CUMC IRB

Provided below is Columbia's sample text that should be included in consent forms that involve genetic testing or research.


Genetics Research

Your blood or tissue sample will be tested for genetic factors that may relate to [an increased risk of developing a disease, an increased chance of disability, etc.] in you or your offspring. [State the specific test(s) to be done, i.e. specify phenotype.]. Genetic factors are personal traits or characteristics that are inherited and run in families. The information obtained from these tests will include genetic information about you. To protect your identity, we will give your sample(s) a unique code number. Your name will not be linked to this code number. Your sample(s) will be analyzed with those of other research participants and the results will be combined in such a way that your sample(s) cannot be specifically identified and linked to you personally.

[If there is a level of certainty that positive test results indicate the individual has or is predisposed to the condition being tested for, use the following statement.] If there is a positive test result, you may want to undergo further independent testing and/or consultation with specialist physicians and/or genetic counselors. Genetic consultation and counseling are not provided through the study, however. You should be aware that insurance companies sometimes use information from genetic testing to deny coverage to applicants.
[If there is no level of certainty about the significance of positive test results, use the following statement.] Because the possible significance of any results of this genetic research is not known, the results of these studies will not be given to you. You should be aware that insurance companies sometimes use information from genetic testing to deny coverage to applicants. This study involves research in genetics that could be used to develop such genetic testing in the future. At present, any information obtained from this research cannot be considered to provide meaningful information about the health of a study participant. Therefore, if you decide to participate in this research study and agree to genetic research, and if you are asked, you should state that you have not had a genetic test.

Please initial the appropriate statement to indicate whether or not you give permission for genetic testing.

YES __ NO __ I agree to have my specimen [blood, tissue] used for genetic research as described above.
 

May 12, 2004