The Review Process for Human Subject Studies
Federal regulations divide human subjects research into three categories according to the level of risk posed to subjects. For all human research projects in which FSU employees or agents are involved, an application for OHSP and/or IRB review must be submitted before human research activities may begin. As a reference only, refer to this engagement guidance and the HRP-311 Worksheet Engagement Determination form in RAMP IRB, under the IRB, Library and Worksheets tabs, also available here, to see how the OHSP and IRB may determine, based upon an FSU employee or agents' involvement in research, whether the research is subject to FSU's Assurance and FSU Policy 7-IRB-0 and requires certification of IRB review and approval.
- Exempt Review
- Expedited Review (also referred to as Non-Committee Review)
- Full Committee Review
1. Exempt review: To qualify for this category, the research must fall into one of eight exemptions at 45 CFR 46.104(d) (refer to page 7 of the pdf of this U.S. Department of Health and Human Services regulation; other signatory agencies have the same exemptions). See also the federally-provided exemption decision charts (beginning with Chart 2). These categories presumptively present low risk to potential subjects because they generally involve either collection of anonymous or publicly available data, or represent research for which the additional scrutiny required by federal regulations may have no added value for the protection of subjects; some exceptions apply. Examples of research that qualify as exempt are:
- Surveys for which subjects' identities cannot be readily ascertained, or if so then with limited IRB review
- Research involving normal educational practices not likely to adversely impact students or educators
- Analyses of discarded pathological specimens without personal identifiers
- Benign behavioral interventions in conjunction with collection of information from adult subjects
Important Distinction: It is the policy of FSU to review and determine whether research proposals meet the definition of “exempt.” The Principal Investigator does not make the decision whether a protocol qualifies as exempt. Only the IRB and the Office for Human Subjects Protection (OHSP) staff have the authority to determine whether a proposal meets the exempt requirements. Please utilize the informational sheet template on our Templates & Required Forms page under "Other Forms" instead of the consent template if your study has received an exempt determination.
2. Expedited review: To qualify for this category, research must fall into one of the nine federally-defined categories of research that may be reviewed through an expedited review process or that may require limited IRB review of certain exempt research. These categories involve research that involves no more than minimal risks to subjects. Some examples qualifying for expedited review are:
- Studies involving collection of hair, saliva, or dental plaque samples
- Studies of blood samples from healthy volunteers (limits apply)
- Collection of data through noninvasive procedures routinely employed in clinical practice (excluding, however, procedures involving ionizing radiation, such as x-rays, DEXA scans and CT; other exceptions apply)
- Analysis of voice recordings
- Studies of existing pathological specimens with personal identifiers
- Exempt activities involving recording of subjects' identifiable information or secondary research involving identifiable private information or identifiable biospecimens.
This type of review process involves a subset of the full committee membership, delegated this authority by the Chair, to independently evaluate the protocol, and when all reviewers concur, the protocol is approval. At FSU, expedited review is performed by two IRB members, and the Chair.
NOTE: Reviews via the expedited process usually take approximately three to four weeks, provided that the application is complete at the time of submission and researchers have answered any questions to the IRB's satisfaction. To ensure the completeness of your application, please review our training requirements and templates/required forms.
3. Full Committee Review: This category of review is reserved for research proposals that are not eligible for expedited review; involve greater than minimal risk or a particular vulnerable population as defined in the regulations, or that may require limited IRB review of certain exempt research. Examples include:
- Invasive physiological or medical research or non-invasive research involving procedures that involve ionizing radiation, such as x-rays or DEXA scans
- Use of FDA-regulated products such as drugs (including supplements deemed as drugs) and devices that require FDA review
- Research where a breach of confidentiality could reasonably place subjects at risk of criminal or civil liability, or be damaging to a subject’s financial standing, employability, educational advancement or reputation
- Exempt activities involving recording of subjects' identifiable information or secondary research involving identifiable private information or identifiable biospecimens.
Important Distinction: Note that protocols involving the deception of research subjects, or other potentially vulnerable populations such as students or economically disadvantaged persons may be reviewed by the full committee.
Full committee meetings are held monthly at a time and location that is subject to change from semester to semester. Information regarding the time and place of meetings may be obtained by checking Meeting Dates & Deadlines posted on this website. Protocols that require review at a convened full committee meeting must be received by the FSU OHSP prior to the posted times on each deadline day.
Principal Investigators and faculty advisors may attend the full committee meeting if requested by the primary reviewer for a protocol, and may provide information to the members; however, they may not be present during the final discussion and vote. IRB members may not participate in the review and approval process of their own protocols.
NOTE: Full committee review process takes approximately four to six weeks, dependent on when a complete application is submitted and researchers have answered any questions to the IRB's satisfaction, within the deadlines. To obtain a high-level overview of select key decision points that may determine the pathway of regulatory review of human research at FSU, click on this algorithm or RAMP IRB algorithm link. The algorithm spans the pathway beginning with a researcher’s submission of their study for IRB review through to FSU human research regulatory approval for the study to begin.
Other Human Subjects Reviews ("Follow On" submissions)
Modifications or Changes to the Protocol (Revisions): When an Investigator desires to amend or change a protocol, even a very small change, he or she must submit to the FSU IRB for review and approval, prior to making any change, a request for an amendment or modification. A protocol change may affect the risks involved with a study, in addition to adverse events, unanticipated problems, or complaints about the research—all of which should be reported to the IRB. A written description of proposed changes to the protocol, informed consent process and/or research instruments must be submitted to the IRB for review and approval.
Minor changes proposed to previously approved protocols (i.e. number of participants, consent language) must be reviewed by the IRB Chair. All other proposed modifications (major changes) will be reviewed using the same process used for the review of the original protocol. Only when it is necessary to eliminate apparent immediate hazards to research participants may, according to the federal regulations, an Investigator be permitted to modify an approved protocol without the prior review and approval of the IRB; even then, the IRB must be promptly informed of the change upon implementation.
Continuing Review (Renewals): With the general exception for studies under expedited review, all protocols approved by the FSU IRB are subject to continuing review at intervals appropriate to the degree of risk, but not less than once in the 12 months following approval. At FSU, this is called the "Renewal" process. If the Principal Investigator does not receive a form for request for continuing review (renewal) within one month prior to the expiration date of the current FSU IRB approval, a request for the form should be made by contacting the OHSP.
If the IRB approval of a protocol expires before it has been re-reviewed and renewal approved, the protocol shall be suspended. While in a suspended status, all study activities, to include for example new subject recruitment or consenting, interactions or interventions with study subjects, and data analyses, must immediately cease. The only exception to this requirement is when there are concerns for the safety or well-being of the research subjects. In such a case, the Investigator must contact the IRB promptly. The suspension will be removed when and if the protocol is re-approved by the IRB.
The IRB, as a courtesy, sends out a written reminder to the Principal Investigator that the approval date is approaching expiration, and a renewal form is attached to the notice. However, it is the responsibility of the Principal Investigator to timely track and schedule their renewal submissions and to apply for renewal prior to the expiration date of the IRB approval. The Principal Investigator will receive a written notification of the IRB's review and decision for continuing a research protocol when the review process is complete. If the protocol has been re-approved, the notice will be labeled as "Re-Approval."
NOTE: All renewals should be submitted at least two full months (60 days) prior to the study's expiration date to account for review time and any possible revisions that may be requested.
Reportable New Information: When there are incidents involving unanticipated problems involving risks to subjects or others (see, e.g., serious adverse events below), non-compliance with applicable law and policy, suspension or termination of research, protocol deviations, agency audits, subjects' complaints and other events related to research, prompt reporting to the IRB may be required. Pursuant to IRB review and depending upon the substance of the report and risks to study subjects, further investigation may be necessary and corrective or mediating actions imposed.
Serious Adverse Events: A serious adverse event (SAE) is a serious, undesirable, and unintended result involving risks to research participants or others. These must be promptly reported in writing to the IRB Chair. The Investigator must provide a description of the event and state whether or not changes are needed in the protocol and the informed consent process. These revisions must be reviewed by the full committee. If the events are determined to place participants at increased risks, the Chair may request re-submission of the protocol for full committee review. If the IRB Committee determines that the research participant may be placed at an immediate risk, the Committee has the authority to suspend or terminate approval of a protocol, requiring the immediate cessation of data collection from research participants. The Investigator will be notified of the Committee action, and the Chair shall contact the appropriate University officials, sponsors, and/or OHRP as required.
To close a study on or before the approval expiration date, Investigators must prepare in RAMP IRB a continuing review/study closure submission for IRB review. Likewise, if a study is terminated by the IRB due to an Investigator's failure to submit a study for a required continuing review, the IRB will notify the study's PI and, as applicable, a student's major advisor to request submission of a study closure.
To close your study already housed in RAMP IRB, follow these steps: under Next Steps create and submit a study continuing review, complete the Continuing Review/Study Closure Information items as applicable (the first 4 research milestones must be checked), acknowledge that the study will be closed, discard any open follow-on submissions related to the study, complete the remaining items, attach any supporting documents as may be needed, then select Save, Finish and under Next Steps select Submit. Your Study Closure submission will move into the queue for review and further handling.
To close your study that was never submitted within RAMP IRB but is instead housed in the legacy HSRS IRB system, complete and submit to OHSP the closure form located here on the OHSP web site.
For FSU research that also involves a non-FSU institution located in the U.S. (referred to as cooperative research), an FSU Investigator or their non-FSU research collaborators may request that FSU rely upon or be relied upon by an external (non-FSU) institution for IRB for review of the research. With some exceptions, such reliance may be required under applicable federal law and policy (e.g., U.S. Department of Health and Human Services regulation, 45 CFR 46, section 46.114; U.S. National Institutes of Health Policy NOT-OD-16-094). This arrangement is permitted when the external non-FSU institution has, like FSU, its own Federalwide Assurance agreement with the U.S. government to conduct research involving human subjects (if otherwise, see below about collaborators at external institutions that lack a Federalwide Assurance). For federally funded research this arrangement should have been considered in the funding application, but such an arrangement may also, subject to federal sponsor and FSU OHSP approval, subsequently be made. In order to implement such an IRB review arrangement, an IRB Authorization Agreement or IAA (referred to at FSU as a Reliance Agreement) must be executed between FSU and the non-FSU institution(s). Review the IRB section (pages 7-8) in the FSU Policy 7-IRB-0 (University Human Subjects Policy) to see the requirements for IRB reliance arrangements.
When preparing to submit a study in RAMP IRB, be sure to indicate either that the FSU IRB will act as the single IRB of record for the non-FSU collaborating institution(s), or that an external IRB will act as the IRB of record for your study. Upon review of your RAMP IRB submission, you will be instructed to prepare to submit a Reliance Agreement in RAMP Agreements (which is separate system from RAMP IRB and used for many different types of agreements). To assist you with a RAMP Agreements submission, you will be provided with the RAMP Agreements How-to-Guide as well as an agreement template to use for editing and uploading; when selecting an agreement type in RAMP Agreements, you will choose "Reliance Agreement". FSU may accept the standard OHRP template, the Smart IRB Acknowledgement letter or other comparable arrangement.
For FSU research that involves an independent collaborator (a non-FSU researcher who is not affiliated with any institution) or a collaborator at an external institution that does NOT have a Federalwide Assurance agreement with the U.S. government to conduct research involving human subjects, an FSU Investigator or their non-FSU research collaborators may request that the FSU Federalwide Assurance (which applies to all FSU faculty, staff and students that may conduct human research) be extended to cover the collaborator. Federal law requires that ALL individuals regardless of their affiliation must be covered by a Federalwide Assurance in order to conduct human research. By extending the FSU Federalwide Assurance to a non-FSU collaborator, this federal requirement is satisfied.
In order to have the FSU Federalwide Assurance extended to cover such a collaborator, an Individual Investigator Agreement or IIA (also referred to as a Reliance Agreement, but different in form) must be executed between FSU and the non-FSU collaborator. When preparing to submit a study in RAMP IRB, be sure to list all external study team members, including study team members that are independent collaborators or collaborators at external institutions that do not have a Federalwide Assurance. Upon review of your submission, you will be provided with a template IIA and instructed to complete and submit the IIA (designating the type of agreement as a Reliance Agreement in FSU’s RAMP Agreements module) for separate review and approval among the parties to the agreement.
Note that this IIA arrangement would generally not apply to circumstances where one or more non-FSU collaborators are affiliated with a non-FSU institution that has its own Federalwide Assurance; in those circumstances the IRB reliance arrangement described above would be applicable. In some circumstances however, an FSU research study may require both an IRB Authorization Agreement and an Individual Investigator Agreement.
Learn more about the FSU Federalwide Assurance.
Completion of Review: When the IRB review process for any submission above is complete, you will receive notification of the Committee’s action. Please read all correspondence carefully because it may request additional information or describe conditions associated with the Committee’s decision. The approval period for a protocol can be for no longer than 12 months (365 days) from the date of the review, but may be less than 12 months, depending on the perceived risks to the research subjects and the timeliness of submission of any requested revisions. Please note that OTHER NON-IRB REVIEWS MAY BE REQUIRED, SUCH AS RESEARCH COMPLIANCE AND/OR LEGAL REVIEWS FOR RESEARCH-RELATED AGREEMENTS, SUCH AS DATA USE AGREEMENTS, BUSINESS ASSOCIATE AGREEMENTS, AND AGREEMENTS FOR USE OR DISCLOSURE OF FERPA-PROTECTED INFORMATION. Contact us with questions or referral.
For questions about your study, check out the Staff Listing tab to the left, or contact your assigned IRB Coordinator
Other Reviews or Requirements
*Note that other non-OHSP or IRB review (e.g., Sponsored Research, legal counsel) may be required before a research project may commence; plan accordingly.