The IRB review of human subjects research is the process through which Berklee ensures the safe and responsible conduct of any such research carried out on behalf of the institution. Researchers, whether faculty, students, or staff, are expected to submit an application for any project that constitutes human subjects research (see the IRB page for more information) using participants from Berklee. Researchers from other institutions who wish to include Berklee students, faculty, staff, or alumni as human subjects must also submit an application to the IRB. The steps for the application process and the necessary documentation are outlined below.
Before you submit your application, please review the Office for Human Research Protections decision charts on what is considered research and what needs IRB approval. After reviewing the information, if you have questions about whether your project needs IRB review, please contact the Berklee IRB at BerkleeIRB@berklee.edu.
- Complete the Protecting Human Research Participants online training course. You may complete this training module at your convenience and at your own pace. Remember that you must complete the course and attach the certificate to your application before your application can be submitted. Please email BerkleeIRB@berklee.edu before registering for the course for information about subsidizing the course fee. Individuals who are receiving funding for their research project(s) are not eligible for the subsidy.
- Complete and submit a Berklee IRB application. The application and other helpful tools can be found below.
- Berklee IRB Application Form
- Overview of questions asked on the IRB application
- Frequently Asked Questions
- Informed Consent Form guidelines and templates
- If you have any questions about how to complete the forms, please contact BerkleeIRB@berklee.edu.
- Your application will be reviewed once the IRB receives your completed application. One of three actions will be taken, all based on the relevant federal regulations (45 CFR 46). The level of review is determined by the nature of your interaction with human subjects and the use of the data obtained, and only the IRB can make this determination.
- The IRB may determine that your research is exempt from the requirements and can proceed without further review.
- The IRB may determine that your research can receive an expedited review by the cochairs of the board without going before the full board. If the IRB determines that your project is exempt or qualifies for expedited review, you will receive a written communication approving your research and allowing you to move forward.
- The IRB may determine that your research must receive a full board review. If your project requires full-board approval, you will be informed of the date and time of the board meeting at which your project will be reviewed. You will be informed and may be asked to attend the meeting where your proposal will be reviewed. If you are asked to attend a meeting, we request that any other co-investigators contributing significant effort to the research attend the meeting as well.
- Following the review of your submission, you will receive a formal response from the IRB. The response may include one of the following:
- Your proposal will be approved without any required changes.
- The IRB will provide you with a list of changes that must be made. When those changes are resubmitted, your proposal will be reviewed again. It is at the sole discretion of the IRB to determine if the changes have been satisfactorily made or not.
- If your application does not meet the requirements for IRB approval after a second review by the IRB, your proposal may be rejected.
Please keep in mind that any changes to the scope of your research after approval has been granted must be approved by the IRB.
If you have any questions about this, feel free to contact the IRB at BerkleeIRB@berklee.edu.
What types of research need IRB approval?
The following types of research require IRB approval:
- Social, behavioral, and educational research
- Ethnography research
- Oral history
- Pilot studies
- Repository research
- Clinical research
- Biomedical research
- Epidemiology research
- Quality assurance activities
I'm just doing a simple survey. Do I need to submit my proposal to the IRB?
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.
I'm not collecting any identifying information in my human participant research project. Do I need to submit my proposal to the IRB for review?
Research projects that include any data collection from human subjects, even if that information is not identifiable, must be reviewed by the IRB. It is up to the IRB to determine if information collected is identifiable.
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.
Do research projects conducted by Berklee students need IRB approval?
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.
Can the IRB approve a project retroactively?
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.
Is my project exempt from IRB review?
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. Therefore, you must submit an application to the IRB, who will then determine if your research project is exempt. If you have any questions about what is considered research and what's an exemption, please contact the IRB at BerkleeIRB@berklee.edu.
If I am working with another institution, which IRB should I submit my application to?
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. A key component of the IRB is to ensure that research follows Berklee policies and takes into consideration the interests of Berklee community members. In order for this to be determined, a proposal must be submitted to the Berklee IRB. If IRB approval has already been granted by another institution, supporting documentation should be uploaded in your application. Upon review, the Berklee IRB may:
- enter into a reliance agreement with the other institution, if your research project qualifies for an agreement as outlined in the Common Rule;
- determine that your research is exempt and does not require a Berklee IRB review;
- provide an expedited review if your research is eligible; or
- require full board review and approval.
It's up to the other involved institution to decide if your project must also be submitted to their IRB.
Do I need IRB approval if my research will be done in another country?
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:
- Your research must comply with the GDPR.
- It is your responsibility to consult with a GDPR expert to ensure your research is compliant.
- 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.
- 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.
- Researchers will be required to provide proof of compliance to the Berklee IRB before approval is granted.
- 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.
What is informed consent?
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.
- As a researcher, you must disclose to participants all the information they need in order to make an informed decision about if they want to participate in the research or not.
- Researchers must ensure that participants understand all the information that is being disclosed to them.
- 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.
What is required in a consent form?
Each informed consent form must contain the following elements:
- Explicit language stating that study participation is voluntary and that participants may choose to stop participating at any time with no negative consequences
- 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
- A clear statement on whether their participation will be anonymous or confidential, and how the PI will ensure anonymity or confidentiality
- 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
- 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.
Does the Berklee IRB have any institution-specific policies that research must follow?
Yes, Berklee has several regulations that researchers must follow.
- 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.
- 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).
- 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.
- 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.
- 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.
Can I use deception in my research?
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
What is debriefing, and am I required to do it with my research subjects?
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.
What are vulnerable populations?
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.