IRB’s protocol summary form queries INDs, IDEs
IRB’s protocol summary form queries INDs, IDEs
The Human Investigation Committee (HIC) at Wayne State University in Detroit uses a nine-page protocol summary form that asks investigators detailed questions about investigational new drugs (INDs) and investigational device exemptions (IDEs). Although the Food and Drug Administration (FDA) has recently proposed new guidance about IND exemptions, it’s still a good idea for IRBs to require thorough explanations from investigators about when they claim an exemption to obtaining an IND number, says Francis LeVeque, DDS, chairman of the Human Investigation Committee at Wayne State.
"It’s incumbent upon IRBs and organizations such as human investigation committees, before they review protocols, to make sure an indication for an IND is either there or not there," LeVeque says. "In our institution, we’ve reworked our protocol summary form, an application for research, and we’re asking specific questions about INDs that will help us determine whether an exception is required."
Here are the institution’s protocol summary form questions that are within the section on "Interventions/Measurements Solely for Research Purposes:"
• Is this a therapeutic/treatment study? If yes, go to next question.
• Does it involve a placebo?
• Is an experimental agent(s)/device(s)/use involved in this project?
• Is this a new indication of the study agent/device/use (new use, altered dose, new route of administration, new participant population, etc.)?
• Provide the IND (Investigational New Drug) number or IDE (Investigational Device Exemption) number.
Note: Approval cannot be granted until the required IND/IDE number is provided.
If the FDA has provided no IND/IDE number for the above indications, please justify why this number is not required. Include a copy of any documents supporting this justification or the name, date, and the essence of verbal communiqué from the FDA. Refer to the HIC web site (www.hic.wayne.edu) Helpful Links for FDA requirements.
• Will non-FDA approved drugs/chemicals without IND numbers be given to research participants? If yes, describe the safety/pharmacology profile of the drug/chemical and provide a copy of the literature search that determined this dose/use.
• Has a copy of the Investigational Drug Brochure/package insert been included?
• Will research participants be exposed to imaging or diagnostic radiation (e.g., X-rays, CT scans, etc.) over and above that given for clinical purposes? If yes,
- Specify the facility where radiation will be given.
- Describe the additional imaging or diagnostic procedures.
- Describe the total amount of the additional radiation exposure in rads/millirads.
Note: In the consent form, the amount of additional radiation and subsequent risk must be described in lay terms. For example, "the amount of radiation from participation in this research study is the same amount that would be received by flying from New York to Los Angeles."
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