Normal Blood, Bone Marrow and Buccal Mucosa Protocol
Condition: Non-atopic; Atopic; Healthy; Normal; Allergy
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      This protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples
      from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells,
      mastocytosis, and allergic diseases. Non-atopic donors will be recruited to donate blood,
      bone marrow, and/or buccal mucosa samples using conventional techniques. The investigational
      nature of the studies in which their blood, bone marrow and buccal mucosa samples will be
      used, as well as the risks and benefits of the donation process will be explained to all
      donors, and a signed informed consent document will be obtained. Donors will be compensated
      according to an established schedule based on the duration and discomfort of the donations.
      Samples provided through this protocol will be used solely for in vitro research. Blood, bone
      marrow, and buccal mucosa samples will be assigned a unique product number and the study
      investigators listed on this protocol will serve as the custodians of the code that links the
      product with a donor s identity. The nature of the in vitro studies in which the blood
      collected in this study will be used is not the subject of this protocol and will be
      described in general terms only. The samples will be used in several Institutional Review
      Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is
      designed to assure adequate and complete informed consent, counseling, and protection of the
      study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human
      Research Protections (OHRP) and other applicable Federal regulatory standards.
    

Detailed description: 
      This protocol is designed to provide blood, skin, stool/rectal swabs, buccal mucosa and bone
      marrow aspirate samples from approximately 250 healthy volunteer donors for use in in vitro
      studies such as studies of cells of the immune system, mastocytosis, and allergic diseases.
      Participants will donate samples using conventional techniques. The investigational nature of
      the studies in which samples will be used, as well as the risks and benefits of the donation
      process, will be explained to all donors, and a signed informed consent document will be
      obtained. Donors will be compensated according to an established schedule based on the
      duration and discomfort of the donations. Samples provided through this protocol will be used
      solely for in vitro research. Samples will be assigned a unique product number, and the study
      investigators will serve as the custodians of the code that links the product with a donor s
      identity. The nature of the in vitro studies in which the blood collected in this study will
      be used is not the subject of this protocol and will be described in general terms only. The
      samples will be used in several Institutional Review Board (IRB)-approved Laboratory of
      Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete
      informed consent, counseling, and protection of the study subjects according to IRB, Office
      of Human Subjects Research Protections, Office for Human Research Protections (OHRP) and
      other applicable Federal regulatory standards.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary Clinical
      
Biospecimen description: 
      Whole blood, serum, white cells, stool, buccal/nasal/skin swabs, saliva, and tissue
    
Keywords: Skin; HV; Allergy; Healthy Volunteer; Non-atopic