Undergraduate Research Involving Human Subjects

The protocol is the research proposal that you submit for human subjects research approval.

Confidential means the study may collect potentially identifiable information from participants.

Anonymous means participants cannot be identified, even by the researcher. 

Claremont McKenna College has a nuanced explanation of the differences and protecting the private and identifiable information of participants. 

"Exempt research" means specific types of research that poses no more than minimal risk to participants and fit into a specific federally-determined category.  This research is called "exempt" because the protocol is not subject to as lengthy a review as projects that may pose a greater risk to participants. ALL research involving human subjects must be reviewed by one of the approval committees (either StudentIRB or Human Ethics) before research commences. You cannot "self-exempt" your research from review.

We recommend using the IRB Journey survey to help determine whether your research may qualify as exempt and should be submitted through StudentIRB, OR if it is subject to full review (in this case, your faculty mentor should submit the project to the Human Ethics (IRB) Committee with you listed as a co-researcher).  

For the exempt category descriptions, please view the Exemption Categories (2018 Requirements)  from HHS.gov. Note that William & Mary only considers research which falls into the first 6 categories to be exempt (categories 7 and 8 are not applicable). 

Other useful explanations about the exemption categories:

• Decision Tool: Does this study qualify as Exempt 1, 2, 3, or 4? - UCSF
• Human Subject Regulations Decision Charts - HHS.gov

When conducting interviews, surveys, or focus groups, human subjects research is concerned with “about WHOM” questions, which means you are asking questions about the subjects themselves (or their opinions). However, if you are asking the individual questions about external facts rather than the “opinions, characteristics, or behavior of the individual,” then you are safely in the “about WHAT” territory, and the research would NOT be considered human subjects research.

The CITI training uses the example of calling the director of a women’s shelter.

“About What” Question:

• What is the average length of stay?

“About Whom” Questions:

• What is your training and experience?
• How do you define the problem of battering?
• How do you manage stress?

Students should submit a protocol to the StudentIRB with their faculty mentor listed as a co-researcher if:

• The proposed research poses no more than “minimal risk” to subjects. The undergraduate student researcher must not cause harm to research participants: "harm" may apply to one's physical, psychological or emotional well-being, reputation, and/or employability.
• All participant identities will be kept strictly confidential.
• The proposed research does not involve vulnerable populations such as prisoners or interacting with children. 
• The proposed research falls into one of six exempt categories (William & Mary does not use categories 7 & 8 for exempt research) (Please see the FAQ about "exempt research" below)

If your proposed research project does not meet this criteria, your faculty mentor should submit a protocol to the W&M Human Ethics (IRB) Committee with you listed as a co-researcher under the personnel section. In many cases, your faculty mentor may already have obtained approval for their research and can add you to their existing protocol once you complete the CITI trainings. Research completed through the School of Education will be approved by EDIRC instead of Human Ethics. 

All participants in your study must complete a consent form with a witness signature before participating in your research. Consent forms must be concise while also giving the full context of a study, including its risks and benefits, so potential participants have all the information they need to make an informed decision. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens.  You must upload a copy of your consent form to the StudentIRB protocol for review by the committee. You may customize this consent form template. 

Your Informed Consent must include the following:

1. Brief statement of study: scope, aims, purpose.
2. What is expected of the research subject (to include expected duration of subject's participation).
3. A statement that there are no perceived risks associated with participation with this research project.
4. A statement advising research subject if there are any anticipated benefits to the subject.
5. A statement describing the extent to which confidentiality of record(s) will be maintained.
6. A statement that the subject has been advised that participation is voluntary and he/she may discontinue participation at any time without penalty.
7. A statement confirming that the research subject is 18 years old or older.
8. A statement advising the research subject that he/she may receive a copy of research results.
9. The name of the faculty advisor for the research and contact information for whom to contact for answers pertinent to questions about the research and research subject's rights.
10. A statement disclosing the source of funding (if any) in the Informed Consent form and attach to the protocol submission.
11. A statement indicating the research has been reviewed by William & Mary Student IRB on (date), is determined to be "Exempt," and will expire on (date).
12. A statement that subject may report dissatisfactions with any aspect of this study to Dr. Jennifer Stevens, Chair of the Human Ethics (IRB) Committee, by telephone (757-221-3862) or email (jastev@wm.edu)

The StudentIRB committee will review your protocol and respond with one of the following outcomes:

• Revise: The committee will let you know what information on your protocol needs to be updated, changed, or included for further review. Most protocols require at least one round of revision before they are approved.
• Reject: The proposed research described is not considered exempt. Instead, you should work with your faculty mentor to have it submitted to PHSC.
• Approved: Your research can now begin. The protocol will expire one year after the start date of your project. After expiration, you can resubmit the protocol to be renewed.

After you have submitted a protocol, make sure that you keep an eye out for status update emails over the following weeks. The email will come from a sender called "Compliance" and the subject line will begin with "[studentirb]".