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Human Research Protection Program (HRPP)

Does my Project Need IRB Review?

Version Date: 12/03/2018

I. Which Projects Must Be Reviewed by the IRB? The University’s IRB has assured federal regulatory agencies that the institution will review and approve all research that meets the federal definition of human subjects research.

Determining whether or not a project meets the federal definition of human subjects research is a two- step process. The investigator must first determine if the project meets the federal definition of research and, if so, then determine if the project includes human subjects. The below will help you assess whether IRB review is required.

Projects including the use of drugs or devices (either approved or unreviewed by the FDA) must be submitted to the IRB.

A. Step One – Is it Research? The Federal for the Protection of Human Subjects (Common Rule) defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable .”

1. Systematic Investigation • Definition: A “Systematic Investigation” is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Systematic investigations include observational studies, or studies, group comparison studies, development, and interventional research. Proje cts that are not systematic investigations include oral histories, journalism, and phenomenological activities. • Gray Areas: Case studies prepared and disseminated for educational purposes are not systematic investigations and therefore are not considered research. If you are unable to prepare the report without disclosing information that would make it possible to identify the patient, you must obtain permission from the patient before using their . Please note the important difference between a case study that is not research, and an experimental research study with an "n" of one (a research study with only one ) that is human subjects research.

2. Generalizable Knowledge • Developing or contributing to generalizable knowledge means that the intent or purpose of the systematic investigation is to produce new data that will be relevant beyond the study population from which is was collected.

Brown University HRPP Does My Project Need IRB Review? Page 1 of 8 • To help determine the intent or purpose of the activity ask this question: Would this project be conducted as proposed if the principal investigator knew that he or she would never receive any form of academic recognition for the project, including publication of results in a medical journal or presentation of the project at an academic meeting? If the project would remain exactly the same, the activity is likely not research. • Gray Areas: may also fall into or out of this definition based on design and intent. Program evaluation is not considered research if the primary intent of the program evaluation is to inform or improve a local process. However, if your primary intent is to generalize the results outside of your local area the activity is research.

3. Research vs. Program Evaluation

Points to Consider Research Program Evaluation

Produce new, generalizable Improve a process, program Purpose knowledge to contribute or . to a broader societal aim. Present a question or Starting Point Assess performance. test a hypothesis. May place participants By design, does not increase Risks/Burdens at risk. participants risk. Systematic data Data Collection Systematic data collection. collection. Answer a research Promptly improve a End Point question. program/process/system. Statistically prove or Compare a Analysis disprove a question or program/process/system to an hypothesis. established set of standards.

If your project does not meet the definition of research according to Step One above, stop here. You do not need to submit an IRB application.

If your project does meet the definition of research, go to Step Two below.

B. Step Two – Does it Involve Human Subjects? The Federal Policy for the Protection of Human Subjects (Common Rule) defines a human subject as “…a living about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Note that the definition of human subject focuses on what information is obtained about people or material that is acquired from people. If either of the following is true, your

Brown University HRPP Does My Project Need IRB Review? Page 2 of 8 research activity involves human subjects:

1. Data about living through intervention or interaction a. Intervention: An intervention may be physical procedures (e.g. venipuncture) or manipulations of living individuals or the living individuals’ environments. b. Interaction: An interaction may be communication or interpersonal contact between investigator (or research team) and the living individual. Examples: • • surveys • observations • manipulations of subject behavior, diet, or environment • physical measurements • specimen collection (e.g. blood tissue) • administration of experimental drugs or devices c. Why “about whom” is key: Consider if the project focuses on the person or if the focus is on , practices or procedures about which the person is knowledgeable. Projects which collect information about policies, practices or procedures – even if the person who provided that information is identified – do not constitute human subject research. Asking a person about someone else does not make that person a human subject.

2. Identifiable private information about living individuals a. Identifiable means: i. the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or ii. the identity of the individual from whom the information was obtained is associated or may be readily associated with the information. b. Private Information: Information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g. medical record, employee or student records). c. Examples of identifiable, private information include the subject’s: i. name ii. address iii. phone number iv. social security number v. medical record number vi. student or employee identification number vii. in some cases, the combination of data such that they can identify a single individual through deductive reasoning • for example: data about employer, job title, age and gender may not individually identify a subject, but when combined, could in certain cases, identify a specific individual. d. What is NOT considered identifiable, private information: Brown University HRPP Does My Project Need IRB Review? Page 3 of 8 i. If the information cannot be linked to a living individual, or is considered public or is given with the expectation that it will be made public and that it will be linked to the individual (e.g. biography or news story), then it would not be considered private identifiable information. For example, use of a publicly available data set that does not contain identifiers or codes linked to individuals does not involve human subjects research. However, use of a publicly available data set that does contain identifiers or codes linked to individuals does involve human subject research. ii. If you obtain/purchase/are given specimens/cells/material/data that has already been collected by someone else for some other purpose, and the specimens/cells/material/data are not linked to any identifiers that would make reasonably possible to identify an individual, the activity is not considered research with human subjects. iii. If your activity does not involve human subjects as defined in the regulations, your activity does not fall under the purview of the IRB. You do not need to submit an application. iv. If you have determined that your research does meet the federal definition for human subjects research, you will need to apply for IRB review and approval before you begin (the IRB cannot review proje cts re trospe ctively).

II. Categories of Exempt Review

A. A human research project may be determined to be exempt from the requirements of the regulations in 45 CFR 46, if the only* involvement of human subjects is in one or more of the following categories:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: a. research on regular and special instructional strategies; or b. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless: a. information obtained is recorded in such a manner that human research participants can be identified, directly or through identifiers linked to the participants; and b. any disclosure of the human subject’s responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or .

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under number (2) above, if: a. the human participants are elected or appointed public officials or candidates for public office; or b. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Brown University HRPP Does My Project Need IRB Review? Page 4 of 8 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: a. public benefit or programs; b. procedures for obtaining benefits or services under those programs; c. possible changes in or alternatives to those programs or procedures; or d. possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food evaluation and consumer acceptance studies if: a. wholesome foods without additives are consumed; or b. the food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

7. Minimal risk non-federally-funded research activities that will not induce distress beyond that of daily life may include (but are not limited to) non-physically invasive interventions or performance of tasks such as: reading/writing/drawing tasks; physical activities such as walking, sitting, or manipulating an object; computer tasks and/or Internet searches; talking and/or listening to words, then making selections, or “think-aloud”exercises; viewing media; role-playing; completing a specific physical or mental action (“imagining”); passive monitoring of space (environment) with sensors; playing a game, height/weight measurements. Please note: If the research is determined to qualify for Brown University Category 7 Exempt status and later becomes federally funded, supported, or regulated, or changes such that it no longer meets the criteria for this exemption, human research activities must cease until a protocol is submitted and approved by the IRB.

B. *”only” means that no non-exempt activities are involved. Research that involves exempt and non-exempt activities is not exempt from the regulations.

C. Exempt review excludes vulnerable populations, such as minors and prisoners.

III. Categories of Expedited Review

A. Applicability

1. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the below categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means 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. Brown University HRPP Does My Project Need IRB Review? Page 5 of 8 2. The categories in the list below apply regardless of the age of subjects, except as noted. 3. 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. 4. The expedited review procedure may not be used for classified research involving human subjects. Brown does not permit the conduct of classified research. 5. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review – expedited or convened – utilized by the IRB.

B. Categories of Review:

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met. 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); or b. Research on medical devices for which (i) an investigational device exemption application (21CFR812) 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.

2. Collection of blood samples by finger stick, heal stick, ear stick, or venipuncture as follows: a. from healthy, non-pregnant adults who weigh at least 110 pounds. For these participants, 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 children2, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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. i. 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).

3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: • hair and nail clippings in a non-disfiguring manner; • deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; • permanent teeth if routine patient care indicates a need for extraction; • excreta and external secretions (including sweat); • uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gun base or wax or by applying a dilute citric solution to the Brown University HRPP Does My Project Need IRB Review? Page 6 of 8 tongue; • placenta removed at delivery; • amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; • supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; • mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; • sputum collected after saline mist nebulization.

4. 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: • physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; • weighing or testing sensory acuity; • magnetic resonance imaging; • electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; • moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

5. 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). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human research participants. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

6. Collection of data from voice, video, digital, or image recordings made for research purposes.

7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, , 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 . (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human research participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

8. 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 Brown University HRPP Does My Project Need IRB Review? Page 7 of 8 participants; ii. all participants have completed all research-related interventions; and iii. the research remains active only for long-term follow-up of participants; or b. where no participants have been enrolled and no additional risks have been identified; or c. where the remaining research activities are limited to data analysis.

9. 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.

C. An expedited review procedure consists of a review of research involving human research participants by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

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