? Which ethical standards and procedures?

13. What the
papers said?

14. What the papers said?
Ethical approval ONLINE CRED
Mention of ethical
approval
17 (12.3%) ZERO (0.0%)
18.90%
58.70%
42.60%
12.30%
0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00%
ONLINE
CRED
Mention of informed consent in studies
conducted in Darfur (2004-2012)
NO YES

15. 5 possibilities
1. These studies were exempted from ethical review
2. Mentioning ethical review was not required
3. Ethical review was considered by the researchers as if granted
4. Pre-approved proposals
5. The ethical review was not part of the template used

16. What the people said? The empirical project
Researchers
• UN agencies (SSIs)
• INGOs (SSIs & FGDs)
Researched communities
• IDPs (FGDs)
• National NGOs

17. What ‘research’ is?
Involvement of human participants
Data collection methods and tools
Purpose of the activity,
The type of data collected
The activity’s associated risks.

18. What ‘research’ is? Quotes from the field
“[T]he reference definition for research or health research … includes any of
the types of [research],... what matters [is] that all of them have human
subject involvement”
“No, I don’t call it research of course. I cannot call this research [...] because by
the nature of the conflict you cannot perform the studies in their scientific,
precise way [...]”
“That’s research definitely [...], they are making use of the data. [...] So I believe
it is research and once being research, not necessarily to be clinical, even the
one conducted at the community level should have ethical clearance”
“No, I don’t call it research of course. I cannot call this research [...] because by
the nature of the conflict you cannot perform the studies in their scientific,
precise way [...]”

19. Lessons from and beyond Darfur!
 Autonomy was not the leading principle. It was trust.
 “Consent in conflict-related studies can be described as a multi-tier, multi-person, and multi-
principle community-situated shared decision-making process in which the participants of these
studies were verbally informed, individually and collectively, of the basics of the intended study,
either directly by the data collectors or indirectly by the community leaders.”
 The communities have developed sophisticated ethical oversight beyond the REB/REC/IRB
model
 [it is] practised within a community-situated, trust-based, continuum of approvals; each
happening at one level of the multi-tier approval system. This apparently complicated approach is
meant to provide more protection, as the collective decision makes the responsibility for this
decision collective as well.
 “They (the leaders) gather the people. There would be an announcement that one of the organisations
will be coming to you and then [the people of the] villages gather to wait for the people of the
organisation to come to them, and when they come, the people of the organisation explain to the people
their perception and then share their views on the appropriate option” (IDP-M2/4).

20. Beyond the 5 possibilities: How the researchers
justified the lack/absence of ethical approval?
 Reasons for not submitting their studies for ethical approval
1. Studies were considered low-risk
2. The ethical standards were followed without formal review
3. Lack of awareness about and advocacy for ethical review
4. Time-related justifications: Emergency, urgency, and time lag
5. Approved by other (governmental) bodies
6. Pre-approval of the tools used
7. NGOs’ reluctance to submit their studies for ethical review

21. What does that tell us beyond Darfur?
 All the features that the ‘real people’ mentioned to refer to ‘research’
apply to many other activities undertaken beyond humanitarian settings
 The blurring of where to draw the line between ‘research’ and
‘humanitarian’ did not stop the communities from finding a way to
oversight both categories
 This blurring also applies to almost any other aspect of public health
emergencies, e.g. ‘research’ vs surveillance, screening, etc.
 Same arguments for skipping ethical review are raised elsewhere.

22. Lessons from and beyond Darfur!
 The flaws in the mainstream review do not make the ‘label’ argument valid
 If research is moving from being on people to be with people, so should ethics.
There are many innovative models of ethical oversight within and beyond
the committees-based model (e.g. SARS, EBOLA, H1N1, COVID-19)
 Ethical oversight ought to be a collective decision within a research-
oriented social contract where ‘we the people’ decide what we want to be
ethically overseen and how
 We need the moral imagination and the moral courage to go beyond the
ethical clichés to move to a more viable, reliable, trustworthy, sustainable
model of ethical guidance and governance

23. Thank you
QUESTIONS ARE WELCOME
This Photo by Unknown Author is licensed under CC BY-SA