• Randomized treatment studies
• Studies using investigational drugs and/or devices
• Behavioral studies involving risky interventions, observations of illegal behavior or very sensitive data/questions

• If subjects will be randomized to a treatment group as part of the study, the study does not qualify for expedited review.
• The activities listed should not be deemed of minimal risk simply because they are included on this list. Inclusion on this list merely indicates that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
• The categories in this list apply regardless of the age of subjects, except as noted.
• The expedited review procedure may not be used where the identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability, damage the subjects' financial standing, employability, insurability, reputation, or stigmatize them unless reasonable and appropriate protections will be implemented to ensure that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
• The expedited review procedure may not be used for classified research involving human subjects.
• The standard requirements for informed consent apply.
• Categories one through seven pertain to both initial and continuing IRB review. Refer to the Modification page to learn about the changes/amendments that can be reviewed under expedited review procedures.

(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Comments: The drug or device must be approved and used exactly according to its labeling. All study procedures other than use of the drug or device must themselves be of minimal risk for the study to qualify for expedited review. Few studies fit this category.

Example: A study examines how well standard doses of ibuprofen relieve headache pain in adults.

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).

If your research involves interaction with subjects, there usually should be a process to ask subjects to participate and confirm their agreement. The IRB has created special consent templates and guidance for exempt studies. 

At this time, funding agencies do not allow investigators to make an exempt determination on their own, nor does the University. You must submit the study to the IRB, which will make this determination.

• Most research on regular and special education instructional strategies, and
• Research on:
  • The effectiveness of instructional techniques, curricula, or classroom management methods
  • The comparison among instructional techniques, curricula, or classroom management methods.

Please note the following restrictions for Exempt category 1 research:

• Prisoners can be enrolled only incidentally, cannot be an intentionally targeted study population
• No interventions allowed

a. The information obtained is recorded by the investigator in a way that the identity of the human subjects cannot be established, directly or through identifiers linked to the subjects;

b. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk or criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

c. The information obtained is recorded by the investigator in a way that the identity of the human subjects can be established, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make the determination. The IRB will determine whether there are adequate plans to protect the privacy of subjects and to maintain the confidentiality of the data as required by 46.111(a)(7).

Please note the following restrictions for Exempt category 2 research:

• Prisoners can be enrolled only incidentally, cannot be an intentionally targeted study population
• No interventions allowed
• Minors can be enrolled only if all the following are true:
  • No identifiers are recorded, and
  • The only procedures are educational tests or observation of public behavior (i.e., minors cannot participate in survey or interview procedures under this category), and
  • If it is an observation study, the PI does not participate in the activity being observed

a. The information obtained is recorded by the investigator in a way that the identity of the human subjects cannot be established, directly or through identifiers linked to the subjects;

b. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk or criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

c. The information obtained is recorded by the investigator in a way that the identity of the human subjects can be established, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make the determination of whether there are adequate plans to protect subject privacy and confidentiality as required by 46.111(a)(7).

“Benign behavioral intervention” means:

Brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. “Brief in duration” is described by SACHRP as follows: “To meet the requirement of brief in duration, the benign behavioral intervention should last a few minutes to a few hours. While it does not have to occur in a single session, the entire time for the intervention should occur on a single day and not exceed a few hours in its entirety.”

Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

• If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement (consent) to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Please note the following restriction for Exempt category 3 research:

• Minors can NOT participate in Exempt 3 research

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

a. The identifiable private information or identifiable biospecimens are publicly available.

b. Information, which may include information about biospecimens, is recorded by the investigator in a way that the identity of the human subjects cannot be established directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;

c. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or

d. The research is conducted by, or on behalf of a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Please note the following restrictions for Exempt category 4 research:

• Research involving subject contact does not qualify for Exempt 4
• Research meeting criteria “c” above (use of PHI that is regulated under 45 CFR parts 160 and 164) cannot be processed as Exempt at UCSF. Because of local HIPAA policy, the UCSF IRB requires that these studies be reviewed as Expedited category 5 instead.

Also of note for Exempt category 4 research:

• Minors can be enrolled
• Data/specimens can have been in existence prior to the start of the research (e.g. “on the shelf”) AND/OR the data/specimens can be collected prospectively.

Categories 2 and 3 include provisions for exempt research with limited IRB review, ensuring sufficient safeguards for subject privacy and data confidentiality (45 CFR 46.1111(a)(7)).

Investigators submitting such exempt research will be prompted to complete the relevant confidentiality sections in the IRB application.

UCSF does not enter into reliance agreements for exempt research. When collaborating with an outside site engaged in activities that meet the definition of exempt research, the collaborating site must obtain an exempt determination from its own IRB or an independent IRB (if the site does not maintain an IRB) to participate in the project with UCSF.

When preparing your application, consider the activities for which the collaborating site will be responsible. Note that obtaining permission to participate (consent), collecting data, conducting group meetings with participants, analyzing data with identifiers, or any other interactions with study participants are considered engagement. Activities such as recruitment (posting or handing out fliers, informing people about the study and asking them to contact the study team for more information), assisting with the design of the project, and providing space are not considered engagement and do not require an exempt determination.

Please contact the IRB if you have questions around the role of your collaborating site before submitting your application.

Review the permitted categories for research involving children.