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STATE OF WISCONSIN, CIRCUIT COURT, COUNTY IN THE MATTER OF THE ESTATE OF For Official Use Amended Waiver and Consent (Informal Administration) Case No. 1. 2. 3. 4. 5. 6. 7. 8. I am by law an interested

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Good Morning everyone. Welcome to our meeting entitled, quot;Proposed Changes, The Federal Regulations for Human Research, Session #4, Enhancing and Clarifying Consent Forms and Establishing Standard Safeguards.quot; How's the audio? Can everybody hear me ok? Awesome! And welcome to everybody who is live-streaming. My name is Jill McNair, and I'm the Director of Education and community outreach for CIS CRP. And CIS CRP is the Center for Information and Study on Clinical Research Participation. We are a Boston based non-profit. We were founded in ... about 12 years ago. And I was invited here today because we do a lot of patient education. We do live programs across the United States educating people about what clinical research is-- what are the benefits, what are the risks, and how to make an informed decision about whether you should participate. And we do not conduct clinical trials, nor do we recruit for them. So the kind folks here who planned the meeting thought that I would be a good choice just to moderate the day-- kind of ... just extract information. Let's find out a little about this proposed rule and get some conversation started. So ... let me see if I can make these slides work here. So the goals of today's meeting are to provide helpful background information; provide overview of the proposed changes; review changes specific to informed consent; provide experts' perspectives on changes; encourage Q and A, and encourage official submission of comments. So how many of you here today are members of the public, or you're a patient? So we only have one. How about ... are the rest of you are Clinical Research professionals? Yes. Excellent! Well, very excited that you're all here. I know there's a lot of people online as well, so we're hoping there are more patients and public online, as well. Here's our agenda today. The first session that we're going to talk about the research landscape, but I do want to mention that today's conversation is really an opportunity to get some dialog moving. But, any questions, any comments that are heard here today are not officially submitted to the docket, so you need to do that yourself. So we encourage you to think about what you want to submit, craft it, and then there are multiple ways you can do it online or via mail. And I'm sure that it's on your table, it looks like, and I'm sure they gave you some information in your packet, as well. So social media. ... so you can tweet questions today. How many of you tweet? Me either. I just opened an account like two weeks ago. Awesome! So let's see if we can get some tweeters. There are probably many more online today who can tweet. You can also email your question, but you can go old-school, and there's comment cards here, and I think we have some stand-up mics, as well, so you can use those. So this is the fourth meeting of a series ... one, two, three, yep actually the fifth meeting. I thought there were only four, but there's a fifth meeting? Ah,...

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What is what is a waiver?

A waiver is a document that allows an individual or organization to relinquish a right or claim.

Who is required to file what is a waiver?

Individuals or organizations who wish to waive a specific right or claim may be required to file a waiver.

How to fill out what is a waiver?

To fill out a waiver, individuals or organizations must provide their name, signature, and the specific right or claim they wish to waive.

What is the purpose of what is a waiver?

The purpose of a waiver is to legally release an individual or organization from a specific right or claim.

What information must be reported on what is a waiver?

Information that must be reported on a waiver includes the names of the parties involved, the specific right or claim being waived, and the effective date of the waiver.