Requesting Project Approval
Dr. Janelle Cortner serves as Principal Investigator and Protocal Chair on the RDP protocol. Investigators may obtain permission to receive
blood samples through the RDP by submitting a Memo of Request
to Dr. Cortner. Leidos investigators who require such samples must submit a request
memo to Dr. Cortner. This memo should describe the nature of the research in sufficient
detail to verify that the samples will not be used to screen for genes or conditions
of known clinical relevance or be used in a manner inconsistent with program restrictions.
- Samples may not be used to conduct studies, such as screening for certain disease-associated
alleles, pathogens or conditions, designed to reveal information of known clinical
relevance or implication. Investigators wishing to re-contact donor(s) for additional
samples when preliminary work suggests a clinically relevant research question must
seek guidance from the NIH Institutional Review Board (IRB) as to whether additional
samples from this population may be obtained and whether a separate, study-specific
protocol should be initiated.
- Coded samples may be provided if required by the nature of the research. Donor codes
will be securely maintained and under no circumstances will donor identity be released
to Investigators. In the event that an Investigator, supported by this protocol,
makes an unexpected finding with potential clinical relevance, such as susceptibility
to an inherited or other disease or the identification of novel infectious agent(s),
the IRB will be contacted to determine whether the donor will be informed and, if
so, how to proceed.
- Studies that require obtaining samples from donor family members will not be supported
by the RDP. If preliminary work gives rise to a research question requiring collection
of samples from donors' family members, the Investigator shall inform the IRB and
seek IRB approval for further use of samples from this population.
Please e-mail Dr. Janelle Cortner,
or call her at Ext. 5712, with questions about receiving approval to obtain samples
through the RDP, or to address any other human subjects research questions.