The University of Iowa
Human Subjects Office

a. Determination of Need for an IND

Manuals

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Studies that involve FDA-regulated products that are submitted without a valid IND number will be reviewed with respect to determining the need for an IND, based on the investigator’s response to questions contained in the New Project application form.

If the UI IRB determines that the study is exempt from an IND and approves the study, the study may begin without submission of an IND application to FDA.  If the UI IRB determines that an IND is needed, the investigator/sponsor must submit an IND application to the FDA and provide documentation of the outcome of the FDA determination to the UI IRB before the UI IRB approves the study.

The UI IRB may consider a study using a drug product that is lawfully marketed in the United States to be exempt from the requirements for obtaining an IND if all the following apply:

  1. The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug; 
  2. If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
  3. The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
  4. The investigation is conducted in compliance with the requirements for institutional review and with the requirements for informed consent; and
  5. The investigation is conducted in compliance with the requirements with regard to promotion and charging for investigational drugs in 21CFR312.7

A clinical investigation involving an in vitro diagnostic biological product that is a blood grouping serum, reagent red blood cells, or anti-human globulin is exempt from the requirements for an IND if:

  1. It is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and 
  2. It is shipped in compliance with 21 CFR 312.160.
  3. A drug intended solely for tests in vitro is exempt from the requirements of an IND if it is shipped in accordance with 21 CFR 312.160.
  4. A clinical investigation involving use of a placebo is exempt from the requirements of an IND if the investigation does not otherwise require submission of an IND
  5. Once the IND is submitted to FDA, the sponsor must wait 30 calendar days before initiating any clinical trials.  During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.  For more information on IND’s, refer to the following link: FDA (CDER) website. UI\VAHCS investigators conducting studies with an IND are required to submit documentation from the sponsor (either a letter or email from the FDA or sponsor, or indication on the commercial sponsor’s protocol) of the IND number assigned by the FDA.  If the IND is an investigator held IND, the entire IND application and the FDA Form 1571 (IND application cover page) are required.  This documentation must be attached to the New Project application in HawkIRB.

Promotion and Charging for Investigational New Drugs (21 CFR 312.7)

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context (e.g. in advertisements, brochures or any recruitment media) that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.  This provision is not intended to restrict the full exchange of scientific information concerning the drug, including the dissemination of scientific findings in scientific or lay media.  Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.

A sponsor or investigator shall not commercially distribute or test market an investigational new drug.  In addition, an investigator should be aware that a sponsor cannot unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.

Charging for an investigational drug in a clinical trial under an IND is NOT permitted without the prior written approval of FDA.  In requesting such approval, the sponsor shall provide a full written explanation of why charging is necessary in order for the sponsor to undertake or continue the clinical trial, e.g., why distribution of the drug to test subjects should not be considered by the sponsor to be part of the normal cost of doing business.

Investigators should include a statement in the “Will it Cost Me Anything to be in this Study?” template section of the Informed Consent Document that there will be no charges for the investigational new drug(s) used in the study.  If this statement is not included in the informed consent document, the UI IRB will only allow its absence if the investigator attaches the prior written approval of the FDA to the sponsor to allow for test subject charges.  This authorization to charge for an investigational drug under this section may be withdrawn by the FDA if the agency finds that the conditions underlying the authorization are no longer satisfied.  In this instance, it is the responsibility of the investigator to submit a modification to the HawkIRB application to include the required statement the informed consent document.  In such cases where charges are allowed, sponsors are not allowed to commercialize the investigational new drug by charging a price larger than that necessary to recover costs of manufacture, research, development, and handling of the investigational drug.  The investigator must be cognizant of this rule when participating in a clinical trial of an investigational new drug.

A sponsor or investigator may charge for an investigational drug for a treatment used under a treatment protocol or treatment IND provided:

  1. There is adequate enrollment in the ongoing clinical investigations under the authorized IND;
  2. Charging does not constitute commercial marketing of a new drug for which a marketing application has not been approved;
  3. The drug is not being commercially promoted or advertised; AND
  4. The sponsor of the drug is actively pursuing marketing approval with due diligence.

The FDA must be notified in writing in advance of commencing any such charges, in an information amendment.  Authorization for charging goes into effect automatically 30 days after receipt by FDA of the information amendment, unless the sponsor is notified to the contrary.