ICF and 2018 Common Rule Your input is important! Thank you for your time filling these questions! Your input is valuable to us to decide our plan moving forward when dealing with changes in the informed consent process. OK Question Title * 1. The 2018 Common Rule, currently effective July 19, 2018, includes a requirement for consent forms to begin with a new section: a summary highlighting the most important parts of the study from the subject’s perspective. Specifically, the document or script must start with "a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This provision further requires that this beginning portion of the informed consent must be organized and presented in a way that facilitates comprehension." Under the new Common Rule, this would only be required for federally-funded studies. However, Emory could expand the requirement and/or we could also start implementing it now. Based on your view of the importance of this new introductory summary in terms of subjects’ comprehension, please select one or more of the below options that reflect your preference: Require for all biomedical clinical trials regardless of funding, FDA regulated or not Require for all socio-behavorial clinical trials regardless of funding Require for studies regardless of type/funding OK Question Title * 2. When introductory summary is required Require only if consent form is more than 4 pages Require always if indicated by study type/risk OK Question Title * 3. Timing of requirements Do not implement for any studies until after the 2018 common rule is effective Require for all studies starting now Let IRB members decide on case-by-case basis now, then require for all studies after Common Rule is effective Let IRB members decide on case-by-case basis now and after Common Rule is effective for non-federally-funded studies (but must require for federally-funded studies) OK Question Title * 4. Other required changes involve additional elements in the consent form, if bio-specimens are collected/used. These include language about ownership, commercial profit, future use, whole genome sequencing, and returning results. Please select the options you feel would work better for our institution. Require the additional elements now Do not require the additional elements until after 2018 common rule comes into effect Let IRB members decide on requirements on case-by-case basis until 2018 Common Rule is in effect OK Question Title * 5. Any additional comments: OK DONE