Research
Institutional Review Board (Research on Human Subjects)
Statement of Policy on Research Involving Human Subjects
Carleton College is committed to academic freedom. Research will not be forbidden because it is innovative, unorthodox, sensitive or otherwise extraordinary. The College protects the right of faculty to conduct research when that research has been reviewed and approved by the Institutional Review Board (IRB).
Carleton College is guided by the ethical principles set forth in the Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (“The Belmont Report“): respect for persons, beneficence and justice. All persons involved in conducting research have an obligation to respect the dignity and integrity of the persons beings studied, including their right not to be the subject of potentially harmful research. Where possible, potential subjects should be provided the opportunity and means to decide freely whether to participate. Researchers who promise confidentiality are responsible for maintaining it and for informing subjects of the limits of their capacity to meet that responsibility. Research procedures should minimize the risk of harm and maximize the possible benefits to the subject and to society. Subjects should be selected for reasons directly related to the problem being studied, not because of their easy availability, their compromised position, or their manipulability. Researchers must exercise special care when the subjects of research are especially vulnerable to harm because they cannot understand the risks or because they are not in a position to refuse their participation in the research.
All research on human subjects conducted by Carleton faculty, students and staff, at Carleton or at other institutions and research sites, must conform to these ethical principles. Research that proceeds in violation of this policy is subject to disciplinary action by the appropriate college official, typically the Provost or his or her designee.
Applicable Regulations
Carleton College has filed a Federal-Wide Assurance with the Office for Human Research Protections. This assurance (1) adopts the ethical principles set forth in the Belmont Report, (2) adopts the federal regulations for the protection of human subjects set forth in 45 Code of Federal Regulations Part 46*, and (3) declares that these ethical principles and regulations apply to all research with human subjects regardless of whether and how it is funded.
*Copies of 45 Code of Federal Regulations Part 46 are available.
Carleton College’s policy on research with human subjects has been approved by the Provost on 3/31/2019.
Research Subject to Review
Definition of Research with Human Subjects
“Research” means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. It does not include oral history, biography, literary criticism, legal research, and historical scholarship, or any other scholarly activity where the researcher is concerned only with the specific individual(s) being studied and not generalizing to a larger class.
“Research” also does not include educational activities whose results are not intended for publication and would not constitute original research in the field. It also does not include institutional research intended for use only at and by Carleton employees or students. However, it is the policy of Carleton College that all such educational activities and institutional research involving human subjects be conducted in accordance with the ethical principles in the statement of policy above. Approval of non-research activities by the IRB is optional. However, it does offer institutional protection to the investigator and or faculty supervisor. In addition, the IRB is authorized to investigate complaints from subjects of such activities and report violations of this policy to the appropriate College administrator.
“Human subject” means a living individual about whom an investigator (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research that uses data on human subjects gathered in earlier research projects requires IRB review, unless the data are rigorously “blinded” (so that the investigator is unable to identify the subjects). Research with these data do not need to be reviewed, provided the researcher is unable to discover identifiable private information.
Research with Other Institutions
When Carleton community members conduct research subject to IRB review at multiple institutions, one IRB must be designated as the IRB of record, agreeing in writing to be responsible for approving and ensuring compliance with the federal regulations. This agreement and documentation of the IRB’s approval must be received by the Carleton IRB before research may begin. Research at schools, camps and other institutions without IRBs must be approved by the principal or other appropriate administrator at that institution.
Research Conducted Outside of the United States
Research conducted by College investigators in foreign countries falls under the College’s purview and guidelines. While we cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct.
While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different mores, traditions, and institutions may require different research protocols, particularly in informed consent, recruitment practices, and documentation. Special attention should be given to local customs and to local cultural and religious norms in drafting written consent documents. Further, researchers should make themselves aware of the pertinent laws and regulations in the country where they work.
Research projects must have been approved by the local equivalent of an IRB before they are presented to the College IRB. Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval. The IRB requires documentation of this “local approval” before it gives approval.
Student Research
Independent class projects (when intended as research and not simply as fulfilling a course requirement), senior theses, research projects and similar exercises, which are intended for public dissemination outside of a Carleton venue, must be independently submitted to the IRB by the student-researcher. However, when students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. Faculty advisors shoulder the responsibility for students engaged in independent research, and instructors are responsible for research that is conducted as part of a course.
As assurance that the College’s guidelines will be followed, the advisor or instructor is required to sign the student’s application for IRB approval.
Policy on Surveying Minors
Many Carleton students are minors (under 18). The federal regulations require that parental consent be secured before minors are surveyed for research purposes if the investigator obtains identifiable, sensitive information about the subjects. ** The Carleton College IRB has adopted the following principles for determining whether and how parental consent for surveys should be secured:
- The IRB requires the consent of at least one parent before doing survey research on minors only when the investigator will obtain identifiable, sensitive information.
- It’s acceptable to secure blanket consent for several surveys, as long as it’s reasonably specific regarding the kind of surveys being administered and the general kinds of uses researchers might put these data to. The parent should have a fairly good idea of the kind of research being done on his/her child, particularly the risks involved (if there are any).
- The investigator should secure a signed letter or an electronic signature indicating consent. Simple failure to respond to a letter requesting consent should not be taken as evidence of consent.
Investigator Responsibilities
Investigators are responsible for the ethical conduct of their research and the conduct of participating faculty, students, and staff. Investigators ensure that research involving human subjects is reviewed and that this review takes place before the research is initiated.
The investigator must also
- Seek approval for making changes in the research protocol
- Report to the IRB unanticipated problems or adverse events
- Reapply for approval when approval expires
- Retain copies of IRB approval documents
- Retain copies of signed consent forms for three years after the completion of the research
The Mechanics of Securing Approval for Research
Procedures
The investigator is responsible for (1) determining whether the project involves research with human subjects and (2) submitting a complete application for approval with all supporting documents. After reviewing the application and its supporting materials, the IRB may ask the investigator to explain some elements of the protocol and may require revisions in the protocol. When the investigator revises a project, the IRB reviews the project again to see whether its concerns have been adequately addressed.
To fully protect subjects, the IRB must approve a project before investigators start to work on it-even before they begin to recruit subjects, since recruitment strategies are part of the review.
Research projects are reviewed at one of four levels, depending on the IRB’s interpretation of the project’s risk to the human subjects and on the federal guidelines that define the categories of review, which are:
- screening for exemption from any IRB review;
- limited review;
- expedited complete review;
- full review.
The level of review can be determined only by the IRB.
If the IRB disapproves the research, it shall provide to the investigator a written statement of the reasons for its decision and give the investigator an opportunity to respond in writing or in person.
Continuing Oversight
If the IRB determines that the work is fully exempt from IRB oversight, no continuing work with the IRB is necessary.
If the IRB determines that the work in question is exempt with limited review, the IRB will require researchers to secure consent from their participants prior to the study. Provided the protocols and purpose of the research do not change, no further IRB oversight is necessary.
All research subject to full review is subject to at least annual review by the IRB and a renewal process.
Research subject to expedited review may be subject to annual review and renewal at the IRB’s discretion.
If research involves extreme risk to subjects, the IRB may require more frequent review and may ask to be kept apprised of all research activity. The investigator is responsible for re-applying for approval after the initial IRB approval expires. The IRB will conduct an expedited review of these applications, unless the research protocol has been modified or new subjects are to be added and full review is otherwise appropriate.
Procedure for Addressing Complaints from Research Subjects
If possible, subjects must be told that they can direct complaints about the conduct of the research to the Chair of the IRB. If the research is on-going, the IRB will document complaints and review research procedures. If the research is completed, the IRB will investigate the complaint, including discussing it with the investigator, and prepare a report. The report will be forwarded to the investigator and to the appropriate college administrator.
Record Keeping
The IRB shall maintain documentation of all reviews, including the application, supporting materials, correspondence among reviewers and between reviewers and investigators, and minutes of IRB meetings. All records association with a review shall be kept for at least than 3 years after completion of the research and made available for inspection and duplication by authorized persons. Records may be kept electronically or in printed form.
Last Revised: November 2, 2020
Last Reviewed: November 2, 2020
Maintained by: Office of the Provost