Home Best Practices Recommendations

Our recommendations for best practices

Donor Protection Issues

• The consent procedure should be voluntary (consider the timing of the informed consent discussion, the vulnerability of surgical patients, the place for the discussion)
  
  
• The consent procedure should be in understandable language
  
  
• Tiered consent should be offered when appropriate that includes:
• choice of type of sample: blood, tissue, etc.
• level of identification : anonymous, de-identified and unlinked, de-identified and linked to medical info
• type of access to medical information: retrospective or prospective
• type of research: general, related to one's disease, genetic research
  
  
• The informed consent discussion should only be conducted by well-trained research nurses or other staff who are not also involved in clinical care. This is to eliminate any appearance of coercion or other conflicts when the clinician is the investigator.
  
  Informed consent discussions should be accompanied with brochures that clearly outline the consent information and additional information in more detail about genetic research, genomics, commercial repositories and their relationship to the medical center. This information should be given to donors along with the offer of follow-up questions.
  
  
• Tissue collection should not, in any way, affect patient care
  
  
• The consent discussion should include the following disclosures:
  • storage time (How long will tissue be stored and, in cases of linked tissue, the link maintained?)
  • research objectives (specific research? general research?)
  • the possibility of genetic research (if applicable and clear explanation of the scope of genetic information)
  • the commercial nature of repository (its name, location, brief description of its relationship to the medical center)
  • that tissue may be used to develop commercial products (e.g., others could profit from this tissue)
  • that derivative products may be made from the tissue ( a single sample could have many end-users)
  • typical end-users (including the possibility of international end-users)
  • risks (including genetic privacy risks)
  • benefits (no direct benefits to the donor, no clinical benefits and no financial benefits)
  • mechanism for maintaining privacy of medical records and tissue
  • the mechanism for de-identifying tissue
  • description of who has access to coding information and where (hospital? repository? elsewhere?)
  • Certificate of Confidentiality
  • contact information for withdrawing tissue or ending linkage to medical information
  • statement of whether donors will be recontacted with research information
  • that the repository and/or the medical center will have appropriate review of research proposals to ensure that tissue and information is used only for legitimate research
  • that the medical center will have an oversight committee to review collection procedures

Institutional Integrity Issues

• Oversight
• IRB review of collection protocols and of end-users' research)
• An independent audit of consent processes and linking protocols
• A medical center steering committee to:
  • monitor number and kinds of access to linked medical records
  • tissue collection issues, patient complaints, repository requests, etc.
  • monitor the separation of collection from patient care
  • monitor potential financial conflicts of interest
  • an exit strategy should the repository stop collecting tissue on site or declare bankruptcy (how will donor tissue/information be protected of repository is sold or closes or ends collecting on site but remains in business?)
• Assessment of access agreements the repository requires of end-users
• Assessment of repository’s oversight committees (IRB and/or ethics advisory board)
  
  
• Role of Community
  • Community perceptions and participation are important in collaborations for without the good will of the community, patients will not be interested in participating in tissue donation. Community members should be allowed to participate in public forums as well as have representation at key meetings throughout the process.
  • Consider a benefit sharing plan with the community should there be any profits from repositories. Since donors do not benefit from tissue donation, a benefit sharing plan can offer the community some return on their good will such as support for local research or educational activities.
    
    
• Handling financial incentives and profits
• separation of tissue collection from patient care
• separation of profits/benefits from those cutting the tissue and involved with patient care