Introduction to Informed Consent [Archive] by Learning Design at UTS

"client should be informed about in order to consent fully during a genetic counselling session."

2024-03-16 02:30:48 UTC

What gene or panel is being looked at in testing, i.e. that testing is only looking at these genes not every gene

Possible outcomes of testing, a pathogenic variant (pv) is identified, no pv or there could be a variant of unknown significance

Implications of each possible finding including discussion of testing for family members, screening and cancer prevention if there is a pv found.

Discussion of no testing for family members if no pv is identified

Discussion of implications of a VUS, no further testing

Testing is only able to use current knowledge and technology, there maybe over genes that we don't yet know of.

Insurance implications: discuss concerns about impact on life insurance policies or income protection, there is a moratorium in Australia

Results

Providing results back the patient, nominate a second person to receive the results if its found the patient is no longer contactable

Do they consent for their result to be used in the testing of other family members

Discuss communication to family members about the availability of testing, the test results may have implications for family members who are not aware that testing is occurring

Sharing of results with doctors and medical record

Storage of the blood sample

Discussion of how long results will take for the next appointment

Discussion if there are any treatment implications for the result

Informed consent

2024-03-17 11:09:05 UTC

I think here are the points that need to be included:

1) The test is out of voluntary.

2) The information of genetic testing, including gene(s) in interest, the purpose, benefits & limitations of genetic testing.

3) The possible results.

4) The implications of genetic testing toward the client and family.

5) The process, turnaround time and cost for genetic testing.

Sample/s and data storage and access should be detailed as part of the consent process. For example, how samples and data will be stored, who has access and whether there will be any third party access to these or whether samples/data will be sent abroad and/or be used commercially.

2024-03-17 22:01:16 UTC

Component of Informed Consent

2024-03-18 00:55:47 UTC

(1) Explanation of the tests and their purposes

(2) Description of risks and benefits

(3) Information on what future decisions participants might be asked to make, including the possibility of medical intervention

(4) The amount of time from patient registration to report delivery

(5) Data storage and data sharing

I

2024-03-18 09:03:42 UTC

A client should be informed of the following in the genetic test informed consent form:

1) What type of test being done and the processes (eg. germline test done via blood or saliva looking for alterations in the genes being tested for related cancers)

2) Possible results of a genetic test (eg. Positive, Negative or Variant of Uncertain Significance)

3) Implications of the genetic test to self and family members

4) Confidentiality of patient data protected