Institutional Review Board for the Protection of Human Subjects
Policies and Procedures
Contents
I. The Federal Common Rule
II. Institutional Review Board for the Protection of Human Subjects
III. Responsibilities and Review Types
IV. Level of Risk
V. Informed Consent
VI. Review Process
VII. Use of Enrolled Students as Research Subjects
VIII. Periodic Evaluation
IX. ReferencesRecommended References
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 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).
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 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.
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 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.
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 , 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.
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., 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. Unit Expedited Review Research 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.
EXPEDITED REVIEW RESEARCH
CONDITIONS TO EXEMPT FROM FURTHER REVIEW
Unit Expedited Review DOES NOT apply to:
· Research where subjects are exposed to “more than minimal risk.”
· Research where subjects do NOT provide verbal or 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 whichthat 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 thatwhich 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.
Full Review Research
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).
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 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.
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 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.
IX. ReferencesRecommended 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. Chicago: University of Chicago Press.
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., Baldwin, E., Blanck, P. D., Rotheram-Borus, M. J., Schooler, N. R., & Thompson, T. (1991). Standards in research: APA’s mechanisms for monitoring the challenges. American Psychologist, 46, 758-766.
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 Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. (Department of Health, Education, and Welfare Publication NO (50) 78-0012. Washington, D.C.: U.S. Government Printing Office.
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). Washington, D.C.: U.S. Government Printing Office.
Office for the Protection of Human Subjects. (1986). Review Procedures to be followed for the Protection of Human Research Subjects (The Pennsylvania State University). University Park, PA: U.S. Government Printing Office.
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 Slippery Rock University. Used by permission.
Document last revised on 7 April 2004.