I ask all of us to listen with open minds respectful of all points of view and respectful of time. This public meeting will hear all views on the topic at hand. We know this issue is of critical interest whether you're in this room, listening via webcast, or for folks not able to participate in any way today but sent comments and definitely are going to be watching. This meeting is intended to help us through the Office for Human Research Protections to develop guidance that is related to informed consent and what constitutes the reasonably foreseeable risk in research that involves standard of care interventions such that risk is required to be disclosed to research subjects. Today's meeting here at Health and Human Services. I anticipate the major traffic issues are going to be the next hour or two getting ready for one o'clock events at the far end of the Mall and then up until about 5 or 6 p.m., so if you haven't looked at any of the notification sites about transportation and logistics today, just for your general awareness.

So we're grateful that you came early, that you made it here, and plan to spend as long as you can. That event, some of you may have experienced firsthand, but we know it's also creating the today's events creating transportation difficulties. Martin Luther King delivering his I Have a Dream speech, though he wasn't originally the featured speaker.īut it's 50 years later now, and we're able to look back and look forward. It's truly an historic day to be in Washington and really when we set the date for this meeting back in the late spring, we didn't realize it was going to coincide with the great events out on the Mall today and the commemoration of the 50th anniversary of the march on Washington which everyone remembers as the reverend Dr. We have over 200 folks registered to participate in person today and quite a number of folks indicating they're going to be on line but we don't have current numbers.īut we're thrilled we have gotten a response to this meeting that we have gotten. Humphrey Building, headquarters of the U.S. Brief summary of comments submitted by, by those who did not present today University of Texas Health Medical SchoolĬase Western Reserve University (Cleveland, OH)Īmerican Association of Medical Colleges (Washington, DC)Ĥ:30 p.m. New England Journal of Medicine & Harvard Medical SchoolĪlion HRPP Accreditation Services (Washington, DC) 4:30 p.m.Presentations & Panel Questions Johns Hopkins Bloomberg School of Public Health (Baltimore, MD)ġ:00 p.m. Seattle Children's Research Institute (Seattle, WA)

Public Responsibility in Medicine and Research (Boston, MA)Ĭhildren's Mercy Hospital (Kansas City, MO)

Presentations & Panel QuestionsĪlliance for Human Research Protection (New York, NY) Department of Health and Human Services (HHS)ĭirector, Office for Human Research Protectionsĭeputy Director for Science Outreach and Policyĭeputy Center Director for Clinical Scienceĩ:15 a.m. Principal Deputy Assistant Secretary for Health Research Considering Standard of Care Interventions Matters Related to Protection of Human Subjects and

Regulations & Policy Archived Materials.

Subpart C Certification Request to OHRP.

Single IRB Exception Determinations has sub items, about Single IRB Exception Determinations.

Informed Consent Posting has sub items, about Informed Consent Posting.

OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements.

OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals.

Decision Charts has sub items, about Decision Charts.

Path to Revising the Common Rule (2011–2018).

Preamble to the Revised Common Rule (2018 Requirements).

Regulations has sub items, about Regulations.

Docket dying light codes