Policy: PROTECTION OF HUMAN
SUBJECTS
Policy No. C026
Supersedes
Policy No.
C026, Dated July 13, 1993
Recommended for Approval by:
Dr. Robert Weber , Provost and Vice President for Academic Affairs
Approved by: Dr. Frank G.
Pogue, President on Effective Date:
2/1/02
Review Date: As Required
_______________________________________________________________________
INTENT
The Human Subjects Review Board
of Edinboro University of Pennsylvania shall be
established for the purpose of protecting
the rights and welfare of human subjects involved in research. Human subjects
shall be interpreted to include the investigators, participants and the
community at large
POLICY
The Human Subjects Review
Board shall review, on a continuing basis, proposals for human subjects research to be conducted under the auspices of
Edinboro University of Pennsylvania.
Both the administration and the principal investigators shall be advised
concerning the acceptability of the proposed project relative to the welfare of
the human subjects based on the accepted codes of ethical principles.
Proposals must be submitted
for review prior to the initiation of data collection. Each proposal will be
evaluated to determine that:
1. rights
and welfare of the subjects are adequately protected;
2. potential
benefits and the importance of the knowledge to be gained from the research
outweigh risks to the subjects;
3. the
subjects are informed and their consent is obtained before participation in the
research, and that the research utilizes methods that are adequate and
appropriate;
4. confidentiality
procedures are sufficient for protecting the subject; and
5. the
researcher possesses the qualifications required for conducting the research.
The Human Subjects Review
Board shall operate under the auspices of the Vice President for Academic
Affairs .
The Review Board may be
requested to serve in an advisory capacity if grievances involving threats to the
welfare of human subjects should be submitted to the President's office. In
order to serve in this advisory capacity, the Board shall be informed of all
grievances 'involving matters related to human subjects research.
It is the responsibility of
the Review Board to inform the University community of basic procedures for
operation and guidelines for reviewing human subject research based upon
accepted codes of ethical principles. These basic procedures and guidelines
shall be available to assist all researchers within the University in order to
provide for the well being of human subjects.
An approval by the Human
Subjects Review Board signifies only that the proposal adequately satisfies
requirements for the protection of research participants. It does not imply,
directly or indirectly, any institutional support or permission to conduct the
study.
PROCEDURE
Membership and Voting
1. Human
Subjects. Review Board will consist of seven members, including one member who is
not an employee of the University and one member currently serving on the
Senate Research Committee. All members except the representative from the
Senate Research Committee shall serve for a term of three years and may be
re-appointed by the President of the University upon recommendation by the Vice
President for Academic Affairs. The
representative from the Senate Research Committee will serve only for the time
period during which he/she is also a member of the Senate Research Committee.
2. The
chairperson of the Human Subjects Review Board will regularly apprise the Vice
President for Academic Affairs of the membership of the Board. When a member's
term expires, the chairperson will inform the Vice President of the expiration,
including whether or not the member wishes to be considered for an additional
term. When an opening occurs on the Board, a call for applications will take
place. The Human Subjects Review Board will review the applications and make
recommendations to the Vice President for Academic Affairs. The President,
based upon recommendations from the Vice President for Academic Affairs, will
appoint members of the Board.
3. Members
of the Review Board may not be involved in review of any activity in which they
have conflicting interests .
4. The
Human Subjects Review Board shall meet as often as necessary to provide review
and advisement, but at least once per semester. Four members of the Board shall
constitute a voting quorum. Acceptance of a proposal shall require a minimum of
four supporting votes .
Levels of Review
All research involving human
subjects will be submitted to the chairperson of the Human Subjects Review
Board. The chairperson shall determine whether the research is exempt from
review or whether a review is required. Research involving the following
situations may be exempted from review:
a. research
in common educational settings where students are not identified;
b. research
using educational tests with no identifiers of subjects;
c. research
using surveys or interviews of adults where respondents are not identified and
the content is benign;
d. research
involving observations of public behavior; arid
e. research
involving collection, study and use of existing data where are not identified.
Exemptions do not apply to
research involving: prisoners, pregnant women, fetuses and human in vitro
fertilization.
Projects requiring review may
be reviewed under two levels: Expedited or Full Review.
1. Research
projects that are judged to present only a minimal risk may receive an
Expedited Review. "Minimal risk" means that the probability and
magnitude of harm or discomfort anticipated in the research are not greater in
and of themselves from those ordinarily encountered in daily life or during the
performance of routine physical or psychological examination or tests. An
expedited review can be made by the chairperson or by one or more reviewers
designated by the chairperson from among members of the Human Subjects Review
Board. If the proposal is approved, the chairperson will inform the other members
of the Board of the approval. If the proposal is not approved, it must be
referred to the full Board for disposition.
A collaborative research proposal that has been reviewed and approved by a
duly-constituted Human Subjects Review Board from the co-investigator's
institution may be handled as an Expedited Review.
2. All
other projects will require Full Review. The Full Review will follow the review
protocol outlined below.
a. The
principal investigator of record must be a non-student employee of Edinboro University
of Pennsylvania. Student research involving human subjects must be conducted
under the direct supervision of a principal investigator. Investigators not
affiliated with Edinboro University of Pennsylvania must identify a non-student
employee at this institution who is willing to serve as the local contact
person.
b. The
principal investigator will submit to the Chairperson of the Review Board one
copy of the Human Subjects Review Application including a one-page statement
describing the purpose of the research, the population and how it will be
selected, and the research method. One copy of any survey, questionnaire,
interview questions and/or informed consent forms to be used in the research
should also be submitted.
c. In
the application the principal investigator must assure the Review Board that
the principles, procedures and guidelines established in the appropriate
ethical principles will be followed and that the Review Board has access to
pertinent records of research. In addition, the principal investigator should
present any information that will aid in evaluating the proposal for compliance
with this policy.
d. Upon
receipt of the material, the Review Board chairperson will distribute one copy
of the submitted materials to each of the members of the Review Board. The
members will independently review the material prior to the meeting of the
Review Board.
e. The
principal investigator must be available to discuss the research project at the
discretion of the Review Board. The principal investigator will be notified of
the Review Board's decision by the chairperson.
Review Board Actions
The Review Board may take one
of the following three actions in regard to the proposed research project:
Approved. Approved Subject to Restrictions. or Disapproved.
1. When
an application has been Approved, the chairperson will prepare a letter of
approval and distribute one copy of it to:
a. the
principal investigator;
b. members
of the Review Board; and
c. the
Review Board files.
A copy of the approval letter must accompany the
proposal when it is submitted to the designated administrative officer for
processing .
2. If
the protocol is Approved Subject to Restrictions, the chairperson will inform
the principal investigator of the restrictions in writing.
The principal investigator
must submit documentation of the incorporation of the restrictions to the
chairperson prior to final approval. The application will then be processed as
an approved application.
Should the principal
investigator be unwilling to accept the restrictions, the Review Board will
note such and the application will be processed as though it had been
disapproved.
3. If
the application is Disapproved, the principal investigator will be informed in
writing of the reasons for the disapproval. Every effort shall be made by the
Review Board and the principal investigator to meet and discuss those elements
of the application which make it unacceptable in order to arrive at a solution.
The principal investigator may then withdraw the protocol or submit a revised
protocol which will be reviewed as in the initial review procedure.
In those cases in which agreement on an alternative approach cannot be
researched, the chairperson will prepare a letter of disapproval and will
distribute it with the disapproved application as follows :
a.
the principal
investigator;
b.
members of the
Review Board;
c.
the appropriate
department chairperson;
d.
the appropriate
dean;
e.
the
Vice-President for Academic Affairs; and
f.
the Review
Board's files.
Appeals
1. The
principal investigator may appeal the decision of the Review Board when an
application has been Disapproved or Approved Subject to Restrictions and mutual
agreement cannot be reached as to an acceptable alternative. The Approval or
Disapproval of the application would be based on the following:
a. should
a degree of deception and/or withholding of information be necessary for
adequate testing of the hypothesis and in the absence of any practical
alternative, justification that the potential benefits to subjects or the importance of the knowledge
to be gained outweighs any potential risks that may be present;
b. the
provision of acceptable debriefing procedures ;
c. the
adequacy of facilities and other resources necessary for completion of the study
and protection of subjects' rights;
d. the
qualifications of the researcher;
e. the
personal risk to the subject;
f.
the adequacy of procedures for securing
informed consent from the subject;
g. the
adequacy of the procedures for maintaining confidentiality ; and/or
h. the
adequacy of measures for the protection of the health, safety , and well-being
of the subjects.
2. Upon
written notification of appeal from the principal investigator, the Review
Board shall name an ad hoc committee of three or more faculty and/or
consultants to review the protocol a second time. The ad hoc committee members
must be acceptable to both the principal investigator and the Review Board. The
application will be reviewed in accordance with the appropriate ethical
guidelines. The decision of the ad hoc committee will be binding for both the
principal investigator and the Review Board.
In the event of disapproval by the ad hoc Review Committee, the
research will not proceed as designed. Notification of actions will follow the
procedure outlined in the paragraph above .