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:


Frequently Asked Questions (FAQs)

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.


Deadlines

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.


IRB Members

2014-2015 IRB Members

  • Timothy Edgar, PhD; Health Communication, Chair
  • Michael Duggan, EdD; Institutional Research
  • Susan Koch-Weser, ScM, ScD; Tufts University School of Medicine, external member
  • Joanne Lasker, PhD; Communication Sciences and Disorders
  • Christina Marin, PhD; Performing Arts
  • Diego Salazar; School of Communication
  • Michaele Whelan; Chief Academic Officer, ex officio, (non-voting member)

IRB Administrator

  • 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]." Please contact Timothy Edgar, chair, at Timothy_Edgar@emerson.edu or at 617-824-8743.


IRB Application and Additional Forms

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.

Additional Forms


Types of Review

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

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.


Resources

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.


Misconduct

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.