MUSC IRB FOR HUMAN RESEARCH

Additional Items for Informed Consent for Research Involving DNA

Add to Procedures When There Are No Identifiers (i.e., name, initials, medical record number, code):

• Sample will be used for genetic research          
• Where the sample is stored              
• Who has access to the sample              
• Inform the subject that since there are no identifiers:      
  -They will not be told the results of the study    
  - They will not be able to withdraw sample at a later date

• How the sample is linked to the subject
• What the security measures are for storage of samples/data
• Who has access to samples/data
  - Investigator
  - If others, list the others -- Specify who and under what conditions          
• If sample/data will be used for other purposes than this research
  - If so, what are the other purposes?
  - Will a new consent be obtained for this research?
• If sample/data will be destroyed at a future date -- When?
• If subjects will be contacted at a future date for more information:
  - What kind of information
  - How subjects will be contacted
• If there are limitations to withdrawal of consent for use of sample/data, describe.
  
• If research findings are disclosed, state:
  - To whom this information can be released.
  - How disclosure will be done.
  - If there is no useful information of relevance to subjects.
  - If genetic counselling will be available provided there is useful clinical information.
  - If subjects can choose not to receive research results. Can they change their choice?
  - Under what circumstances the information will be released to others.
• If there is a possibility of commercial value, state:
  - If the subjects will receive a portion of profits.
  - If they will be asked to waive control over sample/data. If they refuse, will they be allowed to participate?

  If any of the following apply to your research project, then address:

  Are there special risks to:

  - Psychological risk

  -anxiety about discovery of unwanted and uncertain information about future disease risks
  -Impact of no effective therapy
  -Stress for family members

  - Social risks

  -Stigmatization
  -Discrimination
  - Labelling

             - Family relationships
             - Confidentiality
             - Insurability
             - Employment
             - Paternity suits
             - Unknown risks