How to determine whether your study requires IRB Review
The first step in the process of securing approval to conduct research with human subjects is to make the determination that the study does, in fact, meet the federal definition of research with human subjects.
Please review the definitions below to clarify whether your study falls under this requirement.
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Research means "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." This definition includes pilot studies, feasibility studies and other preliminary research.
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Human subject means "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."
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Subject (per FDA) means a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease.
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Clinical investigation (per FDA) means any experiment in which a drug is administered or dispensed to one or more human subjects. When the clinical investigation incorporates devices it means an investigation or research involving one or more subjects to determine the safety or effectiveness of a device.
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Interventions include both physical procedures by which data are gathered (for example, venipuncture) and manipulation of the subject or the subject's environment that are performed for research purposes.
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Interactions include communication or interpersonal contact between the subject and the investigator. Communication does not have to be face to face and may even be entirely virtual.
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Obtaining Identifiable Private Information. An important criterion for this type of research is that the investigator must either know the subjects’ identities or be able to readily determine their identities. There are two kinds of private information included in the federal definition:
--information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place
--information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, such as a medical or school record.
The NSMC Research Determination Worksheet is also a tool that can assist you in making this determination. The worksheet does not need to be submitted to the NSMC IRB, but the IRB will review it upon request. If you have questions about whether or not your study constitutes research with human subjects after utilizing the worksheet, please contact the IRB Administrator and we will be happy to help. If your study does not meet the criteria for research with human subjects, IRB review and approval is not required.
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Obtaining Initial IRB Approval
If the study does meet the definition of research, there are two things investigators must do:
- Complete CITI trainingto conduct research with human subjects and keep training current through the life of the project.
- Submit an application to the NSMC IRBforprotocol review and approval in ADVANCE of initiating any research activities.
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Types of IRB Review
Exemption: A research project is exempt from the requirement for IRB approval when it is determined that the only involvement of human subjects is in one of the categories listed under
45 CFR 46 Section 101(b)(1)-(6) and
21 CFR 56. 104(d). Human subjects regulations do not apply to exempt projects.
Any research project involving human subjects thought to be exempt must be submitted to the IRB for determination of exempt status.
Expedited Review: Review of proposed research by the IRB Chair, rather than by the entire IRB Committee. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
Full Board: Review of proposed research at a convened meeting where a valid quorum of IRB members is present.
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Financial Disclosure
Investigators and all study staff listed on IRB application materials as participating in research must complete a NSMC IRB Research Financial Disclosure Form when the research involves any of the following:
(1) for-profit sponsor or funding source;
(2) a marketed drug, device or other technology, or a drug, device, or other technology in development; or
(3) a new technology, software or therapeutic approach.
As a general rule, in accordance with Partners Human Research Committee and Harvard Medical School policies, any financial interest over $20,000 will preclude study participation of any type. Exceptions may be considered in certain situations and these would need to be reviewed during a meeting of the convened IRB.
IRB Fees
The IRB requires a review fee for all studies initiated and sponsored by private industry or a for-profit sponsor. This fee includes IRB review of original protocol, amendments, unanticipated problems, and continuing reviews.
The fee is $2,000 for a Full Board review and $1,000 for an Expedited Review. Invoices are sent upon receipt of submission.
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Ongoing Management of Study
After an investigator has secured approval of a study, he or she must fulfill the additional responsibilities below:
- Secure prior written approval before altering the research protocol in any way.
- Prepare continuing review applications for review and approval prior to the expiration date provided on notices of approval.
- Report any unanticipated problems to the IRB.
- Retain research data as required by protocol and applicable federal regulations (for example, FDA regulated studies require retention for a period of 2 years following the date of an approved marketing application for drug or device for the indication for which it is being investigated, or if no application is to be filed or is not approved, until 2 years after the investigation is discontinued).
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