Perspectives (Volume I, number 8) (fwd)

[Anne Nothof]

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From: "Fedcan" <fedcan at hssfc.ca>
Subject: Perspectives (Volume I, number 8)
Date: Thu, 04 Dec 1997 14:35:08 -0500

PERSPECTIVES
An electronic newsletter on research and science policy.  A pilot project of
the Humanities and Social Sciences Federation of Canada.

PERSPECTIVES will appear at regular intervals throughout the year and will
be posted on the Federation web site:
http://www.hssfc.ca/Pub/PublicationsEng.html.  Please address your comments
and suggestions to Jacqueline Wright, Executive Assistant, at:
jawright at hssfc.ca.

PERSPECTIVES (Volume I, Number 8)

Editor: Wayne Kondro

Table of contents:
i)      Introduction
ii)     REB Standardization
iii)    Proportionate Risk
iv)     Collectivities
v)      Scientific Review
vi)     Partial disclosure and deception

TRI-COUNCIL ETHICS CODE TO BE REDRAFTED AS A 'STATEMENT OF POLICY'
New regime will be less prescriptive in nature

After three years of squabbling, two revisions and a half-million dollar
outlay, Canada's granting councils are reconsidering the proposed
tri-council code of ethical conduct for research involving human subjects.
But the Social Sciences & Humanities Research Council, Natural Sciences &
Engineering Research Council and Medical Research Council aren't yet
prepared to abandon ship.

SSHRC president Dr. Marc Renaud says that before giving up the ghost, the
councils will make one last-ditch effort at revising the code and tempering
many of its more controversial provisions.

Once the final reports of the most recent round of consultations --
including the findings of nation-wide public hearings conducted by the
Humanities & Social Sciences Federation of Canada -- are completed and
assessed, the councils will rewrite and reposition the code as a "policy
statement" articulating the general principles by which researchers will be
expected to abide in the future, Renaud says.

But the next and final revised version will be "less prescriptive" in nature
and will clarify the notion of proportionate risk so as to give Research
Ethics Boards (REBs) affiliated with universities, hospitals and research
institutes more latitude in determining how research protocols must be=
 reviewed.
=0C
"If that kind of compromise deal doesn't make sense, then, well, forget
about it," Renaud says. "We cannot go on like this. Understand that people
are sick of it, they put so much energy into this."

SSHRC senior policy & planning analyst Nina Stipich adds that the councils
have agreed to "move away" from the highly regulatory, legalistic approach
which many found extremely objectionable in earlier drafts of the code.

At a recent tri-council meeting to discuss the future of the ethics regime,
"there was also agreement that the numbers of 'musts', the articles, the
lines in the sand, would be kept to a minimum in order to give maximum
flexibility for the judgement of the REBs," Stipich says.

But MRC director of innovation-teams Dr. Francis Rolleston stresses the
revised version will still contain a significant number of lines in the=
 sand.

While the revision will be less prescriptive than a code, it'll be more
prescriptive than a mere set of guidelines, Rolleston says. It will identify
and define "absolute requirements," while also articulating other measures
which the councils consider "strong advice" to REBs in performing their
daily duties.

The document will not be called a code, because of the legalistic
connotations which the word conjures up in the French language, Rolleston
adds. "However, we're not going to go back as far as guidelines, at least
not publicly, in which we're saying this is the kind of thing we really
would rather like you to do. The councils are going to be saying, in some
cases, these are the things you absolutely are required to do and these are
the things that are very, very strong advice but obviously, there has to be
some flexibility of interpretation. So it's more than guidelines but less
than a code."

NSERC research ethics officer Catherine Armour adds that the councils will
also be re-assessing the code's overall tone, "which people still find a bit
negative," as well as the imprecision and inconsistencies in its use of
language, which have often led to confusion in the code's interpretation.
But while "there are areas where people have problems -- and obviously we
can deal with those -- I don't think we're looking at a major rewrite."

Those distinctions and re-definitions will be drawn by an advisory editorial
committee comprised of an external representative of each council.  The
final version of the ethics regime will be submitted for approval by council
governing boards at their respective meetings early next year.

Rolleston stresses the councils want to create a "living document," i.e., an
ethics regime which can be readily and quickly modified to reflect the
changing research enterprise.

Dr. Michael McDonald, U.B.C. professor of philosophy and deputy chairman of
the tri-council working group which drafted the most recent version of the
code, adds that it's important to ensure a mechanism exists to conduct
periodic review of the regime. "No one who was on this committee pretended
that they were Moses going up the mountain and getting tablets."

McDonald says the councils must also develop a means of enforcing and
measuring the efficacy of their policies. In the interest of public
accountability, the regime must have annual reporting requirements, as well
as mechanisms to ensure proper "accrediting and monitoring" of REB
operations, including unadvertised site visits. Yet, while many measures,
like an accountability mechanism, remain unresolved, there appears to be
some consensus on the direction the councils will take in addressing other
controversial code provisions. Those include:=20

REB STANDARDIZATION
Every manifestation of the code to date has featured elements designed to
achieve basic standardization of the membership and operations of the
nation's 300-400 REBs.
=20
Essentially, the councils have proposed that REBs be constructed along the
same standards articulated by recent U.S. legislation, under which boards
must include at least two scientific experts; one ethics expert; one lawyer
(but not the university's legal counsel); and one unaffiliated member drawn
from the general community. Operational standardization included mechanisms
to ensure review of the scientific validity of research protocols; as well
as specific requirements governing such features as record-keeping; appeals
procedures; and expedited review.

The measures were designed largely to alleviate the variance in operations
discovered by a 1992-95 review of REBs conducted by the National Council on
Bioethics in Human Research. It found that not only was there variation in
process among REBs but several were operating at odds with existing MRC
guidelines.

The standardization proposals have drawn considerable heat from university
administrators, who have contended that the provisions will constitute an
enormous financial and human resources drain. But the councils appear very
reluctant to completely abandon the bid to achieve more uniformity in REB
composition and operations. Renaud says point-blank that "some
standardization is needed."

However, it appears the councils will relax some requirements, as officials
say the final document will back off the obligation that there be a lawyer
on each REB in favor of a regime which only requires legal review (by a
legal expert who does not have to sit on the REB) of protocols involving
physically and psychologically invasive research, or protocols involving
third-party consent to such invasive research.

"I don't think it was ever the intention that everything under the sun would
go through the level of review that risky proposals do," Armour says.

PROPORTIONATE RISK
In a similar vein, the councils will also more clearly articulate exactly
what sort of protocols have to go before full 'face-to-face' REB review, and
which can be handled through 'expedited review' by REB subcommittees or
individual members.

That notion of 'proportionate risk' is presented within the latest draft
code but is somewhat poorly-defined as a permissible procedure when the
research does not involve more than "normally acceptable risk," which, in
turn, is defined as the risks a person faces in everyday life. In such
instances, the draft code suggests expedited review might be appropriate.

Stipich says the councils will revise the regime to allow "flexibility for
each institution to set up its own system of expedited review ...which
involves probably 95% of the non-risky kind of research in the social
sciences and humanities."

"This is going to be made very clear, including a kind of chart or decision
tree which will give some graphic kind of representation of the review
process steps which involve different types of research activities,
including risky stuff, non-risky stuff, student research, etc.." But the
councils will require face-to-face review for all protocols which go to an
REB for full review.

A more precisely defined notion of proportionate risk will go a long way
towards alleviating the academic community's concerns about the ethics
regime, says University of Calgary vice-president (research) Dr. Cooper
Langford.=20

"The resolution of most of the discomfort lies around that concept. If you
allow for the notion that the procedures are not a single uniform set but
are elaborated in response to what is perceived to be the risk associated,
then those issues can be brought under control."

COLLECTIVITIES
Few aspects of the proposed code have generated as much controversy as the
suggestion that researchers will be obliged to obtain informed consent from
both individuals, and the "collectivities" they represent, in the design of
their protocols, as well as in the publication of results. The code broadly
defines collectivities to include governments, businesses, native groups and
other cultural, religious, ethnic and social groups.

But while the councils have tempered some of the collectivities provisions,
"they've still got a ways to go," says Canadian Association of University
Teachers spokesman Dr. Donald Savage. He argues the definition of
collectivities is still far too broad and should exclude groups like
politicians, bureaucrats, unions and businesses because they're likely to
use the provisions to censor research that puts them in an unfavorable=
 light.

Armour says the collectivities provisions will be re-examined carefully to
ensure that unwanted and undesirable consequences don't ensue. "That's
something we'll have to straighten out. Let's say we're listening and we're
very aware of the concerns and before this thing comes back out, we'll
hopefully have it right."

SCIENTIFIC REVIEW
The proposal that REBs assess protocols for scholarly merit has drawn
considerable criticism as an unwarranted intrusion on academic freedom, even
though the provisions governing such review have been somewhat tempered
through the various drafts so that it only become necessary above a certain
level of so-called 'minimum' risk.

Critics argue that REBS will be unable to properly assess scientific
validity as a majority of members will lack recognized scientific
credentials and the remainder may represent disciplines which differ from
that of the protocol. They've called on the councils to clarify the code's
provisions to allow for the review of scholarly quality only when the
research poses a risk of serious harm, as defined by the disciplines=
 themselves.

"There's lot of key things that have to be defined more clearly," says UQAM
historian and president of the Institut d'histoire de l'Am=E9rique fran=E7ai=
se
Dr. Joanne Burgess. "All along their approach has been to deny there is any
fundamental difference between ethical issues in the social sciences &
humanities and the biomedical sciences. They've tried to always frame it in
terms of risk to psychological well-being, to reputation, to honor."

But Burgess argues the various notions of risk have to be more specific to
each discipline, much as the code's provisions themselves have to be
considered in terms of the impact they'll have on each discipline.

Failure to make distinctions based on discipline, for example, were at the
root of historians' problems with earlier versions of the code, which would
have required them to obtain approval from research subjects before they
could publish research results, Burgess adds. Much as the most recent
rewrite narrowed the scope of the code to "living human beings" and excluded
research involving public domain or archival documents from falling under
the rubric of REB scrutiny, the councils will have to "work on defining the
level of risk" appropriate for each discipline before REB scientific review
kicks in.

But others counter that even such distinctions constitute an intrusion on
academic freedom. Dalhousie economist Dr. Lars Osberg argues that any form
of REB scientific review is tantamount to little more than a "pre-approval
system" which will ultimately result in censorship. A "one-size-fits-all
model of prevention of harm is just not appropriate" for all disciplines.

Stipich notes the biomedical community and social sciences & humanities
community are completely at odds on the value of scientific review by REBs.

But, in the final revision, it'll be made clear that "where there are clear
differences between the research cultures and practices of the communities,
they would be stated very, very clearly and the differences would be
explicitly laid out and the direction would be given to the REBs that they
simply respect the practices and the existing cultures in the different
communities."

PARTIAL DISCLOSURE AND DECEPTION
Among other aspects of the code which researchers find encumbering is a
provision requiring full disclosure of the purpose of research, except in
instances where doing so would compromise the research, as is often the case
with questionnaires or surveys.

In such instances, the ethics regime would create a reverse onus on
researchers to justify to the REB why either partial disclosure or deception
is warranted, as well as how the potential harms to the research participant
fall below the threshold of normally acceptable risk.

That reverse onus angers many researchers, like St. Mary's sociologist Dr.
Linda Christiansen-Ruffman, who believes it casts them as being somehow
"irresponsible" and "unethical" in their research.
 =20
It also presents problems for disciplines like psychology, which has already
evolved its own professional standards regarding deception, says Dr. Janel
Gauthier, president of the Canadian Psychological Association. He argues
that unless the revision clearly defines exemptions by discipline, it'll
only create a bureaucratic "nightmare" for researchers. =20

The code is "very draconian ...unworkable ...and fundamentally flawed" in
various provisions ranging from partial deception to scientific review and
should be completely scrapped, Gauthier adds. It's a case of "dramatic
overkill ...which uses a bulldozer to correct problems which are the
exception and not the rule in Canada."

But the granting councils say they'll make one last effort to redress the
many concerns and draft a document which is still palatable to the research
community.

Stay tuned

Editor:
Wayne Kondro is a freelance writer based in Ottawa.  The former Editor of
the "Science Bulletin", an independent newsletter on national S&T policy, he
is currently a regular contributor to such publications as "Science" and
"The Lancet".




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