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Institutional Review Board (IRB) 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.

All projects conducted at Emerson involving human subjects that meet the definition of research must be reviewed by the IRB. Go to the decision form to see if your project would need to be reviewed by the IRB. Always reach out to Human_Subjects [at] emerson.edu (Human_Subjects[at]emerson[dot]edu) with any questions.

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

Index

CITI Certification

Emerson College faculty, staff, and students conducting human subjects research 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 courses, completion reports for Emerson College community members 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.

External collaborators on studies should submit their CITI certifications or equivalent training through the Emerson community member submitting an application for review. These certifications should meet the requirements of their institutions.
 

Protocols

How to Submit a New Protocol

The IRB application form may be found in InfoReady. InfoReady is a web-based workflow platform designed to streamline and simplify workflow tasks for academic institutions. 

You will need to submit several attachments in order to complete this form. PDFs are preferred, but other types of documents may be included. Links to files, such as Google Docs, cannot be accepted, as the IRB needs an accurate snapshot of what was submitted at the time of submission. Links to documents can allow for information to be changed over time.

The attachments researchers should expect to have ready to include prior to beginning an application are:

  • Recruitment tools. These are usually flyers, the text in emails, social media, and other types of outreach to potential human subjects.
  • Informed Consent. One of the most important documents provided to potential human subjects. As the name implies, these forms provide potential human subjects with what they can expect from the research study, including any potential risks, benefits, what what happens to their data.
  • Research Tools. These are the methods you will be using to obtain your research data. These include items such as surveys, questionnaires, interview/focus group questions and plans, survey instruments, and more.
  • CITI Certification Expiration Dates. Please have the CITI certification expiration date for each member of the research team ready to add to the IRB application. 
    Collaborator CITI certifications should be emailed to Human_Subjects [at] emerson.edu as well, so the IRB may keep a record of their certifications.
  • (For research involving children) - Site Permission Letter(s). If you are conducting research at a site that supervises children, you should have a letter from the institution noting that you have permission to conduct research at their institution.
  • (For international research) If you are conducting research in countries outside of the United States, additional materials may be required, including the following:
    • Local Entity Permission - If applicable, an approval letter or email from the local entity where international human subjects research is being conducted
    • GDPR Addendum - To be included with informed consent forms for research studies in countries using the General Data Protection Regulation (GDPR).
    • PIPL Addendum - To be included with informed consent forms for research studies in China.

How to Modify an Existing Protocol

To modify an existing protocol:

  1. Go to the IRB application in InfoReady
  2. Select “Begin IRB Application”
  3. In the “Select Application” drop-down, choose “Copy Application.”
  4. In the next drop-down field, choose the application you have previously submitted, then select “Copy” at the bottom of the box. This should auto-populate the fields for you from your previous application.
  5. Add “[Modification: ]” to the beginning of your Project Title. If you plan on making multiple modifications, adding a number after modification will make it easier for you (and the IRB) to keep track of the most up-to-date version of your research study.
  6. Make the changes you wish to make, noting the titles of the sections that are being updated.
  7. While submitting changes, make sure current attachments are showing, outdated attachments are removed, and new attachments are added.
  8. At the end of the application, note the sections that were updated, along with a rationale for the modification.
  9. Submit your application.

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

Protocol Check-ins, Renewals, and Closures

After receiving an approval from the IRB, researchers usually either check-in or renew their study with the IRB. Check-ins, renewals, and protocol closures will be handled through progress reports tied to their InfoReady IRB applications.

Protocol check-ins, renewals, and closures are typically processed in 1-2 weeks after submission.

Check-ins. Exemptions and expedited reviews not requiring continuing review are asked to update the IRB annually on the progress of their research study. Check-ins will be scheduled on an annual basis unless the protocol is closed before the check-in date.

Renewals. If continuing review is required, it is the responsibility of the Principal Investigator (PI) to ensure continued approval of their 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.

Closures. 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. A progress report will be scheduled for the end date specified in the application. If a protocol is ready to be closed before this end date, please email Human_Subjects [at] emerson.edu (Human_Subjects[at]emerson[dot]edu). 

 

Templates and Resources

 

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, December, February, March, and April. 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 or during Winter Break, members will conduct the review if available. Please contact the IRB Chair during these periods in advance if you plan on a request for a full review.

Requests for an Exemption or an Expedited Review

Requests for an exemption or an expedited review typically receive an initial response within 7 to 10 days after 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, how much information the IRB requires, etc.

International Research

As noted below, the IRB recommends that researchers planning to conduct international research submit their studies at least three months prior to the anticipated start date of their study.

 

Types of Review

There are several types of review during the IRB process, including full reviews, expedited reviews, and exempt reviews. In the course of a review, an application may be:

  • determined to be Exempt
  • approved through an Expedited review process
  • sent back to the principal investigator (PI) for modifications
  • approved by the full committee
  • 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 requiring continuing review, 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 research studies that meet specific criteria. Usually, these are for very low-risk studies. If you believe that you might qualify for an exemption, you must still complete an 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 provides Categories of Exemption where research may be exempted from regular IRB review. Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the Exemption Categories are exempt from the requirements of 45 CFR 46, except that such activities must comply with the requirements of 45 CFR 46.104 and as specified in each category.

Additional considerations may be needed, or may not allow for an exemption, for study populations such as pregnant women, prisoners, and children.

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.

 

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. Additional Information on Compensation via Survey Platforms. If you are conducting an online survey, create the survey in the platform before submitting the application to the IRB. We suggest that the researcher include the link to the live survey and a copy of the online survey with the application. The link is so the IRB can confirm that the consent language is presented correctly in the online environment. At a minimum, a copy of the survey must be included with the application.

    If the survey is anonymous, the participant’s contact information to obtain the compensation must be collected separately from the collected data. Participants should be notified in the Consent language that, at the end of the anonymous survey, they will receive information for a separate survey to collect contact information in order to provide compensation. 

    For survey studies where a researcher is collecting data using an online survey platform, participants must be informed in the Consent Form that “Contact information collected to provide the compensation will be kept completely separate from anonymously collected research data.”
  3. Additional Consent Form Language. Participants on survey platforms should also be notified with the following language in the Consent Form: “Compensation for participation is not being provided by the Emerson College researchers. Upon survey completion, you may be compensated in the amount previously agreed upon when you started the survey by [Survey Platform name]. Any compensation is directly provided by [Survey Platform name]. If you choose not to complete part or all of study procedures, or if you fail attention checks, you may not be compensated for participation. If you have questions or would like to discuss issues regarding your compensation, please contact [Survey Platform name] directly. You may also discuss this with the research team at [contact information].”
  4. 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).
  5. Gift Cards are “cash equivalents” that can be used to purchase merchandise or which can be easily converted to cash.

PLEASE NOTE: Gift card payments are reportable as miscellaneous income to the IRS. In order to receive a waiver of this College policy, any researcher who plans to disburse gift cards to human subjects participants must first contact the Office of Research and Creative Scholarship for  assistance with acquiring, distributing, and tracking gift cards Please refer to Tax-Reporting Requirements and IRS Obligations of the College below for further information.

Gift cards being held in reserve may be stored securely in a fireproof safe by the Office of Finance or by ORCS, 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.

Emerson students who have worked as employees for the College in the same calendar year will also be issued a Form 1099 for any gift card payments received for participating in human subjects research.

To help minimize the number of participants subject to this rule, ORCS plays a primary role in the acquisition, distribution, and tracking of gift cards on behalf of researchers for IRB-approved projects. Please contact the Executive Director of Research and Creative Scholarship if you have an approved protocol that involves gift cards.

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) 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.

 

International Research

Research conducted by Emerson College faculty, staff, or students in foreign countries poses unique and complex challenges. Each country has different cultures, values, laws, and regulations. Research studies are considered to have an international component when investigators travel abroad to collect data. or investigators use or collect data from participants who are outside of the USA.

Emerson College’s IRB will review research studies against 45 CFR 46 and its Subparts. There will be issues that go beyond the purview of the IRB. Upon approval of a research study, the IRB will forward all approved protocol documents to General Counsel, Risk Management, and Academic Affairs to review, at their discretion, for areas that may include the following–

  1. For registration of international travel with the College’s travel protection program, and any additional steps/precautions as deemed necessary;
  2. Weighing the project’s risks to the researcher’s safety, the College’s international relations and/or reputation, etc. against the potential benefits to the College, relevance to the researcher’s scholarship, tenure-track, etc., and school/department priorities.
  3. For consideration of relevant international laws/regulations normally not applicable to Emerson College and its faculty, students and staff, and referral to outside counsel, if necessary (in particular for countries under GDPR, PIPL, and others).

These offices will be in direct touch with researchers if they have additional questions or concerns.

Given the complexities that can arise with international research, it is recommended that researchers submit their studies at least three months prior to the planned beginning of research.

 

Policies & Guidelines

 

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 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.edu (human_subjects[at]emerson[dot]edu) 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.edu (human_subjects[at]emerson[dot]edu) with any questions.

Current IRB Members

Lindsay Griffin, PhD
Communication Sciences and Disorders, Chair
Voting Member
Scientist
lindsay_griffin [at] emerson.edu (lindsay_griffin[at]emerson[dot]edu)

Joanne Lasker, PhD
Communication Sciences and Disorders, Vice Chair
Voting Member
Scientist
joanne_lasker [at] emerson.edu (joanne_lasker[at]emerson[dot]edu)

Dana Edell, PhD
Performing Arts
Voting Member
Scientist
dana_edell [at] emerson.edu (dana_edell[at]emerson[dot]edu)

Genevieve Alelis, PhD
Institutional Research
Voting Member
Non-Scientist
genevieve_alelis [at] emerson.edu (genevieve_alelis[at]emerson[dot]edu)

Tyler Rowe, MA
Iwasaki Library
Voting Member
Non-Scientist
tyler_rowe [at] emerson.edu (tyler_rowe[at]emerson[dot]edu)

Vinoth Jagaroo, PhD
Marlboro Institute for Liberal Arts and Interdisciplinary Studies
Voting Member
Scientist
vinoth_jagaroo [at] emerson.edu (vinoth_jagaroo[at]emerson[dot]edu)

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

Alexandra Socarides, PhD
Provost and VP for Academic Affairs, Ex Officio 
Non-Voting Member
alexandra.socarides [at] emerson.edu (alexandra[dot]socarides[at]emerson[dot]edu)

Eric Asetta, MA
Office of Research and Creative Scholarship, Ex Officio
Non-Voting Member
eric_asetta [at] emerson.edu (eric_asetta[at]emerson[dot]edu)

IRB Coordinator

Eric Matthews, MBA
Academic Affairs, Part-Time IRB Coordinator
Non-Scientist 
Voting Member
eric_matthews [at] emerson.edu (eric_matthews[at]emerson[dot]edu)