An institutional review board, or IRB, is a group of experts who are appointed to monitor and review biomedical research involving human subjects at a facility. An IRB plays an important role for medical device manufacturers as they will oversee any clinical research activities in order to protect the rights of the human research subjects. In order to conduct a clinical trial on your medical device, you will have to submit and be approved by an IRB.1
Before you can begin your clinical trial, you will have to prepare and submit a packet to the IRB consisting of the following:
- The research protocol
- Informed consent forms
- Recruiting materials that were used to recruit participants
- The Principal Investigator’s (PI) CV.
Depending on the IRB you are submitting to you may also have to submit additional information such as a detailed device description and information on available resources for the study. The IRB will review all submitted information and assess the ethicality of the research which includes ensuring the methods used during the study are designed to minimize patient risk and making sure all subjects fully understand the study prior to participating. IRBs also assess whether the proposed Principle Investigator (PI) is qualified to manage the research.2
Once submitted to an IRB, the review process can follow one of two paths: a full board review or an expedited review. An expedited review usually only takes a couple of days and can be completed by one appointed person on the IRB. A full board review is required if one of the following is true: test participants include minors, have pre-existing medical conditions such as Cystic Fibrosis, or the device requires an Investigational Device Exemption Application. If none of these are true, then the submission is generally eligible for an expedited IRB review.3
Once the IRB approves a submission and the clinical trial starts, the board stays involved by performing continuing reviews of all study-related materials at least once a year. The IRB also reviews all material at the conclusion of a clinical trial.4
IRBs are critical to medical device studies as they ensure the safety of the subjects and regulate the ethicality of the clinical trial. EMMA International can help you prepare for an IRB review and support you through a clinical trial. Call us at 248-987-4497 or email firstname.lastname@example.org to see how we can help!
1FDA (September 2018) IDE Institutional Review Boards (IRB) retrieved on 01/29/2020 from: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-institutional-review-boards-irb
2WHO (2002) Handbook for Good Clinical Research Practice (GCP) retrieved on 01/29/2020 from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/gcp1.pdf
3Johns Hopkins Office of Human Subjects Research (April 2016) Expedited Review Process retrieved on 01/30/2020 from: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/expedited_review.html
4PPD (n.d.) IRB/EC in Clinical Trials retrieved on 01/30/2020 from: https://www.ppdi.com/participate-in-clinical-trials/become-an-investigator/institutional-review-board