COVID-19 Update: Suspension of Face-To-Face Interventions and Interactions with Human Subjects

Dear Faculty, Staff, and Students,

In the context of the COVID-19 pandemic, and Emerson College's commitment to flattening the curve through social distancing and other methods, this temporary policy is being implemented to protect our participants, researchers, students, and the larger community from risk of infection from COVID-19.

Effective immediately, in accordance with guidance promulgated by the National Institutes of Health, Emerson College is directing that all studies involving face-to-face interaction with participants with no direct drug or device therapeutic benefit are to be postponed until further notice.

This guidance does not apply to IRB-approved study activities that do not involve direct subject contact (e.g., chart review, surveys, remote interviews); research that has already transitioned in-person visits over to virtual visits (e.g. interviews, surveys, questionnaires); or research that is being finished up AND requires no further interventions or interactions with human subjects (i.e. working with identifiable data, etc.)

All interventions and interactions with human subjects must be conducted remotely at this time whenever possible. Researchers should consider using telephone, web conferencing, and other electronic means to conduct data collection procedures normally done in-person. These methods may be added when possible and practical for mitigating research risks to human subjects or others related to COVID-19.

Any deviation from a previously approved IRB protocol must first be approved by the IRB via a Modification Request Form. The IRB will be checking the human_subjects [at] emerson.edu e-mail for these modifications, and will expedite them as quickly as possible.

In the coming days, the IRB will be reaching out to individual investigators to check on the status of your protocol, and if you anticipate any disruptions to your research, whether this is due to this temporary policy or other COVID-19-related circumstances. The College is committed to working with investigators to mitigating any such disruptions. In addition to the remote options outlined above, investigators may wish to request an extension of their protocol(s), or make other changes to data collection methods.

The IRB is committed to working with investigators to ensure the continuation of your research while protecting human subjects from risks to the best of our ability. The IRB will be in touch with further updates, and will include these on our website. Please e-mail the IRB at human_subjects [at] emerson.edu if you have any questions.

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. 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.

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.edu. The subject of your e-mail should include the study's protocol number.
  3. One of the IRB Co-Chairs 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, one of the IRB Co-Chairs will inform the principal investigator of the decision.

Protocol modification requests are typically reviewed within 1-2 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.edu. 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. One of the IRB Co-Chairs 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, one of the IRB Co-Chairs will inform the principal investigator of the decision.

Protocol renewal requests are typically reviewed within 1-2 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.edu. 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 InstitutionalTraining 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 IRBCo-Chairs 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.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.

Timetables for typical exemption requests that are approved are typically 2-3 weeks, while typical expedited reviews can take anywhere from 2-4 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

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

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 in order 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 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.

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

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.

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

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.

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 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 Co-Chairs at human_subjects [at] emerson.edu with any questions.

Academic Year 2021 IRB Members

Eiki Satake, EdD
Marlboro Institute for Liberal Arts and Interdisciplinary Studies, Co-Chair
Voting Member
eiki_satake [at] emerson.edu

Roxana Maiorescu, PhD
Marketing Communication, Co-Chair
Voting Member
r_maiorescu_murphy [at] emerson.edu

Joanne Lasker, PhD
Communication Sciences and Disorders, Vice Chair (On Leave Spring 2021)
Voting Member
joanne_lasker [at] emerson.edu

Michael Duggan, EdD
Institutional Research
Voting Member
michael_duggan [at] emerson.edu

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

Lindsay Beamish, MFA
Performing Arts, Non-Scientist
Voting Member
lindsay_beamish [at] emerson.edu

Tylor Orme, PhD
Marlboro Institute for Liberal Arts and Interdisciplinary Studies
Voting Member
tylor_orme [at] emerson.edu

Sara Salimbeni, PhD
Marlboro Institute for Liberal Arts and Interdisciplinary Studies
Voting Member
sara_salimbeni [at] emerson.edu

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

Chris Dearborn, PhD
Suffolk Law School, Prisoner Representative (on reviews involving prisoners as research subjects)
Voting Member (on studies involving Prisoner Representatives)

Michaele Whelan, PhD
Chief Academic Officer, Ex Officio 
Non-Voting Member
michaele_whelan [at] emerson.edu

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

IRB Administrator

Eric Matthews, MBA
Academic Affairs, Part-Time Administrator
Non-Voting Member
eric_matthews [at] emerson.edu