How to Submit

North Star Review Board uses REDCap for its submissions and reviews. REDCap is a secure, web-based application designed for research data management, and made available to academic sites and nonprofit organizations by Vanderbilt University. Our submission form was developed so that researchers only need to answer questions and provide documents relevant to their submission, whether that submission is for a new study or a change to an existing study.If you have submitted to North Star Review Board before, you can submit changes or new studies by going directly to the submission form link.

We ask that researchers or sponsors who are new to North Star Review Board contact us before their first submission. We want to be sure that we understand your needs, and you understand what we expect, so that we can provide our services with as little burden and delay as possible.

If you have submitted to North Star Review Board before, you can submit changes or new studies by going directly to the submission form link.

As a nonprofit entity, North Star’s fees are designed to cover our costs while remaining sensitive to the range of resources available to different kinds of research entities/researchers/sponsors. Please contact us for more information about our fee schedule as our fees are specific to different types of projects.

North Star also uses a subscription model to support its activities. Studies and sites are billed annually at a fixed rate, not submission-by-submission. We believe that there should not be a financial disincentive to improving the science, participant protections, or recruitment of a study. 

Review timelines are dependent on several characteristics of a submission.  We typically provide a response to submissions that can go through “expedited review” (such as low risk studies that fall into the applicable review categories) and exemption determinations within 5 business days. But review time and time-to-approval may not be the same. In general, the more complete the submission, the faster the time to reach a determination.

• Study Protocol: This document should provide an explanation of the significance of the research and any study procedures that will be conducted. There are many excellent templates available for this requirement. The protocol should provide enough information that the board can make assessments on all required elements of IRB review under 45 CFR 46.111 or 21 CFR 56.111, i.e., should demonstrate that:
  • Risks to participants are minimized;
  • The question to be answered and/or direct benefits to participants make the study a reasonable opportunity to offer to potential subjects, and the study is designed in a way that this question can be answered;
  • The opportunity to participate will be broadly offered to the population most affected by the issue under study, and that recruitment will not target populations simply because they are more accessible;
  • Individuals will be asked for their explicit, informed, and voluntarily given consent to participate. Where the science or the population being studied make this difficult, constraints on obtaining consent must be explicitly presented;
  • The wellbeing of participants will be appropriately monitored during the study;
    Participant privacy and confidentiality will be safeguarded.
• Consent Forms: Except in studies that present little risk, consent forms should not be expected to substitute for a personal discussion with a potential participant, but signed consent forms document that individuals have been given the information they need and have agreed to participate. Consent forms must be written in a way that is understandable to participants, and should not be written as a liability defense for researchers and institutions. If children will be recruited, an assent form or other way to explicitly capture their agreement to participate should also be submitted. Research regulations require that forms disclose the following, at a minimum:
  • A description of the purpose of the research and what individuals will be asked to do;
    Risks that participants my face;
  • Benefits that are expected to arise from the research, including both benefits to participants and those that will result from answering the question being asked;
    A description of alternatives to participation, if relevant (e.g., when the research study may provide medical care that differs from the generally accepted standard);
  • How and to what extent the privacy and confidentiality of participants will be protected;
    If the research presents risks greater than those participants generally face, how injuries related to the research will be managed (e.g., will the study provide medical care or reimburse such care?);
  • Who to contact if an individual has questions about their participation, including both questions about the study and their rights as research subjects, or believes they have been injured as a result of their participation;
  • An explicit statement that participation is voluntary, and choosing not to join the study will not compromise care or other benefits to which an individual is entitled. The form should also make clear that individuals may leave the study if they wish, again without loss of other rights or benefits.
  • Information about future use of information collected in the study that has been “de-identified.” This provision is needed because use of such information does not generally require further review or consent, so individuals must be told about it as part of the study in which the information is collected.
• Recruitment Materials: Any material (e.g., flyers, emails, social media posts, brochures, pamphlets) that will be used to recruit individuals into the study must be reviewed to ensure that the opportunity to participate is presented fairly, does not over promise benefits, and does not implicitly or explicitly threaten consequences if individuals choose not to join. Longer documents, such as videos or testimonials, may be submitted as links.
• Participant Facing Materials: Any materials that individuals will interact with  during their participation in the study, or that will guide investigator-participant interactions (e.g., surveys, interview/focus group guides, follow up or reminder emails) should be submitted for review. This material will be reviewed to ensure consistency with the protocol and informed consent form.
• Principal Investigator CV/Resume/Training Docs: While the IRB provides oversight and has the authority to hold an investigator accountable, “on the ground” protection of research participants is the responsibility of the principal investigator. Before approving a research study, the board must have confidence that the investigator has the scientific expertise to run the study (a study that does not yield sound data cannot justify risk or burden to participants) and an understanding of the ethical principles that must guide the treatment of participant. The submission should include a resume or CV for the principal investigator, along with evidence that the investigator has been trained in the protection of human subjects of research. For example, if your organization provides access to CITI and its training courses, a CITI training certificate should be submitted. Should your institution or organization not utilize CITI training, equivalent training is acceptable. Note that the board requires the principal investigator to attest to the adequacy of training and experience for other members of the research team. Accordingly, we do not require submission of CVs and evidence of training for the full team. In line with the Federal Regulations, the principal investigator is responsible for any incidents that arise because a member of the research team misunderstands or fails to follow the protocol.
• Explanatory or Administrative Documents: Documents like study development background, research or partnership schemas, any other material that will help the board understand the purpose and context of the submitted documents, and anything you feel we should know to assist our review.
• If your study is being transferred from another IRB, we also ask that you submit:
  • The original IRBs determinations, including initial review and continuing reviews (for those studies subject to continuing review).
  • Any outstanding or unresolved requests from the original IRB.

All modified documents (e.g., protocol, informed consent form) with changes tracked into the previously approved version of the document. If there are new documents, please describe these documents as “new” when submitting them to be reviewed.

For any change that is substantive (e.g., not spelling or grammatical corrections, or reformatting) a separate explanation of the changes and their rationale.

The term “adverse event” is a term-of-art used in the research regulations. In general, such an event is any occurrence or finding that might change the overall risk of the study. In addition to adverse events, any finding that could lead to such a change should be reported to the IRB, including instances of non-compliance with regulatory obligations or requirements placed on a study by the Board. In general, such reports will be reviewed by a single reviewer. If the event provides evidence that the study’s risks or benefits have changed, it may be forwarded to the full board for review. Similarly, if the event suggests that participants have been placed at risk because the investigator or study team has not followed the protocol, review may be conducted by the full board.

The findings of the board in review of adverse events and other problems may be communicated to federal agencies, research sponsors, and institutions, per the applicable regulations and, for individual research sites in a multisite study for which North Star Review Board is serving as the single IRB, per the details of institutional reliance agreements.

We recognize that the IRB submission process can seem complicated, and that the research regulations can be intimidating and confusing. With this in mind, please reach out to us with any questions about the submission process or IRB review in general.

We use a single form for all submissions. Selecting “Change or new information for an approved state,” will provide an option to indicate that the submission is a  “Safety report or unanticipated problem.” From this, the form will update accordingly and you will have the opportunity to describe the issue, and upload any relevant documents.

If you have questions or trouble filling out any of the fields on the form, please contact us.