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Case study 1:
Is your data safe?

 

Susan has seen an advert asking for healthy volunteers for medical research and is wondering whether or not to volunteer.


Participation involves donating blood samples (from which DNA is analysed) and health information including measurements of her height, weight, bone density and body fat distribution as well as access to her medical notes now and in the future. Doctors and medical researchers will use her DNA analysis and health information when studying the effects of various lifestyles on a number of different diseases like diabetes and heart disease and when developing new drugs to treat them for future generations.

Before deciding whether or not to take part Susan is asked to think about volunteering and to discuss it with her family and friends. Susan is a 48 year old married woman with a brother but no children of her own; her parents have died.

Susan has some questions about taking part. She is concerned that personal information about her health and her DNA could be accessed by hackers and used to discriminate against her by insurers or future employers if she is shown to have a genetic condition. She also wonders about the risks and benefits to taking part.

 

How would Susan’s tissue and information be kept private? 

The information about the Biobank confirms that participants’ confidentiality is maintained by

  • Keeping people’s identity separately from their samples and data with strict control and restricted access
     
  • Cyber security to protect information in databases being accessed by unauthorised means
     
  • All those with authority to access data and samples have signed confidentiality agreements
     
  • Data and samples are coded and are not identifiable by the donor’s identity
 

Who will have access to Susan’s tissue and information?

  • Only researchers who have scientific and ethics approval in place for their research will be able to access samples and information. They may know the age and sex of the donor but will not have access to any personal identifying information.
     
  • These researchers may be working abroad and/or for commercial companies developing new treatments.
     
  • Not all the studies that will be done on the samples and data in the biobank are known about at the present time. Many will be decided in the future.
     
  • Insurance companies and employers will not have access to any individuals’ information or samples.
     
  • Information will not be given to law enforcement agencies unless forced to do so by a court.
     
  • The UK Data Protection Act 1998 standards are adhered to by the biobank. 
     
  • Details about her samples and information will not be shared with Susan herself or her GP, including whether or not she has a genetic condition.
 

What are the risks to taking part?

Risks are minimal. There may be slight discomfort when blood is taken and a small bruise could result later.  A very small dose of radiation results from the scanning for bone density and fat distribution but this is much less than the amount from a routine x-ray. 

 

Are there benefits to participating?

  • There is no benefit to the individual but the information built up from participants will help to understand common diseases and how to prevent and treat them.
 

Susan is reassured by the knowledge that she can withdraw from the biobank at any time in the future and that her samples and data would be destroyed and could not be used in future studies if she chose to do so. Aspects of her data that were part of research studies that had been completed could not be withdrawn but would not identify her. On the basis of this information and having discussed it with her brother and husband, Susan decides that she would be happy to participate in the biobank.  She would like to be part of medical research to help develop treatments for chronic diseases as members of her family have died from heart disease.

 

Case studies

 
Patricia

What could you find out?

Patricia has been diagnosed with breast cancer, and her doctor has asked if she will donate tumour tissue for analysis. She thinks there may be an inherited cause for her cancer – so what could the results mean for her family? 

Baby

What could the long-term impact be?

Baby George has a genetic disorder, and doctors have suggested his parents have their DNA sequenced to help identify his condition. But could they discover issues that might affect children they have in the future?