Faculty Guidelines for Student Projects Involving Human Subjects
The purpose of the following information is to assist faculty involved in guiding students who are submitting applications to LLU’s Institutional Review Board (IRB). This material supplements the routine guidelines, procedures, and policies that apply to all human studies conducted at LLU. This resource provides faculty and students explicit instruction as to how to apply the IRB process in the context of a student’s environment in order to facilitate an expedient, successful application.
Some Definitions and Assumptions
Student Projects. These guidelines pertain to research initiated by students, not faculty. Such projects are frequently designed to satisfy an academic requirement and should always be initiated in consultation with a faculty advisor. The term "student" includes fellows, residents, interns, as well as graduate and undergraduate students, from any department of the University or Medical Center or from another institution.
Principal Investigator. For the purpose of IRB records, all student projects must list an LLU faculty member (usually the faculty advisor) as Principal Investigator to re-inforce the role of the faculty and to assure that a long-term contact person will be available for follow-up review by the IRB. This does not preclude the eventual possibility of a student being credited in publications and reports as the principal investigator.
Academic quality. The role of the IRB is not primarily a research review process but is intended to assure that the involvement of human subjects is conducted in an ethical manner, their rights are preserved, and their involvement is appropriate. Inherent in such a review is the need for a well designed, well organized, thoughtfully presented protocol. Signature of the faculty advisor on the application indicates not just awareness of the application but the academic department’s assurance that the protocol meets its standards of academic excellence.
Human subject research. LLU adheres to federal guidelines which define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains
- data through intervention or interaction with the individual, or
- identifiable private information.
Is it or isn’t it? If any question arises whether IRB review is required or if documentation of not-human-subject determination is required by a sponsor or publisher, complete and submit theIRB Request for Determination. Investigators may also contact the IRB administrator for guidance and clarification. Studies that are human subject research but may qualify for one of the EXEMPT categories must be submitted to the IRB.
Checklist for Student IRB Applications
Any student application submitted to the IRB which does not address each item on the checklist will automatically be returned to the Principal Investigator (faculty member) for completion and will not be scheduled for IRB review until such items are completed.
- The application packet must use the most current version of the IRB application form and adhere to the current IRB guidelines and University policies. For more information, see the Human Studies Life Cycle.
- A faculty member shall be listed as principal investigator.
- Every item on the application shall be answered, including required signatures. If appropriate, "Not Applicable" may be written in. If unclear whether an item on the application applies, call the IRB for resolution prior to submitting.
- All items listed in the LLU Guidelines for Informed Consent must be intelligently incorporated in either the formal consent form, an informational letter, or a verbal script, unless a memo is included with the IRB application justifying why the requirement for informed consent should be waived or any element of the routine elements omitted.
- All pages of the protocol should be numbered. All pages of the consent form must be numbered as directed, i.e., page 1 of 3.
- Protocol or supplemental pages must provide an explicit description of the recruitment of subjects: how (ads? posters? word of mouth? letter? phone?), where (location and environment), under what conditions (stressful? awkward or embarrassing? privacy?), by whom (relationship to subject -- stranger? professional or lay? caregiver? teacher? clergy? family?), deception (as needed by research design). The application materials must demonstrate that the implications of this recruitment process have been carefully planned and address any risk to privacy, social relationships, personal well-being. How such concerns will be resolved should be describe in the materials.
- Exclusion criteria should NOT state the obvious, that is, the opposite of inclusion criteria. In preparing this section, list all inclusion criteria first. Then, assuming the subject meets these criteria, ask yourself if any additional factors would warrant exclusion from the study. If not, just state "none."
- Students as subjects are considered a protected, limited population. Specific groups of students may be targeted if the research topic pertains to that population. Otherwise, if fellow students are recruited to serve as normal healthy subjects, the recruitment methods must reflect creative effort to recruit from the broadest possible pool of potential subjects in order to avoid any inherent coercion or undue pressure of assisting a fellow student or pleasing a faculty member.
- The submission to the IRB must be complete, including a copy of surveys, questionnaires, data collection instruments, recruitment materials, letters to subjects or non-LLU sites, consent forms, etc. If a published, validated survey instrument is used, it may be described (including publication reference) without including it in the packet.
- Items which may be submitted concurrent to or even following initial IRB review include: permission letters from non-LLU sites or collaborating departments, recruitment ads, child’s assent form. Such materials not available for inclusion with the IRB application at the time of IRB review should be described, stipulating the intent to submit at a future date. This is needed to demonstrate awareness of what is required to maintain a complete IRB file. If such items are so mentioned, IRB review will NOT be delayed. However, approval may be granted on a conditional basis pending receipt of stipulated items. Such items will still be subject to review as an amendment, for IRB approval either administratively or, on rare occasion, by full board.
- When making multiple copies for full IRB review: the protocol MAY be copied double-sided, but not the IRB application or consent form. The IRB application should NOT be copied on green paper. Only the original should be on green in order to differentiate the original from copies.
- All materials submitted with the IRB application should be stapled together into a single packet, if at all possible, avoiding the use of paper clips. The following sequence is preferred: IRB application, consent form, protocol, appendix materials (questionnaires, recruitment material, data collecting instrument, etc.)
- If there is a question whether a study qualifies for full IRB review rather than expedited or exempt, consult with IRB staff for a determination prior to making copies as needed for full IRB review.
- If the study involves interaction with patients, the California Experimental Subjects' Bill of Rights is required. This should be given to prospective subjects prior to recruiting them for the study. To illustrate that the investigator is aware of this sequence, a copy of the Bill of Rights should be inserted in the packet just prior to the consent document. (If desired, it can be numbered as page 1 of the consent.)