Fw: MCC rules change, PolyHeme trial, etc.

[Guest guest]

I recieved this message about the need for artificial blood being tested on

subjects without their permission (unconcious, unable to respond?) please

read...ng

----- Original

......................................................omitted....................\

.........

>

> This latest PolyHeme update is a request that, whatever your views on

> the PolyHeme trial in particular or emergency research without consent

> in general, you submit a comment to the state Medical Care Commission

> by Friday. If you have already sent a comment, thanks!! If you haven't,

> please consider it; it's easy.

>

> To remind you of what the actual text of the proposed revision to the

> North Carolina Patient's Bill of Rights is, here is:

>

> The current provision, with the original proposed amendment in all caps:

> 10A NCAC 13B .3302 MINIMUM PROVISIONS OF PATIENT'S BILL OF RIGHTS

> (j) A patient has the right to be advised when a physician is

> considering the patient as a part of a medical care research program or

> donor program. Informed consent must be obtained prior to actual

> participation in such program and the patient or legally responsible

> party, may, at any time, refuse to continue in any such program to

> which he has previously given informed consent. THE REQUIREMENT FOR

> INFORMED CONSENT DOES NOT APPLY WHEN THE FOLLOWING CRITERIA ARE MET:

> (1) THE PURPOSE OF THE RESEARCH IS TO COLLECT SCIENTIFIC DATA;

> (2) OBTAINING INFORMED CONSENT IS NOT FEASIBLE BECAUSE:

> (A) THE PATIENT WILL NOT BE ABLE TO GIVE THEIR INFORMED CONSENT AS A

> RESULT OF THEIR MEDICAL CONDITION;

> (B) THE INTERVENTION UNDER INVESTIGATION MUST BE ADMINISTERED BEFORE

> CONSENT FROM A PATIENT'S LEGALLY AUTHORIZED REPRESENTATIVE IS FEASIBLE;

> AND

> © THERE IS NO REASONABLE WAY TO IDENTIFY PROSPECTIVELY THE

> INDIVIDUALS LIKELY TO BECOME ELIGIBLE FOR PARTICIPATION IN THE CLINICAL

> INVESTIGATION; AND

> (3) THE RESEARCH PROGRAM HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG

> ADMINISTRATION FOR AN EXCEPTION TO THE FEDERAL INFORMED CONSENT

> REQUIREMENTS.

>

> Of note: This amendment would permit waiver of informed consent ONLY

> for research conducted under 21 CFR 50.24, the FDA's version of the

> emergency research consent waiver rule. It would not permit waiver of

> informed consent under the parallel DHHS version of the emergency

> research consent waiver rule. According to representatives of UNC, Duke

> University, and Wake Forest University, it might also leave the

> impression that minimal risk research conducted under a DHHS regulation

> permitting waiver or alteration of consent is NOT permitted by the

> Patient's Bill of Rights.

>

> SO, basically right now, nobody likes this language. It was drafted

> with the best of intentions by MCC staff in response to Duke's question

> about the PolyHeme trial and the Bill of Rights, but is not quite

> adequate or accurate even if everybody believes PolyHeme-style research

> without consent should go forward.

>

> Remember that comments can be short and sweet. My suggestions below are

> only suggestions. There are many things that can be said, depending on

> what your concerns are. Just let the MCC know what you think. More

> than one comment can be sent by any individual, too.

>

> SOME POSSIBLE THINGS TO SAY:

>

> If you do not think that trials like the PolyHeme trial - a high-risk

> clinical trial in which patients could be given an experimental drug or

> other invasive unproven intervention without consent - should be done

> at all, your comment could say something like: " The North Carolina

> Medical Care Commission has a high duty to protect the public and to

> ensure that patients or their families have a right to choose whether

> to join a research study or not. Informed consent is a bedrock value,

> and the proposed rule change goes too far. Do not change the rule to

> allow risky research without consent. "

>

> You could also comment specifically about the PolyHeme trial, saying

> something like: " The proposed rule change would allow the PolyHeme

> trial to go forward. What I have been able to learn about the PolyHeme

> trial is troubling. It has been hard to get straight information about

> it, but it seems wrong to keep patients from getting blood at the

> hospital if they need it. I fear that the company sponsoring the

> trial, which makes PolyHeme and has financial motivations, has not

> provided enough good information to the people who might be drafted

> into this research without their knowledge. "

>

> If you are not sure you are completely against the change, but believe

> that the whole issue deserves further study before the MCC takes action

> on this change, you could say something like: " The North Carolina

> Medical Care Commission has a high duty to protect the public, and to

> be very conservative about changing the Patient's Bill of Rights in the

> way proposed. This matter deserves further study and public

> discussion. Do not make this change at this time. " You could add that

> the MCC needs to be sure that any change it makes is limited to only

> those studies where a waiver of consent is truly needed.

>

> Another option for comment would be to note that emergency research

> like the PolyHeme trial is supposed to have extra protections like

> community consultation and public disclosure, but that process does not

> seem to have worked very well. For example, you may know many people

> who have heard nothing about the study, even though they could end up

> as research subjects. Or you may have been paying attention to the

> process, and know how hard it is to find study information on Duke's

> website, or how long it took for the study coordinator to call you back

> when you tried to get information, or how few people attended community

> meetings, or that community meetings did not reach important groups of

> potential subjects - for example, commuters, people who might be just

> visiting the area during the study, groups with special concerns about

> participating in medical research, or even just people who didn't

> realize that declining to listen meant they might be counted as not

> objecting to the research. You could note that, because this type of

> risky research has these extra community-focused requirements, the MCC

> has a public duty to provide extra protections for North Carolinians

> who might end up as subjects in this kind of risky research, and that

> more time is needed for the MCC to find ways to improve the process

> that are appropriate to its role. (that last part is to be clear

> you're not asking the MCC to become a new IRB - just maybe to use means

> at its disposal to require better communication and notification, or

> something.)

>

> If this reflects your views, you might also want to say that you don't

> think there is a real problem with permitting very low risk research

> without consent for things like medical records research, if IRBs

> follow the federal regulations properly, and that if the MCC wants to

> amend the Patient's Bill of Rights to make that clear, that would be

> fine, but that is very different from allowing risky, invasive

> experimentation without consent.

>

> AND OF COURSE, IF YOU ARE IN FAVOR OF THE PROPOSED CHANGE, PLEASE DON'T

> HESITATE TO SEND A COMMENT TO THAT EFFECT.

>

> The full commission will continue to receive public comment on the

> proposed change until Friday. Anyone interested in expressing views may

> write or send e-mail to Mercidee Benton at the N.C. Division of

> Facility Services, 2701 Mail Service Center, Raleigh, NC 27699-2701 or

> mercidee.benton. Writers should indicate that comments are

> related to proposed temporary rule 10A NCAC 13B .3302.

>

> THANKS TO ALL! (if anyone wants more information on any aspect of this

> after you read janell's article below, just contact me (before

> wednesday, if you want the info for your comment).

> --Nancy

>

> Published: Feb 12, 2005

> Patient study proposal advances

> The state edges closer to a rules change for research on critically

> injured patients.

>

> By JANELL ROSS, Staff Writer

> A state medical board is moving toward a rule change that would allow

> studies on hospital patients so severely injured that they are unable

> to give their consent.

>

> The proposed change would allow a blood substitute study at Duke

> University Medical Center, stalled since January, to move forward. The

> study has been heralded by the company that developed the blood

> substitute PolyHeme as the possible solution to a long-standing problem

> in emergency medicine.

>

> In late December, a Duke committee that oversees research on humans

> approved plans for a trial of PolyHeme. That same week, an unidentified

> person brought Duke's plans to the attention of the state Attorney

> General's Office.

>

> Research on patients unable to give their consent is rare. It is

> allowed under a narrow set of circumstances outlined by the Food and

> Drug Administration in 1996. That same year, North Carolina

> strengthened its patient's bill of rights, requiring doctors and

> hospitals to inform patients if they were being considered for any

> study.

>

> In January, Duke officials, who have said they were previously unaware

> of the state rule, delayed the PolyHeme trial.

>

> Had the Duke trial begun, people who are bleeding heavily as a result

> of accidents, gunshot wounds or other trauma could have been entered

> into the PolyHeme study at random. Most recipients would be too

> critically injured to give their consent. Those entered into the study

> would have continued to receive PolyHeme for up to 12 hours after

> arriving at Duke, unless they or a family member objected.

>

> Duke would receive a fee for each patient enrolled in the trial.

>

> When the N.C. Medical Care Commission, which oversees hospital

> licensing, announced that it would consider the rules change, research

> officials from Duke, the University of North Carolina at Chapel Hill

> and Wake Forest University joined together. The institutions wanted to

> secure a broader rules change allowing everything from the type of

> critical-care research involved in the PolyHeme trial to social science

> research on topics that patients might be unwilling to acknowledge,

> such as child abuse, and noninvasive studies, such as chart comparisons.

>

> Medical ethicists from UNC-CH as well as a few individuals have voiced

> concern about research involving experimental drugs, substances or

> devices used without patient consent.

>

> After discussions Thursday and Friday about scenarios in which the

> public interest might be served by research on patients unable to give

> consent, oversight of this research and the financial relationship

> between institutions and drug companies, the commission's executive

> committee was asked to review the proposed state rule change.

>

> The seven-member executive committee likely will meet in early March.

> If a temporary rule change is approved, the PolyHeme trial could move

> forward.

>

> The full commission will continue to receive public comment on the

> proposed change until Friday. Anyone interested in expressing views may

> write or send e-mail to Mercidee Benton at the N.C. Division of

> Facility Services, 2701 Mail Service Center, Raleigh, NC 27699-2701 or

> mercidee.benton. Writers should indicate that comments are

> related to proposed temporary rule 10A NCAC 13B .3302.

> Staff writer Janell Ross can be reached at 956-2415 or

> jross.

> © Copyright 2005, The News & Observer Publishing Company,

> a subsidiary of The McClatchy Company

>

 

 

----------

 

<fontfamily><param>Times New Roman</param><bigger>hi all,

 

 

This latest PolyHeme update is a request that, whatever your views on

the PolyHeme trial in particular or emergency research without consent

in general, you submit a comment to the state Medical Care Commission

by Friday. If you have already sent a comment, thanks!! If you

haven’t, please consider it; it’s easy.

 

 

This is another long message, so please bear with me; it contains all

the information you should need to submit a comment, and some ideas on

what to say, just to get you started.

 

 

Comments can be short and sweet, and CAN BE SUBMITTED BY EMAIL.

Janell Ross’s excellent summary article appears at the end of this

message; IT CONTAINS THE EMAIL AND MAILING ADRESSES TO WHICH COMMENTS

SHOULD BE SENT, so please read to the end.

 

 

And please forward this email to whomever you think might have an

opinion, anywhere in the state, so they too can comment.

 

 

To remind you of what the actual text of the proposed revision to the

North Carolina Patient’s Bill of Rights is, here is:

 

 

<underline>The current provision, with the original proposed amendment

in all caps:

 

</underline><bold>10A NCAC 13B .3302 MINIMUM PROVISIONS OF PATIENT'S

BILL OF RIGHTS</bold>

 

(j) A patient has the right to be advised when a physician is

considering the patient as a part of a medical care research program

or donor program. Informed consent must be obtained prior to actual

participation in such program and the patient or legally responsible

party, may, at any time, refuse to continue in any such program to

which he has previously given informed consent. THE REQUIREMENT FOR

INFORMED CONSENT DOES NOT APPLY WHEN THE FOLLOWING CRITERIA ARE MET:

 

(1) THE PURPOSE OF THE RESEARCH IS TO COLLECT SCIENTIFIC DATA;

 

(2) OBTAINING INFORMED CONSENT IS NOT FEASIBLE BECAUSE:

 

(A) THE PATIENT WILL NOT BE ABLE TO GIVE THEIR INFORMED CONSENT AS A

RESULT OF THEIR MEDICAL CONDITION;

 

(B) THE INTERVENTION UNDER INVESTIGATION MUST BE ADMINISTERED BEFORE

CONSENT FROM A PATIENT'S LEGALLY AUTHORIZED REPRESENTATIVE IS

FEASIBLE; AND

 

© THERE IS NO REASONABLE WAY TO IDENTIFY PROSPECTIVELY THE

INDIVIDUALS LIKELY TO BECOME ELIGIBLE FOR PARTICIPATION IN THE

CLINICAL INVESTIGATION; AND

 

(3) THE RESEARCH PROGRAM HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG

ADMINISTRATION FOR AN EXCEPTION TO THE FEDERAL INFORMED CONSENT

REQUIREMENTS.

 

 

<underline>Of note:</underline> This amendment would permit waiver of

informed consent ONLY for research conducted under 21 CFR 50.24, the

FDA’s version of the emergency research consent waiver rule. It would

not permit waiver of informed consent under the parallel DHHS version

of the emergency research consent waiver rule. According to

representatives of UNC, Duke University, and Wake Forest University,

it might also leave the impression that minimal risk research

conducted under a DHHS regulation permitting waiver or alteration of

consent is NOT permitted by the Patient’s Bill of Rights.

 

 

SO, basically right now, nobody likes this language. It was drafted

with the best of intentions by MCC staff in response to Duke’s

question about the PolyHeme trial and the Bill of Rights, but is not

quite adequate or accurate even if everybody believes PolyHeme-style

research without consent should go forward.

 

 

Remember that comments can be short and sweet. My suggestions below

are only suggestions. There are many things that can be said,

depending on what your concerns are. Just let the MCC know what you

think. More than one comment can be sent by any individual, too.

 

 

SOME POSSIBLE THINGS TO SAY:

 

 

If you do not think that trials like the PolyHeme trial – a high-risk

clinical trial in which patients could be given an experimental drug

or other invasive unproven intervention without consent – should be

done at all, your comment could say something like: “The North

Carolina Medical Care Commission has a high duty to protect the public

and to ensure that patients or their families have a right to choose

whether to join a research study or not. Informed consent is a

bedrock value, and the proposed rule change goes too far. Do not

change the rule to allow risky research without consent.”

 

 

You could also comment specifically about the PolyHeme trial, saying

something like: “The proposed rule change would allow the PolyHeme

trial to go forward. What I have been able to learn about the

PolyHeme trial is troubling. It has been hard to get straight

information about it, but it seems wrong to keep patients from getting

blood at the hospital if they need it. I fear that the company

sponsoring the trial, which makes PolyHeme and has financial

motivations, has not provided enough good information to the people

who might be drafted into this research without their knowledge.”

 

 

If you are not sure you are completely against the change, but believe

that the whole issue deserves further study before the MCC takes

action on this change, you could say something like: “The North

Carolina Medical Care Commission has a high duty to protect the

public, and to be very conservative about changing the Patient’s Bill

of Rights in the way proposed. This matter deserves further study

and public discussion. Do not make this change at this time.” You

could add that the MCC needs to be sure that any change it makes is

limited to only those studies where a waiver of consent is truly

needed.

 

 

Another option for comment would be to note that emergency research

like the PolyHeme trial is supposed to have extra protections like

community consultation and public disclosure, but that process does

not seem to have worked very well. For example, you may know many

people who have heard nothing about the study, even though they could

end up as research subjects. Or you may have been paying attention to

the process, and know how hard it is to find study information on

Duke’s website, or how long it took for the study coordinator to call

you back when you tried to get information, or how few people attended

community meetings, or that community meetings did not reach important

groups of potential subjects – for example, commuters, people who

might be just visiting the area during the study, groups with special

concerns about participating in medical research, or even just people

who didn’t realize that declining to listen meant they might be

counted as not objecting to the research. You could note that,

because this type of risky research has these extra community-focused

requirements, the MCC has a public duty to provide extra protections

for North Carolinians who might end up as subjects in this kind of

risky research, and that more time is needed for the MCC to find ways

to improve the process that are appropriate to its role. (that last

part is to be clear you’re not asking the MCC to become a new IRB –

just maybe to use means at its disposal to require better

communication and notification, or something.)

 

 

If this reflects your views, you might also want to say that you don’t

think there is a real problem with permitting very low risk research

without consent for things like medical records research, if IRBs

follow the federal regulations properly, and that if the MCC wants to

amend the Patient’s Bill of Rights to make that clear, that would be

fine, but that is very different from allowing risky, invasive

experimentation without consent.

 

 

AND OF COURSE, IF YOU ARE IN FAVOR OF THE PROPOSED CHANGE, PLEASE

DON’T HESITATE TO SEND A COMMENT TO THAT EFFECT.

 

 

</bigger></fontfamily><fontfamily><param>Arial</param><bigger>The full

commission will continue to receive public comment on the proposed

change until Friday. Anyone interested in expressing views may write

or send e-mail to Mercidee Benton at the N.C. Division of Facility

Services, 2701 Mail Service Center, Raleigh, NC 27699-2701 or

<color><param>3332,3332,9998</param>mercidee.benton.</color>

Writers should indicate that comments are related to proposed

temporary rule 10A NCAC 13B .3302.

 

 

THANKS TO ALL! (if anyone wants more information on any aspect of this

after you read janell’s article below, just contact me (before

wednesday, if you want the info for your comment).

 

--Nancy

 

 

 

Patient study proposal advances

 

The state edges closer to a rules change for research on critically

injured patients.

 

 

By JANELL ROSS, Staff Writer

 

A state medical board is moving toward a rule change that would allow studies

on hospital patients so severely injured that they are unable to give

their consent.

 

 

The proposed change would allow a blood substitute study at Duke

University Medical Center, stalled since January, to move forward. The

study has been heralded by the company that developed the blood

substitute PolyHeme as the possible solution to a long-standing

problem in emergency medicine.

 

 

In late December, a Duke committee that oversees research on humans

approved plans for a trial of PolyHeme. That same week, an

unidentified person brought Duke's plans to the attention of the state

Attorney General's Office.

 

 

Research on patients unable to give their consent is rare. It is

allowed under a narrow set of circumstances outlined by the Food and

Drug Administration in 1996. That same year, North Carolina

strengthened its patient's bill of rights, requiring doctors and

hospitals to inform patients if they were being considered for any

study.

 

 

In January, Duke officials, who have said they were previously unaware

of the state rule, delayed the PolyHeme trial.

 

 

Had the Duke trial begun, people who are bleeding heavily as a result

of accidents, gunshot wounds or other trauma could have been entered

into the PolyHeme study at random. Most recipients would be too

critically injured to give their consent. Those entered into the study

would have continued to receive PolyHeme for up to 12 hours after

arriving at Duke, unless they or a family member objected.

 

 

Duke would receive a fee for each patient enrolled in the trial.

 

 

When the N.C. Medical Care Commission, which oversees hospital

licensing, announced that it would consider the rules change, research

officials from Duke, the University of North Carolina at Chapel Hill

and Wake Forest University joined together. The institutions wanted to

secure a broader rules change allowing everything from the type of

critical-care research involved in the PolyHeme trial to social

science research on topics that patients might be unwilling to

acknowledge, such as child abuse, and noninvasive studies, such as

chart comparisons.

 

 

Medical ethicists from UNC-CH as well as a few individuals have voiced

concern about research involving experimental drugs, substances or

devices used without patient consent.

 

 

After discussions Thursday and Friday about scenarios in which the

public interest might be served by research on patients unable to give

consent, oversight of this research and the financial relationship

between institutions and drug companies, the commission's executive

committee was asked to review the proposed state rule change.

 

 

The seven-member executive committee likely will meet in early March.

If a temporary rule change is approved, the PolyHeme trial could move

forward.

 

 

The full commission will continue to receive public comment on the

proposed change until Friday. Anyone interested in expressing views

may write or send e-mail to Mercidee Benton at the N.C. Division of

Facility Services, 2701 Mail Service Center, Raleigh, NC 27699-2701 or

mercidee.benton.

Writers should indicate that comments are related to proposed

temporary rule 10A NCAC 13B .3302.

 

Staff writer Janell Ross can be reached at 956-2415 or

jross.

 

© Copyright 2005, The News & Observer Publishing Company,

 

a subsidiary of The McClatchy Company