An Institutional Review Board (IRB) protects the rights and welfare of human subjects during research or clinical trials. An IRB can approve, exempt, disapprove, monitor, and require modifications in all research activities involving human subjects. The board is composed of five members at a minimum. Members must bring diverse experiences and backgrounds, with at least one member who is not affiliated with the institution and one who is not a scientist.
Here are the top 4 things to know about IRBs and when your project may require one.
#1 An IRB is required for any study involving human subjects
If human subject studies are involved in your SBIR/STTR proposal, an IRB is most likely required. While there are several exemptions that eliminate the need for an IRB, they are highly specific situations. These regulations are in place to ensure safe and ethical practices take place throughout the study, reducing risk to participants and ensuring robust research takes place.
#2 Exemptions
There are eight possible exemptions for human subject research. These include:
- Exemption 1: conducted in an educational setting using everyday educational practices (cannot include any other procedures, such as the collection of clinical data or biospecimens).
- Exemption 2: uses educational tests, surveys, interviews, or observations of public behavior (limited IRB review may be required).
- Exemption 3: benign behavioral interventions in adults (limited IRB review may be required).
- Exemption 4: involves the collection/study of data or specimens if publicly available or recorded such that subjects cannot be identified (may be identifiable in limited cases).
- Exemption 5: research or demonstration projects designed to study, evaluate, improve, or examine an NIH public benefit or service program (applies to projects that NIH itself administers).
- Exemption 6: taste and food quality evaluations
- Exemption 7: storage of identifiable information or biospecimens for secondary research use. Broad consent and limited review are required.
- Exemption 8: secondary research use of identifiable information or biospecimens. Broad consent and limited IRB review are required.
#3 The IRB will review the research plan before determining if the study will be approved
An institution-approved IRB, either internal to the institution or an institution-approved external IRB, evaluates the proposal for the following:
- The risks to subjects are minimized as much as possible.
- The risks to subjects are reasonable in relation to anticipated benefits.
- The informed consent process is adequate.
- The research plan makes provisions for the safety of the subjects during the data collection process
- Provisions are in place to protect the privacy of subjects and maintain the confidentiality of data
#4 Choose your study protocol carefully
The IRB may not review your research plan well if there are insufficient resources to perform a trial according to standard protocol. For example, NSF SBIR/STTR Phase I is typically a six-month project window. Six months is insufficient time to recruit participants, perform a study, and analyze data. Due to time constraints, DoD and NSF agencies recommend that human subject testing not be part of any Phase I proposal. Other solicitations mandate or exclude the use of human subjects. NIH, for example, usually publishes three separate FOAs, one with a clinical trial required, clinical trial optional, or clinical trial not allowed.
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