NCI-Frederick Research Donor Program

REQUESTING PROJECT APPROVAL

Dr. Michael Dean serves as Principal Investigator on the RDP protocol. Dr. Janelle Cortner serves as protocol chair. Investigators may obtain permission to receive blood samples through the RDP by submitting a Memo of Request to Dr. Cortner. SAIC 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. Specifically:

• 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.