Policy on Protection of Human Subjects
I. Purpose of the Policy
This policy's purpose is to protect human subjects of original research conducted either at The College of Wooster or by an employee or student of The College of Wooster. It is intended to assure that subjects of research are aware of their rights and protections. Moreover, the College is required to assure the federal government that such safeguards are being provided and enforced. These safeguards are derived from ethical principles articulated in the Belmont Reportissued by the national Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The Human Subjects Research Committee (HSRC) is the body charged with reviewing, prior to its commencement, all research, whether funded or not, involving human subjects conducted under the auspices of The College of Wooster. The procedures for review described below adhere to the regulations of the Department of Health and Human services (45 CFR 46, as amended and published in the Federal Register on June 18, 1991).
The College has adopted sections from the policies of Middlebury and Bryn Mawr colleges.
The College of Wooster applies a single, comprehensive standard to original research involving human subjects in which there is a potential for harm. This policy shall apply to all original human subject research as defined in section III.
II. Who Must Complete the College of Wooster Human Subjects Research Forms?
Anyone who engages in scholarly research involving human subjects, either on- or off- campus. This includes:
- The College of Wooster faculty and staff;
- The College of Wooster students who conduct independent research;
- Researchers not affiliated with The College of Wooster conducting primary
research with subjects on-campus*; and
- Anyone analyzing unpublished data collected at the College.
Instructors assigning student research as part of a course need not submit a proposal to the HSRC for evaluation unless 1) the results of such research will be published or presented in a public forum (e.g., a conference presentation) or 2) the data collected will be archived so that someone, at a future point in time, could use the data for a project that would result in a publication or presentation. The HSRC strongly discourages class projects with at-risk populations (e.g., children, the mentally challenged, prisoners, etc.). If such populations are employed, instructors are strongly encouraged to seek HSRC approval, even if the conditions listed above are not met. Any instructor may choose to invite committee review for any project. Each faculty member engaging in such an instructional activity is expected to maintain professional standards to protect any human subject in accordance with his or her field, and to ensure compliance with this policy. For Independent Study research, see Section VI.
Oral history projects are excluded from review if the sole goal of the projects is to document an historical event. Projects designed to create generalizable knowledge (e.g., knowledge that would inform policy, be used to develop theory, or develop conclusions that would be generalized to other settings) constitute research by federal definition and should be submitted for review. Creating an archive of data collected for an oral history project for use by other investigators constitutes research as defined by federal regulations and thus needs to be evaluated by the HSRC. Researchers conducting oral history projects should check with their advisor (if the researcher is a student) and department or program chair to assure that a particular project meets the definition of an oral history project before proceeding with such a project. If the status of a project is not clear, the project should be submitted to the HSRC for evaluation.
Human subject research is research involving data from or about living human beings. Any discipline may involve human subject research.
* Visitors to the campus and off-campus scholars engaged in human subjects research involving subjects on campus, do so through the courtesy of an on-campus host and may do so only with the approval of the chair of the HSRC. The host should provide the visitor with appropriate institutional forms including this document and assure that the forms are transmitted to the committee in a timely manner. The host will serve as the primary institutional contact, while the committee will provide institutional approval as necessary.
data: facts, figures, and information. For the purpose of this policy, the term "data" is considered to be material from primary sources analyzed as part of scholarly efforts.
deception: intentionally misleading or providing untruthful information, any concealment, withholding information from participant, trickery, or deceit.
HSRC: The Human Subjects Research Committee.
human subject: any specific living person, or information about a living person, who is the subject (participant) or object of study for the purpose of expanding our knowledge or understanding.
minimal risk: Federal guidelines state, "minimal risk means 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."
original research: any activity conducted for the purpose of expanding knowledge or understanding, including the collection and analysis of data from questionnaires, observation, manipulation, sampling, experimentation, interview procedures, etc. Research using human subjects, even if it is simply verifying existing hypotheses, theses, theories, or ideas, is considered original research. This includes pilot projects and feasibility studies. Works dealing entirely with properly attributed secondary sources are not considered original research for the purposes of this policy. Data gathering for the purposes of fundraising by the external affairs 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 research with alumni, students, or parents regarding college activities and policies are excluded from the category of original research under the purview of this committee.
principal investigator: the primary person conducting the research. The principal investigator (P.I.) can be a professional or a student.
review: a process of oversight resulting in an acknowledgment of the status ("approved," "pending required amendments," or "not approved") of a project under the guidelines of this policy.
risk: potential for physical, psychological, social, or financial harm.
unreasonable harm: any physical, psychological, social, or financial damage or injury, which might have been avoided without sacrificing the goals of the activity, as well as any damage or injury whatsoever whose extent cannot be justified by the contribution of the research to the expansion of human understanding.
IV. 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 his/her area reviewer for the HSRC or the Dean for Faculty Development.
The principal investigator should refer to and follow the guidelines of the relevant professional organizations and, where appropriate, those of governmental funding and regulatory agencies. Faculty members supervising student research have a responsibility for introducing the students to The College of Wooster’s guidelines (See Section VI). At the minimum, research activities should conform to the following:
- Subjects should be made fully aware of any risks.
- The principal investigator shall explain to subjects, prior to their participation,
the objectives of the research, the procedures to be followed, and the risks and potential
benefits. In general this explanation should also be offered in writing. Investigators
shall not use individuals as subjects unless satisfied that the subjects, or others
legally responsible for the subject's well- being, freely consent to participation
with a full understanding of the consequences. The Human Subjects Review Committee
may waive these requirements only if all of the following three criteria are met:
a) The committee is persuaded that the research cannot otherwise be done.
b) The committee is convinced that the potential value of the research outweighs any potential risks to the subject.
c) The research involves minimal risk. In general, subject consent is indicated in writing on an "informed consent" form.
- Investigators shall respect the privacy of their subjects. Investigators shall protect confidential information given them, advising subjects in advance of any limits upon their ability to ensure that the information will remain confidential.
- Subjects, including students who are participating in classroom experiments or faculty scholarship, shall not be induced to participate by means or in circumstances that might affect their ability to decide freely. When course credit is offered for participation 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 participation should be in line with the burden imposed by participation.
- It shall be made clear to subjects that they are free to withdraw from active participation in the research at any time. Subjects who indicate a desire to withdraw shall be allowed to do so promptly and without penalty or loss of benefits to which any subject is otherwise entitled. At the minimum, this shall be clearly stated as part of the informed consent statement.
- Faculty who assign or supervise research conducted by students are responsible for ensuring that these students are qualified to safeguard adequately the well-being of the subjects.
- Subjects of human research are generally provided the opportunity of access to the benefits of that research at its conclusion.
- An investigator shall disclose to a subject, upon request, the source of support for the research.
Faculty members, staff members, or students who are planning research projects involving human subjects are responsible for initiating the review process by submitting their research proposals to the HSRC member in their department who has been designated as the "area reviewer" for their department.
A list of the area reviewers is available on the HSRC website or from the chair of the HSRC or the Dean for Faculty Development. For guidelines specific to Independent Study and other student generated research, see Section VI. The HSRC consists of at least five faculty members appointed by the Provost; at least one member of the community unaffiliated with the College, also appointed by the Provost; and, serving ex officio, the Dean for Faculty Development and Chief Information & Planning Officer. Area reviewers, members of the HSRC, review the proposed research and then assign the proposal to one of the following categories:
- exempt from HSRC review
- expedited HSRC review
- full HSRC review
Many research projects will fall into the exempt category. Research in the exempt category (see Appendix A) requires no further review beyond the area level. Proposals determined by the area reviewer to require expedited review will be forwarded to the chair of the HSRC, who will either evaluate the proposal or designate another member of the HSRC to conduct a review. Proposals judged by the area reviewer to require full review will be forwarded to the chair of the HSRC, and the HSRC as a whole will perform the review.
All research proposals are evaluated with regard to the degree of "risk," if any, to human subjects. The HSRC will provide the area reviewer with a set of forms to aid in the determination of risk. If a research proposal is determined by the area reviewer to involve minimal or more than minimal risk, the area reviewer will send the proposal to the chair of the HSRC for expedited or full review. Under an expedited review procedure, the chair or one additional member of the HSRC, designated by the chair, will review the proposal; the proposed research must involve no more than minimal risk and the only involvement of human subjects must fall under one or more categories, specified under Expedited Review in Appendix A. Full committee review is required when the procedures of the research present more than minimal risk (Full Committee Review in Appendix A) to the subject and/or fall into one or more of the categories specified under Full Committee Review in Appendix A.
There are three possible outcomes to a Full Committee Review:
- Approved -- no further action is required from the investigator prior to initiating the study;
- Revise and Resubmit -- more extensive changes are required before the study may begin;
- Denied -- the proposed research, because of the level of risk involved, cannot be initiated.
Research approved by the HSRC that is continuing must be re-reviewed on an annual basis by the HSRC; the HSRC chair will determine whether a full or expedited review is required or whether the proposal is exempt from further review.
A formal notification describing the decision of the HSRC will be sent to the investigator. Faculty members, staff members, or students who have submitted research proposals for review and have been asked to make revisions or have been denied approval may request the HSRC to review its decision, and may write to or appear before the committee to discuss that decision.
The HSRC will review a list of all projects approved via Full Committee Review that have been initiated or completed at the College or by College employees or students at least once a year. Review forms, copies of any source instruments (e.g., questionnaires, interview scripts, manipulation protocols, debriefing forms, etc.) and the consent form may be obtained from Chair of the HSRC.
Approval of a human subject research proposal is good for one year, unless the project has acceptable but potential risk, in which case approval is given for a six-month period. If the project will continue beyond the approval period, Principal Investigators are required to resubmit documents for review prior to the expiration date of the initial approval. In the initial approval letter, principal investigators are asked to promptly report any unanticipated problems or adverse effects of the research to the HSRC.
Appeals: In the event that an application is denied because the HSRC 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; and 2) any other pertinent information in support of the appeal. The letter should be directed to the Chair of the Committee and mailed with enclosures to the College's Human Protection Administrator. Applications submitted for appeal will be considered by the full board at the next scheduled meeting date. The final decision of the HSRC will be stated in writing to the investigator. If the proposal is not approved, the research cannot be conducted.
The researcher may at any point submit a revised proposal, which will be reviewed as a new application.
Nature of the College Records: The College keeps records of original human subjects research that has undergone either a full or expedited review by the HSRC, along with copies of any research documents (informed consent forms, questionnaires, interview scripts, stress protocols, behavioral manipulation protocols, drug protocols, non-FDA device protocols, debriefing forms, etc.), and a copy of any publication resulting from the research.
VI. Procedures for Independent Study and Other Student Generated Research
- All Students conducting research must have a faculty adviser. Faculty supervising these undergraduate projects are responsible for seeing that their advisees become familiar with the Policies and Procedures of The College of Wooster’s HSRC.
- Faculty are responsible for screening their advisees’ research projects.
- If it is determined by the area reviewer that a project involves greater than minimal risk, the project must be submitted to the HSRC for its review and approval prior to initiating the research.
- If there is any doubt as to whether the project should be reviewed by the HSRC, the Chair of the HSRC should be contacted.
- If there is reasonable expectation on the part of the advisor and the student that the study will be externally funded and/or published, HSRC approval must be obtained.
Approved September 3, 2003
Updated: November 2012 to reflect current administrative titles
Appendix A: Categories of Review
All research, including that which the investigator believes falls into the exempt category, must be submitted to the area reviewer for confirmation of the relevant review category. The criteria used to determine the categories of review are described below.
Review Category: Exempt
Part A: all items must apply
- The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
- The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.
- The research does not involve the collection of information regarding sensitive aspects of subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
- The research does not involve subjects under the age of 18 (except as they are participating in projects that fall under categories 1, 3, 4, and/or 5 in Part B). Part B category 2 studies that include minors should be submitted for expedited review.
- The research does not involve deception.
- The procedures of this research are generally free of foreseeable risk to the subject.
Part B: at least one item should apply
- Research conducted in established or commonly accepted educational settings and involving normal educational practices (e.g., research on regular and special education instructional strategies, research on instructional techniques, curricula, or classroom management methods).
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, where information is recorded anonymously (i.e., so that the human subject cannot be identified, directly or indirectly through identifiers linked to the subject). [NB: All survey/interview/observational research in which elected or appointed public officials or candidates for public office serve as subjects is exempt, whether or not data collection is anonymous.]
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available or the information must be recorded anonymously (i.e., in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject).
- Research (including demonstration projects) conducted by or subject to the approval of federal department or agency heads, and designed to study, evaluate, or otherwise examine (i) public benefit or service programs (e.g., social security, welfare, etc.); (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Research involving taste or food quality evaluations or consumer acceptance studies, where the tested products are wholesome foods without additives, or foods which contain additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Review Category: Expedited Review
Part A: all items must apply
- The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
- The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.
- The research does not involve the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
- The procedures of this research present no more than minimal risk to the subject. ("Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.)
Part B: at least one item should apply
- Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens), where these materials, in their entirety, have been collected prior to the research for a purpose other than the proposed research. [NB: These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or-video-tapes, names will be recorded, even if they are not directly associated with the data).]
- Collection of data through use of the following procedures: a) non-invasive procedures routinely employed in clinical practice and not involving exposure to electromagnetic exposure to electromagnetic radiation outside the visible range (i.e., not involving x-rays, microwaves, etc); b) 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; c) weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, echography, sonography, ultrasound, magnetic resonance imaging (MRI), diagnostic infrared imaging, doppler blood flow, and echocardiography; d) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing involving healthy subjects.
- Collection of data from voice, video, or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- Research on individual or group characteristics or behavior (including but not limited
to research involving perception, cognition, surveys, interviews, and focus groups)
a) Involving adults, where (i) the research does not involve stress to subjects, and (ii) identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation;
b) Involving children, where (i) the research involves neither stress to subjects nor sensitive information about themselves, or their family; (ii) no alteration or
waiver of regulatory requirements for parental permission has been proposed; and (iii) identification of the subjects and/or their responses would not reasonably place them or their family members at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of themselves or their family members.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. [NB: Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or videotapes, names will be recorded, even if they are not directly associated with the data).]
- Research that involves deception. [NB: Deception must be scientifically justified and de-briefing procedures must be outlined in detail. Deception deemed to be more than innocuous by the area reviewer will be forwarded for full review.]
- Prospective collection for research purposes of biological specimens; research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required; collection of blood samples by finger stick or venipuncture.
- Research previously approved by the convened HSRC as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where the research remains active only for the purposes of data analysis; or (c) where the HSRC has determined that the research involves no greater than minimal risk and and no additional risks have been identified; (d) where no subjects have been enrolled and no additional risks have been identified.
Review Category: Full Committee Review
If ANY of these apply:
- The research involves prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as subjects.
- The research involves the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
- The procedures of the research involve more than minimal risk to the subject (where
"more than minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research is greater than that ordinarily encountered
in daily life or during the performance of routine physical or psychological examinations or tests).
- Any research which does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status.