Institutional
Review Board for
the Protection of Human Subjects
As Lock Haven University of Pennsylvania continues to receive federal monies for student financial aid, educational programs, grants, and other financial incentives, compliance with federal mandates and legislation is imperative in order to retain these funds.
The Federal Common Rule thatwhich
requires those agencies receiving federal monies to comply with human subject
protection and rights was passed (August 19, 1991) and
adopted by sixteen federal agencies including the Department of Education. Failure to comply with these basic human
rights may lead to the loss and removal of all federal funds provided to the
institution.
The role of the Institutional Review Board for the Protection of Human Subjects (IRB-PHS) is to ensure compliance with all governmental regulations with the use of human subjects in research. Applicable federal regulations are detailed in Title 45 of the Code of Federal Regulations, Part 46 (www4.law.cornell.edu/cfr/45p46.htm#start).
The IRB-PHS shall be comprised of at least seven members, no less than three of whom possess background and expertise in research in the behavioral and social sciences. One member of the IRB-PHS shall not be affiliated with the institution and shall not be an immediate family member of a person affiliated with the institution.
The Vice President of Academic Affairs shall appoint the members of the IRB-PHS. Members shall serve on the IRB-PHS for a period of year but may be re-appointed to subsequent terms.
The IRB-PHS
members shall elect a Chairperson, Vice-Chairperson, and Secretary from the IRB-PHS members. It will be the
responsibility of the chairperson to receive completed applications following Unit Expedited
Review, to convene and preside at Full Review hearings, and advise
research applicants. The Vice-Chairperson will assume
the responsibilities of the Chairperson if he or she is unavailable. The Secretary is responsible for keeping accurate records
of applications and meetings for the maintenance of archives and reporting to
the Vice President of for Academic
Affairs.
In May of each year, the chairperson of the IRB-PHS is responsible to submit a report of all research activity involving human subjects to the Vice President of Academic Affairs.
All research projects undertaken by students, faculty, staff, or administrators of Lock Haven University of Pennsylvania must be approved prior to involvement of human subjects. The review process is intended for the protection of human subjects, and this shall be the sole purpose of the review.
The Federal Government’s Department of Health and Human Services defines the term “Research” as “a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute ‘research’ for purposes of these regulations, whether or not they are supported or funded under a program that is considered research for other purposes. For example, some ‘demonstration’ and ‘service’ programs may include research activities” (OPRR Reports, 1984, p. 5).
In-class research assignments are not typically treated as research conducted by students, faculty, staff, and/or administrators and are not usually subject to review. Exceptions would be in-class research that in scope resembles faculty/student research.
All requests
for IRB-PHS approval begin with
the researcher’s completing the Lock
Haven University IRB-PHS Application Cover Sheet and
Proposal Narrative (see copy in appendices).
Most
research involving humans posses little risk to the
participants. Hence, to ease the burden of obtaining IRB-PHS approval, two
categories of For research studies involving human subjects,
there are three types of review have
been createds:
(1) Unit Review, (2) Expedited
Review, and (32)
Full Review. The responsibility for reviewing
and approving Unit Expedited Review
research rests with each unit (i.e., department, Graduate Program)
in which research involving human subjects is undertaken. Research protocols are subject
toqualify for Unit Expedited
Review if they pose no more than a minimal risk to human subjects
and meet the requirements listed in Section VI.A. This procedure will allow most research proposals to be
approved within the department, and hence, expedite the start of the research
project. Expedited
Reviews are required if they pose no more than a minimal risk to human
subjects and meet the requirements listed in Section VI.B. Research review
requirementsProposals that do not meet the
requirements for Unit Review and Expedited Review are
subject to Full Review by the IRB-PHS.
Any research
involving human subjects being conducted at LHU that has not received prior IRB-PHS
approval should be brought to the attention of the Chair of the IRB-PHS.
In reviewing any research application, one of the initial determinations to be made is the level of risk to be experienced by the subjects. This decision is made without reference to the procedures planned to remove or detect any harm. There are two classifications, “minimal risk” and “more than minimal risk.”
“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." 46.102(i)
Although not exclusive, there are three research situations that would almost always put subjects in the category of “more than minimal risk”: (1) actual or potential physical harm or mental stress (e.g., reading graphic rape depictions); (2) invasions of privacy (e.g., searching residential trash cans for alcohol containers); and (3) use of active deception (e.g., creating a false emergency). Any reviewer must first make this level of risk classification to begin to determine what level of review is most appropriate.
All human subjects ,
except as described in the section below, must provide signed,
written informed consent in a verbal or written manner.
Subjects in all types of research should sign informed consent forms (see
sample in attached appendices) except as described in the paragraph below. and in the case of Full
Review research, subjects must sign informed consent forms. Informed
consent forms must be written in language
understandable to the subject. If the
consent form is difficult for the subject to read, opportunity for a full
explanation must be provided.
There are three important features
of informed consent: (1) information; (2) capacity; and (3) voluntariness. Subjects must be informed of any information (e.g.,
usually risks) that might reasonably be expected to influence their decision to
participate. The subjects must have the capacity to
understand the information in order to make an informed decision. For minor subjects (under 18 years of age) or other
subjects who cannot sign their consent, a parent, legal guardian, or other
person legally in charge of the subject’s welfare must give written consent. In the case of institutionalized subjects, an
administrator having legal responsibility for the subjects’ care must provide
written consent. For minors participating in research studies,
aIn addition, a consent form that is
written in age-appropriate terminology must also be provided and signed if
possible by the minor. In the case of institutionalized subjects, an
administrator having legal responsibility for the subjects’ care must provide
written consent. Finally,
subjects must provide the informed consent voluntarily and be able to withdraw
consent without penalty. Please note that coercion can
sometimes be very subtle, particularly when requested by persons of authority.
A waiver of obtaining written
informed consent can be requested;,
however, it requires a Full Review hearing
and can be granted by the IRB-PHS for special
circumstances. For example,To
illustrate, following are two examples of research that might
qualify: (1) telephone survey research, and (2) when the only record linking the
subject and the research would be the consent document and the principle risk
would be potential harm resulting from a breach of confidentiality.
Responsibility for initial review
of all proposals resides within the individual units (i.e., departments) in
which research involving human subjects is being undertaken. Each unit, with guidance from the IRB-PHS, will develop an appropriate review procedure for
granting the appropriate level of review (i.e., Unit Review, Expedited
Review, or Full Review) to a proposed
research project. The review procedure
developed by each unit may assign review responsibilities to a particular
faculty member, to each faculty member who sponsors research, or to a departmental
committee. Any member with any
conflict of interest in reviewing a particular application cannot review that
application. Unit review procedures
must be approved by the full IRB-PHS prior to
carrying out the review of research proposals. Any member
with any conflict of interest in reviewing a particular application cannot be
selected to serve as unit representative in
reviewing that application.
Each
unit that wants to carryout expedited reviews of
research will assign one individual to be the Unit Representative to
the IRB-PHS. This individual
will communicate the level of review determined by the unit by forwarding a
copy of the completed Application Cover Sheet (see attached appendices) and
Proposal Narrative (see attached appendices) to the chairperson of the IRB-PHS. It
is the responsibility of the unitUnit representativeRepresentative
to educate researchers of the basic three two review
levels and the timelines required for each level of review. Unit review procedures
must be approved by the full IRB-PHS.
Unit representatives are
required to forward a copy of the completed Application Cover
Sheet (see attached appendices) and Proposal Narrative (see attached
appendices) to the chairperson of the IRB-PHS.
If a
unit has no Unit Representative or an approved unit
review procedure, the Application Cover
Sheet and and Proposal
Narrative can be forwarded directly to the Chairperson
of the IRB-PHS to be reviewed using the Full Review
process.
A researcher who wishes to conduct
a research study whichthat has
been determined to qualify for an
Expedited Unit Review process
must first receive written approval from their unit Unit representative Representative prior
to the undertaking of a research project.
A researcher should submit an
application to their the researcher’s unit Unit representative
Representative, who will then determine the specific
level of review. If the representative determines an
application meets the conditions
for the Unit Expedited Review
process conditions listed on the following
page, a researcher may initiate the study immediately following the sign-off by
the unit Unit representativeRepresentative.
Following the review of the
application and granting exempt Expedited Review status,
the unit Unit representative
Representative will forward a copy of
the completed Application Cover Sheet and Proposal Narrative to the chairperson
of the IRB-PHS for record keeping and auditing
purposes.
All human subjects
participating in Expedited Review research must sign informed consent
forms.
The
following page summarizes the conditions
required for research to qualify for Unit Expedited
Review and thus be exempt from further review.
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· Research where subjects are exposed to “more than minimal risk.” ·
Research where subjects do
NOT provide ·
Research involving · Research where observations are recorded in such a manner that the human subjects can be identified directly or through identifiers linked to the subjects. · Research where disclosure of the subjects’ responses outside the research could reasonably place the subjects at risk or criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. · Research dealing with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol. Six Categories of Research Allowed to be Exempt from
Further Review: The following categories of research may be exempted from more extensive committee review if the conditions listed above are not violated: I. Research conducted in established or commonly accepted educational settings involving normal educational practices such as research on comparison among instructional strategies, curricula, or classroom management methods. II. Research III. Research involving surveys, interviews, or observations and where the investigator identifies himself/herself and states that he/she is conducting research. IV. Research involving the observation (including observation by participants) of public behavior. V. Research involving the collection or study
of existing data, if either the data are publicly
available, or the investigator will record them in a manner that VI. Research on individual or group behavior or
characteristics of individuals, such as studies of perception, cognition,
game theory, or test development, where the investigator does not actively
deceive subjects (e.g., fake emergency) and the research will not involve
stress to subjects. |
A researcher who wishes
to conduct a research study which has been determined to qualify for an
Expedited Review process, must first receive written approval from a committee
member of the IRB-PHS prior to the undertaking of a research project.
A researcher should
submit an application to their unit representative who will then determine the
specific level of review. Research applications that are determined by the
representative to qualify for an Expedited Review process will be sent to the
chairperson of the IRB-PHS within seven days of receipt of the application. The
Chairperson or his/her designee(s) will evaluate the application to determine
if it meets the requirements outlined below.
The chairperson of the IRB-PHS will return it to the researcher with
approval or suggested modifications within seven days of receipt of the
application.
The review can be
conducted by the Chairperson of the IRB-PHS or by one or more reviewers
designated by the Chairperson from among members of the IRB-PHS. Any member
with any conflict of interest cannot be selected to serve as an expedited
reviewer. An individual reviewer may exercise all of the authorities of the
IRB-PHS to approve research; the reviewer may not disapprove research. Any
expedited reviews that are not approved will be reviewed by the full IRB-PHS.
The IRB-PHS Chairperson will regularly advise members of research applications
that have been approved using expedited procedures.
Expedited procedures can
also be used to review minor changes in previously approved Unit Review or
Expedited Review research. The following page summarizes the conditions
required for research to qualify for Expedited Review.
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Any research not
covered by the conditions of Unit Review or Expedited Review
including all research whichresearch that
involves “more than minimal risk," or which could not be
approved using other review categories, will be referred to the
full IRB-PHS committee for review. In
addition, proposals coming from units
that do not have a Unit Representative must use
the Full Review procedure in order to request IRB-PHS
approval.
A researcher who wishes to conduct
a research study, whicthath
has been determined to require a Full Review process, must first receive
written approval from the IRB-PHS prior to the
undertaking of a research project.
A researcher should submit an
application to their the researcher’s unit Unit representative
Representative, who
will then determine the specific level of review. Research
applications whichthat are
determined by the representative to require a Full Review process will be sent
to the chairperson of the IRB-PHS within seven days
of receipt of the application. Units
without a Unit Representative can
forward the application directly to the chairperson of the IRB-PHS.
A majority vote of
members hearing the Full Review application shall be necessary for approval.
The full IRB-PHS will evaluate the application at a regularly convened meeting to determine that all of the requirements specified in 45CFR46.111 are satisfied. A minimum of four IRB-PHS members, one member whose primary concerns are in nonscientific areas, and no less than two of whom possess a background and expertise in the behavioral and social sciences, is necessary for a Full Review hearing. IRB-PHS members who have a conflicting interest in a research project cannot participate in the review except to provide information. The researcher(s) submitting the application will be invited to attend the review hearing for the purpose of elaborating on the research design, but shall not vote in the IRB-PHS decision. For research to be approved, it must receive approval of a majority of the members present at the meeting. The IRB-PHS will notify investigators in writing in a timely fashion of its decision to approve, modify, and or disapprove the research.
All human subjects participating in Full Review research must sign informed consent forms unless a waiver of informed consent is requested in the Full Review application and granted by the IRB-PHS (see section IV).
When offering students research
experiences that might cause the student discomfort, embarrassment, or anxiety as a result of the procedures, or the knowledge generated by
the procedureresearch,
faculty should give students a choice of participating in an activity at a
comparable level of effort thatwhich
does not have the possible side effects.
Choices should be clearly described and
students should not be made to feel that a penalty would derive from choosing
any one of the alternatives.
The view that extensive IRB-PHS review is not required for Unit Expedited
Review level research is predicated on several assumptions that
all faculty members are expected to share. Faculty membersies
involving enrolled students in research experiences are responsible for
protecting the rights of tthose
students by:
1. Adhering to the
ethical principles of their professional disciplines regarding
the appropriate use of educational and research experiences;
2. Requiring students to participate only in
research activities that accomplish a clearly stated educational objectives;
and
3. Informing
students, in advance, of the research participation requirements of a course
and the educational rationale for participation requirements
and the educational rationale for participation, so that students may reach an
informed decision regarding their participation in the course.Adhering
to the ethical principles of their professional disciplines
regarding the appropriate use of educational and research experiences;
·Requiring
students to participate only in research activities that only
accomplish a clearly stated educational objectives;
and
·
Informing
students, in advance, of the research participation requirements of a
course and the educational
rationale for participation requirements and the educational rationale for
participation, so that students have
the opportunity tomay reach
an informed decision regarding their participation in the course.
The IRB-PHS
will conduct random and periodic evaluations of research protocols that were
previously approved by the Board. The purpose is to
determine the status of the project with respect to the original IRB application and to document changes that may have been made in the treatment of human subjects (see
attached letter and questionnaire in the appendices).
Each
May, the chairperson of the IRB-PHS shall submit to
the Vice President of Academic Affairs a written summary of the activities of
the committee in the previous year. The
report shall include, but not be limited to, the following: 1) numbers and types of
Unit
Review, Expedited Review, and Full
Review research undertaken at Lock Haven University of Pennsylvania in the
previous year; 2) the turn-around time required for Expedited and Full
reviews; and 3) recommendations for improving the process.
Adair, J. G., Dushenko, T. W., & Lindsay, R. C. L. (1985). Ethical regulations and their impact on research practice. American Psychologist, 40, 59-72.
American
Psychological Association. (1992). Ethical principles
of psychologists and code of conduct. American
Psychologist, 47,
1597-1611.
Baumrind, D. (1985). Research using intentional deception:
Ethical issues revisited. American
Psychologist, 40, 165-174.
Blank,
P. D., Bellack. A. S., Rosnow, R. L., Rotheram-Borus, M.
J., & Schooler, N. R. (1992). Scientific
rewards and conflicts of ethical choices in human subjects research. American Psychologist, 47,
959-965.
Bronson, R. (1980). The ethics of dental research: An overview of basic principles. Journal of Dental Research, 59, 1214-1220.
Christensen,
L. (1988). Deception in psychological research: When
is its use justified? Personality and Social
Psychology Bulletin, 14 664-675.
Diener, E., & Crandall, R.
(1978). Ethics in social and behavioral research.
Fisher,
C. B., & Fryberg, D. (1984). Participant
partners: College students weigh the costs and benefits of deceptive research. American Psychologist, 49,
417-427.
Grisso, T.,
Kelman, H. C. (1972). The rights of the subjects in social research: An analysis
in terms of relative power and legitimacy. American
Psychologist,
27, 989-1016.
Human Subjects Research
Review Committee. (1984). Investigator Guidelines for Human Research
Protocols. (SUNY-Binghamton). Binghamton, N.Y.: Office of the Graduate School.
National
Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research. (1978). The Ethical
Principles and Guidelines for the Protection of Human Subjects of Research. (Department of Health, Education, and Welfare Publication NO (50)
78-0012.
Office for Protection from
Research Risks. (1984). OPRR
Reports: Title 45, Public Welfare (Department of Health and Human Services,
Part 46 - Protection of Human Subjects). .
Office for the
Protection of Human Subjects.
(1986). Review
Procedures to be followed for the Protection of Human Research Subjects (The
Pennsylvania State University).
Richardson,
D. R., Pegalis, L., & Britton, B. (1992). A technique for enhancing the value of research participation. Contemporary Social Psychology, 16,
11-13.
Thomas, J.J. (1981). Regulations governing research on
human subjects: Academic freedom and the
Institutional Review Board. Academy, 67.
Document last revised on 7 April 2004.
Appendices
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Revised
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