DETERMINING WHETHER AN ACTIVITY IS HUMAN SUBJECTS RESEARCH AS DEFINED BY FEDERAL REGULATIONS

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1 Page 1 of 6 Human Research Protection Page: 1 of 6 DETERMINING WHETHER AN ACTIVITY IS HUMAN SUBJECTS RESEARCH AS DEFINED BY FEDERAL REGULATIONS DESCRIPTION Any proposed activity involving contact with live persons, which involves UC faculty, staff, students, and qualifies as human subjects research must be submitted for IRB review and approval prior to initiation of the activity. RESPONSIBILITY The IRB Chair for the Medical Board and the IRB Chair Social and Behavioral Board are responsible for determining whether the research constitutes human subjects research. PROCESS Questions about the nature of an activity as potential human subjects research should be discussed with the Chair of the Institutional Review Board before beginning the activity. All human subjects research must be submitted to the UC IRB for review prior to initiation of the activity. If the answer is yes to both of these questions, the activity must be submitted to the IRB for further evaluation prior to initiation of the activity.: 1. Is the activity a systematic investigation or clinical investigation, including protocol development, testing, and evaluation, designed to contribute to generalized knowledge? 2. Does the activity involve living individuals about whom the investigator obtains data through intervention or interaction 7 with the individual, or obtains identifiable private information? In addition, if the answer is yes to any of the following questions the activity must be submitted to the IRB for further evaluation prior to initiation of the activity. 1. Does the activity involve the use of a drug (including an approved drug or an overthe-counter drug), other than the use of an approved drug in the course of medical practice?

2 Page 2 of 6 Human Research Protection Page: 2 of 6 2. Does the activity involve the use of a medical device (including an approved medical device), other than the use of an approved medical device in the course of medical practice? (Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals. 3. Will data be submitted to the FDA or held for their inspection? To submit the activity for review, investigators must complete and submit the UC IRB form Determining Whether a Proposed Activity is Human Research According to DHHS or FDA Regulatory Definitions along with any other relevant information (e.g. grant, protocol, data collection tools, letters of collaboration) required to evaluate the activity, prior to initiation of the activity. RESPONSIBILITIES The IRB office staff will review the submission for completeness and assign to an IRB Chair for review. The submission will be reviewed by the IRB Chair to determine if it contains enough information to make a determination of whether the project involves human subjects research. If not enough information is provided, the chair will request additional information from the investigator. Once sufficient information is provided, the Chair will make a determination whether the activity is human subjects research and requires IRB review. Determinations will be made in accordance with DHHS (45CFR ) and FDA (21CFR50.3) regulations and applicable state and local laws. Each determination and the basis of its decision will be documented. Activities determined to require IRB approval would be referred to as not human subjects research. If the activity is determined to constitute human subjects research, the Investigator will be informed in writing to submit the full protocol to the IRB for review prior to initiating the activity. If the work is determined not to constitute human subjects research, the Investigator will be notified in writing of the decision. CONDUCTING HUMAN SUBJECTS RESEARCH WITHOUT IRB APPROVAL It can be very difficult to determine what constitutes human subjects research. In addition to clinical research studies, regulatory requirements to protect human subjects apply to a much broader range of research than many investigators realize, and researchers using human specimens and/or data are often unsure about how regulations apply to their research. Investigators are highly encouraged to contact the IRB office for guidance on determining if an activity constitutes human subjects research requiring IRB approval.

3 Page 3 of 6 Human Research Protection Page: 3 of 6 If the IRB receives a protocol for review after a human subjects research study has been completed, without prior IRB approval, the protocol will not be reviewed. The Investigator will be notified of the regulatory requirements requiring prospective IRB approval of human subjects research. The Investigator will be informed that the data may not be used for any publications, presentations, thesis, or dissertation requirements. The unapproved human subjects research activity will be investigated as described in Policy VII.03-Investigating Allegations of Non-Compliance in Human Subjects Research, and appropriate actions will be taken. EXAMPLES OF HUMAN SUBJECTS RESEARCH: 1. Clinically oriented research. a. Mechanisms of human disease b. Therapeutic interventions c. Clinical trials d. Development of new technologies e. Research using human specimens and/or data including i. Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, from living individuals who are individually identifiable to the investigator(s), even if these materials were collected by others; ii. Residual diagnostic specimens from living individuals that are individually identifiable to the investigator(s), including specimens obtained for routine patient care that would have been discarded if not used for research; iii. Private information, such as medical information, about living individuals that is individually identifiable to the investigator(s), even if the information was not specifically collected for the study in question. This category includes retrospective chart reviews. 2. Epidemiologic and behavioral studies that generate data by means of questionnaires, observation, studies of existing records, and experimental designs involving exposure to some type of stimulus or intervention 3. Outcomes research and health services research studies designed to measure the outcome of medical treatment

4 Page 4 of 6 Human Research Protection Page: 4 of 6 DEFINITIONS The IRB shall use the following definitions to determine whether an activity shall qualify as human subjects research requiring IRB review and approval: 1. Human Subjects Research shall include all activities which either: a. Meet the Department of Health and Human Services definition of research as any systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR ); and which involve person(s) who qualify as human subjects within the meaning of relevant regulations of the US Food and Drug Administration as any living individual about whom an investigator conducting research obtains; (i) (ii) Data through intervention or interaction with the individual, or Identifiable private information or data from which the identity of the subject is or may readily be ascertained by the investigator (45 CFR (f)). -OR- b. Qualify under the Food and Drug Administration regulations as an Investigational use" involving any use of an approved product in the context of a clinical study protocol (21 CFR 312.3(b)) and which involves one or more human subjects as defined in relevant regulations as individual(s) who are or become participant(s) in research, either as recipient(s) of a test article or as a control. A subject may be either a healthy human or a patient (21 CFR (e); 812.3(p)). c. Research activities subject to this policy shall include clinical investigations regulated by the Food and Drug Administration under sections 45 CFR 505(i) and 520(g), including any use of a drug, other than the use of an approved drug in the course of medical practice, and clinical investigations regulated by the Food and Drug Administration under section 45 CFR 520(g), including any use of a medical device, other than the use of an approved medical device in the course of medical practice. 2. Systematic Investigation typically involves a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Examples: observational studies, interview or survey studies, group comparison studies, program evaluation, test development, interventional research.

5 Page 5 of 6 Human Research Protection Page: 5 of 6 3. Clinical investigation means any experiment that involves a test article and one or more human subjects, 4. Designed or contribute to generalizable knowledge typically requires that results (or conclusions) of the activity are intended to be extended beyond a single individual or an internal program. Examples: Activities where there is an intent to publish the results in a peer-reviewed journal or to present at a regional or national meeting, as well as, theses or dissertation projects conducted to meet the requirements of a graduate degree. 5. Individual is a person who is or becomes a participant in research, either as a recipient of the test article or as a control. The individual may be either a healthy person or a patient 6. Intervention includes both physical procedures (e.g. venipuncture) and manipulations of the living individuals or the living individuals' environments. 7. Interaction includes communication or interpersonal contact between the investigator (or research team) and the living individual. Examples: interviews, questionnaires, surveys, observations, manipulation of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), administration of experimental drugs or devices. 8. Information is considered Identifiable if (1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or (2) the identify of the individual from whom the information was obtained is associated or may be readily associated with the information. 9. Private information includes 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). Examples of individual identifiers include the subject's name, address, phone number, social security number, medical record number, student or employee identification number, or 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.

6 Page 6 of 6 Human Research Protection Page: 6 of 6 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, news story), then it would not be considered private identifiable information. For example, use of a publicly available data set that does not contain any 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 subjects research (that would be considered exempt). Applicable, Document(s): 45 CFR (a) 45 CFR (d) 45 CFR (f) 45 CFR (f)(1) 45 CFR (f)(2) 21 CFR CFR 50.3(a) 21 CFR 50.3(c) 21 CFR 50.3(g) 21 CFR 50.3(j) 21 CFR CFR (c) 21 CFR (l) Adoption Date: Created by: Date of Revision: Revised By: Summary of Revision: 03/2005 M. Linke 07/2007 D. Oneill Updated IRB office terminology. Date_Signature_