» Frequently Asked Questions

Below are frequently asked questions related to Institutional Review Board (IRB) policies, procedures, and processes. Contact the IRB if your question is not answered below.

+ - How do I know if my research qualifies for Exempt, Expedited or Full Review?

Exempt Review

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.  Additionally, the only involvement of human subjects falls within one of six categories listed in 45 CFR 46.101. Read descriptions of the six exempt research categories.

Expedited Review

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. Read descriptions of the expedited research categories, as defined by the Office for Human Research Protections (OHRP).

NOTE: The expedited categories describes research that is eligible for expedited review. However, full committee review may be required as determined by the IRB.

Full Review

If the research does not qualify as Exempt or Expedited based on the above research category descriptions, the research will require full committee review.

+ - What is a faculty advisor's role for student-directed research?

The IRB requires a Chapman University faculty advisor to assume a primary role in completing and submitting a research submission for IRB review. While students may serve as the student investigator for student-directed research, the faculty advisor is responsible for the following:

  1. Determine whether projects require IRB review, and assist students during the process.
  2. Ensure that all elements of the IRB submission are completed thoroughly and accurately.
  3. Ensure that all documents (e.g., informed consent/assent documents, recruitment documents, data collection documents) are clearly written (i.e., grammatically correct, written at for the appropriate reading levels of the intended participants) and include all necessary information, which will allow paritcipants to be fully informed of all elements of the research.
  4. Serve as the primary contact for the IRB.

Faculty advisors must also ensure students' understandings of research ethics principles. The Collaborative Institutional Training Initiative (CITI) course modules describe faculty advisors as responsible for the protection of human subjects, and for the following:

  1. Complete the required CITI modules.
  2. Be familiar with ethical and regulatory requirements of human subjects research, and discuss research ethics with students.
  3. Monitor student research, while ensureing the maintainence of confidentiality, privacy, risk reduction, voluntary participation and withdrawal, and informed consent.
  4. Ensure that any unexpected or adverse events are reported to the IRB.

+ - How do I submit for IRB review?

Detailed information that explains how to submit for IRB review is available on the Chapman University Cayuse IRB page.  For quick reference to learn how to submit in Cayuse IRB, view the two powerpoints below.

+ - I want to collaborate with investigators unaffiliated with Chapman. What is needed?

Multi-site research refers to research involving two or more investigators at different institutions. The investigators collaborate under IRB-approved submissions at each institution or through a Center grant where a central IRB is designated.

Investigators must obtain IRB approval from the investigators' institutions to collaborate on the study. One investigator must be distinguished as the Principal Investigator (PI). The PI must first obtain IRB approval from the PI's institution.  Collaborators must then provide their institutions' IRBs with the PI's IRB approval, and obtain IRB approval.

+ - I am a student who wishes to conduct research at Chapman. How can I submit for IRB review?

Students who wish to obtain IRB review can complete and submit a study submission in Cayuse IRB.  Students who are directing the research should be listed as Student Investigators, while faculty and staff advisors should be listed as Principal Investigators.

The IRB requires each student to identify a faculty or staff advisor(s) who will provide direct supervision when developing and submitting IRB submissions. Faculty and staff advisors are required to review each student's IRB submission for clarity and completeness.

Each student and advisor must complete the Collaborative Institutional Training Initiative (CITI) course modules mentioned on the Chapman University Training and Continuing Education page.

+ - I want to conduct a study at Chapman, but I am not a student or faculty at Chapman. Do I need Chapman University IRB approval?

All research procedures conducted by investigators unaffiliated with Chapman University must first be reviewed and approved by their affiliated institutions' IRBs prior to requesting Chapman University's IRB approval. Documents must then be submitted by completing a Cayuse IRB submission. Contact the IRB if you have questions.

+ - What documents will I need to submit in an IRB submission?

Documents to be submitted include but are not limited to the following:

  • Collaborative Institutional Training Initiative (CITI) completions by all investigators
  • Surveys
  • Questionnaires
  • Pre and post assessment tools
  • Debriefing scripts for studies that will involve deception
  • Recruitment material (e.g., flyers, letters, verbal scripts, telephone scripts, email samples)
  • Letters of support for off-campus activities (e.g., schools, community centers, hospitals) 
  • IRBs approval from other institutions (i.e., may be required for multi-site or joint research)
  • Data use agreements
  • Letter to verify accurate translations of non-English forms

*Additional documents may be required based on the nature of the research.

+ - What are the training requirements for multi-site research non-Chapman-affiliated researchers?

Non-Chapman-affiliated researchers must also complete CITI training.  Chapman University's IRB requires that all researchers satisfy the CITI training requirement and submit proof of completion.

+ - What is the difference between consent and assent?

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).

+ - What is the difference between compensation and benefits?

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.

+ - What is the difference between anonymous and confidential data collection?

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.

+ - Is a witness signature required when obtaining informed consent from a research subject?

Obtaining a witness signature is only required in biomedical (treatment) research or research with children or special populations requiring parental/guardian or surrogate consent.

+ - I have several approved modifications to my study. Do modifications change the expiration date of my study?

No, modifications to the study do not change the study's expiration date. Studies are approved between the approval and expiration dates shown on the study's initial approval letter.  Please refer to the study's initial approval letter to see the approval and expiration dates of your study.

+ - Do I need to print out and use the copy of the consent form that shows the IRB approval stamp when consenting subjects?

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.

+ - Should I submit my entire research proposal/thesis with my research submission to the IRB?

While the IRB appreciates that you would include a full research proposal or thesis (that includes literature review, background, etc.), it is not required to include with your research submission. It is much more important for you to provide complete answers to all of the specific questions in the submission. A complete submission allows for consistency and clarity during the committee's review process.

+ - I am not sure if the research I want to conduct qualifies as prospective or retrospective research. What is the difference?

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.).

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