Rethinkers and the Architects of Decay

Are Research Ethics and Research Progress Incompatible?

Greg Koski, PhD, MD, CPI (Honorary)Senior Scientist, Mongan Institute for Health PolicyAssociate Professor of AnesthesiaHarvard Medical School

Trouble in Paradise

The tension between the research community and the ethics committees that review proposed studies has never been greaterEven the most committed advocates point to

“the dysregulation of human research”Calls for regulatory reform have become cries

for “rethinking research ethics”

“Institutional review boards--those federally mandated ethics committees that evaluate all federally funded and most institutionally sponsored research conducted with humans--are often seen by researchers as synonymous with delays, unreasonable requests and seemingly capricious requirements. “

--Beth Azar

http://www.apa.org/monitor/feb02/ethicscost.html

"I viewed the IRB more as a hurdle to get over rather than a way of helping me improve my research.“

--Tom Eissenberg, PhD Virginia Commonwealth University

"IRBs are like school districts, enforcing local ideas of what's acceptable and what's unacceptable.“

--Nora Newcombe, PhD Temple University

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Are we pursuing ethics atthe cost of research progress?

“What we have here is a failure to communicate...”

“What we have here is a failure to communicate...”

--and a failure to educate!

With all good intentions

The National Commission did a truly remarkable job!

The Department of Health and Human Services (as it is now called) tried…Regulations can establish and require processRegulations are a poor vehicle for ethicsRegulations do have a normative functionConception and implementation were flawed

"We need to move in a direction where we all come to value issues involved in human protections. We need to see it as a gain for our research--not a burden--that makes the research better."

-Michael FendrichUniversity of Illinois,

Chicago

“What we have here is a failure to communicate...”

--the ability to communicate is the cornerstone of an effective relationship.

"I have had some wonderful experiences with IRBs. Penn State's IRB, for example, is a model of how an IRB should operate. [Its members] hold in mind the question of what the risk is to the subject and everything they ask ties back to minimizing that risk. They've recently noticed a problem that I overlooked and I'm grateful for that oversight.“

--Sheri Berenbaum, PhD Pennsylvania State

University

Fostering a Good Relationship

Investigators and IRBs share goals and responsibilities in all human researchTo protect the safety, interests and well-

being of research participantsTo promote high-quality, ethical research

The relationship between investigators and IRBs should be collaborative, not confrontational

Fostering a Good Relationship

Effective collaboration requires cooperation, commitment, and above all, communicationConsensusCompromiseConcession

“You can’t always get what you want, but if you try sometimes, you just might find, you get what you need”—The Rolling Stones

First Things First!The investigator bears primary responsibility for

the proposed research“Science without ethics is lame; ethics without

science is blind.”—Albert Einstein

Research must be ethical from the outsetIt does become ethical because of the results it may

provideIt does not become ethical because an IRB approves

itIt does not become ethical because NIH will fund it

In all good human investigation, the ethics goes in before the protocol goes out…

The Key to Success: Learning to see things from another point of view…

How the investigator sees it… How the IRB sees it…

*These magnificent photographs appear courtesy of Dr. Randolf Menzel (Berlin, Germany). http://gears.tucson.ars.ag.gov/ic/vision/bee-vision.html

First Things First!

Look at the completed protocol through the eyes of the IRB

Specifically identify and discuss the critical issues involved in the proposed researchScientific SocietalEthicalSafety

Getting together…

A partnership is an arrangement where entities and/or individuals agree to cooperate to advance their interests.

Some strategies for more effective communications and partneringPartners share, early and often

Talk about challenges before they become problems

Talk about problems before they become obstacles

Deal with obstacles before they become obstructions

Search for reasonable paths around obstacles before they become barriers

First Things First!

Think about the IRB the way you would an IRGAnticipate areas of weakness or concernAddress concerns prospectivelyDo your homework—when data talk, IRBs listen!

Discuss the protocol with a colleague who has been (or is) a member of the IRB

Seek the counsel of the IRB chairperson before a challenging protocol is submitted for review

“It is better to listen in order to understand than to listen in order to reply”--Anonymous

Getting to YesRespond to the IRB as you would to a journal editor!

When the IRB has questions, answer themWhen the IRB has concerns, address themWhen the IRB makes mistakes, correct themWhen the IRB members don’t understand,

educate themAn unreasoned response to an unreasonable

demand rarely promotes understanding and consensus

If you don’t have the training, education and experience to do this, or to conduct the research responsibly, get it!

Whatever you do…

Don’t understate the risks Don’t overstate the benefitsDon’t assume that the IRB understands

Conduct a thorough literature reviewPresent the risk analysis clearly and fairlyJustify the design ethically and scientifically

Address all safety concerns directly with concrete plansReduce the risks wherever possibleDetect potential adverse earlyHave an effective risk management system in place

Report to the IRB religiously…build a trusting relationship

Getting to YesDon’t forget Aretha Franklin’s advice!

R-E-S-P-E-C-TDo unto the IRB as you would have the IRB

do unto you! Keys to resolving dilemmas, ethical and

otherwiseGet more informationBroaden the discussionSearch for common purpose to find solutions

Getting Past No

“The recipe for perpetual ignorance is: Be satisfied with your opinions and content with your knowledge.”--Elbert Hubbard

All IRBs are local The IRB process is an exercise in collective

judgmentBackgroundKnowledgeBeliefsExperienceExpertiseIdiosyncrasiesTraditions

It ain’t over ‘till it’s over…

When you are up and running, don’t forget how you got there and where you are going…Keep the lines of communication openReport first, analyze laterExpress concern, inspire confidenceWhat’s good for the subjects is good for the

science

Beyond IRBs

The strategies and approaches that are effective locally are also effective nationally and beyondOHRPFDAEMASubjectsSponsorsOthers

Rethinking and the need for change

Our approach to ensuring responsible conduct of human subjects research and ethical science is challenged

Improvement of the system will require change at many levels

Research ethics and research progress are not incompatible—they are dependent upon each other

“He who rejects change is the architect of decay…”

Harold Wilson

British Politician and Prime Minister

Thank you!