For research to qualify as "Exempt" from the Code of Federal Regulations pertaining to the Protection of Human Subjects (45 CFR 46 full text), the research must be considered minimal risk and the only involvement of human subjects falls within one of six categories listed in 45 CFR 46.101. Please review those six categories here: Exempt Research Categories.
For research to qualify for "Expedited" review, the research must present no more than minimal privacy, psychological, and/or physical risk to human subjects, and involve only procedures listed in one or more of the expedited categories listed here: Expedited Research Categories, as defined by the Office for Human Research Protections (OHRP).
Please note that research that is included in the Expedited categories list merely means that the research is eligible for expedited review, but full committee may be required if the IRB committee deems it necessary.
If the study does not qualify as Exempt or Expedited as described above, full committee review is required.
The IRB specifies that a Chapman University faculty member must assume the primary role in completing and submitting a research application/protocol for review to the IRB. While students (undergraduate and graduate) may serve as the investigator on any research project, it is the responsibility of the faculty advisor/mentor to:
Faculty advisors/mentors are also tasked with ensuring students understand the principles of research ethics. As mentioned in the CITI Training modules, faculty members who supervise student research are ultimately responsible for the protection of human subjects and must:
Please keep in mind that incomplete or insufficient applications will only delay your own review.
This is considered multi-site research. Multi-site research usually refers to two or more investigators at different institutions collaborating under a single protocol approved at each institution by the resident IRB’s, or coordinated through a Center grant whereby a central IRB is primary.
Each researcher must obtain his or her own IRB approval to participate on the protocol. One investigator is established as the lead Principal Investigator. The lead PI takes the protocol to their respective institution first, and then any other collaborators take the IRB approval to their own institutions to get IRB approval.
Non-affiliated researchers need to go through their respective institutions or seek outside IRB approval.
Undergraduate students may be listed on research applications as co-investigator student researchers. Undergraduate research requires supervision from a faculty or staff sponsor, usually in the form of a class instructor.
The IRB requires that the faculty or staff sponsor review the IRB application for completeness and provide direct supervision when developing and submitting undergraduate research applications.
Undergraduate research is generally conducted to meet a course assignment such as the capstone requirement, through a research internship, as part of a team research project, or as part of a larger research project funded by an internal or external source. In order to submit a protocol, students must complete the NIH research tutorial identified on the Chapman University IRB Training webpage.
All research must be approved by the investigator's home institution prior to requesting Chapman University approval. The appropriate category of research application and supplemental documents must then be completed and submitted to firstname.lastname@example.org.
Please contact the Chapman University IRB with any further questions.
Supplemental documents include (but are not limited to) the following:
Document requirements post IRB approval:
Your project may include special considerations that require additional documentation. If you are not sure of the requirements for your research, please contact the IRB Administration Office.
Non-affiliated researchers must complete CITI training or an alternative through their respective institutions. Chapman University provides CITI training for Chapman faculty and affiliates.
Consent to participate in a research study can only be given by competent individuals who have reached the legal age of consent (typically 18 years old in the U.S.) and have been given sufficient information of the nature, benefits and risks of participation to form a reasoned decision.
Assent in general, is the agreement or expression of willingness of a minor (or individual who is not able to give legal consent) to participate in a research study. Assent given by a minor must be accompanied by informed consent obtained from the subject's parent(s) or legal guardian(s).
Yes, compensation for participation and benefits of participation in a research study are not the same thing. Compensation is payment or reimbursement for the participant's time and expenses (or even class credit) rather than a benefit of the research. Benefits from the research might include an increased self-awareness of health issues, or improved test scores; something that can be directly related to or resulting from the research efforts.
Anonymous means that you will not be receiving or collecting any identifying information about or from the subject(s) and you will have no means to contact the subject and no follow-up will be initiated. Subjects consenting to participate in anonymous research will be provided with consenting information but DO NOT sign the consent document. The subject's agreement to participate is considered passive consent.
When subject research data is collected in a confidential manner, the subject's identifying information may be used to correlate specific serial or grouped data or to contact the subject for follow-up procedures or interviews. To protect the subject's confidential information, all identifying data should be coded so as not to be linked with the subject's individual responses in the final analysis.
Obtaining a witness signature is only required in biomedical (treatment) research or research with children or special populations requiring parental/guardian or surrogate consent.
No. Your original approval letter is the only document you should refer to when determining approval status. Modifications and changes during the original approval period do not alter the original approval period. Modifications are made within the original approval period only.
Yes, the consent form used to consent subjects must show the IRB assigned number, approval and expiration dates, and IRB certification. Consent forms without the IRB information or certification are not valid for use.
Make sure, when requesting modifications, that you change the information or instructions provided in the consent form so that the most current version is used for all new subject enrollment. If changes in the consent form affect currently enrolled subjects, re-consenting of these subjects should be done at their next scheduled study visit or as soon as possible to inform the subject of any changes affecting their continued participation.
Retrospective studies pose a question and look back. Retrospective studies use information that has usually been collected for reasons other than research, such as administrative data and archival and publicly available records. Therefore, the outcome of interest has already occurred (or not) by the time the study is started.
Prospective studies ask a question and look forward. Prospective studies are designed before any information is collected. Study subjects are identified (e.g., new mothers returning to work and obstacles to childcare) and followed forward to see if the outcome of interest (summary of questions asked and answered) happens over time. This outcome is assessed relative to the intervention factor (e.g., managing obstacles to childcare, etc.).