The NCMRR Genetics Core requires that all projects/protocols to be processed and/or funded by the Core obtain IRB approval at their home institution prior to the initation of the project.  Where informed consent is needed the following components must be included for protocols using the NCMRR Genetics Core.  Please feel free to contact us or your local IRB with any questions about when informed consent is needed or for suggested wording to incorporate the items below into your informed consent:

* The overall purpose of the study and why the focus population was chosen (inclusion/exclusion)
* The use of the sample in the proposed study
* Procedure (including how and where)
* Risk and Discomfort: which include for each procedure in the study, eg. blood draw, buccal swab, ID unknown health concerns, sample storage, genetic testing
* Benefits specific to genetic testing
* If and how the participant can have the sample destroyed if she/he decides they no longer what to be involved in the research
* How the sample will be stored (identifiable/de-identifiable/anonymous)
* If results will be reported back from the proposed study and future uses of the sample


The following are optional additions which we feel may be beneficial to include but is not a requirement for us to have in consents for NCMRR studies at this time. Your institution may have additional requirements not mentioned in this listing (we would be happy to review them with you).

* PHI banking: where, how & who has access
* HIPPA (confidentiality)
* Ownership of the sample
* Patient Advocate contact
* A section describing what will happen with sample (DNA or PHI) if participant only completes part of the study and does not request to drop out in writing, which may be indicated as required in the consent
* Voluntary Participation/alternatives to participate
* Who to contact with questions
* DNA banking: this includes content of where and how sample will be stored, what testing will be done, if it will only be done for this study or give participants the options for allowing other studies to be done with de-identified samples
* If results will be reported back from the proposed study and future uses of the sample
* The potential future use (or limitations on the future use of this sample)
* Potential for investigator to profit and plans to compensate subjects (and if none state as such)

We do realize that these items listed above may not be current requirements from your IRB and for some investigators this may require a minor or major modification be submitted to their IRB before studies begin, which means more work in the long run. However, we do feel that this is an important element for each of the studies for which we provide this service, and feel in the that this requirement further insures the protection of both the institutions involved as well as the participants. We look forward to our collaboration with you and please let us know if you have any questions regarding this matter.