Bit more different perspectives.

I might go straight home professor here in school, public health at university and I just want to say, uh also a welcome as, ah, one of the program planning Committee members not only to you here in the audience, but to actually our audience in Europe.

Good afternoon to you.

We have people on the Webcast there, and I want to start out by actually offering a personal perspective as I stand here today to moderate this because I don't stand here with great expertise in human participants and studies other than I've been both and both sides of those.

But I actually stand here today as someone who realizes that between now and the time I take my last breath, I may very well be a candidate as a participant in a study of great importance of which I am going to have for all the reasons already outlined this morning, potentially some issues about how I consent or don't consent to that study.

But more importantly, I'm like many of you in this room.

I have family members or family friends who are by every definition mentally ill who are incapacitated from a standpoint of making cognitive decisions that we would all agree are made with full informed consent because of whatever status they might have.

I have family members who have severe chemical abuse problems who at times may very well be able to make good decisions and canned.

And so it's very hard for any of us up here.

Just to stand here is academicians, because in a sense, this is all really about all of us about all the time.

And so today, what we wanted to do is a part of the program Planning Committee is actually scheduled a session here, which is entitled Multiple Perspectives on the National Debates and Consent Challenges, knowing that there is not a right answer, but we sure it can learn a lot.

And today we're very fortunate to have four different experts with us, all who will provide a perspective on.

I'll introduce each one of them at the time that they would come up.

They will give a 10 minute presentation.

They've all agreed to keep it to 10 minutes out of courtesy for their fellow speakers and so that we can also open it up, then for a dialogue with this audience, which we realize is very important a time then that they're done.

We will ask them to come all up to sit up here as well as our two morning speakers.

And then it's open for all questions and coming.

So our first speaker today eyes to abjure Holding, who is the executive director of the National Alliance on Mental Health, Minnesota.

Su has devoted her career to changing laws and attitudes that affect people with disabilities and their families.

At the National Alliance on Mental Illness, Minnesota, she has focused on the stigma surrounding mental illness and the broken system of care for Children, adults with mental illnesses.

Over the past 25 years, Sue has successfully fought for community and family support and for the laws that enable people with disabilities to fully participate in society.

She has a very important and supported background and that she held positions with the Ark Minnesota.

She understands policy is having served in U.

S.

Senator Paul Wellstone staff and also at the Pacer Center.

We're very honored to have her with us today and sue the floor is yours for the next 10 minutes.

Thank you.

All right, so I'm gonna talk fast.

Um, first, I just want to make sure everyone knows so.

Mental illness affects one in five people in every given year, and it affects everyone.

Children and adults, men and women, people from every race, ethnicity, religion and political parties, Democrats and Republicans alike.

And it affects people from every profession football players, physicians, teachers, artists, musicians, meteorologists.

The symptoms disrupt a person's thinking, feeling, mood, ability to relate to others and daily functioning So you can understand how these symptoms could interfere with decision making.

But mental illnesses air on a continuum, and not every person with a mental illness becomes disabled by their illness or has the capacity to consent compromised?

We prefer to focus on people's strengths using words like courage and determination, not weakness or incompetency treatment.

Effectiveness ranges anywhere between 60 to 80% and we know that early identification and treatment can lead to recovery and prevent them from becoming disabling.

I do want to note that treatment involves much more than medication and includes therapy, diet and exercise.

Complementary therapies such as mindfulness training, social connection to friends, and families and having a reason to get up in the morning, such as having a job, attending school or volunteering.

Unfortunately, in our mental health system here and frankly across the country, we don't use the public health approach to treating people with mental illnesses first.

We don't identify people early.

They live with their symptoms an average of 10 years before seeking treatment.

72 weeks for a young person experiencing their first psychotic symptoms.

Second intensive treatment isn't provided until someone has been hospitalized or committed numerous times.

Assertive community treatment and evidence based practice isn't made available until someone has become disabled due to their illness and has a history of homelessness or hospitalizations.

It's akin to waiting to treat people with cancer until they hit Stage four.

When we discuss involving people with merit, serious mental illnesses and research, we need to keep in mind the continuum and that people are frankly much sicker when they come into our public mental health system.

And by the time people are before the courts, they're extremely ill.

In Minnesota.

Every year, about 4300 people are committed to treatment for their mental illness.

Now, the commitment law is about involuntary treatment.

Nat Competency Guardianship is about competency, and this is a very important difference.

In order to be committed to treatment at least a Minnesota, an individual must have a diagnosis of a mental illness, and there must be a strong likelihood that the individual will harm themselves or others, as evidenced by failure to obtain food, clothing, shelter our Medicare medical care as a result of their illness or inability to obtain these things.

And it's more probable than not that the person will suffer harm, serious illness or significant psychiatric deterioration as a result of not receiving that medical care.

Or there's a recent attempt or threat to physically harm themselves or others.

Or there's recent conduct involving significant damage to substantial property, and there is no less restrictive way for the person to get treatment.

So it's important to remember that people are committed to treatment for a variety of symptoms, including psychosis, but also due to serious depression and thoughts of suicide.

Most people in Minnesota are committed for up to six months and again, commitment is for mental health treatment, not competency.

And it's not guardianship.

As a matter of fact, few people with serious mental illnesses, including people with schizophrenia, are under guardianship because of one word.

Recovery.

Judges are very reluctant to take away people's rights to make the decisions about their lives.

When it's often a temporary situation, many people begin to feel better in a couple of days or weeks once they get treatment.

And many people whose symptoms decrease and are moving towards recovery are placed on a stay of commitment, meaning if they continue to follow their treatment plan, their commitment will be discharged.

The Commitment Live doesn't really talk about competency, except to say that an individual can consent to other types of treatment if the physician believes the person's competent while under commitment.

There is nothing in law that prevents the individual from signing contracts, using their credit card, taking out loans and more.

And there's nothing that prohibit companies or entities from making them accountable for their actions.

So you need to keep this in mind as we turn to discussing allowing people with mental illnesses to participate in research.

Even in 2015 our understanding of the brain is limited and research is really in the beginning stages.

Technology has helped in terms of stronger memorize, but even then reviewing the brain of the 30,000 foot level without a better understanding of the brain and increased funding for research, new treatments for mental illnesses are limited.

But people with mental illnesses and their families hold out hope that new research will emerge and lead to better outcomes, which will allow our society and communities to benefit from their gifts and talents.

We need research of the brain and research to find better mental health treatment, not just medications, but different forms of therapy and technology.

Tom Insel, who just stepped down as the head of N Ame age, wrote that quote.

We need to be humble.

The science of mental illness is still in its infancy, and our treatments, while helping many to get better, do not help enough to get well.

So you have people who have not gotten better, some who have gotten better, but not well, but all of whom desire recovery.

It could be that the side effects of medication are just too difficult, but at the same time the symptoms interfere with their recovery.

They want to find a better treatment so that they can get better and lead full lives.

There are also people who believe in the greater good, if you will.

I'm reminded of the quote that we're here to plant the seeds of trees under whose shade we will not sit.

They wanted to be better for the next generation.

We know this is true for people with cancer whose only hope is a new treatment, and they know it really may not help them, but will increase understanding and treatment of that particular cancer in the future.

It is no different for people with mental illnesses.

Despite having two very good reasons to participate in research, there is still hesitancy.

We want to make sure that although someone with a mental illness hasn't been deemed incompetent by a court, that they're protected nonetheless initially when first hospitalized under a commitment, a person's ability to consent may be compromised.

And of course, it could be compromised any time that they're symptomatic.

And while we shouldn't unilaterally prohibit people with mental illness from participating in research at this time, we should use the tools that exists to determine if they're competent to make decisions.

There's a couple of tools that you be a CC, the MacArthur Competency Assessment Tool for clinical research.

A very small percentage of people stay committed for excuse me for a very long time due to lack of insight.

And they stopped treatment once the commitment is lifted and then they quickly deteriorate.

But is it fair to deny the people with the most serious mental illnesses new treatment that might work better and could help them achieve recovery?

And while they may not have insight, they may want to change their outcomes.

A few people with mental illnesses are under guardianship, so there aren't alternative decision makers or legally authorized representatives.

Even worse, our Mel health system has systematically excluded family members from being involved in a loved one's care or even being able to obtain basic information.

And they often use HIPPA as a shield.

Even though it's, NAMI likes to say, HIPPA doesn't require you to be stupid.

This leaves many people with mental illness, is even more vulnerable and participating in research, because often family members aren't allowed to be involved.

So there's no advocate, if you will in the discussions around consent.

So we need to either include families or make sure a person has an advocate in the process of agreeing to participate and research, and they also want to just mention that prior to the A c a.

Especially Medicaid expansion.

Participating in research for many was the only way to access treatment.

Another issue is that the method of asking for consent is not necessarily effective.

Simply handling someone a form to read and sign isn't the best way to ensure that someone understands what they're signing and understands the benefits and risks.

More should be done to ensure that someone with a melon illness has information and understanding of the information to actually make a decision.

Just as there is a movement and discharge planning to use the teach back method so there should be here.

Studies suggesting adding multimedia tools also improve understanding.

So I'm nearing the end of my time.

But I want to urge people not to paint people with mental illnesses with one brush.

There are many who can consent to participate in research and you are doing it for all the right reasons.

Let's just take extra care that they understand what it means to participate in a particular research study, especially the risks and benefits that they have a family member or advocate with them, and that we have determined outside of a courtroom that they're competent at that moment to consent.

But finally, let's not deny people with mental illness and their families the hope for recovery that can come through research.

Thank you.

Thank you, Sue, for that.

Very good.

Start to the multiple perspectives.

Next, we're going to hear from someone who's already asked a question this morning and someone who has been referred to on multiple occasions because of her well recognized international expertise.

Bar Beer is a professor at Harvard Medical School, senior vice president of research at Brigham and Women's Hospital, director of regulatory foundations, ethics and law at Harvard Catalyst and a former chair of the secretary's Advisory Committee on Human Research Protections.

Department Health Human Service is Barbara is also co chair of the Partners Healthcare Committee and Conflict of Interest.

In addition to our academic responsibilities, she's also was elected to the board of directors of the Association for Accreditation of Human Research Protection programs.

Serving is this president's from 3 4007 She's currently a member of the Double A M C.

A U Advisor Committee and financial conflicts of interest in clinical research and a member of the National Academy of Science Committee on Science Technology in the Law.

It's really an honor to have you here with us today and turn it over to Barbara.

And I want to thank the organizer's for inviting me.

Uh, it's really a pleasure to be here, and we'll be up in a minute.

Hopefully, yes.

Under consent.

Mmm.

That's it?

Yeah.

Good.

So, um, I thought today I'd take a bit of a step back and talk about general consents, not consents specifically for, um, for vulnerable participants.

But I will say that I have no financial conflicts of interest while we're waiting.

I have lots of employment and other opportunities that inform my opinions on having just come from the N s yesterday.

All of those air quote relevant.

Um, and I am very opinionated.

And therefore, um, I gave you, although we cannot see it now, you can, um my conflicts.

So I'm gonna pick up where Jeff left off a little bit.

Which is to say that informed consent is very, very hard to achieve.

And we have never really done a very good job of it, and I think we need Thio.

Think through where we are with informed consent, and it's a significant problem way beyond that of vulnerable populations.

And if we're doing a terrible job on quote, normal people were doing a disastrous job on vulnerable individuals.

There are no standard processes by which elements are presented and described, and the documentation of comprehension at the time of consent or thereafter is not required.

And it's rarely obtained.

And there are very few validated methods for comprehension and even fewer for long term comprehension.

We may ask somebody week later what they remember, but we don't ask somebody six months into a trial what they remember.

Um, there is teach back.

It's very poorly implemented.

It is successful when done right, But there's very little effort, Uh, in in this Theo NPR M, which we heard about this morning, has the goal, which is laudable quote to facilitate perspective, Subject's decision about whether or not to participate in a research study, thereby enhancing autonomy.