Get Started

The first step is to determine if NU IRB review is required. In many cases, the answer is obvious. However, there are many situations where IRB review might not be required or needed. To decide this, we ask 3 questions to determine if the activity is Research involving Human Subjects that requires NU IRB review:

1. Is it Research? Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.Note: if you are testing the safety or efficacy of a device, application, algorithm, drug, or biologic, regardless of contributing to generalizable knowledge, you are considered to be conducting research per FDA regulations.
2. Does it involve Human Subjects? Human subject means a living individual about whom an investigator is conducting research:(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable specimens.

3. Is Northeastern University Engaged in the Human Subjects Research? If one or more Northeastern researchers are conducting research in their Northeastern University role (acting as an agent of Northeastern) or if Northeastern University is the prime recipient of federal funding, Northeastern University is likely engaged. If you have questions about engagement, please review OHRP Engagement Guidance, attend an IRB Drop In Session, or reach out to discuss.

Please see “Defining human subject research” on our Guidance for more information. The Department of Health and Human Services also provides flowcharts that are useful in making this determination. To request a formal determination of whether an activity is or is not Human Subjects Research, please submit a Human subjects research determination form.

If the activity is Human Subjects Research and Northeastern is engaged, please move on to Step 2.

At NU, students may not serve in the role of a PI. This is simply because they are affiliated with the university in a learning capacity and only those with certain types of employment have the requirements to serve as a PI. Students must identify a faculty advisor to be the study PI. This individual should have relevant knowledge as it pertains to the research. The University has a policy on who is eligible to be PI.

Under the direction of the Office of the Vice Provost for Research, Northeastern University requires completion of training on the protection of human subjects and the ethical principles of research for all human subject research (HSR), regardless of whether or not investigators have received funding to support their project. This training is mandatory for all faculty, staff, and students who conduct/supervise HSR whether on campus or off-campus.

Northeastern has an account with CITI, who offers human subject training. All NU affiliates can take this course at no charge. Please note that approval for training is for 3 years. Those who continue to be engaged in HSR will be instructed to complete a refresher course. If you completed this training at another institution, within the 3-year period, simply go into your CITI account and indicate you now an NU affiliate.

Our website provides more information on the training requirement and how to access the CITI modules.

To submit an exempt application, provide the following:

• Protocol application form – exempt.
• PI assurance form – which requires a signature by the Principal Investigator (PI).
• A participant information sheet (if applicable).
• Copies of all instruments, data collection documents , recruitment materials, and any other participant facing materials used in the conduct of the study.
• Letters of support

To submit a non-exempt application (expedited/full board), provide the following:

• Protocol application form – non-exempt
• PI assurance form – which requires a signature by the Principal Investigator (PI).
• Any consent, assent, and parental permission forms
• Copies of all instruments, data collection sheets, recruitment materials, and any other participant facing materials used in the conduct of the study.
• Research team form, when the research team includes more than the PI and student investigator.

To submit a secondary data analysis study, provide the following:

• Data and Specimen Analysis Form
• PI assurance form – which requires a signature by the Principal Investigator (PI).
• Copies of all instruments, data collection sheets, DUAs, agreements, or other ancillary materials indicating approved uses of the data.
• Research team form, when the research team includes more than the PI and student investigator.

The Department of Health and Human Services also provides flowcharts that are useful in making a determination of whether a project will likely qualify for “Exempt” review.

• When completing a protocol application form, be thorough but concise. Protocols should focus on the human subject aspect and not literature reviews, archival or background research.
• Make sure your materials are consistent and filled out completely. Submissions with inconsistent materials or missing materials tend to take additional revision rounds that can add significant time to your time to approval.
• We often see a lack of detail documented regarding recruitment procedures. Consider recruitment strategies. How will individuals come to know about your study? Will you post flyers in a certain area? Will you post social media notices? will you speak before a group gathering? describe the recruitment process in the protocol and be sure to provide copies of all recruitment documents; e.g., flyer, social media post, oral script, etc. Consider how you are ensuring your recruitment strategies result in an equitable subject selection and how any potential power differentials are mitigated (e.g., recruiting NU students, recruiting colleagues, etc). If power differentials exist, be sure to address this in the recruitment section and describe actions you will take to minimize or eliminate potential undue influence or possible coercion.
• Provide all documents you will use to collect data such as: survey document, including those that will be conducted on-line; interview and focus group questions.
• If you plan to provide to pay participants for the participants, the protocol should include when participants will receive their money, the form of payment (cash, gift card, etc.), how it will be pro-rated. Furthermore, compensation should not coerce or unduly influence one’s decision to participate in the study.

Submit all material via email to [email protected].

A few days after you submit, the PI and lead student listed on the application will receive an email confirming the submission was received. This confirmation email will indicate that your study has been assigned to an OHSRP staff member. You will work with this staff member throughout the review process..

After the submission is reviewed, the PI and lead student investigator will receive an exempt determination letter or non-exempt approval material packet via email.

• Use the most current version of the submission forms found on our website.
• Make sure everyone listed on the research team has completed the required human subject training.
• Make sure the principal investigator has read the protocol and signed the assurance form.
• Provide all research material including, but not limited to: protocol application form, consent forms and scripts, data collection instruments, recruitment material, etc.
• Ensure information is consistent across all research material. For example, the study duration in protocol is different from the consent form.
• Use lay language and explain discipline specific terms and concepts.
• Use pictures in your application documents, if possible. For example, a table if there are multiple data collection points; a visual if a device is being used, etc.
• Use a track changes features when responding to IRB stipulations or when modifying an approved protocol and update version dates when any study document is revised
• Plan ahead if you intend to conduct research internationally. Additional considerations and at times additional oversight from non-U.S. ethics committees may be required.
• Be mindful of typos.
• Report if anything unanticipated happens.
• And…remember, do not begin any research until you are in receipt of an IRB approval letter or exempt determination.