Attachment A - Modif. Prev. Approved Expedited List No. 12

Modification to Previously Approved (October 2017) SACHRP Recommendation on Revised Common Rule’s Expedited Review List

 

Previously approved language:

 

12. Creation and maintenance of subject databases to which subjects have provided prospective informed consent or informed consent has been waived by an IRB and does not qualify for exemption under  §__.104(d)(7). Examples: (a) collection of identifiable information for the purpose of establishing subject pools; (b) disease-specific patient registries; (c) screening protocols including interviews, questionnaires and minimally invasive physical assessments, when performed for research purposes, that could not be expedited under one of the categories listed above.

 

 

Revision:

 

12. Creation and maintenance of subject databases to which subjects have provided prospective informed consent or informed consent has been waived by an IRB and does not qualify for exemption under  §__.104(d)(7). Note: This expedited category is intended to cover the creation and maintenance of the database itself once the collection of the data has been approved.