Faculty and staff members looking to submit a new protocol to the IRB should follow the steps below. Students wishing to conduct human subjects research must have a faculty member act as their principal investigator.
Please contact the IRB Chair at human_subjects [at] emerson.edu (human_subjects[at]emerson[dot]edu) with any questions.
Step 1: Does My Research Study Require IRB Review?
The first step in human subjects research is determining whether your research study is human subjects research that would need to be submitted to the IRB. To assist researchers in determining this, we provide the "Does IRB Review Apply? Decision Tree," linked below.
If you have any questions about whether your research should be reviewed by the IRB, we ask that you contact us at human_subjects [at] emerson.edu (human_subjects[at]emerson[dot]edu). If it is determined that your research study does require IRB review, please continue to Step 2.
Step 2: Become CITI Certified
The IRB requires that all members of a protocol's research team receive certification from CITIProgram. This must be done prior to submitting a protocol to the IRB.
The two courses that fulfill this requirement are the Social and Behavioral Research - Basic/Refresher course, and the Social and Behavioral Responsible Conduct of Research course. We recommend that students and faculty who do not regularly conduct human subjects research complete the Social and Behavioral Research - Basic/Refresher course.
The College also offers an Information Privacy and Security (IPS) course for the Emerson community. We recommend taking this course if you are handling research data, though it is not required.
To Register:
- Go to CITIprogram.org and register. Be sure to affiliate with Emerson College during registration.
- On the "Select Curriculum" page: If you are a student or faculty/staff member who does not regularly conduct human subjects research choose "Not at this time" for question 1, "Social and Behavioral Research" for question 2, and feel free to include the IPS course if you would like.
- Complete the Social and Behavioral Research - Basic/Refresher course.
After everyone on your research team receives certification, continue on to Step 3.
Step 3: Developing A Human Subjects Research Application
After the entire research team receives their certification through CITIProgram, researchers may move on to developing their application. The application and other helpful tools can be found below.
- Human Subjects Research Application Form
- Annotated Human Subjects Research Application
- Informed Consent Form Template
- Waiver of Some or All of the Requirements of Informed Consent Form
Each bullet point should be addressed in every section of the application, as missing information is one of the top reasons for delays. We recommend having the annotated application handy while completing your application.
We have included an informed consent form template for your use as well. Each bulleted item should appear in the consent form, and should be found in your application. This will give human subjects the information necessary to make a decision on if they would like to join your protocol.
If you are conducting an anonymous online survey, or have another reason to waive documentation of informed consent (or waive informed consent), we have included the appropriate form above. Please note that even if a waiver of documentation of informed consent is being requested, we still need to see the informed consent language that will be given to potential human subjects.
Once you have completed your application, gather all of your documents together in preparation for Step 3. Typical submissions to the IRB include the following documents:
- IRB Application
- Sample Recruitment text (required as noted in the "Recruitment Tools" section of the application)
- Informed Consent Form (and/or the Waiver of Some or All of the Requirements of Informed Consent Form)
- Copies of All Research Tools (as noted in the "Research Tools" section of the application)
Once this is done, continue to Step 4.
Step 4: Submitting Your Protocol To The IRB
After completing your application and documents, you are now ready to submit your protocol to the IRB.
Send an e-mail to human_subjects [at] emerson.edu (human_subjects[at]emerson[dot]edu) with the subject "Human Subjects Research Proposal - [Name of Principal Investigator]." The e-mail should include the application, recruitment text, informed consent form, research tools, and any other forms as attachments.
The IRB administrator will review the application and materials for completeness. If everything is submitted appropriately, the administrator will forward the application to an IRB member (for expedited/exemption requests) or to the full IRB (for full review requests). If items are missing, the administrator will e-mail a list of items that would need to be added for the submission to move forward.
Timelines
Expedited reviews and exemptions that are approved by the IRB are usually approved within 2-4 weeks. Full reviews that are approved can take anywhere from 3-8 weeks, depending on when the protocol was received in relation to the next IRB meeting, completeness of the application, and whether the research study was approved in the first IRB meeting. These timelines can be affected by the volume of research studies received by the IRB. The IRB recommends submitting your research study well in advanced of the anticipated start date of research.
Next Steps: What To Expect
For Expedited Reviews / Exemptions
An IRB member will review your research study application and documents. One of the IRB Co-Chair will forward any questions, clarifications, and/or a list of edits that need to be made to the principal investigator listed in the research study. Once the IRB Co-Chair determines that the research study is ready to be approved, the IRB Co-Chair will send an approval e-mail to the principal investigator with stamped versions of any informed consent documents (if appropriate). After receipt of the approval e-mail, the principal investigator and the research staff may start to conduct research.
If the reviewing IRB member determines that approval cannot be given for the expedited review / exemption request, the IRB Co-Chair will notify the principal investigator that the research study has been forwarded to the IRB for a full board review.
For Full Reviews
Research studies for full review will be reviewed at the next scheduled IRB meeting. Research studies must be complete by the deadline listed on the main IRB webpage to be reviewed at the next IRB meeting. The IRB recommends that full review protocols are submitted at least 7-10 days prior to the deadline for full review, to allow the IRB administrator to determine what is needed for the application to be considered complete, and for the principal researcher to submit any missing items.
At the full IRB meeting, the IRB will discuss protocols up for full review and determine whether protocols should be approved, approved with modifications required, or not approved. One of the IRB Co-Chairs will e-mail the principal investigator the results of the full review.
Approved research studies may begin research after receiving the approval e-mail from one of the IRB Co-Chairs.
Research studies that received an "approval with modifications required" designation must make the edits that are listed on the e-mail received by the IRB Co-Chair. The IRB Co-Chair will then review those edits through an expedited process. If the edits are approved, the IRB Co-Chair will inform the principal investigator that the research study is now approved, and research may begin.
Research studies that are not approved will receive an e-mail from one of the IRB Co-Chairs stating why the research study was not approved, including items that will need to be addressed to resubmit the research study for full review.