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. If consent form signatures are collected, research is not anonymous.

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 involved 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 before research commences. You cannot "self-exempt" your research from review.

Exemption Criteria:

• 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 (ex. prisoners).
• The research does not take place in another country or involve participants located in another country.
• The proposed research falls into one of six exempt categories

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

Exempt student research protocols are reviewed through StudentIRB by committee chair Kate Patterson. If your research is not deemed to be exempt, it will be reclassified to either expedited or full board research.

Projects are eligible for expedited review if:

• if they do not meet criteria for one of the first six HHS exempt categories
• they pose no more than minimal risk to participants
• they fall under one of the HHS expedited categories
• they do not involve vulnerable populations

Expedited protocols are approved for one year before they must be renewed.

Protocols that are not determined to be expedited by the review committee will be subject to a full board review.

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. However, researchers conducting any studies involving humans still need to submit a protocol to the IRB so it can be officially determined whether the study would be classified as human subjects research or not. Researchers cannot "opt out" from the IRB themselves.

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?

This determination letter allows you to receive grant funding when you intend to conduct human subjects research in the future (90 days or later from award setup), but are not at the point where you have a definite plan ready for review by the IRB. Here are the questions you will be asked on the .118 Determination Form:

• Provide a non-technical description of the research project as is currently known, such as the purpose, study population, information, procedures, etc.
• Describe what must be done before human participants would be involved in the research project (e.g., development of measures, recruitment materials, assays, etc.).
• Explain the estimated timeline for the involvement of human participants.
• Please upload any documents related to this .118 Determination, such as the grant application, a brief protocol document, etc. 

Please note that while you may obtain a .118 Determination Letter at the time you submit your grant application, you still must obtain IRB approval before beginning human subjects research.

Participants in your study must complete a consent form or least be informed of what they are consenting to 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.  You must upload a copy of your consent form (following the template linked below) to your IRB protocol for review by the committee. 

Please access consent form templates and learn more about consent form requirements at the link below.

You must include all study questions, advertisements, informed consents, and messages to participants on your IRB protocol and get approval before proceeding. Any changes to these materials will require you to submit a study modification (see question in the section below). 

If changes are made to these documents and given to participants without IRB approval, then a incident report must be submitted within 48 hours of discovery.

It can take up to 3-4 weeks for IRB 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.

Please allow more time for getting approval for international research.

The IRB 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.
• 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. 

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.

Please review the instructions for submitting a modification here.

If your research involves human participants in countries outside of the United States, there are substantial additional considerations and questions required for the IRB protocol. Please review full details on at the content button link below. The protocol must be submitted to the main W&M IRB rather than to StudentIRB. Materials for non-English speakers must be translated.