Table 2.

Key elements of MGB Biobank informed consent form and fact sheet.

Consent Section	Consent Form Topic	Fact Sheet Topic
Purpose	Study how genes and other factors contribute to disease	Yes
Procedures	Fresh blood biospecimen (up to 5 tubes) and future discarded specimens (blood, urine, tissue)	Yes
	A possible future biospecimen of up to 3 tubes	Yes
	Biospecimens linked to electronic health record	Yes
	Questionnaires about health behaviors and family history	Yes
	Re-contact for other information or studies	No
Research Conducted	Biological and genetic research	Yes
	DNA analysis and how changes in DNA affect health	Yes
Return of Results	Return of results is unlikely, but participants may receive research results of high medical importance	Yes
	Contacting participants and/or their providers with results and/or placing results in a participant’s medical record	Yes
	Single gene variants	No
	Polygenic risk scores	No
	Pharmacogenetics/how genes influence response to medication	No
	Results unrelated to health that may be of interest to participants	Yes
	Research results are not the same as clinical tests	Yes
	Patient and insurer may be responsible for costs of tests and follow-up care	No
Benefits	May not directly benefit, but may help us understand, prevent, treat, or cure disease	Yes
	May directly benefit if researchers find results that are important to a participant’s health	Yes
	There is no payment for biospecimens	No
Biospecimen and Information Storage	Biospecimens are de-identified and the key to decode is stored securely	Yes
	Biospecimens and data are stored indefinitely	No
Researchers with Access	Mass General Brigham investigators	Yes
	Researchers at non-Mass General Brigham institutions must work with MGB investigators to obtain access to de-identified biospecimens	Yes
	For-profit companies must work with Mass General Brigham investigators to obtain access to de-identified biospecimens	Yes
	Central biobanks who may share coded biospecimens and data with other researchers	No
	Biospecimens will not be sold for profit	No
Withdrawing	Participants can withdraw at any time, but it is not possible to destroy biospecimens and information already given to researchers	No
Risks	Potential loss of privacy	Yes
	Influence on insurance companies and/or employers	No
	Cannot predict how genetic information will be used in the future	Yes
	Bruising or infection from blood draw	No
Certificate of Confidentiality	Researchers cannot be forced to disclose identifying information, even by a court subpoena	Yes
	Does not prevent patient from voluntarily releasing information about self-involvement in research	Yes
	Certificate does not prevent researchers from disclosing information without consent such as child abuse and intent to harm self or others	No