Office of Research Integrity

Guidelines for Research Involving DNA - Additional Items for Informed Consent

Standard Paragraphs Consent for Genetic Research on Biological Samples

Linked, Potential Recontact
Linked, No Recontact
Unlinked, No Recontact

Add to Procedures When There are NO Identifiers (i.e., name, initials, medical record number, code):
Must address the following

  • Sample will be used for genetic research
  • Where the sample is stored
  • Who has access to the sample
  • Inform the subject 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

Add to Procedures When There are Identifiers (i.e., name, initials, medical record number, code):
Must address the following

  • 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
    • 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 contacts 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 counseling will be available provided there is useful clinical information
    • If subjects can chooseNot to receive research results. Can they change their choice?
  • 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?
  • Witness Signature Line No Longer Required

The IRB no longer requires the signature of a witness on all informed consent documents. The IRB will review the need to have a witness sign the informed consent document on a case by case basis. If the IRB deems the witness signature to be necessary, this will be communicated to the Investigator upon review of the protocol.

If the current IRB approved informed consent document(s) in use includes a witness signature, the witness signature is still required.

If an Investigator wishes to remove the witness signature line, an amendment must be submitted to the IRB requesting its removal from the informed consent document(s).

VA PROTOCOLS
If a study is being conducted at the VA hospital using the VA informed consent, the witness signature line may NOT be removed. VA regulations require the signature of a witness.

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

  • Are there Special Risks?
    • 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
      • Labeling
  • Family Relationships
  • Confidentiality
  • Insurability
  • Employment
  • Paternity Suits
  • Unknown Risks