TYPES OF REVIEW
This page provides information about the different types of review that your protocol can undergo. If you are unsure whether your project qualifies as “research involving human subjects”, please visit the Does Your Project Require IRB Review page.
In order for research to qualify as exempt, the project must fall into at least 1 of 8 federally-defined exempt categories and present no risk or no greater than minimal risk to the participants. Although this category is called exempt, this type of research does require prospective IRB review. Researchers must submit an exempt application in order for the HSC to assess whether the project qualifies as exempt research. Projects that are low risk may be considered exempt. Some examples of exempt research are:
- Anonymous surveys or interviews involving adults only
- Observation of public behavior without collecting identifiable information (Note: Some research in this example may NOT be human subjects research)
- Use of pre-existing data, documents/records, specimens if publicly available or de-identified prior to acquisition (Note: Some research in this example may NOT be human subjects research)
- Evaluating the effectiveness of school curriculum (Note: Some research in this example may NOT be human subjects research or may be eligible for Expedited Review)
Exempt Limited Review
In certain exempt categories, collection of identifiable information, even if considered sensitive, may be eligible for exemption if the HSC has determined there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of the data. In these instances the HSC will consider:
- The exent to which identifiable information is de-identified and the risk of re-identification
- The use(s) of the information, including how it will be shared, stored, and safeguarded
- The risk of harm to participants if the information is lost, stolen, compromised, etc.
In order for research to be eligible for expedited review, the activities must be considered no greater than minimal risk to the human subjects and fall into at least 1 of 9 federally-defined categories. Once a project is submitted for review, the HSC will assess the level of risk to the human subjects. Some examples of expedited research are:
- Interviews on cultural beliefs or practices
- Research on individual or group identity
- Studies involving the collection of voice, video, digital, or images
Full Board Review
Studies that might be considered greater than minimal risk and do not qualify for exempt or expedited review are reviewed at a convened meeting of the HSC by full board review. The HSC will conduct a risk assessment of studies that are reviewed by full board. Some examples of research reviewed by full board are:
- Research involving vulnerable populations (e.g., prisoners, undocumented immigrants, etc.) given the context of the research
- Research involving active deception
- Research involving individuals who have self-identified as having experienced physical and/or emotional abuse
- Conducting interviews with gang members about illegal practices
Please see the submission deadlines page for Exempt, Expedited and Full Board review dates.