HRPP Newsletter

June 24, 2019

Student Access to Click™ IRB Research Compliance During Summer Months

During the summer months, students will receive an error if trying to log into the Click system if not enrolled or they do not otherwise have access to Click (e.g. MSU employee). The Click system uses MSU Identity Management services and student access to Click is based on current enrollment. During the summer months, if not enrolled, students’ access to Click is removed, even if they are listed on a Click IRB study.

To access Click during the summer if not enrolled, the student’s department will need to submit an Access Request through the eARM process. The department would select the “Generic” access type, identify the student, request access as a “Click Affiliate,” and provide an explanation for why access is needed (e.g. need access to an IRB submission). More information about the eARM process is available at https://tech.msu.edu/network/authentication-authorization/access-requests/

More information about how to get Click Access is available at https://hrpp.msu.edu/click/access.html

HRPP Compliance Office Spotlight

What do the HRPP Compliance Analysts do?

The HRPP Compliance Office is responsible for post IRB approval monitoring and ancillary reviews of clinical research to provide oversight over regulatory areas that affect clinical research not addressed in the IRB requirements. For example, the Compliance office provides education and oversight with the FDA requirements for investigational new drugs and devices (21 CFR 312, 21 CFR 812), registration with clinicaltrials.gov (42 CFR 11, NIH Policy on Dissemination of NIH-Funded Clinical Trial Information), ICH-GCP (E6 R2) guidelines and the HIPAA Privacy Rule (45 CFR 160, 162, 164, 74 FR 42740).

De-identified left over human specimens not research with human subjects or FDA regulated research?

Activities involving de-identified human specimens that do not require IRB approval under the Common Rule Protection of Human Subjects regulation must still receive IRB approval if the activities are subject to U.S. Food and Drug Administration (FDA) regulations. The definition of a clinical investigation involving a medical device can include de-identified left over tissue if the focus is to develop diagnostic products including reagents and test kits or an algorithm for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease. In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]. When in doubt, check with the Compliance office.

How to find finalized consent forms?

If applicable, use the IRB approved finalized consent (with IRB approval language indicating an effective date) to enroll subjects. To find the finalized version of the consent, navigate to the study’s workspace and click on the “Documents” tab. From there, the finalized version will be available under the “Final” column. Remember, if you are obtaining a signed consent you must provide a copy of the consent to subjects. A copy of the signed consent must be provided to the subject if you are following ICH-GCP.

Click workspace and the documents tab

 

Click workspace and documents tab navigation to the final column