Institutional Review Board (IRB)

Institutional Review Board/Human Subjects

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 to the IRB for consideration. Students are required to have a faculty member serve as an advisor for any student project. The supervising faculty member’s responsibilities and criteria may be found in the Student Project Guidelines.

Researchers are also required to take the Collaborative Institutional Training Initiative (CITI) online Responsible Conduct of Research training through Emerson College's subscription.

Protocols

How to Submit a New Protocol

For more information on how to submit a new protocol to the Emerson College IRB, please go to this page for a step-by-step tutorial.

How to Modify an Existing Protocol

To modify an existing protocol:

1. Download and complete the IRB Modification Request Form.
2. E-mail the above form and any appropriate documents to human_subjects [at] emerson.edutitle="Email about modifying a study protocol". The subject of your e-mail should include the study's protocol number.
3. The IRB Chair will provide an initial review of the modification request and then assign them to either expedited or full committee review depending on the level of risk.
4. After review, the IRB Chair will inform the principal investigator of the decision.

Protocol modification requests are typically reviewed within 1 to 2 weeks.

How to Renew a Protocol

It is the responsibility of the Principal Investigator (PI) to ensure continued approval of his or her human participant research study. If an investigator allows his or her approval to expire, all research on the study must cease until renewed approval is granted. Progress of approved research must be reported, in the manner prescribed by the IRB, on the basis of risks to participants, no less than once a year.

To renew a protocol:

1. Download and complete the IRB Renewal Request Form.
2. E-mail the above form and any appropriate documents to human_subjects [at] emerson.edutitle="Email about renewing a study's protocol". The subject of your e-mail should include the study's protocol number. This form should be submitted no later than 30 days prior to the end of the protocol.
3. The IRB Chair will provide an initial review of the modification request and then assign them to either expedited or full committee review depending on the level of risk.
4. After review, the IRB Chair will inform the principal investigator of the decision.

Protocol renewal requests are typically reviewed within 1 to 2 weeks.

How to Close a Protocol

At the end of a protocol, the principal investigator should officially close the protocol with the IRB. This signifies that no further research will be conducted. 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.

To officially close a protocol:

1. Download and complete the IRB Protocol Closure Form.
2. E-mail the above form and any appropriate documents to human_subjects [at] emerson.edutitle="Email about closing a protocol". The subject of your e-mail should include the study's protocol number. This form should be submitted no later than 30 days prior to the end of the protocol.
3. The Protocol Closure form will be filed by the IRB.

If the investigator fails to officially close their protocol with the IRB, the protocol closure date will default to the expiration date given at protocol approval.

CITI Certification

Individuals conducting human subjects research, including collaborators, are required to complete either the Responsible Conduct of Research or Social and Behavioral Responsible Conduct of Research courses hosted by the Collaborative Initiative (CITI) Program.

1. Go to CITIProgram.org
2. Register to create an account. Be sure to affiliate with Emerson College during registration.
3. When asked to select your curriculum, choose "Social and Behavioral Responsible Conduct of Research Course" under Question 1, and "Social & Behavioral Research" under Question 2.
4. Complete the Social and Behavioral Responsible Conduct of Research course or the Social and Behavioral Basic/Refresher 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 either course listed above as a refresher.

Deadlines for Review

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 [at] emerson.edutitle="Email to request an exemption or an expedited review" 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 to 10 days of submission.

Timetables for typical exemption requests that are approved are typically 2 to 3 weeks, while typical expedited reviews can take anywhere from 2 to 4 weeks to receive approval. These timetables are dependent on the time of year, the volume of requests being reviewed by the IRB, investigator response time, etc.

Application & Additional Forms

• IRB Application Form
• IRB Annotated Application (a tool to assist filling out the IRB application form)

Be sure to review the section above titled "How to Submit a New Protocol" for a step-by-step process on submitting a protocol to the IRB.

Additional Forms

• 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
• 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
• Informed Consent Form Template

Types of Review

There are several types of review during the IRB process, including full reviews, expedited reviews, and exempt reviews. 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.

Exemption from IRB Review

Exemptions can be granted for very low risk studies. If you believe that you might qualify for an exemption, you must still complete the standard IRB application and request the exemption. Failure to request the exemption, even if it turns out that you are entitled to the exemption, would be considered noncompliance. No data collection can begin until the IRB officially grants the exemption.

The Code of Federal Regulations (45 CFR 46.101 b) sets out the following situations where research may be exempted from regular IRB review:

Category 1

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

• (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; OR
• (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

Note: This category of exemption is not applicable to research involving minors (45 CFR 46.401 b).

Category 3

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

• (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; OR
• (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Category 4

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable bio-specimens, if at least one of the following criteria is met:

• The identifiable private information or identifiable bio-specimens are publicly available;
• Information, which may include information about bio-specimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
• The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); OR
• The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Category 5

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

• Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Category 6

Taste and food quality evaluation and consumer acceptance studies:

• If wholesome foods without additives are consumed, OR
• If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Category 7

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable bio-specimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

Category 8

Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable bio-specimens for secondary research use, if the following criteria are met:

• Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable bio-specimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
• Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
• An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Expedited Review

If you do not qualify for an exemption, it may still be possible to have your review expedited rather than waiting for a convened IRB meeting. It is important to note that the standard for expedited review and the materials that you will submit are the same as for regular review. The only difference is that the expedited review is done by a single member of the IRB outside of a full review.

Expedited review is available for studies that involve minimal risk.The Code of Federal Regulations (CFR) defines minimal risk as meaning that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The US Department of Health and Human Services provides descriptions of categories for types of research that can qualify for an expedited review.

Full Review

Research protocols that are not eligible for either an exemption or expedited review will be placed on the agenda for the next convened meeting of the IRB. A quorum of committee members must be present for the committee to vote. All committee members review each protocol placed on the agenda for the convened meeting unless a member has a conflict of interest. The committee then discusses the protocol and votes for approval, modification, deferral pending the receipt of additional information, or disapproval.

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. However, it is expected that researchers obtain the informed assent of any children subjects, along with the permission of one or both of their parents/guardians.

Please note that with the changes to the Common Rule, consent forms will now require a concise summary of study activities, risks, and benefits presented to research participants in advance of the body of the consent document.

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

• Download the Emerson College 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 add/delete when necessary for your research study.

Broad Consent

The Final Rule establishes a framework for "broad consent," a type of consent that may be obtained in lieu of informed consent in accordance with basic and additional elements of consent, but only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable bio-specimens. This is not a waiver, but a substitute for traditional informed consent in a range of defined circumstances. Implementation of broad consent must take place at an institutional level and requires a mechanism to track each individual's choice -opt-in or opt-out.

There are currently several obstacles for institutions who wish to implement broad consent. Investigators must track each individual subject's decision to consent or not consent. It is not clear what happens should a subject choose to change their mind at different points in time. OHRP has not provided guidance for the implementation of broad consent at this time. For these reasons, broad consent will not be implemented for Emerson College human subjects research at this time.

Compensation for Human Subjects

A research protocol may offer compensation to human subjects for their participation. Researchers who are conducting sponsor funded research or internally funded research are responsible for ensuring that subjects are eligible to receive payments (in accordance with US Tax and Immigration laws) and for ensuring that the payment process is appropriate. The following section outlines how human subjects can be compensated.

Compensation and Consent Considerations

Payments or non-monetary rewards may be given to subjects as remuneration for time and inconvenience of participation in research studies, as well as an incentive to participate. Compensation can include monetary (gift cards, vouchers, etc.) and/or non-monetary (gifts/promotional items, etc.) remuneration.

There are two ways in which compensation can be problematic:

• Undue influence: An offer of excessive or inappropriate compensation is made in order to obtain compliance.
• Coercion: An overt or implicit threat of harm/negative consequences is intentionally presented by one person to another in order to obtain compliance.

Protocol and Consent Considerations: The protocol application should fully describe the plan for compensation of subjects as well as the reasoning behind the amount, method of payment, proration and scheduling of payment, and any other terms of compensation -- for example, what happens if a subject withdraws his or her participation. All of this information should be included in the informed consent process. It is also appropriate to disclose possible compensation in recruiting and advertising materials. 

Amount of Payments

Compensation should be appropriate for the time and effort subjects devote to participation. The level of payment should not be high enough to cause subjects to accept risks that they would not otherwise accept or participate in activities to which they would otherwise strongly object based on personal values or beliefs.

Some researchers may base the payment amount on the acceptable average wage in the location where the research is conducted or for the specific study population. This is often an acceptable level of payment that does not exert undue influence. When hourly payments are not suitable or feasible, compensation may be task- or procedure-specific (for example, some studies pay subjects per sample collection or survey).

Methods of Compensation

Emerson College facilities the payment of human subjects by researchers through the following methods (in order of institutional preference):

1. Payments to Participants via Online Survey Platforms. For protocols that solicit participant responses via a College-approved online survey platform –such as Qualtrics– a researcher may elect to have the platform pay Human Subjects directly for their participation. For more information on using Qualtrics through Emerson’s site license, click here.
2. Tangible Items/Gifts are non-cash items given to human subjects in recognition of their participation in a protocol. Examples include Examples include: books, trophies, plaques, event tickets, food, Emerson logo items, memento items, pens, pennants, or similar items. Gift items may be purchased via the Workday Marketplace, or submitted for reimbursement via an Expense Report (subject to the College’s purchasing and reimbursement policies). 
3. Gift Cards are “cash equivalents” that can be used to purchase merchandise or which can be easily converted to cash.

Gift card payments are reportable as miscellaneous income to the IRS. It is strongly recommended that a researcher contact the Office of Research and Creative Scholarship for assistance with acquiring gift cards for human subject payments. Gift cards being held in reserve may be stored securely in a fireproof safe by the Office of Finance, upon request.

Prohibition on the Use of Personal Funds. Under no circumstances should researchers use their personal funds to compensate human subjects. These cannot be reimbursed under Emerson’s accounting rules. 

Tracking Human Subject Payments

Researchers on an IRB-approved protocol must maintain a payment log for all payments made to human subject participants. Researchers must record the following information for each Payment to an individual:

1. Full legal name
2. Active phone number or email
3. Date, amount, and method of payment

For protocols that pledge confidentiality to participants, the researcher should use a coded identifier in place of an individual’s name, using the same identifier consistently for each participant. However, the researcher must also record sufficient information so that an individual can be contacted by Emerson for IRS-required information when the $600 threshold is reached.

Tax-Reporting Requirements and IRS Obligations of the College

The IRS treats monetary human subject payments (gift cards or gift certificates) as taxable income to the recipient. This means the recipient is supposed to report the payment when they file a personal tax return at the end of the year. 

As the payer, Emerson must adhere to IRS regulations. The tax treatment of human subject payments depends on the amount paid, the recipient’s tax status, and whether the study takes place inside or outside the U.S.

If Emerson issues $600 or more in Human Subject Payments to an individual in a calendar year, the College is required to report the payments to the IRS and issue the recipient a Form 1099.

Pursuant to the above, Emerson must collect a completed and signed Form W-9 from an individual when they receive $600 or more in Human Subjects Payments in a calendar year. Participants should be notified of this requirement in the Informed Consent Form. 

Payments to human subjects facilitated by a third-party data-collection platform, such as Qualtrics, are typically exempt from the above rule, but must still be logged by the researchers. 

Further Guidance on Paying Human Subjects

For further information, policies and procedures on compensating human subjects, please contact the eric_asetta [at] emerson.edu (Executive Director)title="Email Eric Asetta" for the Office of Research and Creative Scholarship. A dedicated policy to this topic, Payment of Human Subjects Participants in Research, is forthcoming from the College.

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.

Policies & Guidelines

• Research Integrity Training Policy
• IRB Research Subject Recruitment Policy
• Student Project Guidelines

Frequently Asked Questions (FAQs)

• IRB Frequently Asked Questions Document

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 procedures, 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.

Note: The IRB is in the process of updating this FAQ to meet the updated changes to the Common Rule. Please contact human_subjects [at] emerson.edutitle="Email about protocol questions" if you have any questions.

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.

Institutional Review Board Members

Please contact the IRB Chair at human_subjects [at] emerson.edutitle="Email the IRB Chair" with any questions.

Current IRB Members

Roxana Maiorescu, PhD
Marketing Communication, Chair
Voting Member
Scientist
r_maiorescu_murphy [at] emerson.edutitle="Email Roxana Maiorescu"

Joanne Lasker, PhD
Communication Sciences and Disorders, Vice Chair
Voting Member
Scientist
joanne_lasker [at] emerson.edutitle="Email Joanne Lasker"

Michael Duggan, EdD
Institutional Research
Voting Member
Scientist
michael_duggan [at] emerson.edutitle="Email Michael Duggan"

Elena O'Malley, MS, MA
Iwasaki Library, Non-Scientist
Voting Member
Non-Scientist
elena_omalley [at] emerson.edutitle="Email Elena O'Malley"

Lindsay Beamish, MFA
Performing Arts, Non-Scientist
Voting Member
Non-Scientist
lindsay_beamish [at] emerson.edutitle="Email Lindsay Beamish"

Dana Edell, PhD
Performing Arts
Voting Member
Scientist
dana_edell [at] emerson.edutitle="Email Dana Edell"

Lindsay Griffin, PhD
Communication Sciences and Disorders
Voting Member
Scientist
lindsay_griffin [at] emerson.edutitle="Email Lindsay Griffin"

Sharon Kramer, PhD
Berklee College of Music, External Member
Voting Member

Jan Roberts-Breslin, MFA
Interim Provost and VP for Academic Affairs, Ex Officio 
Non-Voting Member
jan_roberts_breslin [at] emerson.edutitle="Email Jan Roberts-Breslin"

Eric Asetta, MA
Office of Research and Creative Scholarship, Ex Officio
Non-Voting Member
eric_asetta [at] emerson.edutitle="Email Eric Asetta"

IRB Administrator

Eric Matthews, MBA
Academic Affairs, Part-Time Administrator Coordinator
Non-Voting Member
eric_matthews [at] emerson.edutitle="Email Eric Matthews"