Responsibilities of Researchers
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 (see Exempt Research) 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" (http://www.nap.edu/readingroom/books/labrats/ ) 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 Three Types of Research Projects
In all cases, researchers must adhere to the Human Subject Research: Guidelines or to the Animal Subjects Guidelines as appropriate.
Cover Pages: Applications for Human Subject: Application Animal Subjects: Application