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What is the IRB?
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.
What does the IRB do?
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.
Additional Information
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. Please use your Franklin University email address, which will link your CITI record to Cayuse IRB.
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.
Conflict of Interest
Each investigator listed on a protocol submitted to the Franklin University IRB must complete a Conflict of Interest Disclosure Statement. Click here to access the form.
Data Security
Franklin University has implemented a data security levels model to help researchers identify the type of data security measures required for their study. All Principal Investigators (PI) are required to prepare a data security plan as part of the IRB submission process.
Please review Data Security Guidelines and use the Data Security Levels document to help you prepare a data security plan that aligns with the degree of risk associated with your study.
Informed Consent
RESEARCH INVOLVING ADULT PARTICIPANTS |
General Consent - Sample 1 General Consent - Sample 2 |
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.
Support and Approvals
All Principal Investigators (PI) submitting protocols to the Franklin University IRB must include letters of support with their IRB applications when research is being conducted at an outside institution or organization of any kind, or when the investigator is otherwise relying on the cooperation of another institution or organization. Click here for an outline of requirements.
If you are seeking access to Franklin University data or want to conduct research at Franklin University (with students or employees or on university grounds), you must have prior approval from the Senior Vice President for Academic Affairs. Click here to complete your research and data request form.
To help you determine whether your research qualifies for EXEMPT, EXPEDITED, or FULL BOARD review, use the Review Category Flowchart.
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.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(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.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(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.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
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.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
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.)
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
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:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
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.
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
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
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 cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
- 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:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
- 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).
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
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 identifiable private information or identifiable biospecimens are publicly available;
- Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
- 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
- The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
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:
- If wholesome foods without additives are consumed, or
- If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
§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:
- (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
- (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
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.
- (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate 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:
- (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
- (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with §46.117; and
- (iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
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
Initial Full Review
Expedited Review
Exempt Review
Continuing Review and Institutional Annual Check-In (IAC)
Modifications, Deviations, and Exceptions - IRB Review of Changes
Unanticipated/Anticipated Problem/Adverse Event Reporting
Protocol Violations
Subject Concerns/Complaints
Noncompliance
Termination or Suspension of Research by the IRB
Study Closure
Mandated Reporting to External Agencies
IRB Office Recordkeeping
Membership of IRB
IRB Member Training
IRB Member and Consultant Conflict of Interest
Generation, Use, and Revision of Standard Operating Procedures
The Conduct of IRB Meetings
Minutes of IRB Meetings
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
IRB Manager
marnie.shaffer@franklin.edu
614-947-6037
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