Institutional Review Board (IRB) and Research Policies

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 2024 Meetings:

• September 12
• October 10
• November 14
• December 12

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 15 other federal departments and went 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 not to 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.

If your survey meets the definition of research laid out by the Office for Human Research Protections, then you need IRB approval. To determine if your survey meets the criteria for research that needs IRB approval, please refer to the Human Research Subjects Regulations Decision Chart. If you have any additional questions, please email BerkleeIRB@berklee.edu.

Research projects that include any data collection from human subjects, even if that information is not identifiable, must be reviewed by the IRB. 

If your research project is using data from existing data sources, it may not require IRB approval. Please refer to the Human Research Subjects Regulations Decision Chart to determine if your research using existing data sources needs to be reviewed by the IRB.

Yes, any activity that falls under the Office for Human Research Protections definition of research must be reviewed by the IRB, even if it's conducted by students. Please refer to the Human Research Subjects Regulations Decision Chart to determine if your project requires IRB approval.

The IRB will not grant retroactive approvals. It is an expectation and legal requirement that researchers will not complete any research with human subjects or with data from human subjects without first receiving IRB approval. 

The first step is to review the Human Research Subjects Regulations Decision Chart, which will identify if your project is considered research. If your project is not considered research, you are not required to submit your project for IRB review. 

There are several categories of research that are considered exempt under the Common Rule. The role of the IRB is to determine if research is exempt, qualifies for an expedited review, or requires full board review. If you believe your project may be exempt from IRB review or are unsure if your project meets the definition of research, please contact the IRB at BerkleeIRB@berklee.edu.

Please reach out to us before submitting to another institution's IRB. In many cases, Berklee and the other institution can sign a reliance agreement which is a formal, written document that provides a mechanism for an institution to delegate IRB review to an IRB of another institution. If IRB approval has already been granted by another institution, we may require you to also submit to the Berklee IRB and include the material submitted to the other institution.

Any research that will be using Berklee students or employees as human subjects or as members of the research team must be reviewed by the Berklee IRB. In addition, other countries may have specific laws governing research using their citizens or taking place in their country. One such law that governs any research done with Berklee Valencia is the European Union (EU) General Data Protection Regulation (GDPR). Due to this regulation, the Berklee IRB strongly encourages individuals working on a culminating experience or thesis project, or individuals with a tight research deadline, to avoid using individuals in the EU as subjects. Should you choose to move forward using EU residents as subjects, please keep the following in mind:

1. Your research must comply with the GDPR.
2. It is your responsibility to consult with a GDPR expert to ensure your research is compliant.
3. Neither the Berklee IRB nor any individual IRB members are experts in the GDPR. Any advice given by the IRB does not constitute legal advice, and it is the sole responsibility of the researcher to ensure their research is in compliance with the GDPR.
4. If it is found that your research is not in compliance with the GDPR, your approval may be revoked until it is brought into compliance.
5. Researchers will be required to provide proof of compliance to the Berklee IRB before approval is granted.
6. If, at any time after approval, you would like to incorporate EU residents into your research, you must notify the Berklee IRB of this change and provide proof that your research is in compliance with the GDPR.

While the GDPR is the most well-known regulation governing data collection and research, other countries may have similar laws, and it is the responsibility of the researcher to determine if such laws exist and ensure their research is in compliance.

Informed consent is an ethical and legal requirement for researchers and a key element in IRB review. The informed consent process consists of several key components, all of which must be met in order for the IRB to approve your application.

1. As a researcher, you must disclose to participants all the information they need in order to make an informed decision about whether they want to participate in the research or not.
2. Researchers must ensure that participants understand all the information that is being disclosed to them.
3. Participants must be informed of the voluntary nature of their participation in the research study, including the fact that they may withdraw at any time.

Each informed consent form must contain the following elements:

1. Explicit language stating that study participation is voluntary and that participants may choose to stop participating at any time with no negative consequences
2. A clear statement of exactly what participants will be asked to do and what will be done with the data the principal investigator (PI) collects about them
3. A clear statement on whether their participation will be anonymous or confidential, and how the PI will ensure anonymity or confidentiality
4. The process for a participant to have data removed from the data set if they choose to revoke consent after their participation is finished and for how study data will be stored
5. Contact information for the PI and for the Berklee IRB

Grammar and spelling mistakes in consent forms can create confusion and make it difficult for participants to understand what they are consenting to. A consent form will not be accepted if it cannot be clearly understood due to grammar and spelling mistakes; it will be rejected. Common issues are:

• using the wrong version of a term (e.g., confusion over similar words such as principal and principle);
• using the wrong version of similar words like there, their, and they’re; where and were; and whether and weather; and
• using inconsistent language to identify individuals involved in the study (i.e., referring to both yourself and the participant as "I" or a lack of clarity on who to contact for further questions).

In addition, consent forms must be written in non-technical language that can be easily understood by the study participants. 

More detailed information about informed consent is available here.

Yes, Berklee has several regulations that researchers must follow.

1. Undergraduate students may not serve as principal investigators (PIs) on any research projects. Instead, their advisor or another faculty member should act in this role. Graduate students may serve as PIs, but they must have an advisor or faculty member serving as a co-investigator.
2. Research proposals and materials must incorporate bias-free design, as outlined in the APA Bias-Free Language guide. Common examples of biased language are:
   • assuming a participant’s gender or using language that implies a specific gender that someone may not identify with (i.e., “He/she will be asked to complete a survey.”);
   • using outdated research terms to describe a group of people (i.e., classifying participants as "white and non-white"); and
   • using terms considered to be disparaging, dismissive, or otherwise biased (e.g., "preferred pronoun," "mankind," "manpower," "birth sex," or using "he or she" to refer to a generic person).
3. Any research carried out by a faculty member or instructional staff, or departments that maintain subject pools of students must adopt the following policies:
   • Before enrolling in a course, students must be informed of the possibility that they may be asked to serve as research subjects in experiments under direction of the faculty.
   • If there is a course requirement that students serve as research subjects, students must be provided with an alternate way of meeting this requirement. During the first week of classes, students must receive a written description of the other ways they can meet this requirement.
4. Each department that regularly requires students to act as research subjects should establish a committee composed of faculty and students to review the research projects using their students. This committee should be responsible for hearing and acting on any student complaints in connection with the research participation requirement.
5. Although Berklee Counseling Services is available to support students, Counseling Services is not available to faculty and staff and is not equipped to support students in acute distress or experiencing a mental health emergency. For this reason, researchers may not provide Counseling Services as the only resource for study participants who may experience distress following their participation in research.

Please refer to the following documents regarding additional policies:

1. Research Misconduct Policy
2. Inclusion of Individuals Across the Lifespan Policy
3. Clinical Trials Registration and Reporting Requirements
4. NIH Principal Investigator Assurance Form

While deception in research is allowed under the Office for Human Research Protections regulation 45 CFR 46, there are strict rules governing the use of deception. Deception may be used only to allow researchers to collect valid data, and it may not be used to encourage, coerce, or otherwise lead a subject to do something they may not have otherwise done. If you are planning to use deception in your research, please contact the Berklee IRB at BerkleeIRB@berklee.edu before submitting your application. Research involving deception must also have a debriefing form that is given to participants at the completion of the study

When participants are asked questions that could be potentially upsetting or they're subject to deception as a research method, debriefing must occur before a participant leaves a research session. A debriefing statement must be given to participants when they leave. Your debriefing statement must avoid jargon and use language that a person without any background knowledge in research or the topic being researched would understand.

Your debriefing statement must include the following: 

• Thank the subject for their participation in your research.
• Provide a full explanation of the hypothesis being tested and why it is being tested.
• Fully describe the procedures that were used to deceive participants (if applicable).
• Describe the justification for why it was necessary to deceive them (if applicable) or the justification for asking potentially upsetting questions.
• Offer to provide the participants with study results.
• Give a list of resources that the participant may consult with if they become distressed after the study.*
• Provide contact information for the principal investigator and the Berklee IRB.

*Please note that Berklee Counseling Services is only available to students and is not equipped to treat someone who may be experiencing acute distress or a mental health emergency. You may include Counseling Services on your list of resources, but it cannot be the only resource offered to participants.

Several populations of people are considered vulnerable and therefore require special considerations in your research proposal. Federally regulated vulnerable populations include:

• pregnant women, human fetuses, and neonates;
• children and minors ages 7–17;
• infants or children younger than 7;
• cognitively impaired persons;
• inmates, prisoners, and individuals who are currently on parole or probation;
• elderly/aged persons;
• individuals who are not fluent in English; and
• economically or educationally disadvantaged persons.

In addition, the Berklee IRB considers Berklee students to be a vulnerable population*. 

If you plan to use any individuals from the above groups, you must follow relevant rules and regulations regarding these groups. IRB approval of research using vulnerable populations can take longer than usual due to the extra precautions that must be taken. For this reason, the Berklee IRB highly recommends that you avoid using individuals from any of the federally-regulated groups in your research if you are on a short deadline or working on a culminating experience or thesis. More information about vulnerable populations in research can be found here.

*The Berklee IRB policy on using Berklee students as participants can be found here.