Blog
What is a Researcher to Do? IRB Review of Applications and Proposals Lacking Final Details for Involvement of Human Subjects
This happens quite often: a researcher would like to apply to a funding agency for a grant to perform a human subjects research study before they can finalize the study methods. But, the agency needs proof of IRB approval as part of the grant application. Can a...
Indiana Life Sciences Collaboration Conference: “Impact of the New Administration: FDA, HHS, CMS, et al.”
Pearl Pathways' own Director of RA/QA Services Becki Nowatzke was honored to serve on the planning committee for this compelling event featuring an outstanding slate of keynote speakers including Jonathan Blum (Principal Deputy Administrator & COO, U.S. Centers...
Studies Using In Vitro Diagnostic Devices with Specimens that are NOT Individually Identifiable
In Vitro Diagnostics (IVDs) are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, to cure, mitigate, treat, or prevent disease. Such products are intended for use in...
COVID-19 Device Testing: Why Your Study Will (Probably) Need Full-Board Review
Independent or Institutional Review Board (IRB) review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to...
Subpart C Certification Forms
An institution that intends to conduct HHS-supported research involving prisoners as subjects must certify that an IRB has made the seven (7) findings required under 45 CFR 46.305(a), including the finding that the proposed research represents one of the permissible...