Submission and Review Process

New Submissions

All new IRB applications will be submitted through the InfoReady system. Review this helpful step-by-step guide on submitting an application in InfoReady.

To ensure a smooth review process, all faculty, staff, and students should begin their IRB application well in advance of their planned research start date. This is because no research may begin until the research study has been approved by the IRB. It is critical to read all instructions and requirements carefully to help avoid any unnecessary delays.

Before you submit your application in InfoReady, be sure you have all required attachments ready to upload. This typically includes:

• 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, and what happens to their data. This allows them to make an accurate assessment of whether they would like to join in the research study.
• 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, measurement instruments, and more.
• CITI Certifications. 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 (human_subjects[at]emerson[dot]edu) as well, so the IRB may keep a record of their certifications.

In addition to these attachments, some studies can require additional information:

• (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. Please upload these documents at the end of the application, in additional materials.
  • GDPR Form Template - For use in research studies taking place in countries governed by the EU’s General Data Protection Regulation (GDPR). This should be added as an addendum to your informed consent form.
  • PIPL Form Template - For use in research studies taking place in China. This should be added as an addendum to your informed consent form.

A complete application is necessary for the review process to begin. After you submit, you will receive an email confirmation and be able to track the status of your application in the Applications tab of your InfoReady account. The IRB will also be in touch to confirm receipt of your research study and to begin the review process.

Modifications to Approved Studies

Modifications will be handled through InfoReady as well in a process similar to new applications. Review this helpful guide for submitting a modification. To submit a modification to a research study, researchers should:

• Go to the IRB application in InfoReady
• Select “Begin IRB Application”
• In the “Select Application” drop-down, choose “Copy Application.”
• 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.
• 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.
• Make the changes you wish to make, noting the titles of the sections that are being updated.
• While submitting changes, make sure current attachments are showing, outdated attachments are removed, and new attachments are added.
• At the end of the application, note the sections that were updated, along with a rationale for the modification.
• Submit your application.

Check-ins, Renewals, and Protocol Closures

Renewals, check-ins, and protocol closures will now be handled through the progress report system in InfoReady.

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, or may need to extend their end date, please email human_subjects [at] emerson.edu (human_subjects[at]emerson[dot]edu).

Unanticipated Problems and Adverse Events

Definitions

While both are not defined in 45 CFR 46, unanticipated problems and adverse events are mentioned in OHRP’s guidance document titled “Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007).”

Unanticipated problems, in general, include any incident, experience, or outcome that meets all of the following criteria:

1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
2. related or possibly related to participation in the research (in the guidance document mentioned above, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

The term adverse event in general is used very broadly and includes any event meeting the following definition:

• Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).

Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.

What Researchers Should Do

If you suspect there is a chance that there was an unanticipated problem or adverse event, please contact the lindsay_griffin [at] emerson.edu (IRB Chair) and the eric_asetta [at] emerson.edu (Executive Director of the Office of Research and Creative Scholarship). After receipt, these events will be reviewed against the current guidance on Reporting Incidents to OHRP (2022), and will be in touch with any requests for more information. A plan would typically be put into place to address the incident and reduce the chances of any additional risks to human subjects.