Obtaining Tissue from the CHTN

The process is not difficult once you have located the key persons with whom to deal.

1. Obtain a packet with forms from CHTN. Phone them at (215) 662-4570 or obtain it from the Web site: http//www.CHTN.ims.nci.nih.gov
   
   
2. Fill out the forms using the following general information: Part II: Self-explanatory
   
   Part III: Funding. Circle 1.
   
   Part A. Fill in Institute, Division, Intramural Research Program.
   
   Period of support is the current fiscal year.
   
   Attach a 2-3 page (max) summary of the research proposal. (Use the same one sent to the IRB).
   
   Part IV (fill out a separate page for each tissue type requested): Call Ms. McGarvey at CHTN and discuss your needs. She will tell you how best to fill out the request form. Be realistic about the size of the samples you want, especially if several procedures are going to be performed. If you want fresh frozen material, indicate that it should be frozen as soon as possible.
   
   
3. AGREEMENT FORM: The "Official Authorized to Sign for the Agency" is the Laboratory or Branch Chief.

1. Dr. Susan Nayfield chairs the NCI IRB that is willing to handle these requests. She is very helpful. Unless you have specific problems or questions, you need not bother her. Just follow these directions. To get the dates for the IRB meetings, call Lynn Sayers 496-9600. They like the applications to be in to them 2 weeks in advance. New procedures may allow these requests to be handled on an accelerated basis that does not require convening the full IRB. Ms. Sayers will notify you if your request qualifies.
   
   
   
2. Obtain NIH form 1195: Clinical Research Protocol INITIAL Review Application. This can be downloaded from the WEB at http//www.mrd.cc.nih.gov/pcsc/protomechanics/pdf/NIH-1195.pdf
   
   If more than one PI is involved, only one person should be so designated for the 1195. Other PIs should be listed under the Associate Investigators and designated a co-PI.
   
   
   
3. A research proposal needs to be included. This proposal must be approved, in writing, by the Scientific Director of your Institute or Division (Lab or Branch Chief signature is not good enough). The proposal is 2-3 pages long (max). It should include a little background, what you intend to do, how many samples you will obtain and how they will be obtained (through the CHTN). Be sure to state in the proposal that the tissues will be obtained from CHTN as anonymous.
   
   
   
4. The packet to send forward consists of:
   
   
   • 1195 form
     
     
   • Memo to Dr. Susan Nayfield as chair, SSIRB, requesting review and explaining that the CHTN requires IRB review.
     
     
   • Precis (1 paragraph summary of the project).
     
     
   • Consent documents are requested from Dr. Nayfield. However, the CHTN does not have consent forms since their material is considered "waste". Therefore I included a photocopy of the information I received in the CHTN packet entitled "Announcing Specialized Banks in the CHTN" and "Changes in IRB Requirements."
     
     
5. Sign the form (first line), have your co-PI sign it (or sign it yourself on the second line if you are the only investigator), have your Lab/Branch Chief sign it, get the Scientific Director (ICD Internal Scientific Review) to sign. The Clinical Director need not sign it.
   
   
   
6. Make 17 copies of the package and send to Lynn Sayers at EPS Room 214.
   
   
   
7. You or one of your co-PIs should be prepared to be present at the IRB meeting to answer questions about the proposal. Ms. Sayers will notify you if you are to attend and the time and place.
   
   
   
8. It will then take up to a month to receive the final copy of the IRB approval form with a protocol number assigned. FAX this to the CHTN and you can begin to receive the samples.
   
   
   
9. Once you have obtained all of the samples from the CHTN, inform the IRB (Dr. Nayfield) so that the protocol can be removed from the files and follow-up need not be done.