Institutional Review Board for
the Protection of Human Subjects
Policies
and Procedures
I. The Federal Common Rule
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 that 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).
II. Institutional Review Board for the
Protection of Human Subjects
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 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 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.
III. Responsibilities and Review Types
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 review have
been created: (1) Expedited Review
and (2) Full Review. The responsibility for reviewing and approving
Expedited Review research rests with each unit (i.e., department, Graduate
Program) in which research involving human subjects is undertaken. Research
protocols qualify for 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. Proposals
that do not meet the requirements for 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.
IV. Level of Risk
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.
V. Informed Consent
All
human subjects must provide signed, written informed consent (see sample in
attached appendices) except as described in the paragraph below. 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. In addition, a consent form
that is written in age-appropriate terminology must also be provided and signed
if possible by the minor. 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. 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.
VI. Review Process
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., 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.
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 Unit Representative to educate researchers of the two
review levels and the timelines required for each level of review.
If
a unit has no Unit Representative or an approved unit review procedure, the
Application Cover Sheet and Proposal Narrative can be forwarded directly to the
Chairperson of the IRB-PHS to be reviewed using the Full Review process.
A. Expedited Review Research Process
A
researcher who wishes to conduct a research study that has been determined to
qualify for an Expedited Review process must first receive written approval
from their Unit Representative prior to the undertaking of a research project.
A
researcher should submit an application to the researcher’s Unit
Representative, who will then determine the specific level of review. If the
representative determines an application meets the conditions for the Expedited
Review process listed on the following page, a researcher may initiate the
study immediately following the sign-off by the Unit Representative.
Following
the review of the application and granting Expedited Review status, the Unit
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 summarizes the conditions required for research to qualify for
Expedited Review and thus be exempt from further review.
|
EXPEDITED REVIEW RESEARCH Expedited Review DOES NOT apply to: ·
·
Research where subjects are exposed to “more than
minimal risk.” ·
·
Research where subjects do NOT provide written informed
consent. ·
·
Research involving minors (age < 18 years), pregnant
women, fetuses, prisoners, and persons with disabilities. ·
·
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 that involves the use of
“educational tests” (cognitive, diagnostic, aptitude, achievement), if the
investigator will record the information in a manner that makes
identification of subjects impossible. 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 makes identification of the
subjects impossible. 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. |
B. Full Review Research
Any research not
covered by the conditions of Expedited Review including all research that
involves “more than minimal risk," 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, that has been determined to
require a Full Review process, must receive written approval from the IRB-PHS
prior to the undertaking of a research project.
A
researcher should submit an application to the researcher’s Unit
Representative, who will then determine the specific level of review. Research
applications that 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.
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).
VII. Use of Enrolled Students as Research Subjects
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 research, faculty should give students a choice of
participating in an activity at a comparable level of effort that 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 Expedited Review level research is
predicated on several assumptions that all faculty members are expected to
share. Faculty members involving
enrolled students in research experiences are responsible for protecting the
rights of those 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.
VIII. Periodic Evaluation
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 of Expedited Review and Full Review research undertaken at Lock Haven
University of Pennsylvania in the previous year; 2) the turn-around time required
for Full reviews; and 3) recommendations for improving the process.
IX. Recommended References
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.
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research. (1978). The
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.
Portions of this
document have been adapted from the human subjects
research regulation of