EXCEPTION TO INFORMED CONSENT:EXCEPTION TO INFORMED CONSENT: WHERE DO WE GO FROM HERE?WHERE DO WE GO FROM HERE?

AN EMS RESEARCHER’S PERSPECTIVE

Dan Spaite

Putting Recommendation 8 into Putting Recommendation 8 into ACTIONACTION

The FDA and OHRP should (must) work with stakeholders:– To evaluate the requirements for exception – Identify serious impediments to EMS research

The FDA, OHRP and stakeholders should (must) work together:– To develop and propose strategies/revisions

» Reduce impediments» Protect subjects

Breaking Down the Specific Breaking Down the Specific RecommendationsRecommendations

National Conference: Stakeholders and regulators

– Recommend improvements to exception procedures

Congress:– Based upon the recommendations, should amend

the laws to: » Reduce regulatory burden » Facilitate research » Protect the rights of subjects

Breaking Down the Specific Breaking Down the Specific RecommendationsRecommendations

Educational Programs: Investigators

– Explain the consent process– Teach strategies for fulfilling the requirements

Educational Programs: IRB members/administrators

– Describe the difficulties in obtaining consent in EMS

– Explain the process of emergency exception to consent

– Promote acceptance by IRB’s– Promote consistency among IRB’s

TWO SETS OF FEDERAL RULESTWO SETS OF FEDERAL RULES

“General Requirements for Informed Consent” – 45 CFR 46.116

“Exception from Informed Consent Requirement for Emergency Research” – 21 CFR 50.24

““General Requirements for General Requirements for Informed Consent”Informed Consent”

Provides for “waiver” of consent (OHRP)– Only MINIMAL risk to the subjects – Will not adversely affect individual rights – Study cannot be practically carried out otherwise– Appropriate information provided to the subjects

Informed Consent is completely waived

The Problem with “Waiver”The Problem with “Waiver”

Minimal risk: “Typical risks and/or discomfort associated with everyday life.”

Reality: Nothing worth studying fits definition Example: Public Access Defibrillation Study Neither CPR nor defibrillation are considered

minimal risk!!!– And here we thought…

““Exception from Informed Consent Exception from Informed Consent Requirement for Emergency Research”Requirement for Emergency Research”

“The Final Rule” Provides for “exception” from informed

consent Administered by the FDA Terminology: “Waiver” and “Exception”

used interchangeably

The Requirements for Exception:The Requirements for Exception: Obtaining consent is not feasible The condition is life-threatening Some possibility of benefit The study is not feasible by other methods Attempts at consent throughout the

study/”therapeutic window”– Competent patient– Proxies/family

Consent documents: Prospectively developed “Community Consultation” “Public Notification”

Community ConsultationCommunity Consultation– A dialogue– Details: NOT in the regulations

» Intent: Permissive » Reality: IRB’s hesitant

– Must verify to IRB:» Appropriately targeted to the right populations » Input received: REPRESENTITIVE of the POTENTIAL

study population» Broad enough to include any who might have an interest

– Appropriate forums for input– Announcements: Whole community or

appropriate populations– NOT the same as “Public Notification”

Public NotificationPublic Notification After Consultation and IRB approval:

– Wide dissemination to the community that the study will occur

After completion of the study:– Public notification of RESULTS

» Lay public » Media » Scientific community

HERE’S THE RUB:HERE’S THE RUB:Profound Societal IssuesProfound Societal Issues

The implementation of these regulations:

“has exposed a fundamental problem associated with conducting research with subjects who cannot provide consent: There is a direct and irrevocable (irreconcilable) tension between the standards of protecting the rights of research subjects and the ability to investigate and improve the care rendered to future patients.”

Individual Autonomy vs. Public GoodIndividual Autonomy vs. Public Good

Societies have generally had:– A high view of individual autonomy…OR– A high view of community good

Not mutually exclusive:– Polar concepts– Generally: Societies lean strongly in one

direction

RELATING THESE PHILOSOPHIES RELATING THESE PHILOSOPHIES TO MEDICAL RESEARCHTO MEDICAL RESEARCH

A High View of Individual Autonomy The Principle:

– “Voluntary, prospective, informed consent given by a competent research subject is the ethical cornerstone of human research and is the embodiment of the ethical principle of respect for individual persons…” (Biros, AEM, 1999)

A High View of Individual AutonomyA High View of Individual Autonomy

The Complication:– If followed absolutely…

» Interventions that may benefit MANY individuals…will never be studied

The Practical Outcome for EMS:– Decisions about care…determined by

» Theory, opinion, and common sense…but…» Not METHODOLOGICALLY SOUND

EVIDENCE

A High View of Public GoodA High View of Public Good

The principle: – Making individual autonomy subservient to

public good would allow research that could decrease mortality, morbidity, and suffering for society as a whole.

– It could also expose problems with interventions that are currently considered “standard of care” that may actually be harmful to patients.

A High View of Public GoodA High View of Public Good

The complication:– History:

» Travesties» Inflicting “science” on individuals for the “public good”

– Mengala’s experiments: » Ideologies that began under the guise of “public good” » “Public good” The good of the STATE » Castration of Jewish boys

WEARING BLINDERSWEARING BLINDERS

Naïve: – A simple discussion about:

» Research models» Scientific methods» Investigating therapeutic interventions

In fact:– Profound philosophical issues

American History: Commitment American History: Commitment to Individual Autonomyto Individual Autonomy

Does not exclude the concept of “doing the most good for the most people”

Errs on the side of protecting individual rights– Even if this potentially compromises the good of

the whole– Even tolerates a poorer “societal outcome” in

order to protect the individual» Ex: Freeing the guilty vs. punishing the innocent

WEARING MORE BLINDERSWEARING MORE BLINDERS

OBVIOUSLY…Scientists can be trusted In fact:

– MOST scientists could be trusted:» To protect individual rights» Without government regulations

But…two factors make non-regulation dangerous

WHY REGULATIONS???WHY REGULATIONS??? Problem #1: Even the most

conscientious researchers need accountability – Creating new knowledge is ADDICTIVE

» Good news: Absorbed in the search to HELP people

» Bad news: Can forget who’s getting HURT

Problem #2:

PROBLEM #2PROBLEM #2

A small number of scientists who will do really bad things to people if society doesn’t protect subjects

FINDING THE BALANCEFINDING THE BALANCE Most protective to most enabling:

– Consent on ALL subjects in ALL studies– Exception only if:

» High bar for benefit/risk for the individual

» Continued attempts at informed consent

» Community Consultation AND Public Notification – Exception only if:

» High bar is met

» Continued attempts at informed consent

» Public Notification

– Exception only if:» High bar is met

» Continued attempts at informed consent

FINDING THE BALANCEFINDING THE BALANCE– Exception without consent if high bar is

met– Exception if some potential benefit to

individuals in study– Exception if any potential benefit to society– No consent or protection of individual

subjects required at all

WHERE DO WE GO FROM HERE?WHERE DO WE GO FROM HERE?

Don’t let the PRIMARY barriers get lost in the angst about the SECONDARY barriers– The primary barriers are NOT the

regulations» Inadequate numbers of properly trained career

researchers» Inadequate funding

WHERE DO WE GO FROM HERE?WHERE DO WE GO FROM HERE?

Example: – Perceived barrier: “I can’t do this project

because I can’t get through the regulatory hoops.”

– Actual barrier: “I don’t have the training, experience, or time (funding) to do this project.”

WHERE DO WE GO FROM HERE?WHERE DO WE GO FROM HERE?

Recognize that there will always be hoops to jump through– We’ve spent a lot of time WHINING– We should spend our energy joining the

effort to balance and optimize the regulations

DOING GOOD RESEARCH IS HARDDOING GOOD RESEARCH IS HARD

GET OVER IT!!!

WHERE DO WE GO FROM HERE?WHERE DO WE GO FROM HERE?

Begin to discuss realistic options for changing the regulations– Where we are--Exception only if:

» High bar for benefit/risk is met» Continued attempts at informed consent» Community Consultation» Public Notification

WHERE DO WE GO FROM HERE?WHERE DO WE GO FROM HERE?

Where we could go? – Exception only if:

» High bar is met» Continued attempts at informed consent» Public Notification

– Exception only if:» High bar is met» Continued attempts at informed consent

TIPS FOR INVESTIGATORSTIPS FOR INVESTIGATORS Before you start…be emotionally

prepared – After understanding the regulations you

WILL experience the “Three H’s”» HOT» HOPELESS» HOMICIDAL

– You will reconsider that job…

HELPFUL HINTS:HELPFUL HINTS:Tips for InvestigatorsTips for Investigators

Know the regulations – Start with the good papers– Go to the original regulations for necessary

details after becoming familiar with others’ experience

» Don’t start with the fine print

TIPS FOR INVESTIGATORSTIPS FOR INVESTIGATORS Early in your hypothesis development,

begin thinking about specific:– Community Consultation strategies – Notification strategies

» Think of targeted groups» Think of dissemination strategies» Make early connections with media personnel

TIPS FOR INVESTIGATORSTIPS FOR INVESTIGATORS Glean strategies from published experiences

– Example: Community Consultation/Public Notification

» Newspapers» TV ads» Websites» Letters to community leaders» Community Newsletters» Public Meetings» Telephone surveys of random community members» Contacting survivors of the condition being studied» Development of a “community advisory board”

TIPS FOR INVESTIGATORSTIPS FOR INVESTIGATORS

Communicate with the investigators of successful and unsuccessful attempts

TIPS FOR INVESTIGATORSTIPS FOR INVESTIGATORS

Begin educating your IRB administrators/members as soon as you have an idea – It’s never too early

TIPS FOR INVESTIGATORSTIPS FOR INVESTIGATORS Remember that funding agencies will be

IMPRESSED if you have done your homework – They WANT to fund this kind of research– But…they have to follow the rules– They aren’t getting many proposals that request

exception– The well-done exception proposals are “head

turners”– Think of the pain as the necessary investment to

get the BIG ONE

TIPS FOR INVESTIGATORSTIPS FOR INVESTIGATORS Keep your ear to the ground:

– Regulatory improvements WILL happen– The literature will continue to report helpful

ideas– Watch for conferences and educational

programs

THE KEYTHE KEY

Get over it…and…

DON’T GIVE UP!!!

THE EMS QUESTION FOR THE EMS QUESTION FOR THE AGESTHE AGES

Background:– Previous attempts to settle this question

» Uniform Data Consensus Conference» EMS Agenda for the Future Consensus

Conference

– Failed MISERABLY!!! This may be our last hope

THE EMS QUESTION FOR THE EMS QUESTION FOR THE AGESTHE AGES

Is the word “pre-hospital”

HYPHONATED??

NAEMSPNAEMSP Extensive deliberations Multiple heated debates Profound philosophical debates

THEIR CONSENSUS…

NAEMSPNAEMSP

OUT-OF-HOSPITAL

THE WORLD AWAITSTHE WORLD AWAITS

“Prehospital”Or

“Pre-hospital”