Franklin University Institutional Review Board (IRB)
The Institutional Review Board (IRB) is a standing committee at Franklin University responsible for all research involving human subjects. The IRB’s primary responsibility is to protect the rights and welfare of human research subjects, in accordance with Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations. Franklin University IRB has the authority to disapprove, modify, or approve research studies based upon consideration of human subject protection.
Human subjects are often used in medical and clinical research as well as social and behavioral research. Franklin University is committed to assuring that research activities conducted under its auspices do not violate the rights and welfare of human participants.
All research that involves human subjects must be reviewed by and must receive approval from the IRB prior to subject recruitment and data collection.The checklist below aims at helping to determine whether an activity requires the IRB review.
Is it research?
A research activity must meet BOTH of the following criteria:
- The activity is a systematic investigation, including research development, testing and evaluation.
- The activity is designed to develop or contribute to generalizable knowledge.
Does it involve human subjects?
Human subjects are involved if ANY of the following conditions are true:
- The activity involves a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual.
- The activity involves a living individual about whom an investigator (whether professional or student) conducting research obtains identifiable private information.
If an activity is categorized as research that involves human subjects, the investigator will need to submit the Application for Human Subjects Research Review to the IRB for approval. If you are not sure if your research qualifies as “human subjects research”, please contact us at firstname.lastname@example.org.
The application for an IRB proposal can be found here.
Utilizing the IRB Application Checklist found below will ensure all components of the proposal are present.
An editable template for the Human Subject Consent Form (in Word format) is available for download here.
All IRB applications from Franklin employees must be reviewed and approved by the immediate supervisors of the Principal Investigators (PIs) before they are sent to the IRB for review.
Students cannot serve as Principal Investigator, but should be listed in the “Other Investigators” section. Student applications are required to have a Franklin University faculty member acting as the PI.
Please allow four (4) weeks from the date delivered to the IRB for notice of the IRB's decision on your proposal. The researcher will be notified via e-mail regarding the status of his/her application.
IRB Application Checklist
- IRB training completion certificate for each investigator (NIH or CITI) (not more than three years old by the research completion date), will need to be attached.
- Background/rationale of the research
- Research purpose
- Research questions
- Research Design
- Beginning/end date
- Research Settings/locations
- Participants (how many, characteristics: age, how they will be identified, recruited, participation incentives)
- Research instruments (survey, interview, focus groups, etc. will need to be attached)
- Quantitative: Identify and define Independent and dependent variables
- Qualitative: Identify and define variables of interest
- Instrument design (sources?)
- Validity and reliability data for the selected instrument(s).
- Threats to extern/internal validity.
- Measure to be used to avoid bias.
- Data collection
- Physical activities
- Informed Consent (will need to be attached)
- Data security
- Data analysis techniques that will be used.
All researchers submitting IRB applications (including faculty, staff, and students) are required to present evidence that they have completed training in protecting human research participants. The training should be less than or equal to three years old.
Training is available from two organizations: (1) the National Institute of Health (NIH), and (2) the Collaborative Institutional Training Initiative (CITI) at the University of Miami. NIH provides a free online training course entitled Protecting Human Research Participants (PHRP) while the CITI training courses do have costs associated with the training.
Researchers are encouraged to choose the free NIH training course, PHRP, which is designed to prepare researchers to understand their obligations to protect the rights and welfare of human subjects in research. PHRP includes six modules and can be completed in multiple login sessions. Total completion time is approximately two to three hours.
To access the NIH PHRP course:
- Follow the link to go to the NIH course Protecting Human Research Participants (PHRP).
- Register for the course.
- At the end of the course, be sure to save an electronic copy of your COMPLETION CERTIFICATE before you log off. This certificate serves as evidence that you have completed the required training.
The Certificate remains current for three years. A current certificate must be submitted with any IRB application.
For those needing to renew their NIH PHRP Completion Certificate, please follow the steps below to insure that the new certificate has the current completion date:
- Log in to the NIH site.
- Select “Edit User Info” from the menu on the right side of the Main Menu, to go to the “Edit Profile” page.
- Scroll to the bottom of the page and select “Retake Course,” which will insure that the new certificate has the current completion date.
For all researchers submitting IRB applications (including faculty, staff, and students), evidence needs to be presented of completed IRB training, which should be less than or equal to three years old.
Researchers wishing to modify an approved research proposal, such as a change in the approved number or type of participants, adding or dropping measures, are required to submit a Modification Request Form, which can be found here.
The IRB Committee will review all Modification Request Forms and notify the PI of approval, denial, or if additional requirements are necessary.
Franklin University has developed guidelines and procedures for human subjects research, which are adapted from the U.S. Department of Health and Human Services Code of Federal Regulations (CFR Title 45, Part 46, last updated in 2009). The IRB Committee created the IRB Handbook to detail its policies and procedures for human subjects research.
The complete IRB Handbook can be found here.
All IRB submissions will be evaluated using the IRB Evaluation Criteria. For a study to be approved all sections of the Evaluation Criteria must be fully addressed. The IRB Evaluation Criteria includes:
- All required components are fully addressed in the IRB Application.
- The research design is appropriate to enable the investigator(s) to answer the research questions.
- Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- 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.
- Selection of subjects is equitable, in consideration of the purposes of the research and the setting in which the research will be conducted.
- Unless waived by the IRB, informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
- Unless waived by the IRB, informed consent will be appropriately documented.
- When appropriate, the safety of subjects will be ensured through appropriate data monitoring methods provided in the research plan.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Federalwide Assurance (FWA)
The Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services has approved Franklin University's application for a Federalwide Assurance for the Protection of Human Research Subjects effective July 22, 2005. Below are numerical designations assigned by OHRP to various components of Franklin’s Human Research Subjects Protection Program:
- Franklin University Federalwide Assurance: FWA00026525, expires Feb. 7, 2023.
- Franklin University Organizational Identifier: IRB00011340
- Franklin University IRB: IORG0009536, expires 12/20/2020