All of the Institution’s human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles from:

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
• Other appropriate ethical standards recognized by federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule.

Federal-Wide Assurance through the US Department of Health & Human Services Offices for Human Research Protections

Status of Maine Medical Center’s Federal Wide Assurance (FWA) and IRB can be searched by any of the following:

• Institution/Organization Name: MaineHealth
• FWA Number: 00003993/Expires 02/26/2029
• IORG number: 0000154/Expires 02/26/2027
• IRB Number: 00000262 Maine Health IRB#1

These terms apply whenever the Institution becomes engaged in human subjects research conducted or supported by any federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.

In general, the Institution becomes so engaged whenever:

• the Institution’s employees or agents intervene or interact with human subjects for purposes of federally-conducted or -supported research;
• the Institution’s employees or agents obtain individually identifiable private information about human subjects for purposes of federally-conducted or -supported research; or
• the Institution receives a direct federal award to conduct human subjects research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.