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Institutional Review Board (IRB) | Current Students | Franklin.edu
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The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The Franklin University IRB comprises faculty and staff members, as well as a community member not otherwise affiliated with the University, who are responsible for overseeing research projects involving human subjects.
The IRB reviews protocols and has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. The IRB makes its independent determination whether to approve or disapprove the protocol based upon whether or not human subjects are adequately protected.
Does my research require IRB review?
The Franklin University IRB reviews and approves any undertaking in which an individual affiliated with the University (faculty, staff, or student) conducts human research.
For purposes of determining which projects require IRB review, Franklin University adheres to the definitions of ‘research’ and ‘human subject’ presented in the Department of Health and Human Services (DHHS) Code of Federal Regulations (45 CFR part 46).
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)].
Human subject means a living individual about whom an investigator (whether professional or student) conducts research and (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)].
Where can I find more information about the regulations and human subjects research?
The Department of Health and Human Services (HHS) regulations at 45 CFR part 46 stipulate substantive and procedural requirements for investigators and institutions engaged in research. You can read the Code of Federal Regulations regarding the Protection of Human Subjects here.
Check out the Office for Human Research Protections (OHRP) to learn more about protecting the rights, welfare, and wellbeing of human subjects involved in research.
To submit a new research protocol or proposal, choose your application form. To help you determine whether your research qualifies for EXEMPT, EXPEDITED, or FULL BOARD review, use the Review Category Flowchart.
Full and Expedited Review
The IRB conducts initial review for non-exempt research at convened meetings unless the research is eligible for expedited initial review. Investigators must submit studies that do not meet the federally mandated criteria for exempt or expedited initial review for full review.
Expedited research categories are as follows:
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
7. 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) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
8. Continuing review of research previously approved by the convened IRB as follows:
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
You may access the application here.
Please note that all IRB applications from Franklin employees must be reviewed and approved by the immediate supervisor of the Principal Investigator (PI) before they are sent to the IRB for review.
Students cannot serve as Principal Investigator and should be listed as Co-Investigator. Student applications are required to have a Franklin University faculty member acting as the PI.
Please submit your completed application to irb@franklin.edu.
Research procedures that meet the categories set forth by the federal regulations [45 CFR 46.104(d)] may qualify for exemption. Research activities are exempt from the human research protection regulations when the only involvement of human subjects falls within one or more categories [45 CFR 46.104(d)]. The categories are as follows:
1. Research, conducted in established or commonly accepted educational settings, that 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, such as:
Research on regular and special education instructional strategies, and
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
3. (i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs:
Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
6. Taste and food quality evaluation and consumer acceptance studies:
Sample Informed Consent Templates
RESEARCH INVOLVING ADULT PARTICIPANTS
RESEARCH INVOLVING MINORS (UNDER 18 YEARS OF AGE)
Parental Consent to Interview Minors
Assent for Minors (14-17)
Assent for Minors (7-13)
§46.116 contains the general requirements for informed consent. Use this checklist as a guide when developing your consent form.
Anyone who conducts human subjects research at Franklin University must complete training before any research activities commence and before submitting a research proposal to the IRB for review. The Collaborative Institutional Training Initiative (CITI) provides an online training course to satisfy this requirement and must be completed by all faculty, staff, and students involved in human subjects research. CITI educational courses help researchers to understand their obligations to protect the rights and welfare of human subjects in research.
Please take the following steps to complete your CITI training:
1. Log on to the CITI homepage: www.citiprogram.org and click on the Register link. You will register with Franklin University in this seven-step process.
2. Franklin learners must complete the Social and Behavioral Research (SBE) course. Additional elective courses are available but not required to conduct human subjects research at the University. The SBE course will take a few hours to complete, but you are not required to complete all modules in one sitting.
Completing the CITI course will keep your training current for three years, after which time you will be required to complete a refresher course that updates your training for another three years. You will receive an email reminder from CITI when it is time to refresh your training. If your training expires during any human subjects research project, you must cease all research activities until your training has been updated.
Submit all completed and signed forms to irb@franklin.edu.
Each individual listed on a research proposal submitted to the Franklin University IRB must complete a Conflict of Interest Disclosure Statement. The statement must be updated annually.
Modifications, Deviations, and Exceptions
Investigators may not initiate any changes in research procedures or consent/assent form(s) without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject. Examples of modifications that require IRB review include, but are not limited to, changes in:
Study personnel removal/replacement;
Advertising materials (e.g., flyers, radio spots, etc.);
Research procedures;
Subject populations (e.g., age range);
Location where research will be conducted;
Consent/assent forms;
Recruitment procedures; or
Date for completion of study.
If the investigator makes protocol changes (i.e., modifications*, exceptions**, or deviations**) to eliminate apparent hazards to the subject(s) without prior IRB approval, the investigator must immediately report the changes to the IRB for review and a determination as to whether the changes are consistent with the subject’s continued welfare. See the Protocol Violations form.
Investigators must promptly notify the IRB in writing of any change in a protocol’s status, such as discontinuation or completion of a study.
*Modifications are defined as changes that impact the overall protocol.
**Exceptions or deviations are changes that impact individual subjects and do not change the overall protocol. Investigators may not initiate these changes without prior IRB review and approval, except where necessary to eliminate apparent hazards to the subject.
The IRB considers enrollment of a research subject in a protocol that fails to meet current IRB approved protocol inclusion criteria or falls under protocol exclusion criteria to be a protocol exception.
The IRB considers a departure from the current IRB approved procedures that impact an individual subject to be a protocol deviation.
Unanticipated Problems and Incidents
Principal Investigators (PI) must file a report with the IRB Office for unanticipated problems or other incidents (e.g., adverse events, complaints, data breaches, noncompliance, inappropriate behavior, and so on) that occur during the course of IRB approved human subjects research and involve risks to subjects or others. These incidents may or will result in physical injury, psychological distress, economic or social risk, or otherwise introduce the potential for harm to subjects in the research process. Events should be reported if the injury, distress, or other event was directly related to participating in the research.
A protocol violation is any exception or deviation involving a single subject that is not approved by the IRB prior to its initiation or implementation. These protocol violations may be major or minor violations.
A major violation is one that may impact subject safety, make a substantial alteration to risks to subjects, or any factor determined by the IRB Manager, IRB Chair, or IRB member as warranting review of the violation by the convened IRB. Examples of major violations may include, but are not limited to:
Failure to obtain informed consent, i.e., there is no documentation of informed consent, or informed consent is obtained after initiation of study procedures;
Enrollment of a subject who did not meet all inclusion/exclusion criteria;
Performing a study procedure not approved by the IRB;
Failure to report serious unanticipated problems/adverse events involving risks to subjects to the IRB and (if applicable), the sponsor; and
Study visit conducted outside of required timeframe that, in the opinion of the PI or IRB, may affect subject safety.
A minor violation is a violation that does not impact subject safety or does not substantially alter risks to subjects. Examples of minor violations may include, but are not limited to:
Implementation of unapproved recruitment procedures;
Missing signed and dated consent form;
Missing pages of executed consent form;
Inappropriate documentation of informed consent, including:
Missing subject signature;
Missing investigator signature;
Copy not given to the person signing the form;
Someone other than the subject dated the consent form; or
Individual obtaining informed consent not listed on IRB approved study personnel list.
Use of invalid consent form, i.e., outdated/expired consent form;
Failure to follow the approved study procedure that, in the opinion of the PI, does not affect subject safety or data integrity, such as:
Study procedure conducted out of sequence;
Omitting an approved portion of the protocol;
Enrollment of ineligible subject (e.g., subject’s age was 6 years above age limit); or
Study visit conducted outside of required timeframe.
Over-enrollment.
If either a protocol deviation or protocol exception occurs without prior IRB review and approval, the Principal Investigator is responsible for completing a Protocol Violation Reporting form and submitting it to the IRB within 14 days of the occurrence. If applicable, the Principal Investigator is responsible for reporting protocol violations to the sponsor and/or the FDA. The IRB is responsible to review reported protocol violations involving human subjects and may request that appropriate measures be taken to rectify the violation to ensure that the violation does not reoccur.
Principal Investigators must submit continuing review reports for studies as long as the research:
Remains open to enroll new subjects; and/or
Remains active for long-term follow-up.
Unless the IRB determines otherwise, continuing review of research is not required in the following circumstances [45 CFR 46.109(f)]:
Research eligible for expedited review in accordance with 45 CFR 46.110;
Research reviewed by the IRB in accordance with the limited IRB review;
Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
For research protocols that do not require continuing review per federal regulations, Franklin University requires PIs to submit a completed and signed Institutional Annual Check-In (IAC) form for all current and IRB approved human subjects research projects. The IAC is a less stringent mechanism of review for project updates.
Institutional Annual Check-In (IAC)
Franklin University requires Principal Investigators to submit a completed and signed Institutional Annual Check-In (IAC) form for all IRB approved research projects that are not required to undergo continuing review in accordance with federal guidelines. The IAC is a less stringent mechanism of review for project updates.
The Principal Investigator (PI) and/or the IRB may close approved protocols under certain circumstances. The PI is responsible for promptly closing out an IRB approved study if any of the following conditions exist:
All research activities including data analysis and reporting are complete.
The PI never initiated the study.
Subject accrual is finished, all data collection is complete and the only remaining activity is analysis of the data, the data are de-identified, and there are no identifying links or codes to the de-identified data.
The PI plans to leave the University and intends to continue the research activities at another institution.
The study has been open for a period of three or more years and the PI has enrolled no subjects in the study or collected no data from records.
When closing out a study, the PI completes the Final Study Report form and submits it to the IRB Office.
Franklin University relies on the U.S. Department of Health and Human Services Code of Federal Regulations (45 CFR 46, last updated in 2018) to guide development of our Standard Operating Procedures (SOPs). Our policies and procedures were adapted by Franklin University’s IRB Office from IRB staff in the Office of Research Integrity (ORI) at the University of Kentucky.
Description of Activities That Need IRB Review
Continuing Review and Institutional Annual Check-In (IAC)
Modifications, Deviations, and Exceptions - IRB Review of Changes
Unanticipated/Anticipated Problem/Adverse Event Reporting
Subject Concerns/Complaints
Termination or Suspension of Research by the IRB
Mandated Reporting to External Agencies
IRB Office Recordkeeping
Membership of IRB
IRB Member and Consultant Conflict of Interest
Generation, Use, and Revision of Standard Operating Procedures
The Conduct of IRB Meetings
Minutes of IRB Meetings
§46.111 details criteria the IRB must consider when reviewing research proposals.
(a) In order to approve research, the IRB determines that all of the following requirements are satisfied:
1. Risks to subjects are minimized:
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, §46.116.
5. Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. For purposes of conducting the limited IRB review required by §46.104(d)(7), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
The Franklin University Institutional Review Board (IRB) is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) as IRB00011340 and complies with the terms of the Federalwide Assurance FWA00026525, expiring August 29, 2023.
Marnie Shaffer
marnie.shaffer@franklin.edu
614-947-6037