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
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
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 who 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.
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 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 Academic
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.
For research studies involving human subjects,
there are three types of review s:
(1) Unit Review , (2) Expedited
Review , and ( 3)
Full Review. The responsibility for reviewing
and approving Unit Review
research rests with each unit (i.e., department)
in which research involving human subjects is undertaken. are subject
to Unit Review if they pose no more than a minimal risk to human subjects
and meet the requirements listed in Section VI.A. 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
requirements that do not meet the
requirements for Unit Review and Expedited Review are
subject to Full Review by 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 informed consent in a verbal or written manner .
Subjects in all types of research should sign informed consent forms (see
sample in attached appendices) 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.
For minors participating in research studies,
a consent form that is
written in age-appropriate terminology must also be provided and signed. 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 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,
Responsibility for initial review
of all proposals resides within the individual units 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 be
selected to serve as unit representative in
reviewing that application.
is the responsibility of the
to educate researchers of the basic three 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.
A researcher who wishes to conduct
a research study
been determined to qualify for a
Unit Review process
must first receive written approval from the unit representative prior
to the undertaking of a research project.
A researcher should submit a
their unit representative
who will then determine the specific
level of review. If the representative determines an
application meets the Unit Review
process conditions 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
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
page summarizes the conditions
required for research to qualify for Unit Review and thus be exempt from further review.
· Research where subjects are exposed to “more than minimal risk.”
Research where subjects do
· 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.
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
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.
Any research not
covered by the conditions of
Unit Review or Expedited Review
including all research which
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.
A researcher who wishes to conduct
a research study
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
their unit representative
will then determine the specific level of review. Research
applications which 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. 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 who 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
faculty should give students a choice of participating in an activity at a
comparable level of effort which
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 Review level research is predicated on several assumptions that
all faculty are expected to share. Facult ies
involving enrolled students in research experiences are responsible for
protecting the rights of those
to the ethical principles of their professional disciplines
regarding the appropriate use of educational and research experiences ; Requiring
students to participate in research activities that only
accomplish a clearly stated educational objectives;
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
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.
Bronson, R. (1980). The ethics of dental research: An overview of basic principles. Journal of Dental Research, 59, 1214-1220.
Human Subjects Research
Review Committee. (1984). Investigator Guidelines for Human Research
Protocols. (SUNY-Binghamton). Binghamton, N.Y.: Office of the Graduate School.
Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research. (1978). The
Office for Protection from
Office for the
Protection of Human Subjects.
Procedures to be followed for the Protection of Human Research Subjects (The
Pennsylvania State University).
Thomas, J.J. (1981).