Office of Research & Creative Scholarship
Human Subjects Review/IRB
The mission of the Emerson College Human Research Subjects Committee/Institutional Review Board (IRB) is to ensure quality research involving human subjects conducted under the auspices of the College. The IRB is guided by ethical principles outlined in the Belmont Report (1979) and legal mandates outlined in the Code of Federal Regulations Title 45, Part 46 (2009).
All projects conducted at Emerson involving human subjects that meet the definition of research must be reviewed by the IRB. Go to the decision tree to see if your project meets the definition of research.
The main purpose of the IRB is to ensure the protection of human subjects through the review, approval, modification, or disapproval of research applications submitted by faculty, staff, or students. The IRB is responsible for communication, record keeping, reporting, monitoring, education of the campus community about ethical issues, and the overseeing of all research activity involving human subjects.
An application must be filled out and submitted, even if the research proposal originates at another institution or organization seeking partnership or a co-investigator. Enrolled students cannot serve as principal investigator. Students are required to have a faculty member serve as a principal investigator for any student project. The supervising faculty member assumes full responsibility for the accuracy of the information provided on the IRB application. A student can be listed as co-investigator.
Researchers are also required to take the Collaborative Institutional Training Initiative (CITI) online Responsible Conduct of Research training through Emerson College's subscription.
See below for information on:
- Emerson College Institutional Charter on Research Involving Human Subjects
- Frequently Asked Questions (FAQs)
- CITI Certification
- IRB Members
- IRB Application and Additional Forms
- Types of Review
- Informed Consent
- Misconduct Policy
- Research Integrity Training Policy
The IRB has compiled the above Frequently Asked Questions (FAQs) document to help inform the Emerson community about the IRB. Topics in this document include general topics, the IRB application process, the consenting process, training-related topics, the lifecycle of the protocol, and what to do with unanticipated problems or adverse events.
Individuals conducting human subjects research are required to complete the Social and Behavioral Responsible Conduct of Research hosted by the Collaborative Institutional Training Initiative (CITI) Program.
- Go to citiprogram.org.
- Register to create an account. Be sure to affiliate with Emerson College during registration.
- When asked to select your curriculum, choose "Social and Behavioral Responsible Conduct of Research Course" under Question 1, and do not select any option under Question 2.
- Complete the Social and Behavioral Responsible Conduct of Research course.
Following completion of the course, the completion report will be e-mailed to Emerson College's IRB. This certification is good for three years. After three years, individuals wishing to conduct human subjects research must retake the Social and Behavioral Responsible Conduct of Research course as a refresher.
Requests for Full IRB Committee Review
The IRB deadline for submission of materials for research involving human subjects that require a full review of the IRB is the first of the month for September, October, November, and December for the fall semester; and the first of the month for February, March, and April for the spring semester. The IRB generally will respond to submissions for a full review within a few weeks after the submission deadline. If there is a request for a full committee review in the summer, members will conduct the review if available. Please contact the IRB Chair during the summer if you have a request for a full review.
Requests for an Exemption or an Expedited Review
Requests for an exemption or an expedited review can be submitted to Human_Subjects@emerson.edu at any time, and do not follow the same deadlines as the requests for full IRB committee review. The IRB typically provides an initial response to a request for an exemption or an expedited review within 7-10 days of submission.
2015-2016 IRB Members
- Timothy Edgar, PhD; Health Communication, Chair
- Joanne Lasker, PhD; Communication Sciences and Disorders
- Christine Skubisz, PhD; Health Communication
- Michael Duggan, EdD; Institutional Research
- Susan Koch-Weser, ScM, ScD; Tufts University School of Medicine, external member
- Christina Marin, PhD; Performing Arts, non-scientist
- Elena O'Malley, MS, MA; Iwasaki Library, non-scientist
- Michaele Whelan, PhD; Chief Academic Officer, ex officio, (non-voting member)
- Eric Asetta, MA; Office of Research and Creative Scholarship, ex officio (non-voting member)
- Eric Matthews, MBA; Academic Affairs, administrator (non-voting member)
Send questions about the process, submitted materials, or inquires to Human_Subjects@emerson.edu, with the subject line "Human Research Subjects Proposal - [Your Full Name]."
IRB Application Form »
- IRB Annotated Application » (a tool to assist filling out the IRB application form)
To request an exemption, expedited review, or full committee review, please complete the IRB application form and send it, along with documents required by the application, to Human_Subjects@emerson.edu. The subject line of the e-mail should say “Human Research Subjects Proposal - [Name of Principal Investigator].”
We have also included an annotated IRB application to assist investigators with filling out the IRB application form. Using this tool should reduce any delays and help to provide the IRB with all necessary information. The IRB FAQ document can also assist you with information on the application process.
IRB Modification Request Form »
- Use this form when you need to inform the IRB about any changes to a protocol that has already been approved.
IRB renewal request form »
- Use this form if you would like to renew your protocol. Please submit this form 30 days before your protocol expires.
IRB Protocol Closure Form »
- Use this form to close your protocol. Please note that the completion of a protocol is considered a change to the protocol, and would require investigators to immediately inform the IRB of such changes.
IRB Waiver of Some or All of the Requirements of Informed Consent form »
- Use this form to request that documentation of informed consent, or certain aspects of the inform consent form, be waived.
"Does IRB Review Apply?" (with decision tree) document »
- Use this document to determine if IRB review applies to your study.
- IRB Sample Assent form »
There are several types of review during the IRB process, including full reviews, expedited reviews, and exempt reviews. More detail about these types of review can be found under the Types of Review webpage.
Applications may be ruled exempt, approved through an expedited review, sent back to the principal investigator (PI) for modifications, approved by the full committee, or denied. In all cases, reasons will be given for the action so the PI may make necessary changes for resubmission or modification.
For multi-year projects, researchers must resubmit their projects for approval each year. Investigators must also resubmit when the level of risk for human subjects changes for an approved protocol.
Informed consent means subjects have been provided with the necessary information about the research and consequences of their participation, and can use this information to decide whether they are willing to participate. At minimum, subjects need to know that the activity is a research project, have an understanding of the project’s processes, risks, objectives, and benefits; and know that they are free to withdraw at any time without any penalties. Special arrangements must be made if subjects have limited capacity to understand the above and thus, give informed consent. Minors cannot give informed consent.
All research involving interaction with human subjects requires informed consent. That the data is collected from friends or colleagues does not waive this requirement. Any deviation of this must be approved by the IRB.
Informed Consent Form Template
The Emerson College Informed Consent Form template can be used by researchers who will be obtaining written informed consent. All bullet points should be addressed in each header, and all headers should appear on the form. Bullet points that are in italics should be addressed if they are applicable to the research study. Please use this template in conjunction with the Informed Consent Guidelines, and add/delete when necessary for your research study.
Before submitting an application, the IRB recommends that students, faculty, and researchers read the Belmont Report and the Basic Health and Human Services policy for Protection of Human Subjects.
Federal regulations may require researchers to obtain a certificate from an online tutorial regarding research with human subjects. Proposers who regularly conduct research involving human subjects should get certification, which is available from the Office for Human Research Protections website.
Emerson College is committed to the highest ethical standards in research as well as teaching, creative activities, and publication. Anyone in the Emerson community who is directly involved with these activities bears the primary responsibility for ethical pursuits of knowledge. Persons found guilty of willful misconduct are subject to disciplinary action by the College.