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Date:
To: DCH Institutional Review Board for Protection of Human Subjects
(IRB)
From:
Research Study or Treatment:
Enclosed is a protocol for this research study or treatment, submitted
to the IRB for its approval. Unless exempted by the IRB, an informed consent/assent
form is also enclosed that conforms to Driscoll Children's Hospital (DCH)
guidelines.
If this study includes use of a drug or device classified by the FDA
as experimental or investigative the IND sponsor is and a statement of
the sponsor's IND number and approval of my use of the drug or device
is attached. If I am or intend to be the IND sponsor, a copy of my application
to the FDA for an IND is attached. This applies to treatment as well as
research use of an investigative or experimental drug or device.
I have read and understand Title 45, Code of Federal Regulations (CFR),
part 46 and Title 21, CFR, parts 50, 56, and 312. My listed co-investigators
and I will comply fully with these regulations and with the directions
and requirements of the DCH IRB. This includes the following, but does
not exclude other requirements.
- The listed investigators will personally explain the
research protocol or investigative treatment protocol to each subject's
parents or guardians and personally sign the consent along with the
parents or guardians and a witness not involved in the study. The original
of the consent will be placed in a section of the permanent medical
record entitled "Research Consent", a copy given to the parents, a copy
sent to the pharmacy if a drug is involved, and a copy placed in the
principal investigator's file.
- If an experimental or investigative agent is to be
used, the agent will be placed under control of the pharmacy to be dispensed
only to patients with appropriately documented consents who are registered
with the IRB.
- Any and all alterations in the protocol or consent will
be submitted to the IRB for approval prior to implementation.
- Case records of each subject, including history, physical,
x-ray reports, lab reports and a copy of the consent will be kept by
the investigator. These will be up to date and available for inspection
by the IRB or its authorized agent whenever requested.
- A copy of the protocol will be inserted into the subject's
permanent medical record when the patient is registered on the protocol
in a section marked "Research Protocol". If the patient is readmitted,
this protocol and consent will be included in the in-patient record
if the subject is continuing on the protocol. A required color-coded
research tab must be filed/placed in the first position before the PATIENT
DATA/DISCHARGE tab which is the very first tab. Tabs may be obtained
from Jucel Nazareno, RN, IRB Monitor, in the IRB Office. Contact phone
number is (361) 694-4619.
- The principal investigator will submit an annual report
to the IRB approximately one month before the anniversary date of the
initial IRB approval of the protocol using the format provided for that
report. Approval of the continuation of the protocol study or treatment
will be determined by the IRB annually or more often.
- Serious or unexpected adverse drug or device reactions,
as defined by the FDA, will be reported promptly to the IRB, the sponsor
and Risk Management.
I understand that IRB members are always available to assist the co-investigators
and me in complying with the ethical demands implicit to conducting
research or investigative treatment in infants and children. I also
understand that my co-investigators and I can be subject to sanctions
for neglecting to comply with federal, state or hospital regulations
concerning research.
Sincerely,
Principal Investigator: __________________________________ |
Date: ______________ |
Co-Investigators and Coordinators:
_______________________________________________ |
Date: ______________ |
_______________________________________________ |
Date: ______________ |
_______________________________________________ |
Date: ______________ |
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