Committee Description and Responsibilities
Anyone conducting research on human or animal subjects needs to inform the Committee and have their research approved by the Committee. The specifics are available at Responsibilities of Researchers. All faculty need to read this document to acquaint themselves with federal requirements. After you have read this document, please complete the Verification Form
Description of the Committee and its Responsibilities
The following document draws partially from federal guidelines regulating Institutional Review Boards and Institutional Animal Care and Use Committees. However, it is not the intention of this document to create a Research Ethics Committee that is in full compliance with those federal guidelines. North Central College is only committing itself to following the specific guidelines stated in this proposal. Note that citations contained in this document are from Title 45 of the Code of Federal Regulations Part 46: Protection of Human Subjects (Revised November 13, 2001) and from the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
Committee Responsibilities, and Procedures
The procedures contained in this document pertain to all research using human participants or animal subjects, and conducted (either wholly or in part) by North Central College employees or North Central College students. For the purposes of this document, "research" shall be defined as the process of collecting data of the purpose of aggregation and analysis.
The Committee will consist of five faculty members to be appointed by the Dean of the Faculty (including a Committee Chair), and the Special Assistant to the President (e.g., Richard Wilders), for a total of six voting members. The Dean of the Faculty will also appoint a representative of the Dean as a non-voting ex-officio member of the Committee. The Dean will ensure that the Committee includes at least one faculty member representing each of the following areas: social sciences, the natural sciences, ethics, law, and humanities. All faculty appointments will be for a three year period, and, to provide continuity, faculty members will serve overlapping terms. Other considerations recommended by §46.107 of the CFR (such as gender distribution) will be taken into account by the Dean in these appointments.
All Committee members will be expected to attend all meetings, and to submit each proposal to full and fair review. Sensitive information provided in research proposals will be treated with confidentiality. Committee members will disclose when they perceive themselves to have a conflict of interest in reviewing particular proposals.
The Committee Chair will schedule meetings as needed (i.e., when there is business that needs to be discussed by the entire Committee, including discussion of research requiring Full Review). These meetings will take place at least twice per term, and once during the summer, unless there are no proposals to review.
Documentation of Research Ethics Committee activities, including minutes of Committee meetings, shall be maintained according to provisions in §46.115, and shall be held in the custody of the Dean. The records required shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. Specifically, these documents will include:
Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
Minutes of Research Ethics Committee meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the Committee; 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.
Records of continuing review activities.
Copies of all correspondence between the Committee and the investigators.
A list of Committee members in the same detail as described in §46.103(b)(3). (6) Written procedures for the Committee in the same detail as described in §46.103(b)(4) and §46.103(b)(5). (7) Statements of significant new findings provided to subjects, as required by §46.116(b)(5).
The primary investigator on any research project that is conducted (wholly or in part) by North Central students, faculty, or staff, that uses human participants or animal subjects, will be required either to submit a Request for Exemption, or to submit an Application for Research Ethics Committee Review to the Committee Chair. These documents will follow the guidelines outlined below.
If a researcher believes that his or her research warrants exempt status, that researcher will forward a paragraph to the Committee Chair explaining why the research is exempt. This Request for Exemption will cite applicable specific criteria for exemption from this document. Requests for Exemption will then be forwarded to a Committee Member, and will be reviewed by that person in a timely manner. Research protocols found to be exempt will not be subject to future review unless the protocol changes.
Unless a non-exempt study clearly warrants a Full Review (based on the criteria presented below) the Chair will forward the application to a Committee member for possible Expedited Review. The Chair will ensure that the workload is equitably distributed among the Committee members (including him/herself).
Committee members will review proposals in a timely manner, and will keep the Chair informed of decisions on all Expedited Reviews, including decisions to submit a study to Full Review (i.e., if the Committee member either finds the study to involve more than minimal risk (defined below) to human subjects, or believes the study otherwise to be in conflict with ethical guidelines).
As early as possible prior to a Committee meeting, applications for studies submitted for Full Review will be distributed to all Committee members. The Committee will discuss and then vote on each application. Applications will be reviewed in the order received.
Ongoing research projects previously given approval by the Committee will be monitored by the Committee, and will be reevaluated by Expedited Review every year in which data collection is taking place (every two years for animal research). The Committee may request more frequent reevaluation at intervals appropriate to the degree of risk of the project. For reevaluation, participants must resubmit their original review application along with a description of any revisions to the original application. This description of revisions must include a description of any modifications made to the original procedures, and a revised assessment of risks and benefits to participants. If a researcher makes a substantial modification to his or her procedures before the research project is due to be reevaluated, it is that researcher’s responsibility to submit the new procedures and a revised assessment of risks and benefits to participants to the Committee for immediate Expedited Review.
Studies using human participants or animal subjects that are performed regularly in a particular course (for pedagogical reasons) and are not Exempt from review (as described below) will be reviewed whenever an instructor proposes a new study or protocol, and will thereafter be reevaluated every five years (using the reevaluation procedures described above). Such studies that instructors are currently using in their courses will be reviewed during the Committee's first year and will thereafter be reevaluated every five years. The Committee may request more frequent reevaluation at intervals appropriate to the degree of risk of the study.
Any department which conducts animal research shall create a plan for animal care and handling which is specific to the animals being used by that department. The Committee will, at least once every six months, review these plans and inspect all of the College’s animal facilities, using the "Guide for the Care and Use of Laboratory Animals" ( ) as a basis for evaluation. Any department using vertebrate animals or vertebrate animal specimens must procure such specimens from certified vendors who themselves follow appropriate ethical guidelines.
The Committee will review concerns about unethical research practices raised by members of the community. Such concerns, along with supporting evidence, should be submitted to the Chair of the Committee for further investigation. If requested, the Committee will make every effort to protect the confidentiality of the party submitting such concerns.
In addition to evaluating individual research projects, the Committee will periodically propose to the administration any changes in College policy and facilities that are needed to provide for the safe and ethical use of research participants.
The Committee will also periodically review the guidelines contained in this document and will revise them as appropriate.
The Committee will obtain appropriate training in issues of research ethics for its members.
The Committee shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the Committee’s requirements (described below) or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement regarding the reasons therefore and shall be promptly reported to the Investigator and the Department Chair.