Use of human tissue-biobank

Aim

To ensure human tissue is handled in a responsible manner

 

Requirements

  • Approval of the project/biobank by a METc or biobank committe

 

Documentation

  •  Documents submitted to the METc
  • Approval of the METc
  • Data and tissue protection procedures
  • MTA (if applicable)
  • Agreements with analysis laboratory

 

Responsibilities

Executing researcher: Fill in the forms of the biobank application
Project leaders: Carry responsibility for the biobank application
Research assistant: N.a.

 

How To

Human tissue: All tissue derived from humans with the exception of foetal tissue, embryos and gametes.
All research project with biomaterials must be approved bij the METc if the project falls under the remit of the human subject act. Projects not under the act and in VUmc must be approved by the VUmc biobank committee. See the website for more information, application forms and procedure.
Visit the biobank website of the VUmc for the in house facilities and procedures

 

Use of tissue with informed consent

A research project utilising human tissue obtained with informed consent from the participant must always be approved by the METC. Either the wmo procedure must be followed or one of the other procedures of the METc, see the website for procedures

 

Further use of tissue with an opt-out procedure

In e.g.  hospitals human tissue is stored for diagnosis and treatment of patients. Under de code of conduct for responsible use of human tissue it is possible to use some of this material for scientific research. The summary of the conditions:
  • The research protocol must be approved by the METc, see the website for procedures
  • It is reasonably not possible to obtain consent from the donor
  • The donor is informed about the possible use of his material for scientific research
  • The donor did not object to the use of his material
  • The material and data are coded by the custodian prior to delivery of the material to the researcher
  • A material transfer agreement (MTA) is signed between custodian an the responsible researcher

 

Dealing with findings

Findings are results of scientific research with human tissue which are considered to be of immediate important for the future health of the individual donor. Prior to the start of the research project the dealing of findings, expected or unexpected must be addressed, in the research protocol

 

Appendices/references/links

Human Tissue and Medical Research: Code of conduct for responsible use 2011 (Federa)

 

V2.1: 22 march 2017: Reference to VUmc biobank procedure
V2.0: 4 sep 2015: Revision format and updated to new code of conduct
V1.1:  1-1-2010  Translation into English and updated