02:06:00 Institutional Review Board

Purpose

To establish a WSCC Institutional Research Board to review and approve research requests while protecting the rights and welfare of human subjects in accordance with federal law.

Policy

I. Institutional Review Board Function

The Walters State Community College (WSCC) Institutional Review Board (IRB) is established to ensure that all research activities (see also WSCC Policy 08:24:00 ) Academic Affairs involving human subjects are conducted in a way that promotes their rights, protects their welfare, ensures safety, minimizes any potential risks, and assures informed and voluntary participation in any research. The IRB also monitors research to ensure that human subjects are protected from undue risk and deprivation of personal rights and dignity. The IRB operates under the U.S. Department of Health and Human Services (DHHS) regulations for the Protection of Human Research Subjects: Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46). The IRB is guided by the ethical principles regarding all research involving humans as subjects as set forth in the April 18, 1979, report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Researcher, titled: “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” commonly known as the “Belmont Report.” The WSCC Institutional Review Board regulates all research activities involving human subjects on all campuses. This committee is responsible for conducting ethical reviews of human research activities, while ensuring compliance with all applicable federal and state laws/regulations. The IRB shall review and have the authority to approve, require modifications in order to secure approval, disapprove, suspend or terminate all research activities covered by this policy. No college official shall approve research that has not been approved by the IRB. Any research involving human subjects conducted at WSCC must be approved by the Institutional Review Board.

II. Composition of the Board - Membership

The chairperson and other members of the IRB are appointed by the president of the college, who serves as final authority for overseeing the activities performed by the IRB. The president also serves as the signatory official on the institution’s federal wide assurance. The IRB must have five or more members of varying expertise and diversity, including at least one individual from outside the college and one non-scientist to promote complete and adequate review of the research conducted at the college. All IRB members must undergo training in human subject protection (including ethical principles, federal regulations, and IRB procedures and policies) and sign a Member Agreement and Confidentiality Form*. The IRB chairperson and at least two board members will commit to two years of board service to ensure continuity.

Per the federal authorization and guidelines, IRB membership must include:

1. Community/Outside member-At least one member who is NOT affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution
2. Scientist-At least one member should have expertise in research/scientific methods
3. Non-Scientific member-At least one member should have a background in primarily a non-scientific area or members of more than one profession/discipline
   
   No IRB member will be able to participate in an IRB review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. If needed, the IRB will be at liberty to invite any individual(s) with competence in special areas to assist in the review of issues requiring expertise beyond that of the board members. For instance, if research involves vulnerable subjects (e.g., children, mentally handicapped or disabled), the IRB may request outside review by a person with expertise in that area. When research subjects include prisoners, a prisoner or prisoner representative is required to serve on the Board. If outside expertise is needed, invited persons may provide information and feedback, but they may NOT vote with the IRB except in the case of research involving prisoners.

III. Definitions

1. A human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains data: 1) directly through intervention or interaction with the individual (e.g., interview, examination, or questionnaire), or 2) indirectly (e.g., through observation), and/or when information is accessed concerning specific, individually identifiable private information through files, data banks or other depositories, or through direct inquiry (Code of Federal Regulations, 45CFR 46.102(f)).
2. 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.
   1. The following may be considered research:
      1. Pilot studies
      2. Interviews
      3. Focus groups
      4. Surveys/Questionnaires
      5. Observation
      6. Case studies
      7. Oral histories
      8. Analysis of existing secondary data
   2. The following fall outside the scope of research applicable to this policy:
      1. Walters State student opinion of course and teaching
      2. Institutional or program evaluation research or assessment if it is directly tied to the employee’s primary work or departmental duties (e.g., financial aid regularly examines student records; Retention Services access student records to provide support services; Institutional Effectiveness and Compliance accesses student success data for reporting purposes; etc.)
      3. WSCC employee performance evaluations
      4. Studies conducted by students under the advisement of faculty for classroom instructional purposes only, when information gained is to be shared in the classroom setting only
      5. State of Tennessee mandated evaluations (academic audits, peer reviews, etc.)
      6. Accreditation mandated assessment and/or evaluation including the analysis of program student learning outcomes
      7. Select grant evaluation activities approved by the grant director or an external/internal evaluator
   3. An investigator is defined as an individual who is involved in conducting human subject research studies. Such involvement includes:
      1. Obtaining information about living individuals by intervening or interacting with them for research purposes.
      2. Obtaining identifiable private information about living individuals for research purposes.
      3. Obtaining the voluntary informed consent of individuals to be subjects in research.
      4. Studying, interpreting, or analyzing identifiable private information or data for research purposes.
   4. Minimal risk, according to federal policy, means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

IV. IRB Review Process

All research involving human subjects requires completion of the WSCC Institutional Research Form. If the investigator is not certain whether a project is subject to IRB, it is his/her responsibility to contact the IRB chairperson for clarification. Directors and/or staff conducting service projects involving human subjects are encouraged to contact the IRB chairperson to determine whether their projects are considered research and require IRB exemption or review. Both internal and external requests for research must be submitted for review. Faculty and staff (both full-time and part-time) using human subjects or identifiable, private information about human subjects to conduct research outside the course and scope of their duties are required to have prior approval from the IRB before research is initiated.

Both internal and external researchers must submit the WSCC Institutional Research Form along with documentation showing that IRB approval has been obtained by their home institution’s IRB, if applicable. Projects must be approved regardless of whether the research is funded and regardless of the source of funds. This policy also applies to students conducting research under the guidance of a faculty member except when research is for classroom instructional purposes only. All research must be reviewed by the IRB and no individual, other than the IRB chairperson or IRB members designated by the chairperson, may exempt a proposal from review or find the research eligible for expedited review. Research that is conducted without IRB exemption or approval is not in compliance with WSCC policy or federal regulations. In these circumstances a non-compliance report will be sent to the president of the college for further action.

Once the WSCC Institutional Research Form has been submitted, the IRB chairperson will determine that the study is either: 1) exempt pursuant to 45 CFR 46.101; 2) eligible for expedited review; or 3) requires full review in accordance with the Department of Health and Human Services (DHHS) regulations. The IRB chairperson will contact the principal investigator if additional information is needed.

Walters State’s IRB is responsible for assessing whether the risks to research subjects are justified by the potential benefits to the subjects or to society. Human subject protection is assured by consideration of the following guiding ethical principles: 1) risks to subjects are minimized; 2) risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may result; 3) selection of subjects is equitable; 4) informed consent will be sought from each prospective subject or the subject’s legally authorized representative; 5) informed consent will be appropriately documented; 6) when appropriate to the research plan, adequate provision is made for monitoring the data collected to ensure the safety of subjects; and 7) when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

The IRB chairperson, or one or more IRB members designated by the chairperson, has the authority to certify research as exempt or to approve it through an expedited process. If a full-board review is required, the IRB chairperson will distribute the application and accompanying materials to the IRB members and convene an IRB meeting. The investigator may be required to attend an IRB meeting to answer questions. The IRB can: 1) approve the project without reservation; 2) approve the project with modifications; 3) defer approval of the project pending resubmission of the research application, or 4) disapprove the research. If the IRB decides to disapprove a research activity, the reason(s) for the decision shall be provided in a written notification to the investigator. The investigator then has an opportunity to respond in person or in writing.

V. Categories of Research Review

Projects involving human subject research fall into the following review categories: 1) exempt from IRB review; 2) eligible for expedited review procedures; 3) research requiring full-board review; and 4) previously approved projects in need of continuing review (Section I) at intervals appropriate to the degree of risk (but not less than once per year). A key factor for projects in the first two categories of review is that the proposed research involves no more than minimal risk.

1. Research that is exempt from IRB Review: Many education projects will be exempt from review by the full IRB if certain criteria are met. The project must involve no more than minimal risk and must be in one of the six categories listed in federal regulations; i.e., 1) research done in educational settings, involving normal educational practices including but not limited to research on regular and special education instructional strategies or research on the effectiveness of, or the comparison of, instructional techniques, curricula, or classroom management methods; 2) research involving the use of educational tests; 3) research not exempt under category 2, involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior if participants are elected or appointed public officials or candidates for public office; 4) research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens; 5) an IRB exemption category applies to federal research only; 6) research involving taste and food quality evaluation and consumer acceptance studies. If an investigator thinks a research project should be exempt from IRB review, he or she must still submit the WSCC Institutional Research Form for verification. Projects that are certified as exempt from IRB review are not exempt from ethical principles and informed consent.
    
2. Research that is Eligible for Expedited Review: Federal regulations allow IRBs to use an expedited review procedure to review minor changes in previously approved research or to review projects that involve no more than minimal risk and that appear in a list of nine categories* established by the Department of Health and Human Services and published in the Federal Register.
   
   These categories include 1) select clinical studies of drugs and medical devices when certain conditions are met; 2) collection of blood samples by finger stick, heel stick, ear stick, or venipuncture when certain conditions are met; 3) prospective collection of biological specimens for research purposes by noninvasive means; 4) collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.; 5) research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis); 6) research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis); 7) research on individual or group characteristics or behavior, and research employing survey, interview, oral history, focus groups, or program evaluations;. 8) continuing review of research previously approved by the convened IRB in limited circumstances; 9) continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified under the expedited review procedure, the IRB chairperson or his or her designee (from among the IRB committee members) reviews the research protocol. This type of research may be approved without convening a meeting of the IRB. Investigators desiring an expedited review should submit the WSCC Institutional Research Form or revised form as applicable.
    
3. Research reviewed by the IRB Board at a Full Board Review (convened meeting): All proposed research projects involving human subjects that do not qualify for exempt or expedited review must be reviewed by the Walters State IRB at convened meetings at which a majority of members are present, including one whose primary concerns are in nonscientific areas. These projects either involve more than minimal risk and/or are not a category of research eligible for exempt or expedited review. The IRB may meet via teleconferencing or asynchronous means if necessary. In order for the research to be approved, the majority of IRB members present at the meeting must approve the research proposal for it to pass. Investigators should complete the WSCC Institutional Research Form when seeking approval.

VI. Investigator Responsibilities

Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by the IRB. Investigators are responsible for ongoing requirements in the conduct of approved research that include:

1. Obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB (45 CFR 46.116; 45 CFR 46.117).

2. Obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)).

3. Ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB as referenced in the institution’s OHRP-approved Federal wide assurance (45 CFR 46.103(b)(4), 45 CFR 46.109(e), 45 CFR 46.115(a)(1)).

4. Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others (45 CFR 46.103(b)(5)).

5. Providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB (45 CFR 46.103(b)(5)).

6. Keeping certain records as required by the HHS regulations for a least three years after completion of the study (45 CFR 46.115(b)).

VII. Informed Consent

Informed consent is a legal requirement and is a core element in the protection of research participants’ rights and welfare. Informed consent is an ongoing process that ensures that participants have been provided information needed to knowledgeably and voluntarily decide to participate in the research. Federal regulations list many specific requirements for informed consent, including descriptions of procedures and foreseeable risks or discomforts to the subject, and a statement that the subject may discontinue participation at any time without penalty. Guidance for developing informed consent documents is available on the U. S. Department of Health and Human Services website to ensure that all of the required elements of informed consent are included. Informed consent is obtained from subjects aged 18 and older. For children under age 18, parental permission and assent from the child (when age, maturity, and psychological state render it possible) is required. When research involves greater than minimal risk and no prospect of direct benefit to the child (for instance, when such research is likely to yield generalizable knowledge about the child’s disorder or condition), both parents must give their permission unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the care and custody of the child. When appropriate, informed consent is obtained from a participant’s legally authorized representative. Videotaping participants or making other images or electronic records requires additional consent because of privacy and confidentiality issues. The use of recordings and other media records to college data must be clearly specified in the Informed Consent Form given to potential participants.

VIII. Research Changes

All requested changes in the conduct of a study and/or changes to study documents must be approved by the IRB prior to implementation of changes. The only exception is a change necessary to eliminate apparent immediate hazards to the research subject (45 CFR 46.103(b)(4)). Changes are reported to the IRB via a revised WSCC Institutional Research Form.

IX. Continuing Review of Previously Approved Research

Expedited and full review research studies have an expiration date. Investigators may not continue their research activities past the expiration date. Institutional Review Board approval is granted for a maximum of one year from the date of IRB approval. The first expiration date is one year after the IRB initially reviewed the research.

Research that extends beyond one year and is not determined to be exempt from review requires that a Continuing Review Form* be submitted. It is the primary responsibility of the investigator to keep track of this expiration date. At least one month prior to the expiration date, the investigator must submit a revised WSCC Institutional Research Form to apply for IRB approval for the next 12 months. Projects that continue without IRB approval are not in compliance with federal or college policy.

Projects that were certified as exempt from IRB review do not need continuing review even if they extend past one year when the scope and nature of the project remains unchanged. However, investigators must seek IRB approval before implementing changes in the scope or nature of exempt projects.

X. Unanticipated Risks - Reportable Event Form

Researchers must immediately notify the IRB(s) of any unanticipated problems involving risks to subjects or others.

XI. Closure of Human Subjects Research Studies - Research Closure Form

Any study that received either expedited or full committee review should submit a notification to the IRB Chairperson within 30 days of completion of the research to close out the study.

XII. Cooperative Research Projects

In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with policy. Per 45 CFR 46.114, cooperative research projects are those projects covered by this policy which involve more than one institution.

The WSCC Institutional Research Form and additional information may be obtained through the Office of Institutional Effectiveness and Compliance. 05/16