Bill No.
8182-02
UNIVERSITY SENATE
STATE UNIVERSITY OF NEW YORK AT ALBANY
University Policies for
Research Involving Human Subjects
INTRODUCED BY:
Council on Research
October 5, 1981
IT IS HEREBY PROPOSED THAT THE FOLLOWING BE ADOPTED:
I.
That the attached policies for research involving human
subjects be implemented for a period of six months.
I I.
Durfog fhE- period, the Re-search -Counc-i T wfH summarfze - - -- - - -- -
changes in activities of the Campus Institutional Review
Board and will solicit reactions from interested faculty
about their satisfaction with campus policies regulating
human subject research.
III. Prior to the end of this academic year, the Council will
report on their findings to the Senate and make recommenda-
tions for future policy.
IV.
That this resolution be referred to the President for his
approval.
APPROVED November 5, 1981
Policies:
I.
In accordance with state and federal regulations and the
highest standard of ethical conduct, it is the responsibility
of the Universitv reasonablv to insure that the ri£hts and
welfare of human subjects, in research conducted u~der its
auspices, are adequately protected.
The primary responsibility
for protecting human subjects rests with each individual who
initiates, directs or engares in research.
II.
In order for the University to fulfill its responsibility,
ALL research involving human subjects conducted under the
auspices of the University must receive urior review and
approval by the Institutional Review Board (IRB), regard-
less of the source of funding.
This inculdes student research
involving subjects from outside the class.
A.
"Human Subjects Research" is defined as a systematic
investigation designed to develop or contribute to
generalizable knowledge, which involves the collec-
tion of data from or about living human beings.
It does not include research utilizing published or
_p_1.1bl_ic~1y _available_ documents or research on elected
or appointed public officiaTs or -c-andidates -for- - - - - - -
public office.
B.
The members of the IRB are appointed bv the Vice President
for Research.
In addition to other reauirements of
state and federal regulations, the membership of the
IRB is comp·osed of individuals of varying backgrounds
who are qualified through maturity, experience, and
expertise, and the diversity of the members' racial
and cultural backgrounds to assure complete and
adequate review of activities commonly conducted by
the institution, and to insure respect for its advice
and counsel for safeguardinp; the right·s and welfare
of human subiects.
The IRB possesses the Drofessional
competence necessary to ascertain the acceptability
of proposals in terms of institutional commitment
and regulations, EPPlicable law, standards of pro-
fessional conduct and practice, and co~munity at-
titudes.
C.
The determination regarding whether a given activity
should be considered human subjects research must
be made by the Institutional Review Board or its
desip;nee.
D.
Certain categories of research involving little or
no risk to subjects need not be reviewed and approved
by the full IRB, but, rather, by a duly authorized
designee.
The IRB shail develop and promulgate
afpropriate categories of research eligible for this
procedure.
III.
The IRB shall adopt appropriate procedures to implement these
policies.
The IRB shall develop all nrocedures with the
advice and counsel of the Council on Research and shall keep
the Council informed of any changes in procedures.
Approved by the Council on ReseaYyQ-, September 16, 1981.
+--
-
Rationale:
University Policies for
Research Invo 1 vinp: Human Sub.i ects
Research involving human subjects is governed by federal and
state regulations, as well as professional standards of ethical
conduct.
Since 1977, the University has been comnlvinv with these
regulations bv requiring that all human subjects research receive
prior review and approval by the University
1 s Institutional
Review Board.
In January 1981 the federal govern!!l.ent published
a new set of regulations governinr.:; human subjects research.
Under the new federal regulations, the government has placed more
of the responsibility for insuring the protection of human subjects -
on the individual institutions.
This was done by significantly
reducin? the scope and requirement of the regulations.
New York
State law, however, has not been revised and its requirements
still remain broad.
11tThile the new regulations provide the Univer-
sity with the op;Jortunity to greatly rE;,duce the burden on re-
searchers and on the IR.B, the University must take care not to
violate the NY State law or to fail to fulfill its responsibility
__ f_p_r _the_ prote_c t t9_n_of _s1.1.9j e~ts _._
After carefully reviewing the new regulations, in light of
the Universitv
1 s resnonsibilities and the necessitv to remain
in comnliance ✓with NY State law, the IRB recommended that the
University adopt policies that go somewhat beyond the federal
regulations in two basic ways.
First, although the federal reg-
ulations state that they only apply to DHHS-funded research, we
should continue to apply the same procedures to all human subjects
research, regardless of funding.
Second, although the federal
regulation exempt broad categories of research, we should not
make exemptions, but continue to review all human subjects re-
search.
Not all research, however, would need to be reviewed by
the full IR.B.
By reviewing all human subjects research under the
same standard, the University can best insure that it is in corn~
pliance with all regulations and is fulfillin8 its responsibility
to subjects.
Under the new uolicies, the IRB will not be reviewing any
more research than it did in the Dast.
The new regulations,
however, give us the opportunity to reduce the burden of com-
pliance on the researchers.
Much of. the research which the IRB
formerly reviewed (about 80%) will now be eligible for
11 expedited
review.
11
Under this procedure one person, designated by the IRB,
would be able to approve these projects without them being re-
viewed by the full IRE.
This will mean much less papen,;,ork and
much less delay for the researchers.
These policies are being presented to the University Senate
/
because the un:iversity
1 s procedures for reviewing human subjects
can no longer be based simply on compliance with regulations, but
must now be based on University policy.
We therefore request that
the University Senate approve these policies and refer them to
the President for his approval.
