Research involving federally protected classes such as pregnant women, children, prisoners etc. must be approved by an Institutional Review Board (IRB) before it can proceed. Claims, evidence, reasoning are all variables of research, which must be included in a study. I am highlighting the following regarding changes to the way the IRB will review and or approve research proposals. If you have specific issues and need help with the IRB requirements and processes, HELP Approach will offer seminars on this process at our retreats.
As of January 19, 2019, the Federal Government changed the types of human subjects’ research, which were previously considered “exempt.” These projects will be exempt from annual IRB review and exempt from the informed consent requirements that apply to other types of research. However, some of the new categories will require prospective participant(s) agreement and a limited form of IRB review. Note however, that even when research is exempt from further requirements of federal regulations, basic ethical standards still apply. The ethical requirements and exempt categories 1-8 are found in the link embedded in below.
The new provision for limited IRB review allows certain research to be categorized as exempt, even when the identifiable information might be sensitive or potentially harmful if disclosed. In order to qualify for exemption, the study must meet the standards of the limited IRB review. If the information is both identifiable and sensitive or potentially harmful, the safeguards offered by the limited IRB review may allow an exemption determination to be made.
Exempt categories 7 and 8 require (broad consent). “Broad consent” occurs when investigators plan to store, maintain, or use identifiable private information or identifiable specimens collected for non-research purposes and the information/specimens are obtained with a broad consent process. Broad consent is a new type of informed consent provided under the revised Common Rule pertaining to storage, maintenance, and secondary research with identifiable private information or identifiable biospecimens. Secondary research refers to research use of materials that are collected for either research studies distinct from the current secondary research proposal, or for materials that are collected for non-research purposes, such as materials that are left over from routine clinical diagnosis or treatments. Broad consent does not apply to research that collects information or biospecimens from individuals through direct interaction or intervention specifically for the purpose of the research.
Visit this link to learn more: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
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