Human Subject Research Guidelines and Procedures

Preface

Berea College has made the decision that all human subject research,* whether funded or not funded, or subject to Federal regulations or not, will be designed such that

The welfare and rights of human subjects are adequately protected and informed consent given, if required. (See section C. below for a description of projects exempt from the institutional requirement of informed consent.)
Human subjects are not placed at unreasonable physical, mental, or emotional risk as a result of research.
The necessity and importance of the research outweighs the risk to the subject.
The researcher(s) is/are qualified to conduct research involving human subjects.
The researchers maintain overall ethical principles. (See section F. below.)

*Human Subject Research is a systematic investigation designed to develop or to contribute to generalizable knowledge such that the subjects of the investigation are living individuals from or about whom an investigator conducting research obtains data.

The purpose of the information below is to make certain that faculty, staff, and students understand the guidelines that must be applied to human subject research and to ensure that they feel supported by the institution as they undertake such research projects. Faculty should feel free to discuss this document and human subject research with the Academic Vice President and Dean of the Faculty, the chair of the Institutional Review Board (IRB), and/or the Director of the Office of Institutional Research and Assessment.

A. Procedures for Approval of the Research

All human subject research to be done by students as part of faculty-supervised work must be approved by the faculty member. If it is not, then it must not be done. If the faculty member feels that substantive ethical issues exist, then the proposal must be brought to the Institutional Review Board.

All human subject research to be done by a faculty or staff member must be presented to the Institutional Review Board, except for research presenting only minimal risk. (See Section C. below.)

Researchers or, in the case of students, the faculty supervisor, may voluntarily consult with the IRB. Members of the College community affected by a research project may bring their concerns to the IRB as well.

B. Research That Has Potential Risk to Subjects

Research which has potential risk to subjects requires informed consent. (See Section E. below.) Research in this category must be reviewed by the IRB. All human subject research to be done by students as part of faculty-supervised work must have faculty review and approval, but if student research has potential risk to subjects, it must be approved by the IRB as well.

Research which has potential risk to subjects includes but is not limited to the following:

Research which involves the administration of drugs or other substances to subjects
Research targeting pregnant women and /or fetuses in utero
Research involving subjects with life-threatening physical conditions
Research involving physically intrusive procedures
Research which previous experience (by the particular investigator or other investigators) has shown to create a potential risk to subjects
Research which potentially could put the subject at risk for legal or civil liability or invade a subject’s privacy in regard to sensitive aspects of his/her behavior (e.g., illegal conduct, drug use, sexual behavior, alcohol use)
Research which involves vulnerable populations. (See section D. below.)

C. Research That Has Minimal Risk to Subjects

Research which has only minimal risk is exempt from the institutional requirements of informed consent and program review. All human subject research to be done by students as part of faculty-supervised work must have faculty review and approval.

Research which has only minimal risk includes the following:

Research in which "the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." (This is the federal definition of minimal risk: http://www.hhs.gov/ohrp/archive/ir/orb_chapter3.htm#e1.)
Research on effectiveness of educational, classroom, and/or instructional strategies, provided that these strategies are familiar, and non-intrusive in their implementation
Research using educational tests (cognitive, diagnostic, aptitude, achievement) if subjects’ identities are thoroughly protected
Research using survey procedures or interview procedures where subjects’ identities are thoroughly protected and their answers do not subject them to criminal and civil liability
Research involving the collection or study of existing data, documents, records, specimens, or other products, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subject cannot be identified directly or indirectly
Research involving momentary, unobtrusive observation in a public place
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 manipulate subjects’ behavior and the research does not involve stress to subjects.

D. Criteria for Approval of All Research at Berea College

Risks to subjects are either minimal (see section C above) or are clearly balanced by the likely results of the research. Note that research involving “high risk,” that is, projects that may induce potentially harmful physical or mental states, will not be permitted
Additional safeguards have been included in the study to protect the rights and welfare of vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, economically or educationally disadvantaged individuals or students who feel compelled to participate
Selection of subjects is equitable
When appropriate, informed consent will be sought from each prospective subject or the subject’s legally authorized representative when this is necessary (See Section E. below.)
When appropriate, informed consent will be appropriately documented and such records will be adequately maintained.
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subject
When appropriate, adequate provisions exist to protect the privacy of subjects and to maintain the confidentiality of data.

E. Informed Consent Form Checklist

The checklist below is provided to ensure that each of the following components is included in all institutionally-required Informed Consent forms.

The Informed Consent form is written in a language understandable to the subject or his/her legal representative.
The Informed Consent form is written in a consistent voice either first, second, or third person (not a combination) with the exception of the Voluntary Consent section, which is written in the first person.
Each page of the Informed Consent form is on original Berea College letterhead, except in cases of collaborative projects when the letterhead from a hospital, university, etc. is acceptable.
If the research is externally funded, the funding agency is listed under funding source.
The title of the study and the name, address, and telephone number of the investigator(s) is listed.
If the principal investigator is a student, the address and telephone numbers of his/her research supervisor(s), clinical Supervisor(s) are listed.
The telephone number 859-985-3487 is listed for contact with the IRB.
A statement that the study involves research and an explanation of the purpose of the research is included.
A concrete description of the study procedures, including the amount of time subjects are being asked to contribute and the nature of the questions or data to be collected, is included. Any procedures which are experimental are identified and any alternative procedures are disclosed.
A description of any risks and possible discomforts to the subject, if any, is included.
A description of any benefits to the subjects is included. If no benefits are expected, this is stated.
A statement describing the extent to which confidentiality will be maintained is included in addition to a clause which states that all information obtained is strictly confidential unless disclosure is required by law.
If subjects will be compensated for their participation, a statement has been included addressing this.
A statement that participation is voluntary, that refusal to participate involves no penalty, and that the subject may discontinue participation and have any data collected (connected directly to that participant as subject) destroyed at any time is included.
A statement indicating whom the subject can contact for any questions about the study is included.
The Informed Consent contains no language through which the subject is made to waive any of his/her legal rights or which releases the investigator, the sponsor, or the institution from liability for negligence.
The entire paragraph under the Section-Voluntary Consent on the Informed Consent form appears in boldface and the first sentence reads: “I have read this consent form (or it has been read to me), and I fully understand the contents of this document and voluntarily consent to participate.”
A space for the subject’s signature, the date, and the signature of a witness is provided.
An assent form completed and signed by a responsible party is included for subjects below 18 years of age.

F. American Psychological Association Ethical Guidelines

The American Psychological Association (1981a, 1987, 1989, 2010) has provided ethical guidelines for researchers. The association outlined the following ten general principles governing the conduct of research with human participants. (See Experimental Psychology , Kantowitz, et.al. for a full discussion of these principles.)

In planning a study, the investigator has the responsibility to make a careful evaluation of its ethical acceptability.
Considering whether a participant in a planned study will be a “subject at risk” or a “subject at minimal risk,” according to recognized standards, is of primary ethical concern to the investigator.
The investigator always retains the responsibility for ensuring ethical practice in research. The investigator is also responsible for the ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom, however, incur similar obligations.
Except in minimal-risk research, the investigator establishes a clear and fair agreement with research participants, prior to their participation, that clarifies the obligations and responsibilities of each.
Methodological requirements of a study may make the use of concealment or deception necessary. Before conducting such a study, the investigator has a special responsibility to (i) determine whether the use of such techniques is justified by the study’s prospective scientific, educational, or applied value; (ii) determine whether alternative procedures are available that do not use concealment or deception; and (iii) ensure that the participants are provided with sufficient explanation as soon as possible.
The investigator respects the individual’s freedom to decline to participate in or to withdraw from the research at any time.
The investigator protects the participant from physical and mental discomfort, harm, and danger that may arise from research procedures. If risks of such consequences exist, the investigator informs the participant of that fact.
After the data are collected, the investigator provides the participant with information about the nature of the study and attempts to remove any misconceptions that may have arisen.
Where research procedures result in undesirable consequences for the individual participant, the investigator has the responsibility to detect and remove or correct these consequences, including long-term effects.
Information obtained about a research participant during the course of an investigation is confidential unless otherwise agreed upon in advance.

G. The Institutional Review Board (IRB)

Constitution of the IRB

Federal policy outlines the membership and responsibilities of the IRB (http://www.hhs.gov/ohrp/archive/irb/irb_chapter1.htm#c4). Members of Berea College’s IRB will be appointed by the Academic Vice President and Dean of the Faculty to fulfill the following requirements:

The IRB will “have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.”
“The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of their racial and cultural heritage and their sensitivity to issues such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.” In this regard, Berea’s IRB will include membership that reflects the racial and cultural heritage of the College’s staff and student body and those of the surrounding community.
The IRB must include

o At least one member who is knowledgeable in the areas of “institutional commitments and regulations, applicable law, and standards of professional conduct and practice.”

o “at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.”

o “at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.”

o An administrative assistant will be assigned to the IRB to ensure that accurate record-keeping is maintained.

Members of the IRB will receive training in the regulations of the College and the Federal Government by reading and discussing the relevant sections of the faculty and staff manuals and IRB Guidebook provided by the Department of Health and Human Services (http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm)

Members of the IRB will serve overlapping, three-year terms, and the Chair of the IRB will be appointed by the Academic Vice President and Dean of the Faculty.

The Associate Vice President for Academic Affairs will serve as the authorized institutional official with oversight of the IRB.

Practices of the IRB

The IRB will meet three times a year to review research proposals involving human subjects: in September, January, and May. All proposals must be submitted such that reviews can take place during these times. Exceptions will be made at the discretion of the IRB chair and the Academic Vice President and Dean of the Faculty.
If a member of the IRB has a proposal before the Board, he/she must be absent from discussion and vote on that proposal.

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