Expert review of research protocols is carried out to ensure that research is well designed and likely to yield generalizable knowledge, and that risks are commensurate with benefits and accurately disclosed to research participants. The IRB has the authority to approve, require modifications, disapprove, suspend, terminate, and observe the consenting process for research that falls within its scope of review.
LRHMC IRB #: IRB00002126
LRHMC FWA #: FWA00002092
Want to Request a Consultation?
You may contact our office to schedule a meeting for guidance on your application. Consultations can help researchers avoid common mistakes and expedite the review process. These advisory consultations can help researchers navigate the IRB’s requirements, policies, procedures, and ethical issues.
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 Activities That Require IRB Review – AD.0213
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:
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
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
If you have an LRH account, click Cayuse Login. You will be logged in automatically using single sign-on. If you have been granted Cayuse access, click on Cayuse Guest User Login.
Checking your Cayuse Human Ethics Application Status
NHSR
Exempt
Expedited
Full Board Review
IRB Oversight and Administration
Protocol Submission and Meeting Administration
IRB Review of Research
Additional Protections for Special Populations
Recruitment and Consent Process
Research Compliance
Guidance
IRB Checklist – Initial Submission (Do Not Submit)
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 – 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 (Do Not Submit)
Form – Waiver of Informed Consent Process (Do Not Submit)
Forms – Individual Investigator Agreement
Forms – Waiver of Authorization or Altered Authorization (HIPAA) (Do Not Submit)
IRB Dates and Deadlines
IRB Review Fees
LRH Guidance Documents
Office of Human Research Protections
Food and Drug Administration
If you have a question regarding your rights as a research participant, you may reach our IRB Administrator via email at LRH.IRB@myLRH.org.
