Undergraduate Research Involving Human Subjects

What is the IRB?

The “Institutional Review Board” is a committee at William & Mary tasked with reviewing research proposals to ensure they comply with federal regulations for human subject research. 

What is a protocol?

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

What is the difference between StudentIRB (Exempt) and Protection of Human Subjects Committee (PHSC)?

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 Protection of Human Subjects Committee (PHSC) with you listed as a co-researcher. 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 PHSC. 

What is the difference between confidential and anonymous?

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. 

What is exempt research? Does it mean that I am exempt from requesting approval?

"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 PHSC) 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 PHSC 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:

• Understanding the Exemption Categories - Oregon State University
• Decision Tool: Does this study qualify as Exempt 1, 2, 3, or 4? - UCSF
• Human Subject Regulations Decision Charts - HHS.gov

I am utilizing data that my faculty mentor previously collected in a different study. Do I need to get IRB approval?

Yes, research involving secondary data still requires IRB review. Your faculty mentor should submit (or revise/renew an existing protocol) through PHSC and add you as a co-investigator. 

What is CITI training and how do I complete it? Do I have to pay?

William & Mary provides free access to the CITI training. The CITI training provides an introduction to the ethics of conducting human subjects research and is required for all faculty and students who plan to work with human subjects. Please note that the training takes several hours to complete, so plan ahead.

You will be required to upload the training completion certificates to your StudentIRB protocol for yourself AND your faculty mentor.

Please check to ensure your training has not expired (expiration date will be listed on the training certificate).

Here are the instructions to access the trainings:

• Go to https://about.citiprogram.org/. Click "Register" in the top right corner.
• Under "Select Your Organization Affiliation" search for William & Mary. Click the agreement checkboxes and then "Create a CITI Program Account."
• Complete the registration steps. You will be able to choose the course(s) that you need to take.
• Finalize your registration. You will then be able to log in and complete your chosen courses.

If you need assistance: Please refer to the CITI Program Getting Started Guide with questions or contact [[cacorb,Cindy Corbett]].

What are my faculty mentor's responsibilities?

The faculty mentor you select to supervise your project must have familiarity with your general subject area and must have experience conducting research with human subjects. For example, a Computer Science professor would not be best suited to supervise a Psychology-based research project interviewing participants. As the Primary Investigator of record, it is the duty of the faculty advisor to review the protocol (and all associated documents) with the undergraduate student before submission to the online system. They will share responsibility for the project as a co-researcher.

What is the informed consent form?

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, if any, 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 Protection of Human Subjects Committee, by telephone (757-221-3862) or email (jastev@wm.edu)

Can I waive the consent form for my study's participants?

In some instances, consent forms may be waived only if the researcher explicity requests a waiver in their protocol by justifying in detail why a signed informed consent form could link the subjects to the data and compromise their confidentiality. 

If participants sign the consent form, how do I ensure their confidentiality?

To best protect participants from being identified, your signed consent forms should never be connected directly to your survey, interview questions, etc and should be stored separately under lock and key. For example, if you create a Qualtrics form for the consent form where participants and witnesses sign their names, this Qualtrics should not also contain the survey questions for your research to help keep any identifiable information separate from participant responses.

How long does it take to get StudentIRB approval?

It can take up to 3-4 weeks for the StudentIRB committee to provide feedback on your protocol. During high-volume times (close to the summer research grant deadlines in the spring), response times will be slower. Plan ahead and submit your protocol well in advance of the start of your research! Most protocols will go through at least one round of revisions.

What happens after I submit my StudentIRB protocol?

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]".

What if I need to make revisions to my research plan after my protocol is approved?

You can resubmit your protocol with the described changes (for example, if you decided to ask additional questions on a survey) and the committee will review them for approval.