economic risk (e.g., loss of employment, loss of potential monetary gain). Both immediate and delayed risks of any procedure involving human subjects will be reviewed by the IRB. In addition, the estimated probability, severity, average duration, and reversibility of any potential harm will be considered according to available empirical data. Furthermore, since certain populations of vulnerable subjects may be at greater risk than others, the IRB will take into consideration the potential risk characterization of the subjects. Victims of child abuse or assault, for example, may be at increased risk in sociological or psychological studies. Children, the elderly, prisoners, the mentally disabled, and various ethnic groups may incur an increased level of risk in certain kinds of research projects. Show Risk can also be classified as less than minimal, minimal, and greater than minimal. Federal regulations (45 CFR 46.102(i)) define minimal risk as, "The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." The term "minimal risk" is used as a base or standard by which the risk associated with research is judged. Examples of "less than minimal risk" procedures include collection of urine, collection of sweat, weighing, pulse measurement, blood pressure measurement, voice recordings, skin fold body composition measurements, and any standard psychological testing with no stress. In actuality, most "less than minimal risk" procedures are interventions that usually (but not always) have no known associated risk. For example, if an investigator were to take one blood pressure measurement using a sphygmometer, this would clearly be a "no known risk" procedure. If, however, the investigator's protocol requires monitoring of the subject's blood pressure every thirty minutes during a five-hour written exam given for board certification, the associated risk would be at least "less than minimal" as opposed to "no known risk." This is because of the inconvenience and discomfort associated with multiple interventions. Since risk is such a relative concept, the IRB classification system does not distinguish between "no known risk" and "less than minimal risk" research except for the purpose of risk disclosure on the consent form. Examples of "minimal risk" procedures include electrocardiography, collection of blood by venipuncture from healthy adults who are not pregnant, moderate exercise testing, administration of standard psychological tests with only a minor level of associated stress, and magnetic resonance imaging. Examples of "greater than minimal risk" procedures include radiology exams (x-ray, CT scan), maximal exercise testing, and stressful psychological testing, including asking sensitive or personal questions on a survey. The IRB will review carefully the risk classification of the research which determines the type of IRB review and consent form format. Under certain circumstances, application of the minimal risk classification will be based upon a consideration of the risks inherent in each subject's life, thereby resulting in a relative standard of minimal risk. Thus, for example, the standard of minimal risk may be different when applied to a person with cancer or an individual with an intellectual disability versus a healthy person.
The Level of Review and Minimal RiskIf your study needs IRB review, the next step is to identify the level of review required – full committee review, expedited review or exempt certification. The level of review reflects the level of risk to the subject. The risk level is compared to “minimal risk” as defined by the federal regulations:
Greater than minimal risk studies require full committee review, while minimal risk studies may be eligible for expedited review or exempt certification. Call the IRB Analyst of the Day at 415-476-1814 if you are unsure about which level of review is needed. Full Committee ReviewThese studies are reviewed by the IRB committee at a convened meeting. Full committee review is required for:
Expedited ReviewExpedited review studies typically are reviewed by a small number of IRB reviewers. Expedited review is appropriate for studies that according to 45 CFR 46.110 and 21 CFR 56.110:
Expedited Review Categories In addition to the information below, see the Minimal Risk Tip Sheet for examples of research activities that may be considered minimal risk. (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). Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:
Research involving materials (data, documents, records or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). Comments: (a) This category refers to materials collected for "non-research purposes," but can be used to cover research materials if the investigator's role is simply to analyze them. That is, if an investigator is receiving materials from colleagues who have separate approval to collect them, and the materials are handled with protections for confidentially, the investigator may apply for expedited review for the analysis. (b) Under limited circumstances, research involving private information or specimens may be exempt or may not qualify as human subjects research. If the project is not human subjects research, IRB review is not required. Examples:
Collection of data from voice, video, digital, or image recordings made for research purposes. Example: Using video recordings to examine communication styles between educators and students Reminder: The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Research on individual or group characteristics or behavior — including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior — or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies. Note: Some research in this category may qualify for exempt certification, most commonly under exempt category 2. Example: Interviewing teenagers about the influence of social media on body image. Reminder: The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Continuing review of research previously approved by the convened IRB as follows: a. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or b. Where no subjects have been enrolled and no additional risks have been identified; or c. Where the remaining research activities are limited to data analysis. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. Exempt CertificationDHHS regulations in 45 CFR 46.104 (Common Rule) identify several different categories of minimal risk research as being exempt from federal policy for the protection of human subjects. Federal HIPAA regulations, California state law and UCSF institutional policies further limit exempt research categories. Please note UCSF does not allow for reliances on our exempt certification. Exempt research involves human subjects, and although it is exempt from the federal policy, you must submit the study to the IRB. The IRB will review the application and certify that the study qualifies for the exemption. You will receive an exempt certification letter, not a letter of approval.The IRB will NOT certify the following types of research as exempt at UCSF: The IRB will NOT certify the following types of research as exempt at UCSF:
Other notes about exempt studies: For exempt research only, you can make minor changes to your study without notifying the IRB. Significant changes must be submitted to the IRB. See the Modification page for examples. Exempt studies have no expiration date and do not require continuing review. Submit a Study Closeout Report when the study is finished. 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. Exempt research must be minimal risk AND fit into one (or more) of the following categoris. You can also use this decision tool to determine which category your study falls into.
Please note the following restrictions for Exempt category 1 research:
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:
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.
Please note the following restriction for Exempt category 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:
Also of note for Exempt category 4 research:
Categories 2 and 3 have provisions for exempt research that require limited IRB review. This means that when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data 45 CFR 46.1111(a)(7). Investigators submitting exempt research that requires limited IRB review will be prompted to complete the appropriate confidentiality sections in the IRB application. UCSF does not enter into reliance agreements for exempt research. When collaborating with an outside site that will be 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, in order to participate in the project with UCSF. When preparing your application please consider which activities the collaborating site will be responsible for conducting. Note that obtaining permission to participate (consent), collecting data, conducting group meetings with participants, analyzing data with identifiers, or any other interactions with the study participants is considered engagement. Activities such as recruitment (posting or handing out fliers, telling people about the study and asking them to contact the study team for more information), assisting with design of the project, and providing space is not considered engagement and does not require an exempt determination. Please contact the IRB if you have questions around the role of your collaborating site before submitting your application. Which of the following is an example of a minimal risk study?Some examples of minimal risk procedures include obtaining small blood samples, urinalysis, EEGs, minor dietary changes, non-invasive swabbing, and some standard psychological tests. Studies involving children that are determined to be minimal risk may be eligible for expedited review.
What is minimal risk research According to TCPS 2?Minimal Risk is defined in TCPS2 as follows: “research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research”.
Is MRI minimal risk?You can take breaks more frequently if you want. Risks/Discomforts: While there are minimal risks from MRI as it is to be performed and MRI scanning itself is painless, participation may involve some discomfort.
Are surveys minimal risk?Your research most likely qualifies as minimal risk if you are collecting data from adults (18 years of age and older) through surveys, questionnaires, focus groups, interviews, non-invasive or non-violent games, passive observation of public behavior, etc.
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