The LRH IRB provides ethical oversight to all activities that meet the regulatory definitions of research involving human subjects.  The LRH IRB complies with both the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) definitions and requirements for IRB review of all research. 

The HIPAA Privacy Rule permits the Institutional Review Board (IRB) to provide a waiver of authorization pursuant to 45 CFR 164.512(i) that the information requested is the minimum necessary for the research purpose.

To determine which activities require review by the LRH IRB see Research That Must be Reviewed by the IRB-AD.0162. 

All persons who are or will be involved in the conduct of human subjects research are required to complete human subjects research training. IRB approval will not be provided if these requirements are not met.  These requirements apply to all persons with a role in the research (e.g., Principal Investigators, Co-Investigators, Project Managers or Research Assistants) and who are designated to:

• • Recruit potential research participants
  • Obtain informed consent from prospective research participants
  • Interact or intervene with participants to collect research data
  • Access identifiable research data

To determine what your training requirements are, depending on your discipline, see Research: Investigator, Research Personnel, IRB Member, IRB Administrator, and Institutional Official Training-AD.0161

CITI Program Training for IRB Requirements

• • LRH uses the CITI Program courses to satisfy Human Subjects Research training requirements. 
  • Access and Register for CITI Program Training here: Research, Ethics, Compliance, and Safety Training
  • Select “Log In Through My Organization” and select Lakeland Regional Medical Center Inc
  • Select “Add a Course” and answer the questions based on your discipline/project requirements 
  • CITI Training Instructions

All new human subjects research must be reviewed by the IRB prior to the commencement of any study activity. Once IRB approval or determination has been granted, researchers must follow IRB Policies and Procedures for follow-on submissions during the course of their research study to remain in compliance. Examples of follow-on submissions include modifications, continuing reviews (when applicable), and reportable new information reports.

Cayuse Human Ethics is the IRB electronic cloud-based protocol management platform used for submission, review, and maintenance of all initial human subjects research applications, as well as NHSR determinations, modifications, renewals, and reporting incidents. 

Cayuse Human Ethics

• Logging into Cayuse Human Ethics
• LRH Training/User Guide for submitting new applications in Cayuse Human Ethics
• Required Forms and Templates (see Forms and Templates drop down below)

Checking your Cayuse Human Ethics Application Status

• Unsubmitted: Application has not been submitted for review.
• Awaiting Certification: Application process is incomplete. The PI must log into the study and click on complete submission, confirm, and certify to complete the submission process for the application to be reviewed.
• Reopened: Application has been reviewed, and edits are pending from the PI. Refer to the letters tab for required changes.
• Approved: Application has IRB approval, and research may begin.
• Withdrawn: Application is no longer active. A new application will need to be submitted.

NHSR

• • To request a NHSR Determination, submit an initial application into the Cayuse Human Ethics platform. 
  • NHSR studies do not require continuing review. 
  • Primary Investigators should submit a request to close the study in Cayuse when the study is finished.
  • For more information, see SOP: Research NHSR

Exempt

• • Federal regulations identify several different categories of minimal risk research as being exempt from the regulations. This does not mean that they are exempt from IRB review, only that some of the federal requirements that apply to non-exempt studies are not applicable to studies deemed exempt. For example, exempt studies are not required to obtain written informed consent and are not required to submit modifications prior to implementation (unless they may affect the exempt status of the study).
  • For more information, see SOP: Research Exempt Review.

Expedited

• • Expedited review falls under the full scope of the regulation and must fall into one of the expedited review categories.
  • All expedited studies must adhere to the requirements for informed consent or its waiver, or alteration. 
  • Expedited studies may or may not be required to undergo continuing review. 
  • All modifications must be approved by the IRB prior to implementation, unless they are necessary for the immediate safety of participants.
  • For more information, see SOP: Research Expedited Review. 

Full Board Review

• • Studies that are not eligible for expedited review (do not meet the definition of minimal risk and/or do not fit into an expedited category) must be reviewed by the convened IRB.
  • All full board studies must adhere to the requirements for informed consent or its waiver or alteration. Full board studies must undergo continuing review at least annually. 
  • All modifications must be approved by the IRB prior to their implementation, unless they are necessary for the immediate safety of participants.
  • For more information, see SOP: Research Full Board Review.

IRB Oversight and Administration

• Research That Must be Reviewed by the IRB – AD.0162
• Investigator, Research Personnel, IRB Member, IRB Administrator, and Institutional Official Training – AD.0161
• Clinical Trial Feasibility – AD.0153

Protocol Submission and Meeting Administration

• LRH Data Management – AD.0159

IRB Review of Research

• Levels of IRB Review- AD.0167
• Emergency Use of Drugs-Biologics for Individual Patients – AD.0199
• Expanded Access- Emergency Use of Devices for Individual Patients – AD.0200
• Expanded Access- Non-Emergency Compassionate Use -Devices – AD.0202
• Expanded Access- Non-Emergency Individual Patient IND -Drugs-Biologics – AD.0203
• Unanticipated Problems & Serious Adverse Events Reporting- AD.0193
• Evaluation of IRB Members, Chairs, and Vice Chairs – AD.0160
• SOP: Research Non-Human Subject Research (NHSR)
• SOP: Research Expedited Review
• SOP: Research Full Board Review
• SOP: Local Context & Ceded Review
• SOP: Modifications to Previously Approved Research

Additional Protections for Special Populations

• Children as Research Subjects – AD.0154

Recruitment and Consent Process

• Informed Consent- Assent- Re-Consenting- Parental Permission- Remote Consent and Remote Assent Process – CL.0218
• Waiver of Elements of Consent- Waiver of Documentation of Informed Consent- and Waiver of Written Authorization – AD 0168
• Illiterate and Non-English-Speaking Subjects – AD.0197

Research Compliance

• Protocol Deviations & Non-compliance- AD.0194
• Conflict of Interest – AD.0157
• Investigational Device – AD.0155
• Investigational Drugs – AD.0156 
• Research Integrity Assurance – AD.0115

Guidance

• Case Report Publication Policy- AD.0163
• eSignature – AD.0207

1.1 IRB Checklist – Local Context Review

1.2 IRB Checklist – Final Report

1.3 IRB Checklist – Expanded Access – Drugs and Biologics

1.4 IRB Checklist – Expanded Access – Compassionate Use – Devices

3.0 Protocol Template – Medical Record Review of Existing Data

3.1 Protocol Template – Research Using Existing Deidentified EHR-Data Analytics Warehouse

3.2 Protocol Template – Biomedical Protocol

3.4 Protocol Template – Social Behavioral Protocol

4.0 Consent Template – Biomedical Informed Consent

4.1 Consent Template – Social Behavioral Informed Consent

4.2 Consent Template – Script for Obtaining Verbal Informed Consent

Form – Confidentiality Agreement

Form – Conflict of Interest Form – Research Personnel

Form – Data Use Agreement

Form – IRB Member and Guest Conflict of Interest

Form – LRH Access Request User Acknowledgement and Agreement

Form – Provisions for Soliciting Assent and Permission of Parents/Guardians

Form – Research Personnel List

Form – Waiver of Documentation of Informed Consent

Form – Waiver of Informed Consent Process

Forms – Individual Investigator Agreement

Forms – Waiver of Authorization or Altered Authorization (HIPAA)

IRB Dates and Deadlines

• • The deadline for submitting completed applications to the IRB office is the 1^st Thursday of every month. 

• • IRB members receive the full board meeting materials on the 2^nd Thursday of every month.   

• • The IRB full board meets on the 3^rd Thursday of every month. 

IRB Review Fees

• • See Research: Clinical Trial Feasibility- AD.0153 

LRH Guidance Documents

• • LRH Guidance – Definitions for Enrollment Numbers

• • LRH Guidance for Requesting a Waiver of Informed Consent for Retrospective Chart Reviews

Office of Human Research Protections

• • HHS Requirements for Institutional Review Boards (Common Rule) 45 CFR 46 | HHS.gov
  • The Privacy Rule or HIPAA  45 CFR 164

Food and Drug Administration

• • FDA Requirements for Institutional Review Boards eCFR :: 21 CFR Part 56 Subpart A — General Provisions