Exempt Category 70
Exempt Category 70 (formerly category 7) is a UC Berkeley (UCB) category of exempt review that was created to reduce researcher burden. This category, which the Committee for Protection of Human Subjects (CPHS) and Office for Protection of Human Subjects (OPHS) has added to the six categories of exemption described in federal regulations, is allowed by the flexibility available under UC Berkeley’s Federalwide Assurance (FWA).UCB’s Category 70 is defined as: Research that involves no greater than minimal risk to subjects, but does not conform to a specific category under 45 CFR 46.101(b), and does not fall within the exclusions listed below.
Frequently Asked Questions
When is a protocol eligible for Exempt Category 70?
OPHS staff, upon review of an application for Exempt Status submitted by the investigator, will determine whether or not a protocol may receive an exempt determination under Category 70. To qualify for exemption under UCB Category 70, a human subjects research project must not be federally funded or regulated; and, comprised only of minimal-risk activities that will not induce distress beyond that of daily life nor reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing in any other way.
Exempt Category 70 activities may include (but are not limited to) non-physically invasive interventions or performance of tasks such as:
- Physical activities such as walking, sitting, or manipulating an object.
- Height/weight measurements.
- Collection of non-invasive, non-sensitive health data, such body temperature or lung capacity.
- Use of an activity tracker such as a Fitbit.
- Use of incomplete disclosure (in certain circumstances)
- Passive monitoring of space (environment) with sensors.
- Secondary use of private, identifiable data. When disclosure of the data outside of the research has the potential to place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way, a non-exempt application may be required.
The following procedures may qualify for review under exempt category 3. However, when they are not brief in duration or do not involve the collection of data through verbal or written responses or audiovisual recording, exempt category 70 may apply:
- Computer tasks and/or Internet searches.
- Talking and/or listening to words, then making selections, or “think-aloud” exercises.
- Viewing media.
- Completing a specific physical or mental action (“imagining”).
- Playing a game.
Examples of activities that qualify for Exempt Category 70 are included below.
When is a protocol not eligible for Exempt Category 70?
A research project will not qualify for Exempt Category 70 if they include any of the following:
- Federally funded research, or funding from non-Public Health Service (PHS) agencies that adhere to federal regulations in their award contracts (investigators should check with the funding agency if unsure).
- Use of HIPAA-regulated data.
- Use of FERPA-regulated data.
- Prisoners as subjects.
- Children/minors as subjects.
- Federal personnel or the Department of Veterans Affairs.
- Procedures, devices, or drugs subject to FDA oversight.
- Collection of biospecimens.
- Invasive biomedical procedures.
- Clinical interventions.
- Sponsor or other contractual restrictions.
- An NIH-issued Certificate of Confidentiality to protect identifiable research data.
- The information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects, and any disclosure of the subject’s responses outside of the research could reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way.
What if my protocol is given an exempt determination under Category 70 but then becomes ineligible?
If there is a change (e.g., the addition of one or more exclusions noted above) to a protocol that causes it to become ineligible for Exempt Category 70 approval, the PI must immediately cease research activities and submit a new, non-exempt application. The CPHS will then review and issue a new approval letter, as appropriate.
Where can I find more information about Exempt Category 70?
If you have questions about Category 70 exempt research, please call the OPHS Analyst of the Day at 510-642-7461 or email us at firstname.lastname@example.org.
Examples of Projects That Fit Under Exempt Category 70
In general, Exempt Category 70 activities are those that involve no greater than minimal risk to subjects, but do not conform to a specific Exempt Category under 45 CFR 46.104(a) and do not fall within the Category 70 exclusions.
What are common examples of research activities that qualify for Exempt Category 70?
(A). Benign behavioral interventions involving 1) verbal (oral) or written responses by the subject, 2) data entry by the subject, or 3) observation of the subject, including audiovisual recording, that do not otherwise qualify for review under exempt category 3. Exempt category 3 describes benign behavioral interventions (involving surveys, environmental manipulations, viewing media, etc.,) that are “brief in duration.” 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. Benign behavioral intervention studies that are not “brief in duration” may be eligible for exempt review under category 70.
Note: In order to be eligible for exemption, survey experiments/interventions must not involve the use of deception.
EXAMPLE A: Online survey participants randomly receive one of
three versions of an article on Uber. One article frames the
company in a positive light, the second article focuses on
negative press, and the third article presents neutral
facts. After reading the article, participants answer the
same set of questions regarding their opinions on Uber.
Framing of the articles is meant to affect participants’
responses. Subjects are expected to participate in several
follow-up surveys, for a total of 8 hours of participation.
- EXAMPLE B: Survey participants view pictures of fictional political candidates and answer questions based on the pictures shown. Pictures vary according to gender, age, or race/ethnicity. Survey questions are intended to evaluate the impact of the pictures on participants’ responses. Subjects are asked to participate on several occasions over the course of a year to determine whether or not their responses change over time. Total study participation is estimated to take 12 hours.
(B).Collection of Data not Using Verbal or Written responses or Audiovisual Recording.
- EXAMPLE A: Participants are asked to provide their height and weight measurements along with survey responses about eating and exercise habits.
- EXAMPLE B: Participants are asked to complete physical activities such as walking, sitting, or manipulating an object, while the investigator observes and takes notes.
(C).Incomplete Disclosure. Under certain circumstances, benign studies that involve incomplete disclosure may be approved under category 70. Incomplete disclosure occurs when an investigator withholds information about the specific purpose, nature, or other aspect of the research. Withholding information may or may not be considered deception. Such studies are evaluated on a case-by-case basis in consultation with the OPHS Director and/or Assistant Director.
Note: Exempt category 3 allows for incomplete disclosure/deception only when the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that s/he will be unaware of or misled regarding the nature or purpose of the research.
- EXAMPLE A: The subjects are surveyed and asked to read one of two randomly assigned scenarios about two products and asked to make a decision about which product they would want. The true purpose of the study is withheld from subjects so as not to bias their responses.
- EXAMPLE B: Participants are asked to complete a writing task involving a product pitch. Subjects will not be told initially that their gender will be analyzed with their writing sample.
(D). Non-invasive data collection (body). Studies in which participants wear a non-invasive device that records non-sensitive health data. The device must not be used to provide participants with any health diagnoses.
EXAMPLE A: Participants wear LASCAR or HOBO data loggers* for a period of 24 hours to measure changes in body
*Data loggers are electronic devices intended to record data over time. LASCAR and HOBO are brand-name devices for recording temperature data.
EXAMPLE B: Participants breathe into a spirometer* to measure air
capacity of the lungs.
*A spirometer is an instrument used for measuring air volume during inhalation and exhalation.
- EXAMPLE B: Clients at a health club are asked to participate in a study looking at the impact of a two-hour session on the benefits of exercise. Clients are provided with a free Fitbit and then asked to come to the club every other day to have a reading taken of their daily steps as recorded on the Fitbit.
(E). Secondary use of private, identifiable data. Studies involving secondary use (i.e. the data were not collected for purposes of the project in question) of identifiable, private data (i.e. not readily available to the public or subjects have an expectation of privacy).
- EXAMPLE: A private data set, not subject to HIPAA, containing individually identifiable subject information is obtained from a researcher at UCLA for analysis at UCB for a new project. The data set is not available to the public, and includes subject home addresses.
If, after reviewing the above FAQ and the Exempt Research Guidelines, you are unsure whether your study will qualify for exempt review, please consult with OPHS staff by emailing email@example.com or calling 510-642-7461.