Genesis Institutional Review Board (IRB)
The Genesis Institutional Review Board (IRB) protects the rights, safety and welfare of human research participants.
The IRB is responsible for:
- Reviewing new research studies
- Ensuring no unreasonable risk
- Providing ongoing review of studies
- Reviewing proposed changes to studies
- Considering adverse events
- Assessing researcher misconduct
All human subjects research that engages Genesis or its employees must be reviewed and approved by the Genesis IRB before the research is started.
In limited circumstances, Genesis may rely on another IRB to provide oversight for a research study. In such cases, there are certain organizational approvals that must be obtained before such agreements are finalized. For questions or assistance with this process, please contact the Research and Grants Administration office at 563-421-7955 or email@example.com
Standard Operating Procedures
The Genesis IRB has developed and follows a set of Standard Operating Procedures that address the laws and regulations regarding research, along with the underlying ethical principles that are the basis of the IRB’s purpose. IRB oversight of research is carried out as described in these Standard Operating Procedures.
- Standard Operating Procedures
The Genesis IRB meets twice a month, year round. IRB meetings are on the second and last Tuesdays of the month at 7:00 am.
Genesis uses IRBNET, a secure online study management and submission system for all of its IRB study submissions. Through IRBNet, you can submit to and receive information from the Genesis IRB from any location at any time.
To submit a study to the Genesis IRB please sign up for an account by going to www.irbnet.org. The principal investigator and all key research personnel on the study should have accounts with IRBNet. The use of IRBNet is provided at no charge to investigators.
The IRBNet User Guide and Frequently Asked Questions provide step-by-step instructions on how to use IRBNet.
Listed below are all of the Genesis IRB applications and forms used to submit a research study. Once the applicable form(s) has been filled out, it will need to be saved to your computer and uploaded in IRBNet along with any other relevant information for the submission. If this is your first time using IRBNet, you will need to complete a New User Registration in IRBNet. If you have any questions, please call the Research and Grants Administration office at 563-421-7955 or e-mail firstname.lastname@example.org
- New Study Application
- Continuing Review Application
- Amendment Application
- Unanticipated Problem, Incident and New Information Form
- Study Suspension Form
- Determination of Research Application
- Study Closure Form
- Waiver of Informed Consent
- Waiver of Informed Consent Documentation
- Waiver of HIPAA Consent
Quality Assurance Program
The purpose of the Genesis IRB Quality Assurance Program (QAP) is to improve the quality of the human research protections program at Genesis.
The Quality Assurance Program will perform routine and for-cause QAP visits to ensure adherence to federal regulations, state and local laws and Genesis Health System Institutional Review Board (IRB) standard operating procedures.
2018 Common Rule Revisions
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule that delays by six months the effective date and general compliance date of the revisions to the Common Rule. The new effective and compliance date is January 21, 2019.