IRB Creation

The Institutional Review Board (IRB)  is an independent committee that works to protect the rights and well-being of people involved in research studies. They deal with ensuring that planned research will keep human subjects safe, all experiments are ethical, and everyone involved is well aware of risks, benefits, and expectations. 

At the University of Califonia, Berkeley, questions should be directed towards OPHS (510-642-7461, ophs@berkeley.edu). 

How to know if you need IRB approval

All activities, regardless of funding source or lack thereof, that involve the engagement of University of California Berkeley employees or agents (including faculty, staff, and students) in the conduct of human subjects research must be reviewed and approved by the CPHS or determined to quailfy for exempt status by OPHS. 

Activities that generally require review include: 

1. Masters theses or doctoral dissertations involving human subjects 

2. Pilot studies involving human subjects

3. Clinical investigations 

4. Epidemiological studies (such as investigations on health outcomes, interventions, disease states and conclusions about cost-effectiveness, efficacy, efficiency, interventions, or delivery of services to affected populations) 

5. Human genetic research (such as pedigree studies, positional cloning studies, gene transfer research, longitudinal studies to associate genetic conditions with health, health care, or social outcomes) 

6. Behavioral and Social Science Studies (such as investigations on individual and group behavior, mental processes, or social constructs)

   1. generate data by means of

      1. surveys

      2. interviews 

      3. observations

      4. studies of existing records 

      5. experimental designs involving exposure to some type of stimulus or environmental intervention and gene frequency studies 

For examples of projects that require approval and those that do not, please review the D-Lab's IRB resources. 

How to know if you qualify for Exempt Status

There are seven categories of research activities involving human subjects that are eligible for Exempt Status. All applications for Exempt Status are reviewed by OPHS staff in 3-4 weeks. If deemed Exempt, your research does not need IRB review. 

Exempt Status research involves human subjects studies that present no greater than minimal risk to subjects and fit into one or more exempt categories:

• Educational Practices: research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or assessment of educators who provide instruction 

• Tests, Surveys, Public: educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior where 

  • data is collected anonymously 

  • data is not connected anonymously but the information is so innocuous that, in the event of disclosure outside of the research, there would be no significant detrimental consequences to the subject

  • data collection is not anonymous and potentially sensitive or harmful information is collected from subjects ONLY if there are adequate provisions for protecting subject privacy and maintaining confidentiality

• Benign Interventions: benign behavioral interventions in conjunction with the collection of information from adult subject through verbal or written responses or audiovisual recording if the subjects prospectively agrees and at least one of the following criteria are met: 

  • the information obtained is recorded in such a manner that the identity is anonymous

  • any disclosure of the human subjects' responses outside the research would not be reasonably likely to place them at risk 

  • that there are adequate provisions for protecting subjects privacy and maintaining confidentiality 

• Secondary Research: secondary research for which consent is not required OR secondary research where there are uses of identifiable private information or biospeciments if at least one of the following criteria are met: 

  • these sources are publicly available 

  • the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects, and the investigator does not contact or reidentify subjects 

• Federal Department or Agency: Research and demonstration projects conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads: 

  • public benefit or service programs

  • procedures for obtaining benefits or services under those programs

  • possible changes in methods or alternatives to those programs or procedures

  • possible changes in methods or levels of payment for benefits or services under those programs 

• Food and Consumer

  • wholesome foods without additives are consumed 

  • a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the FDA or approved by the EPA or FSIS of the USDA

  • a food is consumed that contains an agricultural chemical or environmental contaminant at or below the level found to be safe by the FDA or approved by the EPA or the FSIS of the USDA

• Minimal Risk Misc. (Category 70): research that involves no greater than minimal risk to subjects, but does not entirely conform to a specific exempt category. UCB exempt Category 70 activities include: 

  • physical activities such as walking, sitting, or manipulating an object

  • height or weight measurements

  • collection of non-invasive, non-sensitive health data (ex: body temperature, lung capacity) 

  • use of an activity tracker (ex: Fitbit)

  • passive monitoring of space (environment) with sensors

  • secondary use of private, identifiable data

Preparing for IRB Review Process

There are two types of review that you can pursue: expedited and full review. 

Expedited Review

Expedited Review is conducted by a subcommittee of IRB members, the chair, or an IRB member who has been designated by the chair to conduct these reviews. 

To be eligible for Expedited Review, the research must only include activities that 

1. present no more than minimal risk to human subjects 

2. fit within the expedited review categories specified by federal regulations

This review process usually takes 6-8 weeks at Berkeley. 

Full Committee Review

Full Committee Review is reviewed by a quorum of IRB members at a convened monthly meeting. It is required for all protocols that do not qualify for expedited review. This review process usually takes 6-8 weeks. 

For specific instructions on how to submit your protocol online for review, see Section 3 of the D-Lab's IRB Resource.