Informed consent for each study participant in the BHCMG project must comply with one of the five (5) options for informed consent that are listed below (1A, 1B, 1C, 2, and 3). Submitters must agree to ensure that each study subject for whom a sample is submitted has consented in a manner that conforms to one of these options. Formal consenting does not need to be carried out until after a family has been accepted into the BHCMG project by review of the BHCMG Phenotype Review Committee. However, before entering medical information into this database you should have secured permission from your patient/family for sharing this information.

In every case, it is up to the submitter to determine whether s/he needs to take additional steps to comply with local regulations and policies.

1.  The strong preference is always to CONSENT THE SUBJECT ON THE BHCMG CONSENT FORM

A.  Submitter can obtain consent from the potential subject directly, utilizing the BHCMG consent form:
This requires that the submitter be listed as a consent designee on the BHCMG's IRB protocol. The submitter must forward a copy of the signed consent form to the BHCMG.

• Johns Hopkins University consent form (PDF)
• Baylor College of Medicine consent form (PDF)

B.  Submitter can have subjects complete the BHCMG online informed consent process:
The submitter is responsible for providing the patient/family member with a consent token (a password that will allow each subject access to their consent form) that we will supply through PhenoDB. As we have no link to identifiable information, the submitter must attest to the fact that the subject themselves, or their authorized representative, completed the electronic consent.

C.  If the Submitter prefers, BHCMG will obtain consent from the study subject on the BHCMG consent form. The submitter is responsible for: a) contacting the patient/family member to obtain permission to have BHCMG personnel contact him/her for the purposes of going through the informed consent process; and, b) providing BHCMG with contact information for the patient/family member. Under this consent option, the treating/referring clinician will provide the potential research subjects our contact number and other logistical elements needed for the consent process.

2.  3^rd Party LEGACY CONSENT: The patient/family member previously signed the submitter's IRB-approved research consent form for research pertaining to the disease present in the patient/family member, and the BHCMG ELSI Committee has reviewed and approved the version/date of the consent form the patient/family member signed. BHCMG ELSI Committee approval must be received for each version of the consent signed by every individual whose sample is being submitted to the BHCMG. The submitter must attest that the content and intention of the previously signed consent, and the submitter's local laws and Institutional policies, allow for submission of the patient's/family member's sample and phenotype data to the BHCMG research project.

• Content Required for 3^rd Party LEGACY CONSENT:
• Mention of genetic testing and/or DNA sequencing
• Clause allowing future use of sample
• Clause allowing transfer of sample to another investigator
• Clause allowing use of de-identified phenotypic information in future studies

3.  3^rd Party PROSPECTIVE CONSENT: The patient/family member signed or will sign the submitter's IRB-approved research consent form for ongoing research pertaining to a disease present in the patient/family member, and the BHCMG ELSI Committee has reviewed and approved the version/date of the consent form the patient/family member signed/will sign. BHCMG ELSI Committee approval must be received for each version of the consent signed by every individual whose sample is being submitted to the BHCMG. The submitter must attest that the content and intention of the consent form from the ongoing project, and the submitter's local laws and institutional policies allow for submission of the patient's/family member's sample and phenotype data to the BHCMG research project.

• Content Required for 3^rd Party PROSPECTIVE CONSENT:
• A clear explanation of large-scale genetic sequencing
• Clause allowing transfer of sample to another investigator
• Clause allowing sharing of the data in protected public database
• Discussion of return of results policy
• Description of scientific aims beyond those described in the BHCMG Consent

I, , agree that for each subject I submit, I will obtain consent according to the guidelines outlined above.