Emergency or Treatment Use of Investigational New Drug
Emergency Use of Investigational New Drug (IND)
Some drugs that are generally considered beneficial and relatively safe may remain in the investigative category for years because of the prolonged period of investigation required prior to FDA approval. Other agents of proven benefit may remain investigational because the market for them is too limited to justify the expense of approval and/or marketing. For this reason, emergency INDs are available from the FDA when a patient has a life threatening illness, there is no acceptable standard treatment, an investigative drug is possibly life saving and there is no time for prospective IRB review.
Following are the steps to be taken for emergency use of an investigative drug:
- Request the drug source, usually the manufacturer, to provide it.
- If the drug source is unable to grant permission, i.e. it has no FDA approved protocol, obtain FDA permission by telephone (see Appendix 13 for telephone numbers).
- Obtain IRB verbal permission from a physician member of the IRB, who will so inform the IRB office on the next work day.
- Obtain emergency written informed consent using the DCH form (Appendix 15).
- Provide copies of the completed consent forms to the pharmacy, IRB office and parents.
- Send brief summaries of the justification and outcome to the IRB office within five (5) days.
- If the drug is needed more than twice, apply for a treatment
IND.
Emergency Use of an Investigational New Drug FDA 21 CFR 312.36
http://www.fda.gov/oc/ohrt/irbs/drugsbiologics.html#emergencyFDA forms that are necessary to be filled out can be obtained by clicking on the link below:
Treatment IND
A qualified physician must request a treatment IND from the FDA or request
participation in an FDA approved treatment protocol from the drug sponsor
when an investigational drug is needed more that twice for a serious, life-threatening
illness for which there is no satisfactory treatment. The drug must be already
under investigation and the sponsor actively pursuing marketing approval.
The physician should first contact the sponsor to determine if there is
an "open label" or a treatment IND protocol available for the physician's
participation. If not, the physician can apply to the FDA for sponsorship
of a treatment IND. The FDA investigator and sponsor forms along with instructions
are available in the IRB office or from the FDA.
The physician then submits the protocol and consent form to the DCH IRB
even though the purpose is treatment instead of research. All rules regarding
case records, annual and final reports, consents, amendments and reports
of serious or unexpected reactions are applicable as in a research study.
Treatment Use of an Investigational New Drug. FDA 21 CFR 312.34:35
http://www.fda.gov/oc/ohrt/irbs/drugsbiologics.html#treatment
How to Reach Us
The Driscoll Children's Hospital Institutional Review Board is available to provide information and guidance to participants in clinical research studies and their families regarding their rights as Human Research Subjects. The Institutional Review Board is available to advise and inform investigators who are submitting clinical research protocols and monitor approved research activities in its jurisdiction.
Jucel Nazareno, BSN, R.N., IRB Monitor
(361) 694-4619
Fax: 361-694-5466
Institutional Review Board
Driscoll Children's Hospital
3533 South Alameda St.
Corpus Christi, TX 78411
(361) 694-5000
Statement of Compliance
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