June 11, 2018

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 in a course 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/

Designation as Key Project Personnel on Non-Exempt IRB Projects

HRPP Manual 4-10, Designation as Key Project Personnel on Non-Exempt IRB Projects provides the criteria for who is considered key project personnel and as a result, needs to be listed on a non-exempt IRB project. Although only key project personnel need to be listed on a non-exempt application, all other individuals engaged in human subject research activities must receive and maintain current human subject training, must disclose conflict of interest, and are subject to MSU HRPP requirements. When non-MSU personnel are engaged in human research, there are additional requirements. Learn more at https://hrpp.msu.edu/msu-hrpp-manual-section-4-10 

European Union General Data Protection Regulation

On May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) went into effect. The regulation provides privacy and security protections for personal data collected in the EU. This regulation may impact research involving human subjects conducted in the EU.  Research that may be impacted by the EU GDPR will be reviewed on a case by case basis.

For the EU website about the GDPR, visit https://ec.europa.eu/commission/priorities/justice-and-fundamental-rights/data-protection/2018-reform-eu-data-protection-rules_en#abouttheregulationanddataprotection

For a list of EU member states, visit https://europa.eu/european-union/about-eu/countries_en  

CITI FERPA Modules Now Available

Family Educational Rights and Privacy Act (FERPA) modules have been added to the courses available to MSU faculty, staff, and students in CITI.  One of the FERPA courses provides a focus on research, while another provides a focus on instruction. To view the FERPA courses, log into CITI (https://about.citiprogram.org/en/homepage/) and add the course.

Update on the Revised Rule

On April 20, 2018, the federal departments published a notice of proposed rulemaking that proposed a further delay of the revised “Federal Policy for the Protection of Human Subjects ” until January 2019. While the comment period for the notice of proposed rulemaking has ended, a new notice has not yet been published. Learn more at https://hrpp.msu.edu/announcement/update-implementation-delayed-revisions-federal-policy-protection-human-subjects

HRPP Website – Redesign Coming Soon

The Office of Regulatory Affairs is in the process of updating all of its units’ websites, including the Human Research Protection Program. The website address will stay the same, https://hrpp.msu.edu/, but the format and navigation of the site will change. The HRPP website update is expected to go live soon.