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FREQUENTLY ASKED QUESTIONS & ISSUES

Below are General, RAMP IRB-related and Specific FAQs. To find an answer, click on an FAQ. To return to the list, click again on the FAQ or "v" symbol. For FAQs specific to student-led research, visit this student-led research FAQs page.

General Questions

  • An IRB is a committee composed of scientists and non-scientists (e.g., professionals as well as laypersons) that may be affiliated with an institution or organization, as well as persons not affiliated with these institutions or organizations (referred to as IRB members), that review and provide ethical and regulatory oversight of human research that is proposed and conducted by other persons affiliated with those institutions or organizations. IRB members are expected to have the background, experience and expertise required to ascertain the ethical and regulatory acceptability of proposed and ongoing research, primarily to help ensure the protection of the rights and welfare of individuals who serve as human research participants (human subjects) in research.
  • The Florida State University (FSU) has an IRB. Institutions like FSU which receive federal funds to conduct human research are required by federal law to have an IRB. Federal regulations provide the FSU IRB with the authority to approve, require modifications in (to secure approval), or disapprove all research activities covered applicable law and FSU policy. Furthermore, while research that has been approved by the FSU IRB may be subject to further review and approval or disapproval by FSU officials, these officials may not approve the research if it has not been approved by the FSU IRB.
  • The IRB is not permitted by law to retroactively review human research.
  • Only human research that complies with applicable law and policy is approved by the FSU IRB.
  • Proposed human research that does not comply with applicable law and/or policy or the IRB’s requirements will be returned to the study team until the proposed research meets the IRB's criteria and conditions for approval.
  • Previously approved research which is determined to violate applicable law and policy and the IRB conditions for approval will be suspended and may be terminated. Violations may require reporting to FSU officials, federal regulatory agencies and study sponsors. Subsequent proposed and any on-going research conducted by the study team may be subject to heightened review scrutiny and restrictions.
  • Federal law also requires institutions such as FSU to establish and follow policies that implement requirements for human research regulatory review. At FSU, the overarching policy is 7-IRB-0, and is accompanied by subordinate procedures (standard operating procedures) that are maintained by the FSU Office for Human Subjects Protection (OHSP) in the RAMP IRB Library.
  • Federal law and policy does NOT permit IRB or other human research regulatory review or approval to be performed or granted retroactively (after you have initiated human research). Plan to prepare and submit your research well in advance.
  • IRB review may follow one of several or more pathways. Like the federal law that requires FSU to have an IRB to review human research, the requirement that an activity actually undergo a particular pathway of IRB or other human research regulatory review before the activity is permitted to begin is also governed by federal law. The law dictates the conditions under which an activity must undergo such review as well as how review may be performed.
  • Depending upon the nature of the activity, research may require complete IRB review: through a monthly convened meeting of the IRB; through an expedited or IRB subcommittee process; or by way of administrative review that may be performed by OHSP staff, some of whom also serve as IRB members. Check out our Human Research Review web page for more details about these different types of review processes, including the anticipated review turn-around time.
  • IRB review is scheduled only after proposed human research is deemed by the OHSP as "review ready" (includes the required information and materials submitted in RAMP IRB).
  • To conform to the federal legal requirement to maintain IRB records of communications with researchers, we do not provide regulatory determinations via email or telephone.
    • In order to receive a determination, complete the HRP-503d - Template Determination Form and submit this form in RAMP IRB
    • Once RAMP, under the IRB tab, click “Create New Study” to complete the RAMP IRB application (follow the IRB Researcher's Guide beginning on page 6 for detailed instructions). Then upload your completed determination form under question #8 in lieu of your protocol. Click “Submit” on your study workspace and your submission will be routed to us for review. We will get back to you with a response.
  • Note a distinction between activities that are not research as that term is defined (for which an OHSP administrative, not an IRB, determination may be made) and activities that are deemed exempt from further IRB review (for which either an administrative or an IRB determination is required. At FSU, only the OHSP or IRB is permitted to officially determine whether an activity satisfies federal regulatory criteria for OHSP or IRB review.
  • All FSU researchers, faculty, staff, students or contractors that plan to conduct research that may involve human subjects must submit a research protocol in the University's Research Administration Management Portal (RAMP) Institutional Review Board (IRB) online electronic protocol management system ("RAMP IRB").
  • If there is a question about whether an activity requires IRB review, submit in RAMP IRB a completed HRP-503d - Template Determination Form (available here in RAMP IRB) and related materials; OHSP will review the form and related materials and let you know whether further IRB review is required and if so, what additional information and materials must be submitted. Alternatively, Contact us with this question but submission of a completed HRP-503d - Template Determination Form and related materials may save time and effort as well as answer many questions in advance.
  • The following activities do not usually require OHSP or IRB review (these are examples only; carefully review the criteria): Oral history, journalism, biography, literary criticism, legal research, and historical scholarship, including the collection and use of information that focus directly on the specific individuals about whom the information is collected AND from which activity or analyses of the collected information there is no intent to draw conclusions or generalize findings beyond the specific individuals involved in the activity. However, if the activity or analyses of collected information will be used to document and draw conclusions about the individuals’ collective experiences, inform policy or otherwise generalize findings beyond the specific individuals involved, then these activities will require OHSP or IRB review.
  • If your activity is atypical or if you are not sure if your activity will require OHSP or IRB review, submit a completed HRP-503d - Template Determination Form (available here in RAMP IRB); we will review the form and any accompanying materials that you provide, then let you know.

Generally no. Oral History research projects, in general, are not designed to contribute to generalizable knowledge and do not involve "research" as defined by DHHS at 45 CFR 46.102(d), and therefore do not need to be reviewed by the IRB. Oral History activities are usually intended to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge.

General Principles for evaluating Oral History activities:

  1. Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalizable findings would NOT constitute "research." Example: An oral history video recording of interviews with holocaust survivors created for viewing in the Holocaust Museum. The creation of the video does not intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.
  2. Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (designed to draw conclusions, inform policy, or generalize findings) would constitute "research" as defined by federal regulations. Example: An open ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.
  3. Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR part 46, the creation of such an archive WOULD constitute research under 45 CFR 46.

Example: Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute research under 45 CFR 46 since the intent is to collect data for future research.

Other activities involving open ended, qualitative interviews that have similar characteristics can involve research as defined by the federal regulations, when the activities are part of a systematic investigation designed to develop or contribute to generalizable knowledge.

Note: Even though a specific oral history project may not fit the definition of "research" under the federal regulations, the research must still be conducted in accordance with ethical and legal standards appropriate to oral history, including consent, and legal releases as appropriate. FSU encourages investigators to visit the following Oral History Association links for more information regarding principles and best practices.

Sometimes, especially if the activity is not precisely delineated or under other limited circumstances. Generally however, an activity that only and unequivocally constitutes QI does not require IRB review, unless the QI activity may involve any greater risk than is ordinarily associated with the care, services, practices, processes or outcomes being evaluated—if so, then IRB review is required. Also, an activity that involves both QI and human research will in accordance with applicable human research regulations require regulatory or administrative review in order to determine the need for and type of IRB review, if any.

  • The key difference for purposes of determining whether IRB review may be required is that QI is intended solely to improve the way in which an institution’s care or services are provided to the institution’s or formal consortium of institutions’ patients, residents, clients, beneficiaries or other stakeholders who are directly affected by the QI project. That is, QI findings or outcomes are intended to only apply to those processes and structures directly involved in the QI project. In contrast, research is defined under federal law as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge; findings or outcomes are primarily intended to apply to other contexts and individuals beyond those directly affected by or involved the research. Keep in mind that when QI project findings or outcomes are also intended to be applied to other contexts or individuals, then IRB review is required. Use our “Quality Improvement or Research” algorithm for further guidance.
  • Except as indicated above, a QI activity does not need to be submitted for IRB review in accordance with applicable human research regulations. However, for many professional and scholarly publication purposes as well as for graduate office graduation/manuscript clearance requirements, an official human research/IRB regulatory determination may be required. If so, then you must submit your activity for regulatory or administrative review BEFORE UNDERTAKING YOUR ACTIVITY; applicable law does not permit retroactive review or determinations once such activities have commenced.
  • Before you plan a project that may involve QI, check out and carefully review the “Quality Improvement or Research” algorithm, and design your project accordingly. Importantly, be sure that you explicitly describe in detail your intent, make certain that the description of your activities is consistent with your intent, and that you have sufficiently addressed any matter for which a distinction between QI and research can be unequivocally made. Contact OHSP if necessary. While not dispositive for purposes of a formal determination (for which only the OHSP or IRB have regulatory authority), the algorithm may serve as a quick reference and save you time and effort.
  • Generally all documents and materials used to plan and conduct your study must be submitted in RAMP IRB for review, and the use of our templates is required.
  • All templates are available in RAMP IRB under the IRB, Library and Templates  Follow templates instructions carefully, as these are designed to provide the IRB with information that is  necessary for the IRB to ascertain the acceptability of the research based upon federal regulatory criteria for approval. Save time and effort: submissions that do not use or follow the templates will be returned for correction.
  • Common documents and materials include, for example, the study protocol; actual measures and instruments and anything that human subjects will be asked to read, complete, watch or use; recruitment fliers and messages; consent forms; and outside approvals. Other materials may also be required depending upon study parameters and activities.
  • The RAMP IRB SmartForms will include instructions and directions for you to follow for submitting and uploading study-related information, documents and materials. You are required to submit the complete study protocol (describing, e.g., the study’s background, rationale, objectives, design, sample, methodology, statistical considerations, organization and settings, sites or locations).
  • Studies that involve human subjects (obtaining their data or involving interaction) generally require a consent process through which you will recruit and ask prospective subjects for their permission to involve them in your study.
  • The OHSP and IRB provide a wide selection of protocol and consent templates for your use; these templates are tailored to different types of studies (biomedical; non-biomedical, such as social, behavioral or educational studies) and study populations (e.g., children, adults, limited English language proficiency). Use only the templates available in RAMP IRB under the IRB, Library and Templates tabs. OHSP and IRB criteria for review follow the templated protocols; if you do not use the templates your submission will be returned for correction.
  • Also, if you will only obtain secondary (previously collected) data but not have any interaction with human subjects, then you must provide a list of all data variables or data dictionary (highlighting or indicating what data variables will be obtained). If you will directly or indirectly interact with human subjects (surveys, interviews, focus groups, collect any other data or information, conducted in-person, face-to-face, virtually, remotely or by any other means), then you must provide ANY and ALL material that will be seen, heard, read or completed by or for a human subject, including recruitment fliers or messages, videos, images, and data collection instruments and measures. Sample measures or links to materials do not suffice for IRB finalization.
  • Refer to pages 14-15 of the IRB Researcher's Guide, Checklist of Information to Attach, as a handy reference list of these materials and information.
  • This will depend upon several key factors: if your study (1) is complete, is accompanied by required documents, and satisfactory responses have been provided to any requested clarifications; (2) formally documented by OHSP as exempt and not subject to complete IRB review; (3) will require IRB committee (at a scheduled monthly meeting) or non-committee (subcommittee, also referred to expedited, for which review may be done at any time) review; and (4) requires any other outside or ancillary review (e.g., another institution's IRB reviews; safety reviews for use of hazardous materials or radiation-emitting devices; ethics or conflicts of interest reviews) outside of the OHSP or IRB. With the above caveats, particularly item (1) above:
    • Exempt studies may receive clearance within 2 weeks or 10 business days, often less;
    • Non-committee reviews may be completed within 4 weeks;
    • Committee reviews may be completed within 6 weeks;
    • IF outside or ancillary reviews are required, this may add time before a study may begin, so plan accordingly, such as obtaining these reviews before or while your study undergoes IRB review.
  • Review turn-around is also subject to other factors, such as IRB reviewer availability or workload, complex studies (e.g., studies involving use of drugs, medical devices and other products subject to additional federal laws; agreements or arrangements with other outside agencies, institutions or sponsors). 
  • While ALL studies once approved require on-going oversight by the IRB, SOME studies (e.g., studies in data analysis only with no interactions with study subjects; studies officially determined by the IRB to involve only minimal risks to study subjects) do not require the formal and focused annual (or other more frequent) continuing review that is required of other studies. When this continuing review is not applicable, IRB approval letters indicate no expiration date. Refer to the FAQ about closing out a study when your study is actually complete so that the study may be officially closed to further IRB oversight and our records updated accordingly.
  • If you leave FSU, you must either close your study or (if the study is to remain on-going at FSU) modify your study to designate another FSU researcher as the study’s principal investigator (PI).

    • To close your study in RAMP IRB, follow these 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 designate another FSU researcher as the study’s PI, follow these steps: create and submit a study modification, indicating the indicating the scope as “other parts of the study,” providing modification information (e.g., status of study enrollment), and the explain that you will designate a new FSU PI. On the Basic Study Information page, under Local Principal Investigator, indicate the new FSU PI, make any necessary changes to this or other pages, and answer Yes or No to the Additional Requirement page about the PI’s student status (and if Yes, indicate the name of the faculty advisor or major professor), then Finish and Submit (Under Next Steps) the modification. Your modification will (after faculty advisor review for a new FSU student PI, if applicable) move into the queue for review and further handling.
    • Note that if another FSU researcher is designated as your study’s PI, you may remain on the study team provided that your new institution (if you have a new institution) is aware of your continuing role on the study, and you make any necessary arrangements with your new institution to rely on the FSU IRB for continuing oversight of the study.
    • For additional instructions about continuing review and study modification submissions, refer to the to the Researcher's Guide to RAMP IRB, or to the OHSP Researchers Training slides available in RAMP IRB Help Center.
  • To close your study that was never submitted within RAMP IRB, complete and submit to OHSP the closure form located here on the OHSP web site.
  • If you have additional general questions not listed above, contact OHSP or refer to the contact information in the left panel, and your question will be routed to OHSP staff for follow-up with you directly. For FAQs specific to student-led research, visit this student-led research FAQs page.

RAMP IRB-related Questions

  • RAMP IRB is accessible within the myFSU portal as an icon under the myFSU Links section, and you must therefore have a valid FSU user credential. The system is designed to be part of the single sign-on process, allowing FSU credentialed users to conveniently access RAMP IRB along with other systems within a single platform using one set of login credentials. Use any of the means below to access the RAMP IRB system to submit your study:
  • IMPORTANT NOTE: The RAMP IRB SmartForm application includes many help buttons and uses business logic to guide you in completion of your submission. Also when study documents (e.g., study protocol, consent forms) must be submitted, many templates are available, all tailored to the scope and complexity of your research; these are found under the IRB, Library and Templates tabs. 
  • For step-by-step instructions, refer to the Researcher's Guide to RAMP IRB, or to the OHSP Researchers Training slides available in RAMP IRB Help Center.
  • For other questions about using RAMP IRB, including obtaining assistance with using RAMP IRB, visit this general RAMP IRB FAQ web page, also available at: https://ramp.research.fsu.edu/faqs/irb/
  • Respond to a Clarification Request in RAMP IRB, not by email or telephone call since these responses cannot be entered by staff into the RAMP regulatory file for your study. In the RAMP IRB submission workspace for the study, under the “History” tab, carefully review the requested clarification(s). When you are ready to provide the requested information and documents, under Next Steps click “Edit Study”, make any requested changes to the SmartForm and/or upload requested documents, and then click “Exit” on the SmartForm once all revisions have been completed. Be certain to click “Submit Response” on the study workspace (to the left of the workflow diagram) and then click OK. Only then will your submission return to our queue for further handling.

  • Do not attach study-related documents to a comment or response submission since these materials cannot be readily accessed or finalized by the IRB or maintained with other study documents when the documents are located outside of the proper submission or SmartForm location or section.
  • In limited circumstances and only as an interim measure you may be instructed to provide the IRB with requested information or study-related documents as an attachment to a comment or response submission; note however that you will still be required to provide those documents in the correct workspace or SmartForm location when your study is made available for you to edit so that these materials may be finalized by the IRB.
  • To submit a Continuing Review, log into RAMP IRB and under the IRB and Help Center tabs refer to the IRB Researcher's Guide on p. 10 for instructions on creating and submitting a Continuing Review to renew your IRB approval before IRB approval expires.

  • If you have additional questions use the “Add Comment” feature (to the left of the workflow diagram and listed below under Next Steps) on your study workspace to ask your question and select the option to send an email notification about your question to your IRB Coordinator (whose name is listed above and to the left of the workflow).
  • To make a change or revise your study: log into RAMP IRB and under the IRB and Help Center tabs refer to the to the IRB Researcher's Guide on p. 10, then follow the instructions on submitting a Modification. Note the modification scope “Other parts of the study” will allow you to edit any of the original SmartForm sections except for study team member information; if you need to make changes to both study team member information and another section of the SmartForm, then both scopes should be selected.
    • Was your study determined to be exempt from IRB review? If so, then in the official exemption determination letter that you received for this study you will find a list of planned study changes that do not and do require submission for review. Look over these examples to see if your proposed changes will require review. If so or if you are not sure, follow the instructions on p. 10 of the IRB Researcher's Guide to create and submit a modification for this study.
  • To close your study: log into RAMP IRB and from the Help Center refer to the to the IRB Researcher's Guide on p. 10, then follow the instructions for submitting a Continuing Review (which process is also used to close a study). Note that in order to close a study, the first 4 research milestones in section 4 on the Continuing Review/Study Closure page must be checked. BE sure t acknowledge that the study will be closed, discard any open follow-on submissions related to the study, complete any remaining items or respond to any other questions, 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.

  • If you have additional questions use the “Add Comment” feature (to the left of the workflow diagram and listed below under Next Steps) on your study workspace to ask your question and select the option to send an email notification about your question to your IRB Coordinator (whose name is listed above and to the left of the workflow).

 

FSU researchers:

  • CITI training completion documentation is synced with RAMP IRB each evening through a nightly data transfer. You should wait for the next day after CITI training course completion to add yourself to a RAMP IRB submission.

  • Your CITI profile must:
    • Affiliate with FSU, and
    • Be accurate, including using your official FSU email address as the primary email.
  • The data transfer feature is a courtesy to the FSU research community, and made possible by separate arrangement between the 2 proprietary vendors that support CITI and RAMP IRB. However, if your CITI training completion documentation does not transfer, then you will be required to upload the CITI training completion documentation within the RAMP IRB submission workspace.
  • Refer to the Investigator Manual for information about CITI human subjects research training requirements or visit our website’s training page for step-by-step instructions on how to enroll in the correct training: https://www.research.fsu.edu/research-offices/ohsp/investigator-resources/citi-training-requirements/. Only the specified training will suffice for IRB review purposes.

Non-FSU researchers:

  • You must provide the FSU Principal Investigator with a copy of your CITI training completion documentation, and the FSU Principal Investigator must upload the copy in other study documents within the RAMP IRB submission workspace.
  • Direct questions about funding or grants to your contact in the Sponsored Research Administration (SRA) since those questions are most likely to be associated with the RAMP Grants module, which the OHSP/IRB does not manage; if you are unsure who to contact in SRA, contact their support desk at: RAMP-Grants@fsu.edu. Note however that for ANY IRB submission for which you have documentation of funding, you must add the related grant or funding information in your IRB submission since special IRB-related requirements apply to grant-funded studies.
  • Always log in to RAMP IRB and view your study submission’s workspace to check the status of your submission. The workflow diagram and the History tab entries will indicate your study’s submission status. In the figure below, the example workflow diagram indicates that your study is in the Pre-Submission state (the study has not yet been submitted to OHSP and IRB for their review), and under the History tab it shows that you have created (but not submitted) your study.

  • For a more detailed explanation about using the workflow diagram to check the status of your submission, click on this RAMP IRB workflow explainer
  • Be sure to follow instructions on the Final Page in the RAMP IRB SmartForm for your study, which states that you must “click Submit” in order for your study to ever enter the IRB review queue. With many thousands of FSU researchers, the IRB does not search out for studies in the Pre-Submission stage to follow up for reasons in delay as there may be a myriad of reasons why study staff maintain their studies in the Pre-Submission.
    • Note that only these individuals who are authorized to actually submit to the IRB (i.e., Principal Investigators (PIs) or PI proxies) will be able to see the “Submit” button. If you are not the PI or PI Proxy for the study, then you will not be able to see nor execute the “Submit” feature. The study PI or PI Proxy needs to log in; they will see the “Submit” button above the “Assign Primary Contact” button. The PI has the option to “Assign PI Proxy” so therefore they can click Submit or they assign another study team member as PI Proxy; that study team member will then have the authority to click “Submit” on the PI’s behalf for this study.
  • Special note if you receive the notification “Response Time Exceeded”: these notifications are only intended as a courtesy to alert you that it has been 14 days since clarification was requested on your submission and our office has not yet received your response. You may still make or submit edits and take the time that you need to do (unless you have been specifically told about a deadline for re-submission; check your correspondence from IRB). You will continue to receive these notifications until you take the required action noted in the Clarification Requested instructions.
  • Refer to our Human Research Review web page to learn about IRB turn-around times. The referenced anticipated turn-around times apply only to submissions that are complete (required forms, materials, information and requested clarifications have been submitted or completed, including completion of the required CITI human subjects training for all study staff). Carefully review ALL requirements before submitting otherwise you will risk needless further delay that could have been anticipated and avoided.
  • If you have about the status of your submission, contact OHSP use the “Add Comment” feature (to the left of the workflow diagram and listed below under Next Steps) on your study workspace to ask your question and select the option to send an email notification about your question to your IRB Coordinator (whose name is listed above and to the left of the workflow); there, in response to the question about who should receive the email notification about your comment, select "IRB Coordinator." This will help to ensure that the IRB Coordinator assigned to your submission will receive a notification that your comment has been posted in your RAMP IRB workspace. Alternatively and if you have not yet submitted your study (i.e., your study is still in the Pre-Submission status) or an IRB Coordinator has not yet been assigned to your submission (i.e., no name is listed next to "IRB Coordinator"), contact OHSP or refer to the contact information in the left panel, and your question will be routed to OHSP staff for follow-up with you directly.
  • If you have a RAMP IRB-related question not listed above, contact OHSP using the “Add Comment” feature (to the left of the workflow diagram and listed below under Next Steps) on your study workspace to ask your question and select the option to send an email notification about your question to your IRB Coordinator (whose name is listed above and to the left of the workflow); there, in response to the question about who should receive the email notification about your comment, select "IRB Coordinator." This will help to ensure that the IRB Coordinator assigned to your submission will receive a notification that your comment has been posted in your RAMP IRB workspace.

  • Alternatively and if you have not yet submitted your study, contact OHSP or refer to the contact information in the left panel, and your question will be routed to OHSP staff for follow-up with you directly.
  • For RAMP IRB-related FAQs specific to student-led research, visit this student-led research FAQs page.

Specific Questions

  • Generally, YES (a few exceptions may apply; see exceptions below).
  • *Preliminary research activities may include procedures, processes, testing, trials and other actions undertaken with the intent to assess and refine or modify a research plan or other aspects of the research (e.g., design; approach; methods or activities; instruments or measures; test products; researchers and study teams’ roles and responsibilities; recruitment; consent; interventions or interactions with human subjects; and data extraction, collection, analyses or storage), and which activities are undertaken prior to performance of the main or larger study. Sometimes these activities may variously or ambiguously be referred to as piloting, feasibility or practice activities.
  • Preliminary research activities are subject to required IRB or other human research regulatory review when those activities meet the definitions of research and human subjects as those terms are defined under federal regulations.
    • Research means a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”, and generally refers to a planned study employing empirical principles and methodology to formulate, examine or test hypotheses, collect data or information, characterize phenomena, acquire knowledge and interpret results. Generalizable knowledge refers to results or findings that have relevance beyond the individuals, sample or program from which data or information are collected, including information that is added to the literature.
    • Human Subject means a living individual about whom a researcher (whether faculty, staff and students, as well as contractors) obtains information or biospecimens through intervention or interaction with the individual OR obtains (even in the absence of intervention or interaction) identifiable private information or identifiable biospecimens related to an individual, for a research purpose.
  • Note that the applicable regulations make no reference to an activity’s size or scale in the definition. Non-research projects can be large in size and scale; research projects may be small in size and scale. Additionally, the intent to publish, present or otherwise disseminate or share results is not a determining factor for whether an activity involves research; the findings from many activities that may not meet the definition of research may still result in the finding’s publication or dissemination. Note also that the regulations make no reference to whether information or biospecimens collected from living individuals are added to the main or larger study; the act of simply obtaining an individual’s information or biospecimen as part of preliminary research is categorically done for a research purpose.
  • Due to their nature and intent to test, assess and refine or modify a research plan or other aspects of the research, preliminary research activities will require IRB or other human research regulatory review WHEN those activities involve researchers’ interventions or interactions with living individuals about whom information or biospecimens are collected, or involves (without intervention or interaction) researchers’ obtaining individuals’ identifiable private information or identifiable biospecimens.
  • Preliminary research activities should always be described in the research protocol as well as carefully and prominently distinguished from the main or larger study activities. The description should include an explanation about how preliminary research activities will be used to test, assess and refine or modify the research plan or other aspects of the research, as well as how if at all human subjects will be involved and their data used. If human subjects will be involved, the recruitment and consent process (including the consent form) must inform human subjects that they will be involved in preliminary research activities and how their information or biospecimens will be used, and whether their data will be added to the main or larger study and retained, destroyed or deidentified.
  • Exceptions: under limited circumstances, preliminary research activities may not require IRB or other human research regulatory review because they are not part of a systematic investigation or because the activities do not involve human subjects. These may include, for example:
    • Visiting or evaluating a potential site to see if the research is possible.
    • Going through a consent process with friends to see if the information is comprehensible.
    • Sharing your survey or interview instrument with a few experts in the field for their feedback as to whether the questions are appropriate for the topic and/or study population.
    • Asking an expert for their advice or guidance regarding how to monitor an intervention or procedure for a study population’s safety.
    • Soliciting feedback or an opinion from a colleague or mentor about research design.
    • Consulting a community advisory board or an organization’s leadership about what you propose to study or how best to conduct your study involving their constituents.

The above exceptions may be subject to change, and other examples may be added to the list above.

  • If there is any question about whether preliminary research activities will require IRB or other human research regulatory review, contact OHSP. Alternatively, submit in RAMP IRB the HRP-503d - Template Determination Form (available here or under the RAMP IRB Library and Templates tabs), and we will let you know.

Usually yes. Review of individuals' previously collected information or biospecimens may require IRB or other human research regulatory review. To be considered previously collected information or biospecimens, the information or biospecimens must be "on the shelf" at the time the research is proposed. Some existing data studies that utilize a source that is publicly available or that do not have any identifying information may be excluded from the definition of research involving human subjects, and may therefore not require IRB review. In order to determine whether your proposed research may require IRB review, please contact our office for assistance.

Students may be involved as study subjects, but particular care must be taken when students are not of majority age (in which case their parent's permission is required) and because there is an inherent power differential between the students and the faculty, instructors or supervising staff who may serve as Principal Investigators and/or members of research teams. This differential may create undue influence or be perceived to coerce students to participate in research projects. No matter how well-intentioned, students may feel compelled to participate believing that failure to do so will negatively affect their grades and the attitude of the instructor or staff (and perhaps other students) toward them. For this reason, the IRB may not, in general, permit an instructor to use his/her own students as subjects in the instructor's research project. The IRB will review whether collection of data by a third party or a student's consent (and parental permission) to use his/her own data be obtained after grades are entered, as possible ways to mitigate concerns regarding this type of research.

The IRB will also carefully consider whether students are being recruited or involved because they are a convenient and accessible sample as opposed to representing a chosen target group for research inquiry.

Yes. Research conducted in schools may require District School approval, Principal of school approval, or District IRB or review board approval, depending on whether the school is public or private and on the requirements of a particular school district. Leon County Schools requires approval at the District level (see Hints for Researchers), and has a review board that determines whether the study can be conducted using Leon County students as research subjects (including data collection or analysis). Depending on the nature or design of the research, teacher consent may also be required. Note that parental permission and child assent must always be obtained, unless an appropriate waiver has been granted by the FSU IRB. All such school approvals shall be submitted to the IRB for inclusion in the protocol file. The IRB may require district approval as a condition of FSU approval, or may permit the researcher to obtain district approval at a later time, as long as proof of school approval is submitted as required by the IRB.

The FSU Laboratory School also requires that researchers obtain FSU Laboratory School permission/approval prior to engaging in any research activities involving its students. Please contact the FSU Laboratory School directly to request this permission. 

Research involving the derivation and use of human embryonic germ cells from fetal tissue may be conducted with Federal support. Research on existing human embryonic stem cell lines may be conducted with federal support if the cell lines meet the US President's criteria which he announced on August 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html). Research involving the derivation of new stem cells from human embryos or the use of human embryonic stem cells that are not listed on the NIH Human Embryonic Stem Cell Registry may not be conducted with federal support.

In Vitro research and research in animals using already derived and established human cell lines, from which the identity of the donor(s) cannot readily be ascertained by the investigator, is not considered human subject research and is not governed by the HHS or FDA human subjects protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56. IRB review is not required for such research.

HHS-conducted or supported research that uses human cell lines where the donor(s) may be identified including cells that retain links (such as a code) to identifying information is generally considered human subject research that is governed by 45 CFR 46 because the donors are human subjects. IRB review and approval is required for such research. Please refer to Stem Cell Guidance for more information.

The following techniques for assuring confidentiality are listed on a continuum according to the degree of prospective harm that may occur:

  • Substitute codes for personal identifiers and store the key in a different physical location;
  • Remove the face sheet, which typically contains personal identifying information such as name, telephone, address;
  • Data with personal identifiers should be kept in locked files, access to the data should be controlled by the researchers with specified procedures;
  • Research assistants should be educated in the importance of confidentiality and the potential risks of harm to subjects. In situations of serious risk, assistants could be asked to sign confidentiality agreements;
  • Access to data can be controlled electronically, perhaps by storing very sensitive data on computers not attached to a network where hackers could penetrate the files. Electronic files can be protected with key words, and portable computers should be appropriately secured;
  • The data can be manipulated electronically, for example by encrypting data files;
  • The data can also be recoded to eliminate identifiers by collapsing it into categories;
  • Research involving many data files on the same person can use anonymous linkage systems; and/or
  • Researchers may apply for a federal National Institutes of Health Certificate of Confidentiality to protect sensitive information from subpoena or other legal processes or governmental agencies. The U.S. National Institute of Justice (DOJ) provides guidance about when a Privacy Certificate is required.
  • Many incidents (e.g., adverse events, breach of confidentiality, awareness of abuse/neglect/misconductprotocol deviations) require reporting to the IRB within business 5 days from when researchers become aware of the incident. Refer to page 3 on our HRP-214 - Reportable New Information form to see what incidents require reporting; refer also to the section, "What are my obligations after IRB approval?" in the Investigator Manual.
  • To submit a Report of New Information: log into RAMP IRB and under the IRB and Help Center tabs refer to the IRB Researcher's Guide on p. 13, then follow the instructions on creating and submitting a Reportable New Information.

 

  • Only if RAMP IRB is not accessible because of scheduled downtime or other circumstances and due to which you may miss the required reporting to the IRB within 5 business days, you may complete and send by email (humansubjects@fsu.edu) attachment a Report of New Information (RNI) (HRP-214 - FORM - Reportable New Information). The RNI will be acknowledged and reviewed and, as needed, you will be contacted for further information and instructions (which may include resubmitting the RNI through RAMP IRB once accessible).
  • The OHSP office does not recruit research participants; rather, the office is responsible for the regulatory review and monitoring of FSU research studies involving human subjects. However, depending on the type of research in which you are interested in participating, you may consider looking over one of the FSU research centers and/or institutes (list located at this link) and then using their contact information to inquire about available studies. Also consider looking over our own guidance for prospective research participants: Becoming a Research Participant | FSU Office of Research

Yes, a CAMS COI submission will affect review of an IRB submission in one or more of the following ways:

  • Any new RAMP IRB submission or study modification involving FSU employees or agents who have not already completed a CAMS Disclosure Profile, disclosed new or updated financial interests, or otherwise have had review of their interests completed or their conflicts’ status deemed acceptable may require that the employee or agent take prompt action in CAMS to satisfy these requirements in order for a RAMP IRB submission to proceed to human research regulatory review.
  • An IRB submission WILL NOT proceed to IRB review if the COI tab or COI “Status” that appears in your study workspace for any member of the study team is any of the following: (a) Team Member(s) without Certifications; (b) Awaiting Profile Update; and (c) Administrative Review (see image below).

ANY of the above statuses pertaining to any member of a study team above will delay IRB review of a submission in the RAMP IRB queue. You are strongly advised to promptly tend to any CAMS submission for which one of the above statuses exists in order to avoid unnecessarily prolonging IRB review of your RAMP IRB submission.

  • An IRB submission may proceed to IRB review if the COI “Determination” or “Status” that appears in your study workspace for every member of the study team is one or more of the following: (a) No Review Required; (b) Unrelated; or (c) Withdrawn (see image below).

  • If a determination is made that a member of a study team has a conflict of interest, direct and specific disclosure to research participants (human subjects) about such interests is required. Such disclosure must be included as part of the informed consent process, and may be conveyed as follows: in the first paragraph in the “What else do I need to know” section of the HRP-502 consent form, after the first paragraph in the “What is this study about” section of the HRP-502a or HRP-502c consent forms, or at the end of the first paragraph in the HRP-502i Information Sheet form. The IRB may require additional language. Refer to our HRP-502COI – TEMPLATE COI Consent Language Template in RAMP IRB (or here on the OHSP Templates & Required Forms web page; scroll down to the Consent-related Templates section and look for the Conflicts of Interest Consent Language Template) for different types of interests to disclose to human subjects. Any of these forms missing such language will be returned to the study team for correction.
  • The IRB will not approve of an IRB submission (new, continuing review or modification) unless any related COI management plan is deemed by the IRB as having satisfied federal regulatory criteria for approval of research. This includes revisions to a COI management plan, as well as implementation of informed consent procedures through which study subjects are adequately informed about investigators’ conflicts of interest (see bullet above). Note that the IRB may regardless of any other FSU office’s conflict of interest review outcome determine that a conflict of interest does exist; require additional information about researchers’ interests; impose additional requirements in order to minimize such conflicts; require that study subjects be informed about such interests or conflicts; and take any other actions to ensure that human subjects are both protected from research risks implicated by a conflict of interest as well as informed about such conflicts of interest.*
  • Submission in CAMS of any new or change in a COI disclosure for any study team member for an existing IRB study may, if a COI management plan is imposed based upon the submission, require a RAMP IRB study modification. If a study modification is not initiated by the PI and the OHSP/IRB becomes aware of the new or changed COI disclosure, the PI will be contacted to submit a study modification.
  • COI disclosures reported in a RAMP IRB submission before implementation of the CAMS COI module will appear in the Basic Study Information section (Question 7) and/or Local Study Team Members section (Questions 1 and/or 2 for external team members) of your RAMP IRB SmartForm or workspace as depicted in the images below:

Note that the “?” button for Question 7 above provides related information and instructions as depicted below:

Review of these pre-CAMS RAMP IRB COI disclosures may be handled similarly as those that are reported in CAMS, including the requirement that human subjects be informed about the conflict of interest. Refer to our HRP-502COI – TEMPLATE COI Consent Language Template in RAMP IRB (or here on the OHSP Templates & Required Forms web page; scroll down to the Consent-related Templates section and look for the Conflicts of Interest Consent Language Template) for different types of interests to disclose to human subjects.

  • CAMS is accessible within the myFSU portal as an icon under the Links section, and you must therefore have a valid FSU user credential. The system is designed to be part of the single sign-on process, allowing FSU credentialed users to conveniently access CAMS along with other systems within a single platform using one set of login credentials. Use any of the means below to access the CAMS system to submit your study:
  1. Click on the CAMS icon within the myFSU portal; or
  2. Click on the CAMS link within an Outlook email notification (which occurs when you need to take action in the system).
  3. Type the CAMS website address in your internet browser: https://cams.fsu.edu 

IMPORTANT NOTICE:

Federal law provides the IRB with authority to, for example, review human research; require modifications to secure approval; and ensure that legally effective informed consent will be and is obtained, including disclosure of the above interests. FSU institutional officials may not approve of research involving human subjects that has not been approved by the IRB, including IRB approval of or required modifications for COI consent language (see 45 CFR §§46.109, 46.111(a)(4), 46.116; 42 CFR §50.605(a)(1)(ii); and 45 CFR §94.5(a)(1)(ii)).

  • If you have a specific question not listed above, contact OHSP using the “Add Comment” feature (to the left of the workflow diagram and listed below under Next Steps) on your study workspace to ask your question and select the option to send an email notification about your question to your IRB Coordinator (whose name is listed above and to the left of the workflow); there, in response to the question about who should receive the email notification about your comment, select "IRB Coordinator." This will help to ensure that the IRB Coordinator assigned to your submission will receive a notification that your comment has been posted in your RAMP IRB workspace.

  • Alternatively and if you have not yet submitted your study or your specific question is not related to your submitted study, contact OHSP or refer to the contact information in the left panel, and your question will be routed to OHSP staff for follow-up with you directly.
  • For FAQs specific to student-led research, visit this student-led research FAQs page.