Who Must Complete an Application for Review of Human Subjects Research?
Anyone formally affiliated with CMC (faculty, staff, students) who engages in scholarly research involving human subjects, either on- or off-campus, must apply for IRB approval. Researchers who are not affiliated with the CMC but want to conduct research using CMC students as participants must have their research approved by the CMC IRB. Additionally, students, faculty, and staff from the other Claremont Colleges who want to use CMC students as research subjects must submit an application to the CMC IRB, even if approval has already been received from the home institution. Anyone using unpublished data from human subjects that was collected at the College must submit their research protocol to the IRB for approval.
The CMC IRB will not approve any proposal by a non-CMC researcher which is not of minimal risk. Campus resources may not be used to recruit participants for such projects, nor may such projects be conducted on the CMC campus. Research projects utilizing surveys with minimal or no risk may be an exception to this policy and may be given permission to be conducted on the CMC campus.
“Human subject research” involves systematic collection of personal or private data from living human beings. Please see the definitions below for additional markers of research that falls under the purview of this committee.
All faculty and students are urged to evaluate their research agendas in light of this policy in order to determine whether or not their research qualifies as “human subjects research,” even if human subjects or concerns regarding human subjects are traditionally not common in their disciplines.
Animal Research
CMC’s IRB does not review research involving animal subjects. If your project does involve animal subjects, please contact Marion Preest, Chair of the KSD Institutional Animal Care and Use Committee (IACUC) by phone at (909) 607-8014 or by email at mpreest@jsd.claremont.edu. Information about Keck Science’s policies regarding animal use in research can be found on their Guidelines for Use of Animals webpage .
Exempt Research
What kind of research qualifies as exempt?
Please use the HHS Decision Chart #2 and the HHS criteria listed below to help determine if your research qualifies as “exempt” from IRB. If you believe that your research qualifies as exempt under the HHS Code of Federal Regulations, the CMC IRB requests that you turn in an Exemption Form. The CMC IRB will review Exemption Forms to ensure that all submitted exempt research qualifies as exempt under federal regulations. If the IRB believes the research to be non-exempt, an IRB Application for Review will be required, and the research must discontinue until IRB approval is received.
Projects granted exempt status must meet one or more of the following criteria listed in 45 CFR 46.101(b):
Category 1 - Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
Category 2 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research could reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation. (Note: Exemption for survey and interview procedures does not apply to research involving children. Exemption for observation of public behavior does not apply to research involving children except when the investigator does not participate in the activities being observed.)
Category 3 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2 above if: (a) the subjects are elected or appointed public officials or candidates for public office; or (b) federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Category 4 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to them.
Category 5 - Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to these programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
Category 6 - Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consumed; or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Why do I have to file an Exemption Registration Form?
Although the current HHS regulations do not require administrative review before a study is determined to be exempt, most institutions follow current federal recommendations and carry out such an administrative review. CMC is following proposed regulatory changes related to Advanced Notice of Proposed Rulemaking (ANPRM) for revisions to the Common Rule by requesting that an Exemption Form be filed for exempt research. This allows for oversight and recordkeeping of exempt research from the IRB and the Office of Institutional Research.
Research for a Class Project
If research is done for a class project, does not include vulnerable populations, involves no more than minimal risk, and will not be presented or published (e.g., as a thesis, scholarly paper, or community forum), then this research does not require formal review. For the research to be classified as exempt under HHS federal regulations and the CMC IRB, an Exemption Form must be submitted. Additionally, the IRB requests that the investigator complete the CITI training.
If an investigator begins a non-research project and later finds that the private identifiable data about living individuals gathered could develop or contribute to generalizable knowledge, the investigator must submit a proposal to the IRB for review and approval or certification of exemption from IRB review for the analysis of the data for research purposes prior to publication or presentation of the data (e.g., journal article, poster session, public speech or presentation, or project report). Investigators who determine during the conduct of a non-research project that non-research project data derived from private identifiable information about living individuals could develop or contribute to generalizable knowledge must seek IRB approval at that time, prior to the collection or analysis of additional data which s/he intends to analyze for research purposes.
Research Methodology Classes
Some projects assigned to students in research methodology classes are designed to teach students skills and provide the opportunity to practice methods such as observation, interview, or survey techniques, data analysis, etc. and may have a research component. Such classroom projects that are exclusively intended for instructional purposes and are not intended to develop or contribute to general knowledge or literature in the field need not undergo review by the IRB. However, instructors and students are expected to follow federal guidelines and CMC policy when designing and conducting class projects with human volunteers. For the research to be classified as exempt under HHS federal regulations and the CMC IRB, an Exemption Form must be submitted. In addition, the IRB strongly recommends that the instructor and his/her class complete the CITI training.
When course-related projects are intended to develop or contribute to generalizable knowledge, they are subject to federal guidelines and are required to undergo IRB review and approval, prior to the initiation of the research activities, including contact or recruitment of subjects.
CMC IRB encourages faculty members who anticipate that course-related projects may develop or contribute to generalizable knowledge to consult with the IRB early in the semester in which data will be collected.
Definitions
IRB: Institutional Review Board. Claremont McKenna College’s IRB is responsible for the ethical oversight of all research involving human subjects conducted by CMC faculty, students, or staff, as well as such research that uses CMC faculty, students, or staff by outside investigators.
Original Research: systematic investigation, including pilot projects and feasibility studies, designed to expand generalizable knowledge or understanding, including collecting and analyzing data from questionnaires, observing subjects, manipulating experimental conditions, sampling, experimenting, etc. Research using human subjects, even if it is done simply to verify existing hypotheses, theses, theories, or ideas, is considered original research.
For the purposes of this policy, the following are not considered “original research” and thus do not fall under the purview of the IRB (see exemptions for more information):
- works that deal entirely with secondary sources (public data sets are considered such secondary sources)
- activities in which human subjects perform exclusively for instructional purposes (though the intent or effort to publish data from such activities-at any time-converts these activities to original research involving human subjects)
- data gathering for the purposes of fundraising by the public affairs and alumni offices; market research for the purposes of admissions recruiting; recruiting efforts for faculty or staff; statistical data collected for the management of institutional affairs; and basic feedback surveys for program evaluation purposes
- journalism
- information collected for entertainment purposes
- oral history
Human Subject: any specific living person about whom a researcher obtains (1) data through interaction with the individual, or (2) private information. Interaction includes contact (including observational studies) or communication with the individual, manipulation of the subject, or manipulation of the subject’s environment. Private information includes information that can be identified with an individual and that is obtained in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been recorded for specific purposes and which the individual can reasonably expect will not be made public (e.g., medical records).
Experts sharing facts or professional opinions in the area of their expertise are not considered human subjects for the purposes of this policy.
Principal Investigator (PI): the primary person conducting the research. The principal investigator can be a professional or a student.
Risk: potential for physical, psychological, social, or financial harm. A research protocol deemed to put its subjects at no risk may be eligible for exempt or expedited approval (Anonymous surveys often constitute no-risk research.)
By contrast, minimal risk means that some potential for harm exists, but that the probability and magnitude of harm 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. Research that involves minimal risk often is eligible for expedited or full approval.
Unreasonable Harm: any physical, psychological, social, or financial damage or injury that can be avoided without sacrificing the goals of the research. Unreasonable harm also includes any damage or injury so extensive that it cannot be justified by any contribution the research might make to human understanding.
Anonymous Data: data that by virtue of the method of collection can never reasonably be connected with the person providing them. Anonymous data can be obtained by using questionnaires that are returned by mail (in envelopes with no return address or other identifying markers), questionnaires that are collected by one of a group of subjects and returned to the researcher, or internet surveys (with software that renders it virtually impossible to connect answers with respondents). Questionnaires that collect data anonymously do not require separate written consent; consent to use the data is implied when the respondent completes the questionnaire (a statement that explains this principle should be printed at the beginning of any such survey).
Non-Anonymous Data: data that, by virtue of how it is collected or the nature of the information, can be connected at some point, no matter how brief, to the person providing them. This category includes questionnaires that the researcher collects personally from a group of subjects (unless a ballot box or envelopes are used). It also may include cases in which the researcher can recognize the handwriting of one or more of his or her subjects and could therefore potentially match the data with a specific respondent.
Confidential Data: non-anonymous data that a human subject gives an investigator with the understanding or assumption that the human subject’s privacy will be honored. Divulging the source of non-anonymous data to an outside party, or failing to ensure that no outside parties will be able to connect data with their source, normally constitutes a violation of confidentiality. This IRB presumes that all data collected from human subjects is properly considered confidential, unless subjects have explicitly waived their presumption of confidentiality in writing.
Deception: intentionally misleading or providing untruthful information; any concealment or withholding of information from a participant; use of trickery or deceit.
General Principles
All researchers conducting original research are responsible for protecting their subjects from the risk of unreasonable harm. The principal investigator has initial responsibility for determining whether such a risk exists. A faculty member is responsible for supervising research undertaken by students in the context of his/her courses or departmental/program curriculum. If there is any doubt about risks, the principal investigator should contact the IRB.
The principal investigator should follow the guidelines of the relevant professional organizations and, where appropriate, those of governmental funding and regulatory agencies. Faculty members supervising student research are responsible for introducing the students to CMC’s guidelines.
At a minimum, research activities at CMC should conform to the following standards:
- Informed consent: The principal investigator must explain to subjects, before they participate, the objectives of the research, the procedures to be followed, the associated risks, and the potential benefits. Investigators must not use individuals as subjects unless they are satisfied that the subjects, or others legally responsible for the subjects’ well-being, freely consent to participating and fully understand the consequences.
In general, subjects should signal their agreement to participate by signing a written consent form, though a researcher may make the case for using oral consent instead. The requirement for written consent may be waived under one of the following conditions:
- the research involves no or only minimal risk
- the consent form will be the only evidence linking the subject and the research, and the primary risk of harm is to the subject’s privacy
See: U.S. Health and Human Services Informed Consent Checklist for more information
Anonymous surveys do not require written consent, though the explanations of the research protocol that are standard on a written consent form should be included at the beginning of the survey. Consent to participate is implied when a subject completes and returns the survey.
Research involving deception compromises a subject’s ability to give truly informed consent. The Institutional Review Board will consider requests to waive some of the requirements for informed consent for research that intentionally involves deception, but only if all of the following criteria are met:
- The research cannot be done without the deception.
- The potential value of the research outweighs any potential risks to the subject.
- The subjects are informed of the true nature of the research as soon as possible.
- The research involves no more than minimal risk (federal requirement).
- Confidentiality: Investigators must respect the privacy of their subjects. Investigators must protect confidential information given to them and must advise subjects in advance of any limits on their ability to ensure that the information will remain confidential.
If the data gathered by a student researcher is not anonymous, the IRB recommends that the data be turned over to the faculty sponsor, who then becomes responsible for either ensuring that it is destroyed or archiving it with his or her data. In cases in which a student is planning to go on to graduate school and may want to continue the research or use the data in future projects, he or she may request permission from the IRB to retain the data. Permission is contingent on the student’s agreement to protect the confidentiality of the data.
For more information on the differences between Anonymity and Confidentiality, see: Anonymous vs. Confidential [PDF].
- Coercion: Subjects, including students who are participating in classroom experiments or faculty scholarship, must not be induced to participate by means or in circumstances that might affect their ability to decide freely. When course credit is offered for participating in research, some other mechanism to earn that credit must also be made available to those students who choose not to participate as human subjects. Rewards for participating should be in line with the burden imposed by participating, to avoid presenting an undue influence on a person’s ability to freely choose to participate (or not).
Researchers must inform subjects that they are free to withdraw from active participation in the research at any time. Subjects who indicate a desire to withdraw will be allowed to do so promptly and without penalty or loss of benefits to which any subject is otherwise entitled. At the minimum, this condition must be clearly stated as part of the informed consent statement.
- Women & Minorities in Research: NIH Guidelines on the inclusion of women and minorities research were issued in 1994 and updated August 1, 2000. Specifically, the guidelines now state:
“It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant purpose of the research.”
Additional information concerning the NIH policy on inclusion of women and minorities as subjects in clinical research is available on the NIH Inclusion Policies webpage.
- Disclosure: An investigator must disclose to a subject, upon request, the source of support for the research.
- Transparency: All IRB approved source instruments used by researchers may display the IRB Protocol Number assigned by the CMC IRB. Source instruments include: consent forms, surveys, questionnaires, interview scripts, visual displays, etc. This allows for IRB staff and committee organization and provides assurance to research participants that the research has been approved by the CMC IRB. If you cannot find or remember your IRB protocol number for your approved research, you may send a request to IRB@cmc.edu.
- Additional CMC Approvals for Surveys and Recruitment Methods: Research involving surveys or certain types of recruitment methods of CMC constituents must be approved by the appropriate CMC Senior Staff in addition to CMC IRB approval. Often, recruitment methods such as requests for email distribution lists to recruit students for an online survey are denied by Senior Staff due to survey saturation and institutional priorities. When planning your research, please contact the CMC IRB and the appropriate Office/Senior Staff if you have questions regarding recruitment methods.
For more information on surveys and recruitment methods, please contact the Office of Institutional Research.
- The Claremont Colleges: If you wish to recruit participants at any of The Claremont Colleges, you are subject to the rules and guidelines set by each college’s IRB and should contact each IRB to find out what they require. If you are a faculty, staff, or student from one of the Claremont Colleges, and wish to recruit members of the CMC community, or if you are a student and your research is being carried out under the supervision of a CMC faculty member, you must receive IRB approval for your research at your home institution before applying to the CMC IRB.
Procedures for IRB Review
Research using human subjects falls into one of three categories:
Exempt: Research that qualifies under HHS Federal Regulations as exempt from IRB approval. Protocol for research submitted as exempt follows the guidelines set above.
Expedited: Research that involves only minimal risk (see definition above), and therefore can be expedited by the IRB Chair. This normally means that the Chair or a designated alternative from the IRB committee reviews the application.
Full: Research that falls into at least one of these categories may require review by the full-board of the IRB:
- presents more than minimal risk
- is funded by federal grants
- involves deception
- involves subjects from a group awarded special protections (e.g., children)
The Institutional Review Board Chair determines which level of review is necessary for a given project. This means that all research proposals involving human subjects must be submitted for IRB review and approval.
Timeline: Applications are acknowledged by email to the Principal Investigator (PI) immediately upon submission. Exemption proposals typically are reviewed within a week; Regular (expedited) proposals typically are reviewed within three weeks. Proposals requiring full-board review by the IRB committee may take up to six weeks, as the full board only meets about twice a semester, or on an as-needed basis.
The CMC IRB Chair will send an initial approval email to the PI (and PI’s advisor, if the PI is a student) once the research has been approved. The IRB Coordinator will then send an electronic approval letter to the principal investigator. The letter will ask the PI to promptly report to the Institutional Review Board any unanticipated problems or adverse effects that the PI encounters in the process of completing the research. IRB approval is typically valid for 12 months from the date of approval unless otherwise indicated.
Researchers whose applications are not approved by the IRB will be provided a list of the concerns cited by the committee. Normally such researchers will be invited to respond, revise, and resubmit their application for a new review.
Appeals: If an application is denied because the Institutional Review Board feels the risks outweigh the benefits of the research, and the investigator disagrees with the committee’s disapproval decision, the researcher may appeal the decision by re-submitting the same application form and 1) a letter of appeal presenting the researcher’s arguments for approval, 2) any other pertinent information in support of the appeal. The letter should be directed to the Chair of the Board and mailed with enclosures to IRB - Office of Institutional Research - Bauer North 1st Floor, 500 East Ninth Street, Claremont, CA 91711. Applications submitted for appeal are considered by the full board at the next scheduled meeting date. The final decision of the IRB is delivered in writing to the investigator. If the proposal is not approved, the research cannot be conducted.
Nature of CMC IRB Records: CMC Office of Institutional Research is home to IRB recordkeeping and administrative activity on campus. The Office of Institutional Research keeps records of all applications for approval of human subjects research, including any research documents (informed consent forms, questionnaires, interview scripts, stress protocols, behavioral manipulation protocols, drug protocols, non-FDA device protocols, debriefing forms, etc.) and documentation of the researcher’s CITI training. The records also include any email correspondence between the researcher and the IRB. The aforementioned documentation constitutes the full CMC records of any project approved by the Committee. Records are kept for three years after the conclusion of the research.
The researcher is responsible for keeping all data and documentation gathered during the research, including all signed informed consent forms and any publications resulting from the research. In the case of student research, the student’s advisor will arrange for this documentation to be stored. These records are also kept for three years after the conclusion of the research.
The CMC Office of Institutional Research not only keeps a record of all IRB approved research, but also keeps track of survey activity on campus, both IRB approved and exempt. Some information on surveys used by CMC offices on a regular basis is available to the public in the form of a CMC Survey Inventory on the Institutional Research website.
Oversight and Authority
The Claremont McKenna College Office of Institutional Research, as informed by the guidelines and federal regulations of the U.S. Department of Health and Human Services is the author of these policies, which were approved by the CMC IRB Committee. CMC Office of Institutional Research would like to acknowledge the IRB’s of Pitzer College, Middlebury College, and Bryn Mawr College, for their assistance in the formation of CMC’s IRB policies and practices.
|