Appendix F: Use of Drugs, Biologic Agents, or Devices
1.
2.
Section A: Drugs/Biological Products/Chemical Agents
Will any drugs/biological products/chemical
No – go directly to Q#12 (Devices)
agents be administered as part of this
Yes
research study?
Will any non-FDA approved
No – go directly to Q# 3
experimental/investigational drugs, biological
Yes
products, or chemical agents be used?
a. List all non-FDA-approved drugs,
biological products, or chemical agents to
be used:
b. Provide the current Investigational New
Drug (IND) Number and attach a copy of
the IND approval letter:
c. If the FDA has not provided an IND
number, justify why a number is not
required. Include a copy of the FDA
documents that support this justification.
3.
4.
Refer to the IRB website, Helpful Links, for
FDA requirements.
Will dietary supplements (marketed herbs,
vitamins, minerals sold over-the-counter) be
used for this study?
a. List the products and describe the
safety/pharmacologic profile of these and
provide a copy of the literature search that
determined this dose/use
b. Is the study intended to evaluate the
supplement’s ability to diagnose, cure,
mitigate, treat, or prevent a disease?
c. Provide either a new IND#, exemption
category number or a waiver from the
FDA and attach a copy of the FDA
communication
List all FDA-approved marketed drugs or
diagnostic agents that will be administered as
part of this research study.
a. Will these drugs/agents be used for a new
indication? (e.g., new use, new
combination of two or more drugs, altered
dose, new route of administration, new
participant population, etc).
Appendix F
No – go directly to Q# 4
Yes
No – an IND is not required for the dietary
supplements, go directly to Q# 4
Yes
None – go directly to Q# 5
No – an IND is not required for the FDA-approved
drugs/agents, go directly to Q# 5
Yes
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Form Date: 10/2013
Appendix F: Use of Drugs, Biologic Agents, or Devices
5.
6.
7.
8.
b. If this is a new indication, describe the
planned use of the study drug/biologic
product/chemical agent
c. If this is a new indication, does the study meet all of the following criteria?
No
 The drug product is lawfully marketed in the United States.
Yes – an IND is not
 The investigation is not intended to be reported to FDA as a wellrequired for the
controlled study in support of a new indication and there is no intent to
FDA-approved
use it to support any other significant change in the labeling of the
drugs/agents, go
drug.
directly to Q# 5
 In the case of a prescription drug, the investigation is not intended to
support a significant change in the advertising for the drug.
 The investigation does not involve a route of administration, dose,
patient population, or other factor that significantly increases the risk
(or decreases the acceptability of the risk) associated with the use of
the drug product (21 CFR 312.2(b)(1)(iii)).
 The investigation is conducted in compliance with the requirements for
review by an IRB (21 CFR part 56) and with the requirements for
informed consent (21 CFR part 50).
 The investigation is conducted in compliance with the requirements of
§ 312.7 (i.e., the investigation is not intended to promote or
commercialize the drug product).
d. Provide either a new IND#, exemption category number or a waiver from
the FDA and attach a copy of the FDA communication
Has a copy of an investigational drug brochure
No, state why not:
and/or package insert been included with this
Yes
submission?
Will this study involve a placebo?
No – go directly to Q# 7
Yes
a. Select the box that best describes the
With standard therapy or active treatment.
reason for placebo use.
In place of standard therapy or active treatment. If
current medication is stopped, explain how
participants safety will be monitored:
Other (describe):
Will the drugs, supplements, agents, or
No
placebo be administered under the direct
Yes – go directly to Q# 8
supervision of the Principal Investigator or a
co-investigator responsible to the PI?
a. State who will administer:
Describe the drug accountability plan that
includes receiving, storing, dispensing, and
final disposition and accountability of the drug.
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Appendix F: Use of Drugs, Biologic Agents, or Devices
9.
Will the study involve use of infectious agents or non-plasmid recombinant
DNA?
Note: Use of certain biological agents requires review and approval by the WSU
Institutional Biosafety Committee (IBC). To determine if this applies to your
research, follow the instructions and complete all applicable forms here:
http://www.oehs.wayne.edu/oeh&s/BioAgents/BioAgentForms.htm
10.
Yes (see note)
Not sure? Contact the WSU Biosafety Officer at 577-1200.
Will the study involve use of plasmid recombinant DNA?
No
Note: Use of certain biological agents requires review and approval by the WSU
Yes (see note)
Institutional Biosafety Committee (IBC). To determine if this applies to your
research, follow the instructions and complete all applicable forms here:
http://www.oehs.wayne.edu/oeh&s/BioAgents/BioAgentForms.htm
11.
No
Not sure? Contact the WSU Biosafety Officer at 577-1200.
Will the study involve use of chemotherapeutic
No – go directly to Q# 12
(cytotoxic, anti-neoplastic) drugs?
Yes
a. Will work with these chemotherapeutic
No
drugs be performed in a WSU-owned
laboratory?
Yes Note: Use of chemotherapeutic drugs require registration
through WSU Office of Environmental Health & Safety (OEH&S). For
more information, contact the WSU Chemical Hygiene Officer at 5771200.
Provide Building and Room Number:
Note: The principal investigator is required to oversee the maintenance of the study drugs, including dates,
quantity, and use by participants.
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Section B: Devices
The FDA can assign a non-significant risk status for a device; however, the Institutional Review Board must
assess the use of that device in a particular protocol. The IRB must do their own risk assessments for:
1. All devices used in a new protocol enrolling human participants in research and/or
2. When a non-approved device is used for single-time (compassionate) use.
See IRB Policy/Procedure: Approved and Non-Approved Devices
12.
13.
Will a medical device be used in this study?
a. Is the device being studied to evaluate its
effectiveness and/or its safety?
“Non-significant risk” device study: Does this
device meet the criteria for a non-significant risk
device study? (For assistance, go to the FDA
website: www.fda.gov/oc/ohrt/irbs/devices.html#risk
a. Provide a justification from the sponsor why the
device does not pose a significant risk, the IDE
exemption category number, and/or a copy of all
FDA or sponsor documents supporting this
justification.
Note: If the IRB determines that the device is of
significant risk, an IDE number will be required.
No – STOP, Appendix F is complete
Yes
No – STOP, Appendix F is complete
Yes
No – go directly to Q# 14
Yes
Justification:
Exemption category #:
FDA/sponsor documents are
attached:
No
Yes
b. Briefly describe reports of prior investigations with
this device.
c. Abbreviated IDE review:
Device Labeling:
Studies that pose a NonSignificant Risk must
IRB Approval:
comply with the
abbreviated review
requirements under 21 CFR Informed Consent:
812.2(b). Please indicate
your plans to comply with
Monitoring:
these requirements as
follows:
Records and
14.
Reports:
Further information and a
description of these
requirements is available in the Commercialization:
“Handbook for Investigators”
available on the IRB website. If
more space is needed, please
attach a separate page.
“Significant risk” device study: Please provide
Justification:
justification for it’s use
Does this device meet the criteria for a significant
No – answer Q# 14a
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risk device study?
a. If no, is this a new indication for the use of this
device (e.g., new use, new participant
population)?
b. If yes, is this an FDA approved device?
15.
Provide the Investigational Device Exemption (IDE)
number and attach a copy of the IDE approval letter.
Note: approval cannot be granted until receipt of the
exemption number.
16.
17.
Exempt from requirement to have an IDE:
If the FDA has NOT provided an IDE number for the
above indication, justify why their review is not
required. Include the IDE exemption category
number and/or a copy of all FDA or sponsor
documents supporting this justification.
Refer to the IRB website, “Helpful Links”, for FDA
requirements:
www.fda.gov/oc/ohrt/irbs/devices.html#risk
If the IRB determines that the device is classified as
significant risk, an IDE number will be required.
Describe the device accountability plan that includes
receiving, storing, securing, dispensing, final
disposition and accountability of the device.
Note: The principal investigator is required to oversee
the maintenance of the device, including dates and
use by participants, and disposal.
Appendix F
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Yes – answer Q# 14b
No
Yes
No
Yes
Number:
Issue Date:
No IDE number – answer Q# 16
IDE exemption category number:
Justification for exemption:
FDA or sponsor documents are attached to
support this justification?
No
Yes
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