IRB AT CATAWBA COLLEGE
(Faculty Approval: March, 2022)
Most professional organizations have adopted standards for ethical treatment of subjects. These standards typically presume that an institution has established an "Institutional Review Board" (IRB) to mediate questions that may arise concerning whether specific research activities adhere to these standards. By establishing an IRB, the faculty of Catawba College affirms to our constituents, the community, and funding agencies that we value -- and practice -- a commitment to the well-being of research participants.
The College Purpose Statement [and several of the Specific Aims] extant when this document was approved (March 30, 1993; modified: May 3, 1997 and May 5, 2009) outlines our intent to instill a sense of integrity, social responsibility and ethical comportment in dealings with others for our students. One way by which we can model this intention is by giving public priority to the ethical treatment of subjects who participate within our various research activities. The presence of this IRB does not imply, however, that questionable research activities occur or even are expected; rather, IRB procedures acknowledge that our ethical commitment to human participants indeed is exercised.
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PURPOSE AND SCOPE OF THE IRB
Purpose
The purpose of the Catawba College IRB is to promote a responsible liaison between representatives of the College who engage in research activities involving human subjects and the subjects who participate in these activities. The IRB will accomplish this purpose by regulating the use of human subjects in research activities in order to ensure that (1) persons supervising these activities are made aware of, and in compliance with, professional standards concerning the treatment of human subjects, and (2) those who serve as subjects are being treated fairly, ethically, and responsibly.
Scope of the IRB
A research activity refers to any undertaking that involves the collection of data (by active or passive means) from human participants.
The Code of Federal Regulations (CFR) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR §46.102 (d)]
Research activities that are within the scope of IRB approval mechanisms specifically include:
- Research activities conducted by a faculty member, undergraduate student, or graduate student using students, other faculty, special populations, and/or members of the College and non-College community. A faculty member, who serves as a representative of the College in the implementation of a research activity [45 CFR §46.102 (d)] involving research volunteers must serve as the principal investigator (PI), submit a proposal to the IRB, and receive approval of the proposal before beginning the research. IRB may not approve research retroactively. The faculty member will bear full responsibility for that activity and should have the necessary training in order to conduct such research. The PI will submit a broad outline of the proposed procedures used and types of data to be collected must be included (e.g., "The student will study memory as affected by learning either concrete or abstract words"). A faculty member must submit proposals on behalf of students for research projects (e.g., serve as PI). It is also recommended that individuals (e.g., students) who play a role in conducting research should undergo the necessary training but at the very least be supervised by the PI in charge of the study. However, if an activity is undertaken under the aegis of another professional organization, and will be presented without affiliation to Catawba, review from Catawba College’s IRB committee is not required, but is available upon request.
IIRB uses the following decisional charts to help determine if the research involves human subjects.
- The following would be considered examples of research needing IRB review:
- Undergraduate theses that may be presented in a professional venue
- Honors’ theses
- Master’s theses
- Surveys
- Experiments
- Questionnaires
- Observations/participatory research using behavior mapping
- Interviews of sources who will be named or described.
- Class projects designed to develop or contribute to generalized knowledge and be shared outside of the classroom
- Class activities conducted by students and/or faculty such as surveys, experiments, or questionnaires. Class activities/projects that involve students in the class as participants and are designed with the sole purpose of providing students with training and experience with research methods to enhance pedagogical instruction do not constitute research unless it involves protected populations or sensitive information. Faculty are strongly encouraged, but not required, to contact and discuss the specifics of the class activity with a member of IRB to ensure the activity qualifies as a class project or a research activity as IRB will not approve research retroactively. Faculty must bear full responsibility for that activity (e.g., conduct project according to the relevant ethical standards of the relevant discipline) if deemed a class project. Faculty should also remember that sharing of personal information does not differ for a class assignment, class project or research activity, be sensitive to the nature of the obtained information, and not require students to share information the student is not comfortable sharing. It is recommended self-disclosure instruments (e.g., opinion surveys about current events, personality tests, questionnaires about social and personal behavior, and the like) appear in the course syllabus. Faculty using such instruments regularly in a particular course are encouraged to seek guidance from the IRB regarding submitting a proposal requesting ongoing approval. If approved for ongoing use in a specific course, such self-disclosure instruments (e.g., opinion surveys about current events) need not be resubmitted unless fundamental changes are made to the focus of the instruments or the instructor intends to use the instrument in a different course.
Examples of protected populations for research studies needing IRB approval:
- Catawba College Students
- Children/minors
- Decisionally Impaired
- Institutionalized
- Non-native English Speaking
- Students from PI's Class(es)
- Prisoners
- Pregnant women
- Mentally or physically challenged individuals
Examples of sensitive information:
- Relating to an individual’s psychological well-being or mental health
- Relating to references, attitudes, beliefs, perceptions, or practices regarding sexual or religious preferences
- Relating to the use of alcohol or drugs
- Relating to illegal behavior
- Relating to information otherwise protected under federal and/or state law and/or Catawba institutional policy
Research activities that are outside the scope of the IRB include:
- Research with animal subjects.
- Student Evaluations of Courses.
- Typical Educational Practices. To the extent that individual subjects are not identifiable or their participation is voluntary and the data collected is used for internal purposes only, certain educational practices need not be reviewed. These include:
- surveys and activities comparing different course pedagogies or structures,
- unobtrusive observations made by students in the classroom,
- data gathering in the context of off-campus placements (provided those organizations are subject to their specific policy guidelines), and
- interviews by the press, providing the respondent has an option to decline.
- Research conducted by administrative units or student groups that does not impose a participation requirement. Studies intended to obtain demographic information and for which aggregate data are obtained (e.g., freshman CIRPs) and instruments used for course placements need not receive IRB approval.
- Secondary analysis of publicly available datasets with deidentified, confidential data (such as US census, labor statistics, etc.)
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MEMBERSHIP OF THE IRB
The IRB will consist of at least five members with varying backgrounds per § CFR 46.107. These regulations state each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.
(a) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
(b) Each IRB shall include 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.
(c) No IRB may have a member participate in the IRB's initial or continuing review of any proposal in which the member has a conflicting interest, except to provide information requested by the IRB.
(d) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
Faculty appointed to IRB will serve one year, although subsequent reappointments are not precluded. In order to prepare for proper review of IRB proposals, the IRB must complete the training resources provided.
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CRITERIA AGAINST WHICH PROPOSALS WILL BE EVALUATED
The IRB will evaluate a proposal according to the standards put forth by the disciplinary organization of the submitter. In the absence of such disciplinary standards, the IRB will use the Guide for Research with Human Participants of the American Psychological Association (APA) (http://www.apa.org/research/responsible/human/index.aspx), which emphasizes “informed consent by”, “minimal risk to”, and “confidentiality” about human subjects.
Proposal Submission Process
- A faculty member must serve in the role as the “principal investigator,” submit the proposal to the IRB, and receive approval for the proposal prior to the beginning of the research activity. Students are not able to submit proposals, only faculty PIs. Proposal and consent forms may be obtained from the IRB website.
- The faculty Principal Investigator must complete the proposal forms including signature and submit to the IRB chair via irb@catawba.edu.
The IRB will operate during the academic year, therefore submissions outside the academic year (i.e., during the summer months) will not be reviewed.
- In extraordinary circumstances (e.g., preparation of grant proposals), the Chair of the IRB may grant "provisional" approval to a proposal, e.g., submitted during the summer with the understanding that the full IRB must act on the proposal at the beginning of the academic term.
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REVIEW PROCESS AND TIMELINE
- Upon receipt of a proposal, the Chair of the IRB or a designee of the Chair will determine if the proposal meets the standards of Exempt, Expedited or Full review (seeCFR 46.109).
- Proposals that meet Exempt review criteria (defined by not greater than minimal risk (45 CFR 46.104) will be reviewed by the Chair/designee. Recommendations for approval or deferral will be sent to the PI via the Chair within 5 business days.
- The chair will ensure no conflict of interest exists (see below).
- If the chair does not approve the proposal, the proposal will then go in front of the full board for review.
- Proposals that meet Expedited review criteria defined by minimal risk (see below) will be sent to three members of the committee for their review. Recommendations for approval or deferral will be sent to the chair within 5 business days.
- The chair will ensure the selected committee members do not have a conflict of interest (see below). The selected committee members must disclose any conflict that may not be known to the chair. In this case, another member of the board will be selected.
- If not all three members approve the proposal, the proposal will then go in front of the full board for review.
- Summary of Expedited Categories:
- Clinical studies of drugs and medical devices only when certain conditions are met.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
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IRB ADVERSE EVENT/UNANTICIPATED PROBLEMS POLICY
The purpose of this policy is to identify and outline procedures for adverse events and unanticipated problems that may occur within Human Subject Research.
Definitions:
- An adverse event occurs when there is a change or violation to the IRB protocol that can cause physical, psychological, social, economic, legal and/or informational harm. An adverse event in research is an event that meets any of the following criteria:
- Examples of reportable adverse events include, but are not limited to:
- Enrollment of vulnerable populations when the study did not approve the enrollment.
- Failure to obtain informed consent.
- Is life threatening (serious adverse event).
- Adversely affects the rights, welfare and safety of the subjects.
- Adversely affects the integrity of the research data.
- Adversely affects the subject’s willingness to participate.
- Unanticipated Problems are any incident, experience or outcome that may change/alter the IRB-approved study and are not adverse events. An unanticipated problem in research is problem that meets any of the following criteria:
- Examples of reportable unanticipated problems include, but are not limited to:
- Over-enrollment.
- Inappropriate documentation of informed consent (e.g., missing signatures, missing dates, copy not given to subject).
- Unanticipated given the research procedures that are described in the research protocol and related documents (such as informed consent and the characteristics of the subject population being studied).
- Related to the participation in the research.
- Suggests that the research places subjects or others at greater risk (including physical, psychological, economic, or social harm) than was previously known or anticipated.
If an Adverse Event or Unanticipated Problem Occurs, the PI should follow these procedures:
- Review the Definitions of Adverse Event and Unanticipated Problem
- Identify the incident as an Adverse Event or Unanticipated Problem
- Complete the Adverse Event/ Unanticipated Problem Report Form and Email to the IRB chair at irb@catawba.edu
- The IRB Committee will notify the PI of the review outcome.
IRB Process for Adverse Event/Unanticipated Problems Policy
- Upon review of the report, the IRB Chair will:
- Determine if the report includes necessary information
- Perform an initial review
- Consult with IRB members and/or appropriate individuals if necessary.
- If there is imminent risk of harm to participants, the IRB Chair has the right to require the PI to suspend the study pending review by the convened IRB board.
- If the participants are not at imminent risk of harm, then the report will be reviewed at the next scheduled meeting of the convened IRB.
- The convened IRB determines whether the incident constitutes an unanticipated problem involving risks to subjects or others, and specifies any corrective actions. Corrective actions may include, but are not limited to the following:
- Acknowledgement/acceptance without further recommendation;
- A request for further clarification or a corrective action plan from the investigator;
- Changes in the protocol (e.g., additional tests or visits to detect similar events in a timely fashion; changes to the confidentiality measures employed in the study, changes to inclusion/exclusion criteria);
- Changes to the informed consent document(s);
- Notification to enrolled subjects and/or re-consenting when appropriate;
- A change in frequency of continuing review;
- Further inquiry into other protocols utilizing particular dietary supplements, devices, or procedures in question;
- Additional training for investigators and/or research staff;
- Monitoring of the research procedures or informed consent process;
- Referral to other organizational entities (e.g., University Counsel);
- Suspension or termination of IRB approval for the study; and
- Post-approval monitoring or other monitoring actions deemed appropriate by the IRB.
- The IRB committee will notify the PI of the review outcome. The review outcome includes one of the following:
- IRB committee acknowledges/accepts the report and deems no further follow-up is required.
- IRB committee requests clarification(s), additional information or revisions to the approved IRB protocol.
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CONSENT
Please see CFR 46.116 for the general requirements for informed consent and CFR 46.117 for documentation of informed consent. Please use Catawba College Informed Consent form to all proposal submissions.
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IRB RECORDS
The IRB, per § CFR 46.115, shall prepare and maintain adequate documentation of IRB activities, including the following:
An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in §46.109(f)(1).
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in §46.108(a)(2).
(6) Written procedures for the IRB in the same detail as described in §46.108(a)(3) and (4).
(7) Statements of significant new findings provided to subjects, as required by §46.116(c)(5).
(8) The rationale for an expedited reviewer's determination under §46.110(b)(1)(i) that research appearing on the expedited review list described in §46.110(a) is more than minimal risk.
(9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in §46.103(e).
(b) The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency at reasonable times and in a reasonable manner.
We would like to acknowledge the use of IRB guidelines on class-related projects from the University of Maine, University of North Carolina, University of Michigan, Midwestern State University – Texas and Saint Louis University. Adverse and Unexpected Events policies adopted from Davidson College Human Subjects IRB Application Support Forms, Iowa State University Office of Research Ethics, and Boston University (BU) IRB Exception and Deviation Policy.
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