Frequently Asked Questions
Below you will see various FAQs to help guide you. If you have a question that was not answered, please reach out to the IRB Office for assistance.
How will the changes to the common rule affect new submissions to the IRB?
How will the changes to the common rule affect our studies?
What should we do now?
How will new information be announced?
What about Broad Consents?
Where can I find the new forms?
How do I know if a Project is “Human Research Subject” and needs review by the IRB?
My research is not federally funded. Do the federal regulations governing research still apply to it?
How long does it take for an approval of a new project?
I need my protocol approved right away. Can it be “expedited”?
Do I need to report changes to my protocol to the IRB?
May I begin recruitment of participants while approval of protocol is still pending?
What is a Scientific Review and why is it required by the IRB and who performs that function?
Can someone from the IRB Office look at my paperwork before it's submitted through iMedris?
If my research qualifies as Exempt, does that mean that I do not have to submit a protocol for review?
I will be collaborating with another institution. Do I need to submit to BCHS’s IRB and the other institution’s IRB?
What are the BCHS Research Minimal Risk Categories?
Q: How will the changes to the common rule affect new submissions to the IRB?
After November 1, 2018, new protocol submissions to the BayCare Health System IRB will be required to use updated consent and waiver templates that will be sent to each coordinator/regulatory person. These are simply updates to existing forms that contain the new required elements of the rule. If a study is approved prior to the 1/19/19 effective date of the new rule, it will remain on the old rule until its next Change in Procedure or Continuing Renewal. At that point, it will transition to the new rule. If a study is approved on or after 1/19/19, it will automatically be governed by the new rule.
Some studies under the new rule may no longer require annual review. The DDOTS system or the IRB off will prompt you when review is required for your BayCare IRB approved studies.
Q: How will the changes to the common rule affect our studies?
Existing Full Board Protocols
Protocols that were reviewed by a full board and are open to enrollment or still in an intervention phase will see the fewest changes under the new Common Rule. At the time of the next renewal or significant amendment affecting the informed consent form that occurs after 1/19/19, you will be requested to update the waiver and consent form to meet the new requirements.
Existing Expedited Protocols
Most studies that were originally expedited by the IRB under the old rule will now be eligible for less frequent review, beginning on 1/19/19. At the time of the next renewal or significant amendment affecting the informed consent form that occurs after 1/19/19, you will be requested to update the waiver and consent form to meet the new requirements. BayCare IRB will require an abbreviated renewal (a check-in) every two years in order to keep the study active. This will automatically be prompted by the DDOTS electronic submission system.
Existing Exempt Protocols
There will be no changes to these protocols. If you have an exempt study that has ended, it is important to close the study with the IRB.
Additional Requirements for Federally Funded Studies
For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form must be posted to a publicly available Federal website (yet to be specified) after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject.
Q: What should we do now?
Pay attention to news and announcements from the IRB. Beginning November 1, new submissions must use the new consent and waiver templates.
Q: How will new information be announced?
This FAQ will be updated if/when guidance is issued from OHRP and when additional policies have changed. We will also share information via email once available.
Q: What about Broad Consents?
The term “Broad Consent” as defined by the new regulations applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, BayCare will not pursue broad consent at this time. Investigators can continue to use biospecimens that are coded or to seek waiver of consent for use of biospecimens with identifiers retained consistent with current practices.
Q: Where can I find the new forms?
Copies of the new forms were emailed to all established research staff. If you are unsure whether or not you have an updated form, you may simply ask the IRB office for a copy until the forms are posted on our intranet or access them through iMedris.
Q: How do I know if a Project is “Human Research Subject” and needs review by the IRB?
The BCHS office of the IRB has tools available to help you determine whether your project requires IRB review. One of those is Decision Tree to Determine IRB Review.
Q: My research is not federally funded. Do the federal regulations governing research still apply to it?
It depends. BCHS IRB has created ethical standards for the conduct of all human research, regardless of funding, that are very similar to the federal criteria for approval of research. The federal regulations are considered a “floor” for the ethical conduct of human research and our policies reflects these policies.
Q: How long does it take for an approval of a new project?
Researchers should plan on a minimum of 30 business days for the review process (from the time of submission until a determination is made by the IRB). Please carefully edit and proofread all application materials before submission to the IRB as incomplete and missing information will cause delays in the project application review process.
Q: I need my protocol approved right away. Can it be “expedited”?
Expedited does not mean "quick". Expedited review refers to a process of review for certain research that falls within categories established by federal regulations. If a protocol meets the specific qualifications for Expedited review (as determined by the IRB), it will not require review by the fully convened IRB. Instead, the proposed research may be reviewed and approved by a co-chairperson and the IRB Office Staff. Please note that Expedited research still undergoes robust review and a minimum of 30 business days should be anticipated.
Q: Do I need to report changes to my protocol to the IRB?
Yes, amendments that require approval include (but are not limited to) changes in Principal Investigator (PI), inclusion/exclusion criteria for participants, research sites, recruitment strategies, informed consent process or documentation, assessment tools, testing procedures, confidentiality measures, and/or privacy safeguards for participants. Conducting a study with unapproved changes is a violation of policy and could result in a finding of noncompliance.
Q: May I begin recruitment of participants while approval of protocol is still pending?
No. Final approval by the IRB is necessary before any recruitment or enrollment procedures may begin. The IRB may reject or modify a submission of a project for approval for several reasons; therefore to recruit participants for any project before IRB approval is premature.
Q: What is a Scientific Review and why is it required by the IRB and who performs that function?
The requirement for scientific review of new projects submitted to the IRB can be in one of the following ways:
- Review by the department chair/designee in which the Principal Investigator (PI) is administratively located for purposes of leading or supervising the research;
- For Nursing, or graduate student thesis or dissertation research, review by the student’s dissertation or master’s thesis committee and your Nursing Council;
- For Pharmacy residents or students, these projects must first go through their designated Pharmacy Residency Director.
Please contact the IRB at 727-467-4577 with any questions.
Q: Can someone from the IRB Office look at my paperwork before it's submitted through iMedris?
All submissions to the IRB receive a thorough preliminary review by BCHS IRB staff before getting reviewed by the assigned IRB reviewers. As part of this "pre-review," the IRB staff may ask you to make changes or provide additional information. If you have specific questions about your submission (such as when it is appropriate to request a waiver of documentation of consent), you can call the IRB office or schedule a consultation with an IRB staff. Note that submissions not formally made in iMedris cannot be viewed through the system.
Q: If my research qualifies as Exempt, does that mean that I do not have to submit a protocol for review?
No. The Federal Regulations do make certain categories of research exempt from the regulations. However, BCHS IRB policy does not allow researchers to self-exempt their human participant research projects. Instead, determining if a project meets exemption criteria is an administrative review process handled by our IRB staff.
Q: I will be collaborating with another institution. Do I need to submit to BCHS's IRB and the other institution's IRB?
If you are BayCare faculty or staff, and you are the person primarily responsible for the conduct of the study, you must get the BCHS IRB approval to conduct your research regardless of where the research takes place. Researchers should contact the IRB whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research. Limited reporting to the BCHS IRB on the status of the project throughout the project will be required. If an Authorization Agreement was not accepted by the IRB; then the project should be submitted to BCHS IRB for review.
Q: What are the BCHS Research Minimal Risk Categories?
These categories are potentially what the BCHS IRB will use when reviewing non-federally funded research:
- Research, involving educational tests or conducted in established or commonly accepted educational settings, which specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research that includes interactions involving survey procedures, interview procedures, focus group or observation of public behavior (including visual or auditory recording).
- Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens for secondary research use.
- Storage or maintenance (repository) of identifiable private information or identifiable biospecimens for potential secondary research use.
- Prospective collection of biological specimens for research purposes by noninvasive means or blood samples by finger stick, heel stick, ear stick, or venipuncture.
- Collection of data through noninvasive procedures (not involving x-rays, anesthesia or sedation) that are either routinely employed in clinical practice or use FDA approved medical devices (e.g. MRI, MEG, EEG, strenuous exercise of healthy individuals).
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) that involves brief, harmless behavioral interventions (e.g. solving puzzles, environment manipulation, completing an online task, etc.)