Biospecimen Collections in the Proprietary Period
The NHLBI Biorepository contains biospecimens from studies which are in the Proprietary Period, a period of time in which the biospecimens are stored in the NHLBI Biorepository prior to their availability for sharing according to the NHLBI Data Set sharing policy timeline. The current list of Proprietary Study biospecimen collections and their Parent Study contact information is listed below.
- A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus with Tacrolimus/Methotrexate as Graft-Versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN 0402) (https://web.emmes.com/study/bmt2) (Alan Howard, firstname.lastname@example.org)
- ARDS Clinical Network Prospective, Randomized, Blinded, Placebo-controlled, Multi-center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury or Acute Respiratory Distress Syndrome ARDS (OMEGA) (http://www.ardsnet.org/)
- ARDS Clinical Network Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol versus Placebo for the Treatment of Acute Lung Injury (ALTA) (http://www.ardsnet.org/)
- Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Comparing Peripheral Blood Stem Cell Transplantation Versus Bone Marrow Transplantation in Individuals With Hematologic Cancers (BMT CTN 0201) (https://web.emmes.com/study/bmt2) (Alan Howard, email@example.com)
- Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin's Lymphoma (BMT CTN 0401) (https://web.emmes.com/study/bmt2) (Alan Howard, firstname.lastname@example.org)
- Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102) (https://web.emmes.com/study/bmt2) (Alan Howard, email@example.com)
- Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) (https://web.emmes.com/study/bmt2) (Alan Howard, firstname.lastname@example.org)
- Cardiothoracic Surgical Trials Network (CTSN) (http://www.ctsurgerynet.org/) (Albert Lee, email@example.com)
- Early Versus Delayed Enteral Feeding to Treat People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN Study) (http://www.ardsnet.org/)
- Hemostatic Factors in the Coronary Artery Risk Development in Young Adults (CARDIA) Study (http://www.cardia.dopm.uab.edu/)
- IPFnet Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis (STEP-IPF)
- Pediatric Heart Network Trial of Pulse Steroid Therapy in Kawasaki Disease (http://www.pediatricheartnetwork.or...)
- Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients with Cardiovascular Disease (FOCUS) (Jeffrey L Carson, MD, firstname.lastname@example.org)
- Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) (http://www.topcatstudy.com/) (Akshay Desai, email@example.com)
Investigators are urged to refer to Section 4.0 of the Handbook for detailed information on the application process for Proprietary Period studies. The following steps briefly describe the process:
Contact the Parent Study to initiate the discussion regarding your request. Minimum document requirements for Parent Study evaluation include your research plan, your CV, and evidence of your funding to perform the research. Ethical and legal considerations will be assessed as per Parent Study policy. You will also need to provide the Parent Study with your Parent Study Approval Form so that they can document their review and approval.
STEP 1: When the Parent Study has completed its review and has provided the electronic manifest of the biospecimens they have selected for you, you are ready to submit your request into BioLINCC. Selecting Submit Proprietary Study Request will bring up the application screen (You must be a registered user to apply. Register now.).
STEP 2: Complete the required elements of the Proprietary Study Request. These include your administrative and contact information, shipping information for the biospecimens, and a FedEx account number to pay for shipping to you. Select the name(s) of the Proprietary Study(ies) you are interested in from the drop-down box. Finally, the following documents are required attachments to your application:
- A scanned image of the signed Parent Study Approval Form
- An electronic manifest listing of the approved biospecimens, generated by the Parent Study
- Your full or expedited IRB approval for the proposed research
STEP 3: You will be notified when the BSI Inventory Confirmation Report has been generated. It is your responsibility to forward the Report to the appropriate Parent Study staff for their review and approval on the sign-off cover sheet to the Report. If there are discrepancies, the Parent Study is responsible for providing you with a complete replacement electronic manifest and this process will be repeated.
STEP 4: Scan the Parent Study-approved BSI Inventory Confirmation Report sign-off sheet and upload it to your request. The selected vials will be reserved and a Research Material Distribution Agreement (RMDA) will be posted for you to download, have signed and upload back to your request application.
STEP 5: When all requirements have been met, BioLINCC will forward your request for final approval by NHLBI. Upon receipt of NHLBI approval, BioLINCC will release your requisition to the NHLBI Biorepository to initiate the requisition/shipping process.