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The MedStar Health Research Institute (MHRI) Office of Research Integrity (ORI) has worked to simplify the process for case reports.
What is the Current Process?
Current IRB Form 2C, Case Report Review Request, states that under U.S. Federal Regulations (45 CFR 46) case reports are not considered “research”. This form is compliant with regulations and prevailing industry interpretation on the definition of research. However, MHRI has requires IRB acknowledgment of all case reports even that the IRB was not necessary. The acknowledgment is beyond what is required by regulations. This project focused on eliminating unnecessary steps, specifically eliminating the acknowledgment for case reports.
Why the Change?
Simply stated, to make it simpler and reduce unneeded work. IRBs must guard against IRB mission creep, in which IRBs spend time, energy, and staffing resources attempting to prevent a growing list of imagined, minor, or highly unlikely harms.1,2 IRB mission creep can lead to a system of over-regulation while underprotecting.1,2 Upcoming changes to the Common Rule (compliance date January 19, 2018) are focused on ensuring IRBs better protect human subjects involved in research by facilitating valuable research and reducing burden, delay, and ambiguity for investigators.3 Our change is in line with that philosophy to modernize, simplify, and enhance the current system of oversight.3
So What Happens Now?
The ORI website has been revised to include the forms for Case Reports, along with Frequently Asked Questions about case reports. View the revised webpage.
On that webpage, you will have access to some key documents needed to perform case reports.
- A HIPAA Authorization Form to use with Patients
- MedStar HIPAA Guidance for Case Reports
- A letter to provide to journals stating that IRB review is not necessary
If you have any questions, please contact MHRI-ORIHelpDesk@MedStar.net.
1 C.K. Gunsalus, et al., Mission Creep in the IRB World.Science 2006;312:1441. Available at https://science.sciencemag.org/content/312/5779/1441.
2; Ronald F. White, Institutional Review Board Mission Creep: The Common Rule, Social Science, and the Nanny State. Independent Review; Spring 2007:547-56. Available at https://kanagawa.lti.cs.cmu.edu/11780/sites/default/files/IRB-Readings-tir_11_04_05_white.pdf.
382 FR 7149, 7149 (January, 19, 2017). Available at https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm.