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National Naval Medical Center Directorate for Professional Education Clinical Investigation Department. Research Course

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National Naval Medical Center

Directorate for Professional Education

Clinical Investigation Department

Research Course

“The National Naval Medical Center is an approved provider of continuing nursing education by the Navy Medicine Manpower, Personnel, Training and Education Command, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.”

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National Naval Medical CenterDirectorate for Professional EducationClinical Investigations Department

Introduction to Research at NNMC

Marina Borovok, PhD

Head of Research Education,

Clinical Investigations Department,

NNMC

“The National Naval Medical Center is an approved provider of continuing nursing education by the Navy Medicine Manpower, Personnel, Training and Education Command, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.”

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Disclosure Statement :

This CE/CME activitydoes not have commercial support,and has no conflicts of interest.

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learning objectives
Learning Objectives
  • Learn about Navy research and research at NNMC

2. Know about research support services available at NNMC

  • Become familiar with the ethical research issues
  • Questions

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lo 1 learn about navy research and research at nnmc
LO 1: Learn about Navy research and research at NNMC

History of Naval Medical Research

  • Establishment of the Navy, 13 October 1775

On Friday, October 13, 1775, meeting in Philadelphia, the Continental Congress voted to fit out two sailing vessels, armed with ten carriage guns, as well as swivel guns, and manned by crews of eighty, and to send them out on a cruise of three months to intercept transports carrying munitions and stores to the British army in America.

The first American Naval Surgeon, Joseph Harrison, and two surgeon’s mates, Henry Tillinghast and John Scott, were aboard the Alfred

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Retrieved from

http://www.awiatsea.com/Narrative/New%20Providence%20Expedition.html

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history of naval medical research
History of Naval Medical Research
  • 1798 - Congress established the Department of the Navy
  • 1842 – The Bureau of Medicine and Surgery (BUMED) was established by an Act of Congress. Dr. William P.C. Barton became the first Chief of the Bureau (later known as the Surgeon General).
  • 1850 - Navy surgeon E.R. Squibb set up a laboratory to manufacture, process, and test medicine. Research included standardizing large-scale production of ether and chloroform.
  • 1853 – An Act of Congress authorized the building of a Naval Medical Laboratory on the grounds of the Brooklyn Naval Hospital.

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navy surgeon e r squibb
Navy surgeon E.R. Squibb
  • In 1851, at the Brooklyn Naval Hospital, Dr. Squibb set up a laboratory and built the first still for making anesthetic ether.
  • Between 1852 and 1857, he discovered processes for making chloroform, fluid extracts, bismuth salts, and other preparations.

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bristol myers squibb www bms com
Bristol-Myers Squibbwww.bms.com
  • After Squibb had resigned from the Navy, he started a laboratory of his own to supply the Army with reliable drugs.
  • By 1883, he was manufacturing 324 products and selling them all over the world.
  • Squibb retired in 1895 and passed most of the responsibility for managing the firm to his sons, Charles and Edward. The company became known as E.R. Squibb & Sons.
  • Currently, the company is known as with 30,000 employees, and $20.6 billion Net Sales in 2008

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history of naval medical research1
History of Naval Medical Research
  • 1924 - Division of Medical War Planning (BUMED) organized to study the experience of WW I
  • 1941 – The Research Division of BUMED was established.

The Naval Research and Development Board was organized.

  • 1946 - Office of Naval Research established
  • 1947 Naval Institute for Dental and Biomedical Research established

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naval medical research today
Naval Medical Research Today
  • Today, "Navy Medicine" encompasses a community of 51,000 Navy medical personnel, including 43,000 uniformed care-givers, nearly 4,000 medical corps, 3,000 nurse corps, 2,600 medical service corps, 1,500 dental corps, 27,000 hospital corpsmen and 3,500 dental technicians.
  • These professionals provide care for nearly 786,000 active duty Navy and Marine Corps personnel, 886,000 dependents and Navy and Marine Corps retirees and their dependents or survivors numbering 1,126,600 of a total beneficiary population of almost 3,000,000 people.
  • Navy Medicine operates 33 hospitals, 213 medical clinics, 168 dental clinics and five drug screening laboratories.
  • In addition, the community includes a research and development command, which includes medical and dental health research institutes, units and laboratories. The community has its own health sciences education and training command which operates four schools.

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naval research achievements
Naval Research Achievements
  • Heat stroke
  • Process of aging
  • Tropical disease
  • Blast injury protection
  • Adaptation to altitude
  • Extracellular fluid requirements
  • Influenza type B variant
  • Natural infection cycle West Nile Fever
  • Rubella vaccine
  • Anthrax detection

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research at nnmc
Research at NNMC
  • NNMC’s goal remains to promote excellence in health care and militarily relevant research and human subject protection.
  • Good research helps contribute to our knowledge and ultimately improve the quality of care we, and others, provide.

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research at nnmc1
Research at NNMC
  • Current research efforts at NNMC are ongoing:

head injury/TBI, stroke,

colon, breast cancer, leukemia and lymphoma,

investigational chemotherapy,

virtual colonoscopy,

diabetes management,

infectious disease,

dental imaging.

2009 NNMC Publications Data

235 Publications

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recent nnmc publications
Recent NNMC Publications

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recent nnmc publications1
Recent NNMC Publications

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recent nnmc publications2
Recent NNMC Publications

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recent nnmc publications3
Recent NNMC Publications

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recent nnmc publications4
Recent NNMC Publications

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recent nnmc publications5
Recent NNMC Publications

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lo 2 know about research support services available at nnmc
LO 2: Know about research support services available at NNMC

I.

II. Administrative support

III. Educational support

IV. Resources:

Darnall Resource Center, Stitt Library, IT tools.

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i about iceberg
I. About ICEBERG

Interdepartmental Collaborative Bethesda Research Group

http://nnmcresearch.wikispaces.com

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about iceberg
About ICEBERG
  • In July of 2008, the administration of the National Naval Medical Center (NNMC) in Bethesda, MD allocated resources to enhance and support research at NNMC.

The Interdepartmental Collaborative Bethesda Research Group (ICEBERG) was organized.

The group’s primary function is to support research at NNMC.

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iceberg members
ICEBERG members
  • There are nine ICEBERG members, senior researchers with strong track records of research funding and success, who are dedicated to research in the following areas:

CDR Brooks Cash (Gastroenterology)

CDR Leonard Henry (Surgical Oncology) 

LCDR Jonathon Forsberg (Orthopaedics)

LCDR Michael Keith (Rheumatology) 

LCDR Rachel Lewis (Radiology) 

LCDR Edward Miller (Cardiology) 

LCDR Arnaldo Rivera (Brain Injury)

LCDR Jason Wong (OB/GYN) 

Dr Mohamed Shakir (Endocrinology and Metabolism)

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iceberg members involvement in research related activities at nnmc
ICEBERG members involvement in research-related activities at NNMC

ICEBERG members are involved in many research-related activities at NNMC:

  • mentoring trainees on projects and protocols that may lead to professional presentations and publication of research results, and helping researchers with protocols on an as-needed basis
  • conducting various research lectures, workshops, and presentations
  • serving on the Institutional Review Board and the Scientific Review Panel
  • working on their own rigorous research projects,
  • publishing books, book chapters, andpeer-reviewed articles in leading journals.

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iceberg mission and vision
ICEBERG Mission and Vision

Help National Naval Medical Center to become a premier research organization in the Department of Defense.

Important dimensions of this mission are:

  • establishing research visibility;
  • improving research productivity;
  • offering mentorship opportunities;
  • fostering academic excellence through education,

professional training and development,

and diverse scholarship.

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how the nnmc research community could benefit from iceberg now
How the NNMC research community could benefit from ICEBERG now?

Mentored Research Initiative

Mentored Research Objectives:

  • Provide the opportunity to work with NNMC research mentor on a current project at NNMC that may lead to professional presentation and publication of research results.

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how to apply for mentored research
How to Apply for Mentored Research
  • Please complete application form provided during this presentation and on the web athttp://nnmcresearch.wikispaces.com/MENTORSHIP
  • Please return the completed form along with a copy of your current CV to Dr. Marina Borovok via emailmarina.borovok@med.navy.mil
  • Questions? Please call 301-295-2876

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ii administrative support of research at nnmc
II. Administrative Support of Research at NNMC

Responsible Conduct of Research Service (RCRS)

  • Website:

https://nnmcintra/SiteDirectory/RCRS/default.aspx

  • Questions? Please call RCRS:

Ms. Toby Perkins, RCRS Coordinator, at (301)295-2269, or e-mail: Toby.Perkins@med.navy.mil

Ms. Elizabeth Narvaez, RCRS Coordinator,

at (301)295-2275,

or e-mail:elizabeth.narvaez@med.navy.mil

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ii administrative support of research at nnmc1
II. Administrative Support of Research at NNMC

Main message from RCRS to prospective researchers:

PLEASE CONTACT RCRS TO REVIEW YOUR DRAFT PROTOCOL

BEFOREOFFICIAL SUBMISSION

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iii educational support
III. Educational support

Research Course

  • 8 CME/CE CREDITS – 2 days (7:00-13:00 )
  • Provides guidelines for research protocol design, successful navigation through the SRP and IRB processes, and funding for research projects.
  • Course PP slide show is available at: https://nnmcintra/SiteDirectory/RCRS/default.aspx

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iv resources darnal resource center stitt library it tools research links
IV. Resources: Darnal Resource Center, Stitt Library, IT tools, Research links

Darnall Resource Center

https://nnmcintra/SiteDirectory/gear/darnall/default.aspx

Services:

  • Literature Search,
  • Scientific Writing for

Manuscripts and Protocol Preparation,

  • Statistical Analysis and more.

Need help with protocol?

Please call Darnall: 301-319-8856

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iv resources darnall resource center
IV. Resources: Darnall Resource Center
  • Literature Search help:

Mr. Fredric Simms, MLS

Medical Researcher,

Phone: (301) 295-0080

E-mail address: James.Simms@med.navy.mil

  • Scientific Writing for Manuscripts and Protocol Preparation help:

Dr. Brian Deevey,

Medical Editor,

Email: brian.deevey@med.navy.mil

Phone: (301) 319 8911

  • Statistical Data Analysis help:

Dr. Francois O. Tuamokumo

Mathematical Statistician

Phone: (301) 319 8788

Fax: (301) 295 6001

Email: francois.tuamokumo@med.navy.mil

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iv resources darnall resource center1
IV. Resources: Darnall Resource Center

WORKSHOPS

Workshops are offered all year long at NNMC on a per-request basis.

Topics:

  • Literature Search
  • Scientific Writing for Manuscripts and Protocol Preparation
  • Statistical Analysis

Please call Darnall to schedule a workshop:

301-319-8856

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iv resources stitt library
IV. Resources: Stitt Library

Websites:

Intranet: https://nnmcintra/SiteDirectory/STITT/default.aspx

Internet: https://www.bethesda.med.navy.mil/professional/stitt_library/index.aspx

Services:

- Access to online content;

- Additional Research Services.

Need access to Online Content at any time from anywhere?

Interested in a Workshop on How to Access Multiple Literature DB via Athens?

Please contact Mrs.Ann Holman

Email: ann.holman@med.navy.mil , Phone: 301-319-8411

Need help with In-Depth Reference Questions Related to Patient Care?

Please contact Mrs. Tahirih Fusscas

E-mail: Tahirih.Fusscas@med.navy.mil Call: 301-295-1185

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iv resources it tools
IV. Resources: IT tools

Virtual meeting room DCO

https://www.dco.dod.mil

  • DCO– Defense Connect Online - provides DoD users worldwide with a second option for enterprise collaboration services.
  • The DCO meeting room capabilities are: the DCO Portal, webconferencing, instant messaging, screen and file sharing, whiteboard, video and audio capabilities, hosting large meetings, and more.

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understand the importance of ethical research and learn about the hrpp at nnmc
Understand the importance of ethical research and learn about the HRPP at NNMC
  • Scientific research with human subjects has provided valuable information to help characterize and control risks to public health.
  • Its use has also raised particular ethical concerns for the welfare of the human participants in such research, as well as scientific issues related to the role of such research in assessing risks.

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virtual meeting room dco
Virtual meeting room DCO

Live Training Sessions: https://www.dco.dod.mil/public/dsp/liveTraining.cfm

Recorded Training Sessions:

https://www.dco.dod.mil/public/dsp/tutorials.cfm#

To schedule a training session for your department please contact Dr. Marina Borovok:

301-295-2876, or via e-mail at Marina.borovok@med.navy.mil

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iv resources it tools1
IV. Resources: IT tools

Turnitin

Turnitin is a Plagiarism Prevention Software.

Website: http://www.turnitin.com/static/index.html

  • Plagiarism Prevention:Instantly identifies papers containing unoriginal material.
  • Peer Review:Participants can review and respond to their colleagues' work online.

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iv resources it tools2
IV. Resources: IT tools

Turnitin

To schedule a training session or to create an account please contact

Ms. Ann Holman:

301-319-8411, or via e-mail at

Ann.Holman@med.navy.mil

Or

Dr. Marina Borovok:

301-295-2876, or via e-mail at Marina.borovok@med.navy.mil

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iv resources it tools3
IV. Resources: IT tools

IRBNet

www.irbnet.org

  • RCRS is pleased to announce the adoption of the industry leading IRBNet software, a robust set of electronic tools supporting the management, submission, review and oversight of our research protocols.
  • IRBNet is secure, web-based, and easy to use.

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irbnet
IRBNet
  • Effective 15 June 2009,  all the submissions for publication clearance will be accepted via IRBNet; and the approval steps remain the same.

Please stay tuned for further announcements

  • Questions? Please call RCRS:

Mr. Luis Calvo is the NNMC IRBNet expert.

His e-mail address is Luis.Calvo@med.navy.mil,

phone # is 301-295-2275.

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irbnet submission site
IRBNet submission site
  • IRBNet submission site is accessible through the Defense Medical Research Network (DMRN) portal available at https://www.us.army.mil/suite/page/596540
  • This site is being developed as a research resource center containing in addition to your IRBNet resource, your IRBNet local helpdesk contacts, training session, tutorials, surveys, links to CITI training, and many other and future research related resources.

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irbnet submission site access instructions
IRBNet submission siteaccess instructions

Step 1 – Obtain your AKO/DKO Login

Navy military members and government civilians should register for DKO

unsponsored accounts. Here are instructions:

1) Proceed to AKO/DKO Login screen (https://www.us.army.mil)

2) Click the "Register for DKO" link

3) Select "Create Joint Account"

4) Enter SSN and DOB

5) Complete registration

Navy contractors should register for DKO sponsored accounts. Here are instructions:

1) Proceed to AKO/DKO Login screen (https://www.us.army.mil)

2) Click the "Register for DKO" link

3) Select "Create Sponsored Account"

4) Choose "Contractor" account type

5) For Sponsor enter the DKO username of a Navy military member or Navy civilian

6) Complete registration

Navy sponsor must log in and confirm sponsorship

(My Account > Settings >Sponsorship Management) before contractor will have access to his/her

account.

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irbnet submission site access instructions1
IRBNet submission siteaccess instructions

Step 2 – Access the DMRN portal

1). Proceed to the DMRN site at https://www.us.army.mil/suite/page/596540

2). Login using your AKO/DKO username and password

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irbnet submission site access instructions2
IRBNet submission siteaccess instructions

Step 2 – Access the DMRN portal (cont.)

3).Click Login; you are at the DMRN site

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irbnet submission site access instructions3
IRBNet submission siteaccess instructions

Step 3 – Access the IRBNet Submission site

1). Click on the IRBNet Entry button ;

You are at the IRBNet Submission site.

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lo 3 become familiar with the ethical research issues ethical and regulatory foundation

LO 3: Become familiar with the ethical research issuesEthical and Regulatory Foundation

human protections history good bad and ugly the development of ethics rules
Human Protections History…Good, Bad and UglyThe Development of Ethics Rules

Historical events that contributed to formulation of research regulations:

  • 1947 Nuremberg Code : International Code of Research Ethics
  • 1955 Wichita Jury Study : Protection of Social Institutions
  • 1962 Thalidomide Experience : Federal Enforcement of Informed Consent
  • 1964 Declarationof Helsinki : Expansion of Principles from the Nuremberg Code

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the nuremberg code august 1947
The Nuremberg CodeAugust 1947

Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war.

This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics).

The Basic Elements of the Nuremberg Code are requirements for:

  • voluntary and informed consent,
  • favorable risk/benefit analysis, and
  • the right to withdraw without penalty.

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1955 wichita jury study
1955 Wichita Jury Study

Researchers at the University of Chicago conducted a study of jury decision-making processes.

The study involved audio taping jury deliberations. To avoid influencing jurors, they were not told they were being studied.

The public reacted strongly. The basic concern was that deception was used in a setting where privacy and confidentiality were critically important.

Congressional hearings were held and a federal law was passed barring any future recording of jury deliberations. This was the first time that well intentioned research resulted in establishment of federal guidelines to protect the public. It focused attention on how, in some settings, important research questions cannot be answered without compromising the integrity of important social institutions.

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1962 thalidomide experience
1962 Thalidomide Experience

Thalidomide is a drug that was used in the 1950’s to treat a variety of unpleasant symptoms associated with pregnancy. At the time that thalidomide was being used in the US, it was not standard practice to inform patients of the investigational nature of medications that were still in the testing phase of the regulatory practice. After a large number of pregnant women were treated with thalidomide, it became clear that this drug caused severe growth deformities in their infants.

Public outrage led to an amendment to the Food, Drug, and Cosmetic Act, (The Kefauver-Harris Bill). This legislation was passed to ensure greater drug safety in the United States.

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1964 declaration of helsinki
1964 Declaration of Helsinki

The World Medical Association met in Helsinki, Finland, and issued recommendations to guide physicians in biomedical research involving human subjects.

The declaration reinforced the principles of the Nuremberg Code and added two key points:

1) The interest of the subject is higher priority than society

2) Every subject should get the best known treatment.

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national research act of 1974
National Research Act of 1974

The National research act of 1974 established the modern IRB system for regulating research involving human subjects.

The act passed federal regulations that required IRB approval to conduct most kinds of research involving human subjects, defined the policy and procedures that an IRB must follow when reviewing research, and established the criteria that an IRB must use to approve research conduct.

The National Research Act of 1974 established the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. This commission is made up of a diverse group of individuals representing the fields of ethics, religion, law, industry, medicine, and other disciplines.

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belmont report http hhs gov ohrp humansubjects guidance belmont htm
Belmont Reporthttp://hhs.gov/ohrp/humansubjects/guidance/belmont.htm

"Ethical Principles and Guidelines for the Protection of Human Subjects of Research"

April 18, 1979

  • Foundation document for ethics in human subjects research in the United States
  • Product of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1974-1978

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belmont report
Belmont Report

The three principles are:

  • Respect for Persons involves recognizing the personal dignity and autonomy of individuals, and special protection of those with diminished autonomy.
  • Beneficenceis the obligation to protect people from harm by maximizing anticipated benefits and minimizing possible risks of harm.
  • Justicerequires that the benefits and burdens of research be distributed fairly.

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specification of ethical guidelines
Specification of Ethical Guidelines

In 1981 the Department of Health and Human Services established IRB regulations (45 CFR 46) that are now common to most federal agencies and have become known as the “common rule.”

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research
RESEARCH?

“A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizeable knowledge”1

1 Common Rule, 45 CFR 46

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federal regulations http hhs gov ohrp humansubjects guidance 45cfr46 htm
Federal Regulationshttp://hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
  • 1981 regulations based on Belmont report
    • DHHS CFR Title 45 (public welfare), Part 46 (protection of human subjects)
    • FDA CFR Title 21 (food and drugs), Parts 50 (protection of human subjects) and 56 (Institutional Review Boards)

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federal regulations
Federal Regulations
  • 1991– the “Common Rule”
    • Adoption of the 1981 regulation by all agencies that conduct or fund research involving human subjects
    • Includes the Department of Defense as 32 CFR 219 and DoDD 3216.02
  • Source of specific guidance on IRB function, approval criteria, verbiage for informed consent

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important regulatory sources
Important Regulatory Sources
  • http://www.hhs.gov/ohrp/
  • http://www.fda.gov/oc/ohrt/irbs/
  • http://navymedicine.med.navy.mil/humanresearch

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slide62

Department of the Navy HUMAN RESEARCH PROTECTION PROGRAM(reference material) http://www.onr.navy.mil/sci_tech/34/docs/secnavinst_3900_39d.pdf

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real life and death
Real Life…and Death!

1999 The University of Pennsylvania

Tragedy

Jesse was 18 years old. He suffered from ornithine transcarbamylase deficiency (OTC), an inherited liver disease that causes life-threatening levels of ammonia to build up in the blood.

The disease was the result of a genetic mutation and as such was not as severe - some of his cells were normal which enabled him to survive on a restricted diet and special medications.

Jesse Gelsinger was the first person publicly identified as having died in a clinical trial for GENE THERAPY.

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jesse gelsinger
Jesse Gelsinger
  • Gelsinger joined a clinical trial run by the University of Pennsylvania that aimed to correct the mutation.
  • On Monday, September 13 1999, Gelsinger was injected with adenoviruses carrying a corrected gene in the hope that it would manufacture the needed enzyme.
  • He died four days later, apparently having suffered a massive immune response triggered by the use of the viral vector used to transport the gene into his cells.
  • This led to multiple organ failure and brain death.
  • Gelsinger died on Friday, September 17th at 2:30 PM.

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slide65
FDA suspends trials at gene-therapy lab in 2000.http://archives.cnn.com/2000/HEALTH/01/22/gene.therapy/

After investigating the OTCD study, the U.S. Food and Drug Administration ordered a halt to all clinical trials at the IHGT back in March.

The University announced in May that, among other changes, the IHGT would no longer conduct human trials, limiting its experimentation to cellular, molecular and animal models.

That announcement was followed a month later by a warning letter from the FDA faulting the animal experiments used to justify human research at the lab.

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slide66
In March of 2000, The University of Pennsylvania has asked federal regulators to reopen its gene-therapy clinical trials

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real life and death1
Real Life…and Death!

2001 Johns Hopkins’ Tragedy

The volunteer, Ellen Roche, died on June 2, a month after she inhaled an unapproved drug as part of a research study to examine the causes of asthma. Her lungs were destroyed, apparently by the chemical she inhaled, hexamethonium. She was 24 and a technician at Johns Hopkins.

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2001 johns hopkins tragedy
2001 Johns Hopkins’ Tragedy

- REPORT OF INTERNAL INVESTIGATION INTO THE DEATH OF A VOLUNTEER RESEARCH SUBJECT http://www.hopkinsmedicine.org/press/2001/JULY/report_of_internal_investigation.htm

- ARTICLE “Johns Hopkins’ Tragedy: Could Librarians Have Prevented a Death?” http://newsbreaks.infotoday.com/nbreader.asp?ArticleID=17534

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understand the importance of ethical research and learn about the hrpp at nnmc1
Understand the importance of ethical research and learn about the HRPP at NNMC

IRB

The Institutional Review Board (IRB) is responsible for protecting the rights and welfare of research subjects.

The IRB makes final decisions as to what constitutes NNMC related human subject research and how subject protection must be implemented.

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slide71
IRB

The IRB at NNMC consists of 17 members that meet every month to review the Human Use Protocol Application submitted by the Principal Investigator (PI).

IRB administration is located in NNM Building 1(Tower), 4th floor, RCRS spaces. Ms. Sheila Gaines is the IRB administrator.

E-mail address: sheila.gaines@med.navy.mil,

Phone: 301-295-6512

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ethical considerations
Ethical Considerations
  • Belmont Report
    • Respect for persons
    • Justice
    • Beneficence
  • Federal regulations
    • IRB approval

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ethical considerations1
Ethical Considerations
  • Investigator responsibilities
    • Scientific misconduct
      • Fabrication
      • Falsification
      • Plagiarism
    • Authorship
    • Conflicts of Interest

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scientific pitfalls
Scientific Pitfalls
  • The research question is not clearly articulated
  • Data analysis is not clearly planned
    • Data don’t answer the question
    • Specific data elements are not defined (without specific data elements you can’t plan your statistical approach)
  • Statistical approach is weak

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references
References

7. FDA Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. The FDA Information Sheet Guidance page. Available at http://www.fda.gov/oc/ohrt/irbs/ . Accessed April 28, 2008.

8. Graduate Education and Research Center. The GEAR Center page. Available at: http://www.bethesda.med.navy.mil. Accessed May 1, 2008.

9. IRB Guidebook. The Office for Human Research Protections (OHRP) page. Available at:

http://www.hhs.gov/ohrp/irb/irb_guidebook.htm . Accessed April 28, 2008.

10. National Naval Medical Center, Graduate Education and Research. The DCMilitary.com page. Available at:http://www.dcmilitary.com/special_sections/sw/020107_NNMC/ss_104626_32017.shtml)

11. Regulations and Ethical Guidelines for Conduct of Research Involving Human Subjects. The Office of Human Subjects of Research page. Available at: http://ohsr.od.nih.gov/guidelines/index.html. Accessed April 28, 2008

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questions
Questions

???

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thank you
Thank You!

My Contact Information:

Marina Borovok, PhD

Head of Research Education

Clinical Investigation Department

Professional Education Directorate

National Naval Medical Center

8901 Wisconsin Avenue,

Bldg. 1, Rm. 4372,

Bethesda, MD 20889

Phone: 301-295-2876

Fax: 301-295-1490

E-mail: marina.borovok@med.navy.mil

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