Institutional Review Board (IRB)

According to the Office for Human Research Protections: Institutional Review Boards (IRBs) "review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants.... IRB reviews help to ensure that research participants are protected from research-related risks and treated ethically, a necessary prerequisite for maintaining the public’s trust in the research enterprise and allowing science to advance for the common good."

Only activities that fall into the category of human subjects research, as defined by federal policy in title 45, section 46 of the United States Code, require IRB review. In general, this means:

• the activities must first qualify as research, defined as a systematic investigation that develops or contributes generalizable knowledge; and
• the research should involve collecting data through interaction or intervention with a living individual, or indirectly collecting identifiable personal data about a living individual.

If you are planning any activity that involves interaction with or collecting data about living individuals, please use the Human Research Subjects Regulations Decision Chart to determine if your research requires IRB approval.

A video has been created by the U.S. Department of Health and Human Services' Office for Human Research Protections to explain more about social and behavioral research.

If you are unsure whether your research requires IRB approval, please contact the IRB before submitting your application at BerkleeIRB@berklee.edu.

As soon as you have determined that your planned activity involves human subjects research, you should start the application process for IRB review. The IRB meets once a month, and review and approval must take place before any research subjects are recruited. You should allow a minimum of 30 days for IRB review. You may be invited to attend the IRB meeting at which your project is reviewed. 

Remember that the IRB is not just here to make sure you comply with regulations, but also to help you succeed with your research. If you have questions, please don't hesitate to contact us at BerkleeIRB@berklee.edu.

Fall 2023 Meetings:

• September 14
• October 12
• November 9
• December 14

Submissions are due two weeks prior to meeting. The IRB does not meet regularly during the summer. If the need for IRB approval arises during the summer, please email BerkleeIRB@berklee.edu.

The Common Rule is the major set of federal policies that regulate research involving human subjects. The prior Common Rule was established by the Office of Human Research Protections in 1991. Changes to the Common Rule were announced on January 18, 2017 by the U.S. Department of Health and Human Services and fifteen other federal departments and go into effect January 21, 2019. The increase in multi-center research, advancement in the analyses of biological specimens, and recalibration of risk to the level of review are among the factors precipitating the regulatory changes. These changes are meant to ease some researcher burden while also enhancing the protection of human subjects. Both biomedical and social-behavioral research are affected by these changes.

Broad Overview of Key Changes:

• Definition of “Human Subject” expanded to cover the collection of biospecimens. The new definition includes “a living individual about whom an investigator, whether professional or student conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
• Activities deemed not to be research. The final rule amended the definition of “research” to clarify four new activities that are deemed to not be “research”. These are: Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship); Public health surveillance activities; Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and Certain activities in support of intelligence, homeland, security, defense, or other national security missions.
• Elimination of the requirement for annual continuing review with respect to certain categories of research/minimal risk studies.
• Elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.
• Reliance on single institutional IRB approval for collaborative research.
• Consent form changes: Consent forms now need to include a brief summary that explains the research to potential participants in an easy-to-understand and clear manner. It is now mandated that consent forms be concise while also giving the full context of a study, including its risks and benefits, so potential participants have all the information they need to make an informed decision. Broad consent is a new type of informed consent provided under the revised Common Rule pertaining to storage, maintenance, and secondary research with identifiable private information or identifiable biospecimens.