REQUEST FOR HUMAN BIOLOGICAL MATERIALS


Requests for human biological materials for research are regulated by both internal Laboratory of Pathology procedures and the Clinical Center Medical Administrative Series M01-2.

If you are using the 3-part form click here for instructions. The LP and the Medical Records Department jointly created an electronic version of the form NIH-2803-1, displayed in Appendix A of the M01-2 policy. Click here for instructions on using the electronic form. When substituting the single page electronic version in place of the 3-part form, please be sure to print three (3) copies for each application and instruct users to enter any additional data (including signatures) on all three (3) copies. After final signature is obtained on all three (3) forms, one of each copy is sent to:

a. Medical Record Department (10/1N211)
b. NCI/CCR Laboratory of Pathology (10/2B50)
c. Research Record

Intramural investigators, including the Principle Investigator or members of the research team, must use the Intramural Request for Human Biological Materials for Research Purposes to obtain human biological materials for research from stored in the LP archives.

Additional information regarding human biological materials may be reviewed at the Office of Human Subjects Research (OHSR). You may refer to OHSR Information Sheet #17 which summarizes these polices or contact the LP Clinical Laboratory Manager for additional informaton.

Click here for examples and the approval pathways to obtain human biological materials.

OTHER HELPFUL WEB LINKS

• MAS 01-2 Medical Administrative Series / SUBJECT: Procurement and Use of Human Biological Materials for Research
  http://internal.cc.nih.gov/policies/show_policy.asp?pol_number=M01-2

• OHSR Web site
  http://ohsr.od.nih.gov/

• REQUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING HUMAN SUBJECTS (OHSR Exemption Form)
  http://ohsr.od.nih.gov/info/Review_Form.php3

• Protection of Human Research Subjects
  Computer-Based Training for Researchers http://www.nihtraining.com/ohsrsite/cbt/cbt.html

• CC Medical Administrative Series
  http://intranet.cc.nih.gov/mec/mas/index.shtml

• The Standards for Clinical Research Within the NIH Intramural Research Program complements Guidelines for the Conduct of Research in the Intramural Research Program at NIH http://www.nih.gov/news/irnews/guidelines.htm

• A Guide to Training and Mentoring in the Intramural Research Program at NIH http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm. These statements encompass the NIH standards of training, ethics, and conduct for scientists.

• Clinical Research Training Course http://www.nihtraining.com/cc/crt/indexvideo.html
  
  
• Protomechanics: A guide to Preparing and Conducting a Clinical Research Study
  http://www.cc.nih.gov/ccc/protomechanics/index.html
  
  
• Bioethics at the NIH
  http://www.bioethics.nih.gov/
  
  
• Clinical Services in the Department of Clinical Bioethics
  http://www.bioethics.nih.gov/clinical/index.html