Request for Determination that a Proposed Activity is
Not Research or is Not Human Subjects Research
Instructions:
Federal regulations require prospective IRB review of all human subjects research. Some categories of activities are difficult to discern as to whether they qualify as research or research involving human subjects. Therefore, the IRB has established policies and procedures to assist in this determination.
Some research projects may be classified as “not involving human subjects” if they involve obtaining, collecting, or using human data or specimens that are coded or do not include personally identifiable information.
The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations have different definitions of the terms for research and human subject. The HRPP office will use the information provided on this form to determine if the federal definitions apply to this activity for either agency. If the activity is deemed to meet the definition of research involving human subjects, you will be required to complete and submit a full Research Application.
Submit 1 signed original of this form and supporting documentation as applicable to the situation.
An e-mailed version may be sent to in advance of the signed original – a Research Coordinator, Associate, or Assistant may complete the form and send it via e-mail, but the Principal Investigator must be CC:’d on the e-mail submission.
**Please note: This form may not be appropriate if this proposal is funded by a federal grant that involves human subjects for which you are the PI or the direct recipient of the grant.
Date of Request:Principal Investigator: / Reference #:
Department: / Best Contact Phone #:
Primary Contact Person:
(If different from PI)
Title of Activity:
Funding Source:
How would you classify this activity? Check the best choice below.
Routine Quality Improvement/Quality Assurance (QA/QI) - systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of health care in particular settings. QI involves deliberate actions to improve care, guided by data reflecting the effects (e.g., types of practical problem solving; an evidence-based management style; the application of science of how to bring about system change; review of aggregate data at the patient/provider/unit/ organizational level to identify a clinical or management change that can be expected to improve care).
Health Surveillance - an ongoing part of the medical care and public health care functions closely integrated with timely dissemination of these data to those responsible for preventing and controlling disease or injury (may include emergent or urgently identified or suspected imminent health threats to the population to document the existence and magnitude).
Case Report/Case Series – use of medical information collected from a clinical activity rather than a research activity and presented on no more than three (3) patients. Case reports are generally done by retrospective review of the medical record and highlights a unique treatment, case or outcome. The examination of the case is usually not systematic and there is usually no data analysis or testing of a hypothesis. Investigators must ensure that the HIPAA privacy rules are followed with respect to using or accessing PHI (a HIPAA authorization or waiver may be required)
Drug Use Evaluation (DUE) Protocol
Program Evaluation - This refers to assessments of the success of established programs in achieving objectives when the assessments are for the use of program managers, for example, a survey to determine if program beneficiaries are aware of the availability of program services or benefits. [Note: Non-research evaluation is generally designed to assess or improve the program or service rather than to generate knowledge about a disease or condition.]
Customer Satisfaction Surveys - This refers to surveys of program users to obtain feedback for use by program managers. This is similar to program evaluation.
Other (describe here):
None of the above. Explain:
Design and Intent of the Proposed Activity/Project:
1) Provide a brief summary of the proposed project. Please attach your full protocol or proposal plan along with submission of this form.
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Request for Determination that a Proposed Activity is
Not Research or is Not Human Subjects Research
2) Is the project intended to: (a) improve the process/delivery of care while decreasing inefficiencies (b) implement a practice to improve the quality of patient care, and/or (c) collect patient or provider data about the implementation of the practice for clinical, practical, or administrative purposes (e.g., measuring or reporting provider performance data)?
Yes No N/A
3) Is the proposed project conducted by the clinicians and staff who provide care or are responsible for the performance quality in the institutions where the project will take place?
Yes No
4) Is the project flexible, including rapid and incremental changes such as in a plan-do-study-act (PDSA) cycle?
Yes No
5) Does the project have a formal hypothesis to be tested with a statistical analysis plan?
Yes No
6) Will the project involve a sample of the population (staff or patients) ordinarily seen in the institution where the project will take place?
Yes No
7) Will the planned activity only require consent that is normally sought in clinical practice and could the activity be considered part of the usual care?
Yes No
8) Is it true that most of the current patients at the institution where the planned activity will take place could potentially benefit from the project?
Yes No
9) Is the risk to the participants no greater than what is involved in the care they are already receiving? OR Can the burden of participating in the activity be considered acceptable or ordinarily expected when changes are being introduced to the way care is provided?
Yes No
10) Is there a plan to publish findings, describe the project in a peer-reviewed publication or present it in a public forum? (if yes, explain)
NO YES. Explain:
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Request for Determination that a Proposed Activity is
Not Research or is Not Human Subjects Research
Data and Materials:
1) Does the project involve the collection or analysis of data regarding health facilities, businesses, or other organization or units which are not individual persons?
Yes No
2) Does the project require data or specimens from deceased persons only and no data from living individuals will be collected? (If yes, complete and submit a “Verification of Use Form”.)
Yes No
3) Is an investigational device or drug being used to test specimens in this research? (If yes, under FDA regulation the “research not involving human subjects” designation is not applicable. A complete Research Application is required.)
Yes No
4) Describe the type of data or specimens to be used in the project. Provide an estimated number of data/specimens to be used (i.e. sample size). (Please address the following questions in your description: Are/were the data or specimens collected for purposes other than the proposed activity? Are/were any extra data/specimens collected for the purpose of this activity?)
5) Describe the source of the data or specimens (i.e. existing samples in (provide name of person’s lab), purchased samples from (provide company’s name), waste material gathered from (describe accordingly), downloaded data from (describe data source), etc.)
6) Check off any of the following HIPAA identifiers that will be contained in the data:
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Request for Determination that a Proposed Activity is
Not Research or is Not Human Subjects Research
Names
Geographic subdivisions smaller than a State
Dates (except year)
Telephone #
Fax #
E-mail addresses
Social security #
Medical record #
Health plan beneficiary #
Account #
Certificate/license #
Vehicle identifiers and serial #, (i.e. license plate #)
Device identifiers and serial #
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address
Biometric identifiers, including finger and voice prints
Full face photos and any comparable images
Unique identifying #, characteristic, or code
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Request for Determination that a Proposed Activity is
Not Research or is Not Human Subjects Research
None of the identifiers listed above will be included with the samples/data used for this project.
7) Will the data or specimens be coded in any way? (if yes, address 7a. – 7e.)
Yes No
7a.) Explain how the code is derived (if you do not know how the code was established, please make a statement reflecting that).
7b.) Is there a possibility that anyone associated with the project would have the ability to link the code to an individual?
Yes No
7c.) Will the key to decipher the code be destroyed prior to the initiation of the research?
Yes No
7d.) Does the investigator and the key holder have a written agreement in place prohibiting the release of the key? (If yes, please attach)
Yes No
7e.) Are the data/specimens being released from an IRB-approved repository in which there are policies and procedures in place prohibiting the release of the key to investigators under any circumstances?
Yes No
Principal Investigator’s Signature:Date
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