Identified medical records can be used for research if the patients have given informed consent for a specified use of the data.
Institutions conducting human subject research with consented records should be able to answer these informatics-related issues, many of which involve tracking transaction data:
1 Does each consent form have an identifier and a locator, a study number, and a data element indicating that the consent form itself was approved by an IRB?
2 If needed, could you put your hands on the physical consent document?
3 Does your database indicate the specific study for which consent was approved?
4 Was the consent form sufficiently detailed, allowing the patient to approve certain uses of specimens/data and decline other uses?
5 Is each consent tagged with tracking data?
6 Was the consent approved or declined?
7 What day was the consent signed?
8 Does the institution have a policy that applies to situations wherein a subject cannot provide an informed consent (e.g., infants, patients with dementia)?
9 If the institution has a policy of excluding certain classes of patient from providing informed consent, has the institution received approval for the policy from its IRB?
10 For children and challenged subjects, was the informed consent document signed by a surrogate?
11 For children and challenged subjects, how is it determined who may act as a surrogate, and how is the identity of the surrogate recorded and tracked?
12 Did the consenting subject change her mind and withdraw consent after consent had been approved?
13 If consent was withdrawn, what date did this occur?
14 If consent was withdrawn, was consent withdrawn for a particular use of a specimen/data, or for all purposes described by the consent document?
15 If consent was withdrawn, does the withdrawal of consent apply to more than one consent form?
This list was excerpted from my book, Biomedical Informatics.
- Jules Berman tags: informed consent
