Research Involving Human Subjects
Requirements and Procedures
Purpose of the Requirements and Procedures
Berea College requires that all research involving human subjects, 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.)
“Research” is defined as, “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities” [45 CFR 46.102(d)].
A “human subject” is defined as, “a living individual about whom an investigator (whether professional or student) conducting research obtains: data through intervention or interaction with the individual or identifiable private information” [45 CFR 46.102 (f)].
Berea College recognizes that oral history projects have not always been recognized as equivalent to the “research involving human subjects” that constitutes the main concern of these Requirements and Procedures. As such, the College has taken account of these potential differences in these Requirements and Procedures by including a member on its IRB with oral history training and experience, as well as accounting for oral history projects as a separate category of “expedited review” that are subject to consideration using the best practices promulgated by oral historians. Nonetheless, the College does maintain that oral history projects can involve risks to those who provide information to the historian or student conducting such projects, and therefore oral history work by Berea College students, faculty, or staff must pass through the independent review mechanisms established below in these Requirements and Procedures.
The purpose of the information below is to make certain that faculty, staff, and students understand the guidelines that must be applied to research involving human subjects 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 Provost, the designee of the Provost, or the Chair of the Berea College Institutional Review Board (IRB).
A. Membership of the Berea College Institutional Review Board
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, the Berea College IRB will include members who reflect the racial and cultural heritages of the College’s staff and student body and those of the surrounding community.
The IRB shall consist of seven (7) voting members, including six (6) members appointed by the Provost from among the full-time teaching faculty of the College, one (1) member appointed by the Provost 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, and one (1) member who will serve as the designee of the Provost. After the initial sequence of partial-term appointments have ended, each newly appointed faculty or outside member will serve a term of three (3) years, with individual terms sequenced to overlap and thereby allow for continuity of membership. The members of the IRB will elect the Chair of the IRB, during the regular September meeting each year, to serve during the upcoming twelve-month period. If a member of the IRB is directly associated with a proposal before the IRB, that member must be absent from any discussion and vote on that proposal.
In particular, appointments to the IRB will provide for the following areas of expertise and experience:
- at least one (1) member whose primary disciplinary training and concerns are in the social sciences;
- at least one (1) member whose primary disciplinary training and concerns are in the natural sciences;
- at least one (1) member who is knowledgeable in the areas of institutional commitments and regulations, applicable law, and standards of professional conduct and practice;
- at least one (1) 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;
- at least one (1) member who previously has conducted substantial research involving human subjects and whose research was subject to an IRB review; and,
- at least one (1) member who previously has conducted substantial oral history projects using recognized best practices for such projects.
The IRB will meet no fewer than three (3) times each year to review research proposals involving human subjects and oral history projects. Three (3) of these meetings will take place in September, January, and May of each year. 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 College’s faculty and staff manuals and the IRB Guidebook provided by the Department of Health and Human Services (http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm) or by receiving other equivalent training provided through the resources of the College. An administrative assistant will be assigned by Provost to the IRB to ensure that accurate record-keeping is maintained.
B. Procedures for Approval of a Proposed Project
All research involving human subjects or oral history projects to be conducted by students as part of faculty-supervised work must be reviewed, approved, and supervised by the faculty member. Such faculty member becomes responsible for such research or project as the Primary Investigator (PI) and remains responsible for the compliance of that research with ethical research standards, including IRB review, applicable at Berea College. No student may conduct research involving human subjects or oral history projects without a supervising faculty member who has agreed to serve as the PI for that research.
All research involving human subjects or oral history projects to be conducted or supervised by a faculty or staff member must be submitted for review to the Institutional Review Board if the research or project is part of that faculty or staff member’s responsibilities or incentives as an employee of Berea College. Once submitted, the IRB will determine whether that research or project is covered by IRB review, exempt from IRB review, subject to expedited IRB review, or subject to full IRB review.
Once research or an oral history project is submitted to the IRB for review, the Chair, the full committee or the Chair’s designee will take one or more of the following actions:
- Determine the authority of the IRB to review the research proposal or oral history project.
- Determine whether the research proposal or oral history project is exempt from review under applicable federal guidelines.
- Approve the research or project through expedited or full-committee review.
- Disapprove the research or project through full-committee review.
- Modify the research.
- Conduct continuing reviews of the research or project.
- Observe and/or verify changes to the research or project.
- Suspend or terminate approval of the research or project.
- Observe and/or verify the informed consent process and the research or project procedures.
Researchers, or in the case of students the faculty supervisor acting as PI, are free to consult with the IRB about any issue of compliance under these requirements and procedures. Members of the College community affected by research or an oral history project may bring their concerns to the IRB as well.
C. The IRB Application
The IRB will provide an application form for faculty or staff seeking approval of research involving human subjects or of an oral history project. Applications for IRB approval of such research or project must contain, at a minimum, information that allows IRB members to assess:
- Basic Required Information:
- The qualifications of the principal investigator (PI) and any collaborators
- A complete description of the proposed work
- Provisions for the adequate protection of rights and welfare of subjects
- Compliance with pertinent federal and state laws/regulations and institutional policy
- Consideration of any special requirements for DHHS and FDA-regulated research (in addition, other funding agencies may also have similar requirements or expectations)
- Analysis of Risks and anticipated Benefits
- Identification and assessment of risks and anticipated benefits
- Determination that risks are minimized
- Determination that risks are reasonable in relation to potential benefits
- Informed consent
- Clear and full explanation of the informed consent process and documentation to be used for the study.
- Assent process
- Assent process and documentation protocol
- Explanation of the process for receiving and documenting the affirmative agreement of those legally responsible for any minor or decisionally-impaired individual who may participate
- Selection of subjects
- Equitable selection in terms of gender, race, ethnicity
- Benefits are distributed fairly among the community's populations
- Additional safeguards are provided for vulnerable populations susceptible to pressure to participate
- Ensure that subject recruitment does not invade individuals' privacy and that procedures are in place to assure that the confidentiality of the information collected is monitored
- Research plan for collection, storage, and analysis of data
- Clinical research studies often include data safety monitoring plans and/or data safety monitoring boards (DSMB). IRBs will review the plans to ensure they are adequate to protect human subjects
- Research design / methods
- Are appropriate, scientifically valid and therefore, justify exposing subjects to potential risks
- Additional information – Special Populations
- About identification, recruitment and safeguards if the research involves special populations
D. Expedited Review by the IRB
In deciding whether any research involving human subjects qualifies for expedited review by the IRB, the Chair will apply the standards maintained by federal law. Therefore, in considering expedited review, the Chair may not grant such review if the proposed research involves any work with prisoners, surveying or interviewing of children, or observations of public behavior of children when any investigator participates in the activities being observed. The Chair may grant expedited review if the research involving human subjects meets both of the following two criteria. The first criterion is that the research may not involve more than “minimal risk” to the individuals involved, meaning that the probability and magnitude of harm or discomfort anticipated in the 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.
The second criterion that must be met is that the research clearly conforms to one of the following nine (9) categories: (1) clinical studies on drugs or medical devices for which an investigational new drug (IND) or an investigational device exemption (IDE) application is NOT required (or a study with a cleared/approved medical device that is being used in accordance with its cleared/approved labeling); (2) the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture; (3) the prospective collection of biological specimens for research purposes by noninvasive means; (4) the collection of data through noninvasive procedures routinely employed in clinical practice (for example, physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy, weighing or testing sensory acuity, magnetic resonance imaging, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography, moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual), provided that the noninvasive procedure must not involve general anesthesia or sedation routinely employed in clinical practice or procedures involving x-rays or microwaves, and provided that where medical devices are employed, they must be cleared/approved for marketing (studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications); (5) research involving data, documents, records, or specimens that have been collected or will be collected solely for non-research purposes (such as for medical treatment or diagnosis); (6) collection of data from voice, video, digital, or image recordings made for research purposes; (7) research on individual or group characteristics or behavior; (8) continuing review of research previously approved by the IRB where the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and, the research remains active only for long-term follow-up of subjects, or where no subjects have been enrolled and no additional risks have been identified, or where the remaining research activities are limited to data analysis; or, (9) continuing review of research not conducted under an investigational new drug (IND) application or investigational device exemption (IDE) and where categories two through eight (2-8) do not apply.
Upon receipt of a request for IRB review, the IRB Chair may determine that an expedited review is appropriate in certain cases. The Chair may conduct that expedited review or designate one of the other members of the IRB to conduct that expedited review. In no case is the Chair required to grant an expedited review, even if the research appears to meet the criteria set forth above. Based on this determination, the Chair or designated IRB member must determine the following during the expedited review process:
- Have the risks to subjects been minimized using procedures that are consistent with sound research design?
- Are the risks reasonable in relation to anticipated benefits?
- Is the selection of subjects equitable?
- Are adequate procedures in place to ensure privacy and confidentiality?
- Is there a plan to monitor the data and safety of the subjects, if necessary?
- Will informed consent be sought and appropriately documented?
- Are safeguards in place to protect vulnerable populations?
If an IRB application includes the use of oral history interviews or similar oral history methods, then that application will be processed initially using an expedited review. The IRB Chair may not deny an expedited review of such an application, nor may the Chair conduct the expedited review of the project. Instead, the IRB Chair will designate the IRB member, who previously has conducted substantial oral history projects using recognized best practices for such projects, to conduct the expedited review. The designated member will determine whether the above standards for expedited review are met through the application of the best practices maintained by oral historians, especially as those best practices are demonstrated through the guidelines adopted by the nationally-recognized professional associations maintained by oral historians. In a case where the IRB member who previously has conducted substantial oral history projects using recognized best practices for such projects has a conflict of interest in terms of the project then under review, the IRB Chair will designate another oral historian with similar credentials to conduct the review on a pro tempore basis for the Board.
As the result of an expedited review, the Chair or a Chair’s designee may approve the research or oral history project as presented, or ask for modifications of the research or project before giving final approval. The Chair or the Chair’s designee may not deny approval during an expedited review. Any research or project that does not receive final approval during an expedited review must be submitted by the IRB Chair for full IRB review.
E. Full IRB Committee Review Process.
During a full committee review, the IRB must meet the following requirements:
- The review must be conducted at a convened meeting of the IRB. A majority of IRB members (a quorum) must be present at the meeting.
- At least one member whose primary concerns are in nonscientific areas must be present at the meeting.
- In order to approve research, the IRB must determine that all of the applicable requirements specified in 45 CFR 46.111 (and if applicable, 21 CFR 56.111) are satisfied.
- A majority of the members present at the meeting must approve the research or oral history project.
- IRB members who have a conflict of interest in the research or project may provide information to the IRB but cannot participate in the review or be present for voting. Members with a conflict do not count toward the quorum for the review of that research or project.
- The IRB must notify the PI(s) and the institution in writing of its decision to approve, modify or disapprove the research or project.
- The IRB must keep detailed documentation of meeting activities including attendance, voting on actions, the basis for the actions, and a written summary of the IRB discussion of controverted issues and their resolution.
Federal policy lists Basic Criteria that the IRB must apply [45 CFR Part 46.111 and 21 CFR Part 56.111] when reviewing research involving human subjects. To approve such research, the IRB must determine that:
- The risks to subjects are minimized.
- The risks are reasonable in relation to any anticipated benefits to the subject, and to the advancement of knowledge.
- The selection of subjects is equitable.
- Informed consent will be sought.
- Informed consent will be documented.
- Where appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure safety of subjects.
- There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects.
The IRB must determine that these conditions exist at the time of initial review and at each subsequent review conducted by the IRB.
F. Informed Consent Form Checklist
The checklist below is provided to ensure that each of the following components are included in all Informed Consent forms used for research involving human subjects or oral history projects at Berea College.
- 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 the student's 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 one's 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.