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The title of this webinar
is Multi-Jurisdictional Research in TCPS 2.
Hello, everyone, I'm Hanan Abdel-Akher,
a senior policy analyst
with the Secretariat on Responsible Conduct of Research.
I'm joined today by Dr. Lawrence Felt.
Dr. Felt is a member of the Panel on Research Ethics.
He is professor of sociology
at Memorial University in Newfoundland.
Dr. Felt has a lot of practical experience
with multi-jurisdictional research and ethics review,
both as a researcher and an REB member.
He is currently chair
of the provincial Health Research Ethics Authority
that provides ethics review for all health research
undertaken in the province of Newfoundland and Labrador.
This is a recorded presentation.
As a result, there is no question and answer period
following the presentation.
If you have questions pertaining to this topic,
we invite you to participate
in our regular interpretation service.
Simply submit your questions
to the Secretariat on Responsible Conduct of Research.
The contact information will be provided
at the end of the presentation.
At the end of this presentation,
you should have a basic understanding of TCPS 2 guidance
on ethics review mechanisms of multi-jurisdictional research,
what is possible, how it can be operationalized,
who contributes to this process, and how.
These issues are of interest to all involved in research ethics.
It is of particular interest to REB members and chairs,
REB administration staff, as well as researchers.
We will start
with what constitutes multi-jurisdictional research.
We will address alternative ethics review mechanisms
for the review of multi-jurisdictional research,
and the roles and responsibilities
of those involved
in making ethics review mechanisms possible.
Using a case study approach, we will explore those issues.
We will then conclude the presentation
with tips for researchers and REBs.
The topic of multi-jurisdictional research
was referred to as the review of multi-centred research
in a couple of paragraphs,
and the review of research in other jurisdictions or cultures
in an article in the first edition of the TCPS.
Given the rise of collaborative research
and the globalization of research,
and therefore the need for guidance,
this topic is now given its due prominence and detailed guidance
in a full chapter, chapter 8, of TCPS 2.
Multi-jurisdictional research
refers to research involving more than one jurisdiction.
Here we are referring to the involvement
of more than one institution and/or more than one REB,
because they have jurisdiction over the research.
This could be in any discipline of research
anywhere in Canada or abroad.
Within the context of TCPS 2,
a "jurisdiction" refers to authority and responsibility
for the research either:
due to the research being conducted
within the auspices of an institution,
or using its resources,
to recruit members of the institution
as participants in the research;
or that the research is conducted
by a member of the institution
irrespective of the research site.
Some examples of multi-jurisdictional research
are provided in the first section of chapter 8.
A classic example of research involving multiple jurisdictions
is research involving humans
conducted by a team of researchers
affiliated with several institutions.
By virtue of their affiliation with those institutions,
and the fact that they carry with them
the name of their institution and its reputation,
the institutions have jurisdiction over the research,
and this research would be considered
multi-jurisdictional research.
Another example: a researcher affiliated
with an eligible institution conducts research
in jurisdictions outside his home institution,
whether in the same province, in another province,
or in another country.
By an "eligible institution,"
I'm referring to the eligibility of the institution
to receive and manage funds of the three agencies:
CHR, NSERC, and SSHRC.
And therefore required to follow TCPS 2
in the ethical conduct of research involving humans.
Larry, would you like to add something here?
Dr. Felt: Just a few things. And welcome.
And thank you, Hanan. Just a few summary statements.
Multi-jurisdictional research, as Hanan has said,
and as we'll see in the webinar, takes many forms.
It's increasingly common too.
At one time, the primary form
might have been multi-site clinical health drug trials.
Now, through changes in granting initiatives,
for example with SSHRC in the social sciences,
with their larger participatory and multi-disciplinary granting,
it's become more and more common.
And I guess the, you know, it's also important, given this,
that individual researchers and the local research ethics board
understand that they're ultimately responsible,
as Hanan just said.
Just... very few kinds of suggestions
for researchers and ethics boards respectively
in the context of this multi-jurisdictional research.
For researchers, and to a lesser extent, I guess,
for ethics boards and ethics offices as well,
it's really important to be proactive.
In other words, if you know that you're going to be engaging
as a researcher in multi-jurisdictional research,
try to find out from people that may be your co-investigators
about these other jurisdictions.
Discuss with your own and possibly other relevant REBs,
concerns they might have, requirements,
timelines, and so forth.
For the REB, and if it's a larger institution,
there may be actually an ethics office
within which the REB is situated.
Visit other REB websites, and CAREB.
Networking, which is an overused term
perhaps in a lot of different contexts,
is still very, very important here.
National organizations such as CAREB,
the Canadian Association of Research Ethics Boards,
are really very helpful.
Where possible, attend regional or national meetings
of CAREB or of others.
Once you begin to become a little bit familiar,
this is the REB or perhaps the ethics office,
you can provide local educational sessions
on multi-jurisdiction to potential researchers,
graduate students undertaking research, et cetera.
There are also increasingly other resources,
such as this webinar, that can help you.
And finally, make sure
that your university understands your mandate,
particularly as it may expand
in the context of multi-jurisdictional research,
and supports it in, not just in terms of mandate,
but appropriate levels of support where possible,
that the demands on ethics boards
and research ethics offices does increase to some extent
in the context of multi-jurisdictional.
And it's important that the institution
to which you're attached understands this mandate
and understands the necessity
of providing appropriate resources
to allow you to carry out that mandate.
Thanks, Hanan.
Hanan: Okay. Thank you, Larry.
I invite you now to read this case
and respond to the question.
If you responded "yes," this is correct.
Institutions involved have jurisdiction over the research
because their members are conducting this research.
I invite you now to read the second case
and respond to the question.
If you responded "yes," this is correct.
In addition to the researcher's home institution,
the other institutions have jurisdiction over the research,
given that they are granting the researcher access
to classroom space and student information
on which the institution has authority
and for which they have responsibility.
Now, moving to case study #3,
I invite you to read this case and respond to the question.
The correct answer is "no."
This is not multi-jurisdictional research.
The only institution with jurisdiction
is that of the researcher conducting the research.
The researchers are being recruited as participants
to provide their own disciplinary experience.
This research is being conducted without the collaboration
or involvement of the other institutions.
The first issue to determine...
these are considerations for case studies #1 to 3.
The first issue to determine
is whether there are multiple jurisdictions over the research.
As an affiliate of the institution,
researchers are required to submit their research for review
by their institution's REB,
as was seen in the first case study.
Another consideration is whether it is necessary
for the researcher to collaborate with the local sites
to carry out their research.
The details provided in the second case study demonstrate
that the researcher is dependent on the other institution
to grant the researcher access to classrooms
and contact information for students.
The third consideration is to determine
whether the local sites are involved in any way
and what the nature of involvement is.
As was seen in the third case study, institutions
to which the recruited researchers are affiliated
are not involved in any way.
The only institution that has jurisdiction
is that of the researcher conducting the research.
And now we move to research ethics review models.
In the case where the research requires multiple REB reviews,
the model of ethics review is similar to that followed
for single site review, namely independent ethics review
by several REB, whether concurrently or sequentially.
Its advantages include that ethics review
of a research project at every institution
brings the needed knowledge of local research,
the relationship and knowledge of local researchers,
and the diversity and variability
of experience and expertise
that bring assurance in the ethics review process.
Yet multiple independent reviews bring some challenges.
They risk yielding inconsistent ethics review processes,
redundancies, and delays or inefficiency,
especially for time-sensitive research.
And when reviewing the same research
from their perspectives,
local REBs may reach different conclusions
on one or more aspect of the proposed research.
Results that may be confusing, or frustrating,
or difficult to resolve for researchers.
Two other sets of alternative research ethics review models
are described in TCPS 2.
The first is REB review delegated to an external,
specialized, or multi-institutional REB.
This occurs when two or more institutions
choose to create a single, joined REB,
or to appoint an external REB
to which they delegate research ethics review.
This arrangement could be based on geographical locations,
or the volume of reviews, or the sharing of resources,
or for specialized expertise.
REB review delegated to an external, specialized,
or multi-institutional REB could be established at the regional,
provincial, or national level.
The other alternative model described in TCPS 2
is the reciprocal REB review in which more than one institution
enters into an agreement to accept each other's REB review.
This could be a blanket agreement
or on a case-by-case basis.
The intent of introducing those ethics review models in TCPS 2
is to clarify the type of possible arrangements
that may facilitate the ethics review process
for research involving multiple jurisdictions.
We have to remember though, that those models, other models,
or a mix of models are all optional.
The intent is not to prescribe a specific model
for certain types of disciplines or research projects.
The advantages
of alternative research ethics review mechanisms
include the pooling of expertise,
where some REBs specialize in certain areas of research,
or have specific expertise,
or are knowledgeable with a certain participant pool.
Another key advantage
is streamlining REB review procedures
and decreasing redundancy, time, and energy
of REBs and researchers alike.
It is a one-stop shop for researchers.
Concerns raised about alternative review models
include the possible unfamiliarity
of external reviews, REBs with local issues,
institutions' concerns about issues of liability
and accountability.
I should mention here that liability is a separate issue
outside the scope of this policy.
It is for institutions
to handle through mechanisms other than the REB,
but likely in collaboration with the REB.
I should also mention that we hear more and more
about institutions getting into formal agreements
to adopt ethics review models
or to pilot implementations of models.
This is a sign that institutions appreciate the benefits
of adopting ethics review models that meet their needs,
and that they have found ways to address liability issues
at the local level.
Issues relevant to ethics review multiply
when it comes to multi-jurisdictional research,
and so should be put into the selection of the review model
that is appropriate for the research.
The success of an alternative review model
involves considerations of context.
This includes an understanding
of the discipline and field of research
which is normally informed by input from the researcher.
Consider what the scope of the project is.
Is it multinational, longitudinal,
or is it a time-limited project
and small number of jurisdictions?
What are the characteristics of the targeted persons
and groups at the individual sites?
Are participants vulnerable
within the context of the research?
Are there differences in values and cultural norms?
What is the level of risk
associated with the research under review?
A key factor contributing to an effective
and successful process for ethics review
of multi-jurisdictional research is trust between REBs
and supporting policy environments through, by,
and of participating institutions.
What are the relationships between REBs
to be involved in the ethics review?
There are a variety of formal and informal REB chair members
and administrative relationships already established in Canada.
Another consideration is whether the ethics review model
benefits from the experience, expertise,
and any specialization of REB members.
Federal, provincial, national
and international policies and legislations
and differences in institution requirements
also need to be taken into account
in the selection of the review model.
Attention to operational issues is an important consideration
for the success of the ethics review
of multi-jurisdictional research.
This includes issues
such as clarifying roles and responsibilities
for the initial review and for continuing ethics review.
Larry, do you have comments here?
Larry: Uh, yes. Just a few comments
that I hope will be helpful to people.
I think it's very clear
that there's a great deal of flexibility
provided that certain criteria are met
in choosing the appropriate model.
It's not a question of one size fits all.
The best choice ultimately is essentially a balance,
I think, between timeliness and efficiency
for the researcher, on the one hand,
with an appropriate level of due diligence
in carrying out the TCPS guidelines
and founding principles of equity, social justice,
and respect for participants,
and confidentiality and privacy of course,
given the risk level for all participants
to the research process, including the researcher.
There are local resources,
and I'll talk a bit about this perhaps later on,
that a local REB can recruit on an ad hoc basis...
the TCPS provides for this;
that may be able to give them special expertise
to assist the REB in its evaluation.
These might be people that are,
if it's in a different culture or in a different country,
who may be former nationals
or even current nationals of those places
and have expertise that may be useful.
It's also possible,
since you don't always need to invent a new model,
to look around. I had mentioned earlier
how important it was to be proactive.
Well, it's quite possible that some model is already existent.
Maybe several regional boards have been deliberating
on cooperative arrangements;
and then you could fit into that.
There is, within Canada now, several initiatives
that usually go under the term "harmonization."
And part of just becoming aware through networking
is that you may be able to avail of their experience
and even become part of a review process
within one of those networks.
If your REB is part of an office of ethics research,
there will be an ethics officer there,
and much of this can be undertaken
by the research ethics officer.
There is, I think, a trend in,
certainly in mid-size to larger institutions
to develop their own offices of ethics,
of research ethics, sorry.
And that they will have expertise beyond the REB itself.
Usually the REB or REBs
are bodies within that office of research ethics.
So there may be resources there
that can help this being done as well. Thanks, Hanan.
Hanan: Thank you, Larry,
for this practical cultural experience
that you shared with us.
What... so article 8.1 provides the first step
in the decision making path
for selecting an alternative ethics review model.
This first step is the authorization of the model
by the institution.
It is the institution that makes the decision
to approve an alternative ethics review model.
The institution remains responsible
for the ethical acceptability of the research
whether or not it has adopted an alternative review model,
and irrespective of where the research is conducted.
Normally when considering whether to adopt a new model,
this would be done in consultation
with the institution's REB.
This process should be based on an official agreement
agreed to by all institutions involved, based on decisions
by the highest levels of the institutions.
Such agreements are normally based on trust,
respect, and understanding,
and do not diminish the responsibility
of the institutions involved.
Approvals based on those agreements should be documented
and reported to the full REB through the chair.
The point in reporting is informational
and should not trigger
a duplicate research ethics review.
Other roles and responsibilities and operational issues
such as who is responsible
for keeping the official records of the REB
and for continuing ethics review
should be also considered in the agreement.
As for article 8.2, it provides the second step
in the decision-making path for selecting a model.
Once the institution has authorized a model,
REBs and researchers can select the most appropriate
research ethics review model appropriate for their research.
Obviously, if a specific model
is deemed to be appropriate for research,
steps should be taken to either...
(Audio cuts out for 10 seconds)
And the researcher consider the ethics review mechanism
at the planning and design stages of the research.
It should not be an afterthought.
In considering a model,
the researcher should consult his REB.
The REB should collaborate with the researcher
in selecting the appropriate model for the research.
Article 8.1 and its application clarify
that this is the principal REB's responsibility,
to make a final decision on the selection
of the appropriate review model for the research under review.
The ... efforts invested early in the process
will prove to benefit all involved.
I invite you now to read case study #4.
Larry: Hello.
Hanan: And to respond to the questions.
The correct answer is the last one, "E": any of the above.
All models are possible.
Considerations for selecting a model
that I previously described should be taken into account.
This includes the number of institutions involved,
the duration of the project,
previous experience of the institutions working together,
the availability of required experience and expertise,
differences in laws, REB operational issues,
local issues, and others.
So, institutions with previous experience working together
may be more comfortable delegating the review
to one of the four REBs.
Institutions may create a single joint REB
composed of representative members of all four REBs
with the necessary experience, expertise, and knowledge,
and membership representation required in TCPS 2.
Institutions may delegate the review
to an external centralized REB that may already exist
and has the necessary specialization
in this area of research.
For example of... an REB that exists
is the Ontario Cancer Research Ethics Board, OCREB.
If many differences exist in law, REB in operations,
local issues, institutions may decide to have the research
reviewed independently by all REBs.
Front and centre to the selection of the model
is the impact on participants, whether in ensuring
that the required expertise is involved in the review,
or in finding ways to assure familiarity
with the study group or population and local issues.
The adopted model should not compromise the protection
of participants.
Researchers concerned about paperwork is one consideration,
but should not be the main reason
for adopting a specific model.
Larry, do you have an experience
that you'd like to share with us here?
Larry: Just... just a few comments.
And that's a... I think that overview
was a good illustration of the flexibility
with which most multi-jurisdictional research
may be reviewed within TCPS 2 guidelines.
I guess I would re-emphasize the importance of being proactive,
building contacts, learning of ongoing arrangements
as part of the REB learning process.
It's also, I think, really, to kind of summarize this
and put it in place, to kind of think of it
in terms of a vision, of where are we going,
where is this review process going, and it's...
In many ways, although there are many more actors
and stakeholders involved,
it's very similar to what we're trying to create
even in a single site.
And basically, what that is is which...
we're trying to set up a situation
in which the consequences and assurances
for individuals and groups for research participation
are seen as integral
to the very best research practices and design.
In other words, this is a kind of a vision
in which the ethical review process, rather than being seen
as something out there that you go get
is really seen to be embedded
in the very best practice of research itself.
So that it's all part of a seamless part
with the trust, with the understanding,
with the collaboration
and communication that we would normally...
before ethics review would associate
with the researchers themselves,
and perhaps their research assistants.
So this is really an integrated kind of vision.
And what multi-stakeholder...
multi-jurisdictional research does
is it adds a number of players and the kind of nuances,
but it doesn't really fundamentally differ
from that vision that really all research ethics,
at least in my judgement, is really striving for,
and that is a seamless integration.
Hanan: Thank you, Larry.
Article 8.3 confirms that if a model has been approved,
then the terms agreed to of that model, apply.
In the absence of a model,
the second part of the article applies.
The default becomes independent ethics review
by the REBs involved:
basically, that research outside the jurisdiction
of the institution, whether in Canada or outside Canada,
require review by the home REB and the REB
or other responsible review body, if any,
at the research site.
Note that this article acknowledges
that there may be situations where an REB
or other responsible body may not exist.
In the absence of another REB or equivalent,
at least the home REB will review the research.
I'll now move to case study #5
and I'll give you the time to read through the case.
And to, please, respond to this question.
The correct response is yes.
The research can proceed in the absence of ethics review
at the other two sites.
As we've seen, Article 8.3 acknowledges
that while some jurisdictions may have established REBs
as required in TCPS 2,
other jurisdictions
may not have developed ethics review mechanisms.
The researcher must satisfy the home REB
regarding his or her efforts to find an ethics review body
in the other country.
The researcher should also demonstrate his knowledge
of the study group and population.
The researcher may have previously studied this group
or population, for example,
or have linked with local researchers or other researchers
who have experience with the conduct of research
involving those same groups and populations.
The home REB should recognize
that ethics review mechanisms may not exist in the other site.
In the absence of ethics review mechanisms in the other site,
the home REB has a heightened responsibility
to bring the necessary, relevant expertise
and knowledge on the REB.
This could be sought from an ad hoc advisor, for example.
What is important to remember is that research participants,
wherever they are,
should be afforded the same respect and protection
in accordance with the core principles of TCPS 2:
respect for persons, concern for welfare, and justice.
Larry, did you have...
Do you have any experience with such situations?
Larry: Yes, I do, as a matter of fact.
Both as a... Simultaneously,
as a REB chair and as the supervisor of a PHD student.
It's not uncommon for researchers,
particularly graduate students working in foreign locations,
very often they're remote cultures,
to have difficulty finding appropriate local organizations
or groups to provide ethical review.
And given the importance of local context for issues
such as consent, confidentiality, et cetera,
this can pose really special challenges.
Nonetheless, it's been my experience
that satisfactory... solutions, with a little bit of innovation
can be crafted with the Canadian REB
and the researcher working together.
A case study was one of my students working in a rural area
of Southeast Asia on rural economic development.
It turned out that there was no local REB,
not even a national one for this country.
What we were able to do is,
within the local community here of St. John's,
we were able to recruit a person that had lived
and was a national of the country
and was familiar with its culture and so forth.
And through working with him,
the board got a general understanding
of what might be potential areas
that we would want to assure ourselves of.
And then with that, the researcher,
through the use of her interpreter informant
in the country,
was able to make contact with a school teacher
at a nearby community who was, once again,
a member of that society, but spoke quite good English.
And between them, they were able to work out
not only what would be an appropriate procedure
for documenting consent, assuring privacy
and confidentiality, et cetera.
But also an independent person who people could contact
if they had difficulties or issues
but, for whatever reason or other,
felt uncomfortable contacting the researcher themselves.
And this actually worked out quite, quite well.
It was, admittedly, a fairly low-risk kind of study,
but I think when you're in very different cultural contexts
in a society that you're... in the case of the student,
they were not very well, you know, knowledgeable
prior to going there, that we were quite pleased.
There were no calls or concern expressed
and that this was all documented.
As Hanan has said, we documented this very clearly
for the Research Ethics Board.
I stepped down because of a conflict,
obviously as chairing it.
But the Board was quite satisfied with the procedure
that had been worked out, and felt it appropriate.
And, provided that those guidelines
and procedures were followed, they approved the research.
Hanan: Very interesting.
Thank you, Larry.
Article 8.4 outlines some of the basic information
that researchers should provide to their home REB.
This information can either be determined by the provisions
of the adopted research ethics review model,
if one had been agreed to,
or researchers provide to their home REB;
information about rules at the research site where it exists;
names and contact information of REB or comparable body if known;
information about targeted populations
and other relevant circumstances.
Sharing this information
can facilitate opening dialogue between REBs,
especially where there are points of disagreement
between the REBs on the review of the same research.
I will now move to case study #6,
and I'll give you the time to read through the case.
And to respond to the relevant question here.
And the answer is C:
that the researcher may make the requested changes.
The researcher must be able to explain to the Canadian home REB
why the requested change
intended to meet the REB standard requirement
may not be possible or appropriate
for the context of this research and local conditions.
So, for example, where the requested changes
relate to the host country's legislative requirements,
there would not be much room for discussion.
Another strategy for the researcher
is to open lines of communication
with and among both REBs: the Canadian home REB
and the local REB in the other country.
As we've seen, Article 8.4 lists some of the basic information
that the researcher should provide to his home REB.
The Canadian REB should be cognizant and sensitive
to how its requirements apply within the context
of the specific research under review.
The REB must be able to assess
whether its requirements are appropriate
to the context of the specific research under review.
It should be able to understand the different rationales
for the divergent positions on the requirements.
And the Canadian REB should be collaborative
in opening the dialogue with the foreign local REB
or equivalent body.
Both the researchers and the REB's ultimate role
should be to reach a point of agreement
where the requested changes can be made
by adapting the Canadian REB's advice to local conditions.
Again, Larry, do you have experience with this?
Larry: Yes, a couple of comments.
We've had a couple of examples of this:
what appears, or at least initially appeared,
to be gridlock between a local REB
and the REB that I was involved with.
One of these had to do with, in clinical trials,
on the specific wording of consent forms.
And if I can... I have...
Our two oldest children are both lawyers
so they'll forgive me for making these comments.
But when, particularly with drug trial forms,
these are usually the product of legal construction.
And they can be so long and so detailed that it is...
Well, we've had feedback from local REBs
and other jurisdictions simply saying,
"We can't understand what this consent form means."
I mean, basically... How do you under...
How do you expect participants to understand?
And what we've done is,
consistent with what Hanan has said before, is dialogue.
We've told them the kind of constraints that we're under.
Sometimes, we have... we've tried as best as possible
to do a shortened version, that basically translates
what are largely legal issues about liability,
and responsibility and so forth, which are obviously important.
But we've tried to translate those
into a kind of knowledge and expression
that we think the research participants would understand.
The legal people have been very good as well,
and they understand
that all of the participants in this research
are not likely to be lawyers like themselves.
And where there is trust and dialogue, we have found
that you can usually find some arrangement that is workable.
There are a few cases that I'm not familiar enough,
but I've just heard about,
that would pose particular challenges.
For example, at a general level, with respect to consent,
what if, among people who are treated as adults in a society,
that consent is to be provided by someone else?
For example, in a husband and wife relationship,
if the local custom is for the male to provide consent
for his partner's or spouse's participation.
These pose real challenges, but once again,
I have never encountered a situation
in which trust and dialogue and understanding,
and, if necessary, the use of local people
who basically understand both sides,
I mean, local and the other site,
that we haven't been able to get a resolution
that we think is consistent with TCPS 2
and also goes as far as possible
to recognize the appropriateness and the legitimacy
of local boards as well.
So this can sometimes be a real challenge,
but I would say that in 95-98% of these cases,
that even consent forms, which are one of the areas
where this shows up most often, in my experience,
discussion, dialogue and some trust on both ends
because both sides have some claim for responsibility
for the research process.
And once again, it's not as if there's a silver bullet.
But when people are talking and when people are trusting
and when there is respect, that lots of things can be done
that could not otherwise be done.
Hanan: Thank you, Larry.
That's very interesting.
So we're now speaking to researchers.
I have some tips for you, researchers.
Take time to understand
and engage the targeted community you plan to study.
You need to invest time and thought in strategies
to familiarize yourself with those norms and practices,
and to minimize risks to participating individuals
and communities.
This is of particular importance for the culture,
values, language or traditions may be different from your own.
Think of strategies
of how you can ensure effective communication
with the participants,
if you do not speak the participants' language
in recruitment and consent discussions.
Work with your REB.
Inform the REB of how you plan to proceed
with the research at the site,
and how you would seek access to the targeted population.
The relationship between a researcher and his or her REB
is essential in informing the selection
of the appropriate model,
and serves a two-way education process.
Consult your REB early at the design stage of your research.
And now, some tips for home REBs.
For home REBs, be sensitive to context and open communication.
Make use of provisions in TCPS 2,
such as adding an ad hoc member
or other resources if deemed necessary
to bring any missing knowledge or expertise to the REB.
As an REB, be sensitive
to context of the research under review.
Open communication with the researcher and other REBs,
or equivalent ethics review bodies.
REBs should not prevent research from proceeding
solely because the research cannot be reviewed and approved
through a formal REB review process in another country
or another jurisdiction.
And I'm sure Larry has some tips for you based on his experience.
Larry: Well, once again, thanks, Hanan.
Many of these have already been covered,
but I have a few here that I would like to share.
At least, they've been useful in my own experience.
And forgive me if I've mentioned some of these before.
But there are a lot of resources and they're increasing.
I use... I used earlier the example of this webinar
to help researchers,
research ethics offices, and REBs
to become more familiar with multi-jurisdictional research.
This webinar is one, and I hope a very useful one.
It has been, I think, a real contribution in TCPS 2
of chapter 8.
Remember that the TCPS 2 is a guide.
It is not a schematic... Like, if you buy something
and it tells you how to put it together.
It gives you the rules and, if you want,
the kinds of conditions to be met.
But it leaves a great deal of flexibility,
and I think that's quite appropriate.
And I think there's much in chapter 8 that's really helpful.
We've talked about the researcher and the REB
in the home context.
Building that kind of partnership
as early as possible, with dialogue and so forth.
And that also goes for wider contexts
for both researchers and for REBs and ethics offices.
And I've already mentioned some of the ways
in which that can be done.
Being proactive: the earlier you start to understand this
and the more you see it as a seamless part
of doing best practice research,
the more effective this is going to be.
Be flexible,
consistent with TCPS guidelines for best practices,
but do not be afraid if necessary,
and I kind of underscore "if necessary", to innovate.
My experience has been that sometimes, my first reaction
has been, "Oh, we need to do something new.
This has never been covered."
And I think with a little bit of searching,
you'll find that most... the overwhelming numbers of issues
that you're encountering, somebody else in Canada
even in... probably perhaps even in your province,
have encountered them, have tried to work on a solution,
perhaps have crafted one.
We've talked already about some of these things
in the context of other kinds of arrangements
that are already existent.
Be flexible.
I can't emphasize enough the importance of education,
both for you, and to share that education
with your own constituency.
And that includes, I'll say again,
that as REBs and their mandate
and their workload has increased,
it's important that the highest level administrators
to which they report understand that
and build an independent but supportive relationship
that includes a realization that sufficient resources are needed.
To the extent possible, some of... I think back
to that Southeast Asian example of my own,
that some of the solutions from that came from that teacher
in the Asian community
next door to where the research was going on.
They were immensely useful in offering suggestions.
We've talked about REB networking,
and if resources permit,
provide ongoing educational experiences.
What we've tried to do, and it can be hard
given the kind of financial pressures on most institutions
of which REBs are a part, but we tried to make sure
that when voluntary courses are given
for personnel in the office,
that we try to send people to them,
or bring those courses to them if they're available online.
The networking function is better done in person,
but we try within our financial capacities to do that.
And finally, I think that Hanan had mentioned this,
but if I can speak as a member of the Interagency Panel,
we're always welcome, I think that I'm correct in saying this,
for important, really provocative questions
or encounters
to the Interagency Panel for interpretation and guidance.
And periodically, we release some of these questions,
and at least what our best guess, or not just best guess,
but best informed response might be
as to how they might be resolved.
And this is a living, ongoing process.
And if you follow these kinds of steps,
I think that you'll be much better able to participate
both as a researcher and as an REB
in this quite rapidly expanding type
of multi-jurisdictional research.
And I thank you all.
I hope that this has been a useful...
from my perspective, a useful experience for you.
I know that every time I go through my own notes here
and so forth, I think of new things.
And so I hope the same is true of you.
Hanan: Thank you very much, Larry.
This is useful.
And so to summarize, multi-jurisdictional research
provides great opportunities but also come with challenges,
including those of ethics review.
The challenges can be managed by collaboration,
communication of the multiple players involved,
as Larry was mentioning in his case studies
and the tips that he provided.
And ethics review of multi-jurisdictional research
requires ... trust and education
of all involved in the process.
Researchers and REBs
should accord participants in other countries
the same protections and respect
that Canadian participants enjoy.
Home REBs should be sensitive to local needs,
especially those with particular cultural context.
And I would like also to bring to your attention
some of the educational resources that we have.
So the Panel on Research Ethics provides a diversity
of educational resources on TCPS 2 for the community.
One of the educational resources
is our interactive online tutorial
that we encourage you to complete.
Over 72,000 users have completed this tutorial to date.
You can view our webinars online
on the Panel on Research Ethics website.
And if you have any questions,
you can send them through our interpretation service.
We also have interpretations posted
on the Panel on Research Ethics website,
and we'll keep posting them periodically.
So keep visiting the Panel on Research Ethics website
for all updates on TCPS 2 educational initiatives.
A group of researchers
are conducting an independent evaluation
of the panel's educational initiatives.
So we encourage you to give them your feedback...