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Human Research Protection Program (HRPP) Does My Project Need IRB

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Human Research Protection Program (HRPP) Does My Project Need IRB 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 information 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 Policy 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 knowledge.” 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, interview or survey studies, group comparison studies, test 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 case study report without disclosing information that would make it possible to identify the patient, you must obtain permission from the patient before using their data. 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 subject) 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: Program evaluation 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 system. 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 individual 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 individuals 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: • interviews • questionnaires • 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 policies, 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 education instructional strategies; or b. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management 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
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