Student Research

The BSPH IRB Office supports the School’s mission and excellence in public health by ensuring students have the resources and information they need to apply ethical principles in their research interactions with humans and/or their data, regardless of whether IRB oversight is required.

BSPH IRB Office Student Determination Request Form

All student projects must have a preliminary review by the BSPH IRB Office to determine whether they are human subjects research (HSR) requiring IRB oversight or whether they can be conducted with no further action, unless: a BSPH PI is adding you as a student investigator to an existing, BSPH IRB-approved study or the project has been pre-determined to involve human subjects research, in which case this process may not be required.

To obtain a formal determination and documentation from the IRB, you need to submit a BSPH IRB Office Student Determination Request Form. Work with your Project Advisor to complete the relevant sections of the form that best describe your project. Then, submit the form to the BSPH IRB Office at bsph.irboffice@jhu.edu, and make sure to copy your advisor on the email.

Project Advisors identified on the Student Determination Forms may be a full-time BSPH faculty member or an external advisor. Note that if the project is found to require a submission to the BSPH PHIRST system, you will need to identify a BSPH faculty member to serve as the principal investigator for this work, and the external advisor may be named on the PHIRST application as a co-investigator.
Students with IRB approval or a determination letter from a U.S.-based external institution should submit external study documentation (protocol and approval letters) with the BSPH IRB Office Student Determination Request Form. The BSPH IRB Office will review it and decide whether the proposed work by the student will involve HSR. If it does, the BSPH IRB Office will help determine whether it will be possible to rely on or accept the external IRB approval or determination, depending on the nature of the research and the student’s role in the external research. For a study with external approval, the Project Advisor may be a non-BSPH faculty member. However, if a PHIRST application is required (for example, a new application must be submitted to support the request to rely on the external IRB), a BSPH PI will need to be identified to support and submit the application. The external investigator can still serve in the role of a Project Advisor for this work. Note that the BSPH IRB cannot rely on external IRBs outside the U.S.

The BSPH IRB Office will review the Request Form and within 2 weeks, email you and your advisor if any additional information is needed during the preliminary review process or to provide you with documentation of its determination.

Please note the following possible next steps:
- A new PHIRST application is not required: In the determination email, the BSPH IRB Office will provide you and your advisor with formal documentation of its determination and confirm that no further action is required.
- A new PHIRST application is required: If the BSPH IRB Office determines that your project is human subjects research, a new PHIRST application is required. In the determination email, the BSPH IRB Office will provide a rationale for its determination (see categories listed below), guidance about submitting a new PHIRST application for your human subjects research project, and will copy the IRB Navigator, IRBNav@jh.edu, who can work with you on your PHIRST application. If you have an external advisor, at this point you will need to identify a BSPH faculty member who can serve as the principal investigator for this submission.

BSPH IRB Office Determinations

After reviewing the determination form, the BSPH IRB Office will issue one of the following determinations:

Not Engaged in Human Subjects Research – While the project itself is human subjects research, BSPH is not: the primary grantee of federal funding, consenting participants, collecting data/biospecimens or otherwise interacting with human subjects, or obtaining or using identifiable (or linkable) private information/biospecimens. See OHRP Guidance http://www.hhs.gov/ohrp/policy/engage08.html
Research/Not Human Subjects Research – Key Informant Research involving information from individuals about something other than themselves, disclosing no personal opinions, and not exposing respondents to employment or other risks.
Research/Not Human Subjects Research – Secondary Data Analysis involving the use of existing, de-identified data/specimens, including publicly available data.
Not Research/Practicum Fulfillment Activity involving a project to satisfy your BSPH practicum requirement. There is no research question, and you are not an “investigator” (meaning involved with the design, data collection, or analysis of a research study).
Not Research/Public Health Practice involving “program development or evaluation” in the delivery of public health practice services.
Not Research/Public Health Surveillance involving activities, including the collection and testing of information or biospecimens, conducted, requested, ordered, required, or authorized by a public health authority.
Not Research/Quality Assurance involving an organization, government entity, clinic or practice conducting a self-evaluation to determine whether it meets identified standards of quality in the delivery of a service or product. There is no research question.

Exempt human subjects research (HSR). A PHIRST application is required in order to receive an Exempt determination.

Exempt HSR with an Exempt determination from an external U.S. research institution’s IRB. The research activity must include adequate student supervision. In such cases, the BSPH IRB may accept the Exempt determination made by the external U.S. research institution’s IRB; a PHIRST application is required.

Non-exempt HSR refers to research that involves human subjects and is subject to IRB review under federal regulations, which requires a PHIRST application to initiate.

Non-exempt HSR to be conducted at an external U.S. research institution with IRB approval by that institution’s IRB. The research activity must include adequate student supervision. In such cases, the BSPH IRB may consider entering into a reliance agreement deferring JHU review responsibilities to that external institution’s IRB; a PHIRST application is required.

Submitting a New PHIRST Application

PHIRST, Public Health Institutional Review Submission Tracking, is the BSPH IRB Office’s web-based electronic application submission system.

If the BSPH IRB Office determines that the student project qualifies as human subjects research and requires a new PHIRST application, the student needs to follow these steps:

STEP 1 - Secure a Principal Investigator (PI).

To start work on the PHIRST application, you must have a faculty member with a primary appointment at BSPH who agrees to serve as the Principal Investigator (PI) and will be responsible for all aspects of your student project. This faculty member is typically your advisor.

STEP 2 - Register in PHIRST.

Register in PHIRST choosing “student investigator” and “study contact” as your roles - see the PHIRST User Guide for instructions on how to do this. Contact the PHIRST Helpdesk at bsph.phirsthelp@jhu.edu, phone 410-502-5780, or toll free 1-888-262-3242 if you need assistance.

STEP 3 - Complete human subjects research training through CITI.

When you register in PHIRST, you will be asked to upload your CITI completion certificate(s). See the BSPH IRB Training page that outlines the training modules you will need to take. All students must complete the BSPH Basic Human Subjects Research Course. It takes about four to 6 hours and can be completed anywhere, any time. Instructions are in the CITI FAQs.

STEP 4 - Request the PI to start the PHIRST application.

The faculty member who is PI must start the application process in PHIRST, identifying themselves as having the “PI role” and naming you as the “student investigator” and “study contact”.

STEP 5 - You and the PI collaborate on the research application.

You will need to start working on the research plan. On the Research Plans webpage, there are links to the following templates: Research Plan for Secondary Data Analysis of Existing Data/Specimens and Research Plan for New Data Collection. There is also a link to an instructional template, Research Plan Instructional Guide, that provides detailed information about what is needed in each section of the template. Be sure to use only the templates that are on the website as they are often updated.

If you are collecting new data, additional documents you will likely need to include in your PHIRST application are any recruitment materials (texts for emails, for example), consent forms, and any questionnaires/surveys.

STEP 6 - Once you are ready, the PI must click “submit”.

Adding a Student to a BSPH IRB-Approved Study

If the student’s project falls within the scope and aims of an active, BSPH IRB-approved study, the PI for the study will need to submit an Administrative Amendment Application through the PHIRST system to add the student investigator to the study team. The student must be registered in PHIRST in order for the PI to find the student’s name in the PHIRST system, and the student must have completed the PHIRST registration process that requires uploading of the Human Subjects Research (HSR) CITI training certificate. In addition, if the approved study research plan does not have a student oversight section completed that would cover the student’s activities, a parallel study amendment must be submitted, outlining the plans for supervising the student’s activities on the study. Note that under certain circumstances (e.g., a protocol is reviewed by a community board and amendments would result in additional time, effort, and material costs), a copy of the study determination form may be submitted in lieu of protocol amendment. Contact the BSPH IRB Office to determine if your project requires this approach.

Helpful Resources

For a quick overview of the application and submission process, check out these helpful Student Research and the BSPH IRB Office FAQs.

All BSPH students must follow the BSPH Ethical Code for Student Activities that Involve Human Interactions.

Need More Information?

Can’t find the answer to your question? Email us at bsph.irboffice@jhu.edu or contact the IRB Navigator IRBNav@jh.edu.