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1
Intramural Research Program Administrative Review
Followup Barry Hoffer, M.D., Ph.D. Director,
Division of Intramural Research, NIDA February 4,
2009
2
Administrative Review

• On April 1718, 2008, the Director of the
  National Institute on Drug Abuse (NIDA), Nora D.
  Volkow M.D., convened the NIDA Scientific
  Director Administrative Review Committee,
  composed of members from the National Advisory
  Council on Drug Abuse and prominent scientists
  from the drug abuse and addiction field.
• The charge to this committee was to provide an
  administrative review of Dr. Barry Hoffers
  contributions as Scientific Director of NIDAs
  Intramural Research Program (IRP).

3
NIDA Scientific Director Administrative Review
Committee

• Daniele Piomelli, Ph.D., Committee Chair
• Professor of Pharmacology and Biological
  Chemistry
• University of California, Irvine
• Peter W. Kalivas, Ph.D.
• Professor and Chair, Department of Neurosciences
• Medical University of South Carolina
• Mary Jeanne Kreek, M.D.
• Patrick E. and Beatrice M. Haggerty Professor,
• Head of the Laboratory of the Biology of
  Addictive Diseases
• The Rockefeller University
• Richard Nakamura, Ph.D.
• Deputy Director, National Institute on Mental
  Health
• National Institutes of Medicine
• Linda J. Porrino, Ph.D.
• Professor, Department of Physiology and
  Pharmacology

4
The Review Committee made the following
recommendations on ways to further improve the
IRP

• Communication and Cooperation
• 1. Increase the transparency of decision-making
  processes.
• 2. Increase chance (water-cooler) interactions
  among IRP scientists.
• Utilize tools of social network analysis to
  enhance interactions among IRP scientists.
• Conducting Human Research on Drug Abuse
• 4. Improve recruiting for protocols.
• 5. Improve interactions with the NIH
  Institutional Review Board.
• 6. Enhance supervision of the contract with the
  Maryland Psychiatric Research Center.
• 7. Extend collaborations with clinical
  investigators at other NIH Institutes for more
  effective use of the NIH Clinical Center.
• Consider alternative venues for clinical
  research.
• Cultural Diversity among IRP Researchers
• 9. The committee wishes to emphasize that Dr.
  Hoffer has done a tremendous job at supporting
  the scientific success of minority researchers
  within the IRP. Still, given lingering
  perceptions regarding cultural diversity at the
  NIH, it is important that he continues to
  maintain a high level of vigilance on this
  delicate issue.

5
Communication and Cooperation

• The actions outlined below address all three
  recommendations
• Recommendations
• Increase the transparency of decision-making
  processes.
• Increase chance (water-cooler) interactions
  among IRP scientists.
• Utilize tools of social network analysis to
  enhance interactions among IRP scientists.
• Actions
• Continue with open door policy to work directly
  with staff member on any issue of concern
• Established Quarterly Town Hall meetings for all
  IRP staff
• Address issues such as funding, new
  initiatives, new management processes/policies,
  announcements, awards
• Established Monthly Branch/Section Chief meetings
  
• Scientific presentation with potential for
  collaborations. Management issues presented and
  discussed
• Supports activities to improve employee
  engagement
• Employee of the month award
• Combined Federal Campaign fundraisers
  book/DVD sale and bake sale
• Holiday Celebration
• Established Workgroup looking into creating
  websites for the PIs
• Created a position of Associate Director for
  Translational Research to help advise on these
  issues (Amy Newman)

6
Communication and Cooperation (continued)

• The actions outlined below address all three
  recommendations
• Recommendations
• Increase the transparency of decision-making
  processes.
• Increase chance (water-cooler) interactions
  among IRP scientists.
• Utilize tools of social network analysis to
  enhance interactions among IRP scientists.
• Actions (Continued)
• Encourages participation in relevant seminars
  given by NIDA extramural or other ICs in NIH
• Mini Symposium conducted all IRP staff
  encouraged to attend
• Training made available to all staff, especially
  geared toward trainees. In cooperation with
  Sharon Milgram, NIH Office of Intramural
  Education and Training
• How to fund your NIH training Proposal
• Statistical Analysis Statistical Strategies
  for Small Samples
• Academic Job Search Research and Teaching
  Statements workshop
• Giving a Science Talk workshop
• Job Hunt Strategies workshop
• Goal is to have a workshop per month working
  on Grant writing now
• Encouraged maximum participation in the Annual
  Bayview Research Symposium which is attended by
  400-500 people
• Encourages maximum participation in the Hopkins
  Bayview Lecture series

7
Conducting Human Research on Drug Abuse

• Recommendation
• 4. Improve recruiting for protocols.
• Actions
• Identified areas in the screening process that
  could be made more efficient and work better for
  the research candidate as well as the NIDA study
  teams.
• Flow in the screening process
• Efficiencies in identifying all studies for which
  a candidate might qualify
• Internal communications
• As a result of our findings and efforts, we were
  able to achieve
• More streamlined and efficient screening process
  from phone screen to in-person screening to
  clearance
• More participants involved in more studies and
  across branches
• Increased communication between Recruiting staff
  and study teams
• Looked at recruiting and outreach and worked
  closely with the Clinical Directors as well as
  the IRB to create IRB acceptable and effective
  materials.
• Expanded shopping mall based outreach and
  placement of signage in eye catching areas to
  boost recognition of NIDA.
• Participated in area substance abuse conferences
  and outreached to community providers to increase
  exposure for the Archway Clinic.

8
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• 4. Improve recruiting for protocols. (continued)
• Actions
• Advertising and Outreach
• NIDA recruitment website approved Feb, 2008 and
  URL added to all advertisements
• Expanded outreach efforts to include treatment
  centers and colleges
• Developed Protocol Summaries with IRB approval
  for all active studies
• Continuously running targeted print ads for all
  user groups
• Phone screening
• Streamlined the phone screen process with IRB
  approved changes
• Improved database branching logic to better
  assist phone screeners in pre-qualification and
  assessment of callers who may be eligible for
  more than 1 study
• Improved procedure for appointment reminder calls
• Appointment reminder letter with directions and
  map approved by IRB and in use
• Improved support for DC callers (e.g. phone
  support and unique materials created)
• Cross training of staff In-person screeners able
  to log into Call Center to provide back up to
  call staff at busy times

9
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• 4. Improve recruiting for protocols. (continued)
• Actions
• Using the techniques described in the previous
  slide, the number of protocols and the number of
  participants has increased in every study.
• There are now more candidates approved for
  studies, to such an extent that in some cases the
  number of referrals is straining the study teams
  capacity to book candidates in a timely way.

10
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• 4. Improve recruiting for protocols. (continued)
• Actions
• The NIDA Clinical Director has worked with the
  MPRC support and professional staff as well as
  MMG to develop a auxiliary NIDA-IRP recruitment
  station in West Baltimore at MPRC on the Spring
  Grove Campus
• The NIDA screening protocol has been modified and
  approved by the UMB IRB to all participant and
  patient screening at this site.
• The existing infrastructure constructed for the
  NIDA/MPRC contractual collaboration has been
  adapted for new recruitment activities.
• The Clinical Director, with the NIDA IRP staff,
  has forged an agreement with the University of
  Maryland at Baltimore County (across Wilkins Ave
  from MPRC) in Catonsville to enable active
  recruitment for students and staff for NIDA IRP
  research studies.
• This site will expand outreach for participant
  recruitment into West Baltimore with close access
  to West Side Baltimore County, Howard County and
  northern Anne Arundel County.
• The MPRC staff will bring their considerable
  expertise in evaluation and recruitment of
  participant with major mental illness to enhance
  the prospective pool of research applicants.
  This will be very important as the number of
  NIDA/MPRC collaborative studies increases.

11
Conducting Human Research on Drug Abuse

• Recommendation
• Improve interactions with the NIH Institutional
  Review Board.
• Actions
• Clinical Director and/or Deputy Clinical Director
  meet with the Chair of the IRB regularly
• Protocol approval process has been agreed to,
  formalized and streamlined
• NIDA invited to participate in the Executive
  Steering Committee of the Combined NeuroScience
  (CNS) IRB
• NIDA IRP uses the same protocal tracking software
  as the rest of the CNS IRB
• Memorandum of Understanding for providing support
  to the Chair of the IRB completed
• Membership of IRB augmented to include people who
  understand NIDAs unique mission and research
  substance abuse expertise is found in NIAAA
  representation on the NIDA IRB
• Ongoing discussions with MPRC IRB and NIH Office
  of Human Subjects Research for a release
  agreement for IRB dual reviews similar to the
  MOU with JHU
• Data Safety Monitoring Board close to being
  established working with the IRB Chair

12
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Enhance supervision of the contract with the
  Maryland Psychiatric Research Center
• Actions
• In July 2005, the NIDA entered into a 5 year
  contractual agreement with the MPRC to
  collaboratively provide
• Residential research and support services
• Clinical and medical services
• Dual diagnosed psychiatric and substance
  dependent research volunteers
• Facilities and infrastructure designed to
  accommodate specific research activities
• Dr. Carlo Contoreggi, M.D. serves as the NIDA
  Project Officer
• Dr. Deanna Kelly, Pharm. D. serves as the MPRC
  Principal Investigator

13
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Enhance supervision of the contract with the
  Maryland Psychiatric Research Center (continued)
• Actions
• Change in leadership at the MPRC has helped
  strengthen relationship with NIDA
• Clinical Director and Deputy Chief, AMB spend
  Tuesdays at the MPRC site to provide clinical and
  management oversight
• Scientific Director has met several times with
  management officials from the MPRC to outline his
  expectations of the program
• All protocols are approved by NIDA Scientific
  Review and NIDA IRB as well as UMB IRB and DHMH
  IRB
• The number of approved protocols has increased
  dramatically
• A Scientific Liaison (Alane Kimes) has been
  established whose role is to be responsible for
  integrating areas and determining commonalities
  of research between NIDA and MPRC clinical and
  pre-clinical work. This has provided for

14
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Enhance supervision of the contract with the
  Maryland Psychiatric Research Center (continued)
• Actions
• Specifically the NIDA and MPRC have collaborated
  to
• Establish the BSU (Brief Stay Unit), domiciliary
  accommodations where individuals participating in
  NIDA-MPRC protocols can be housed up to 14 days.
• Recruit highly qualified research nurses,
  research associates, technicians, and IT support
  staff
• Renovate the NIDA wing of the Spring Grove State
  Hospital Tawes Building designed to include
  smoking chambers, participant testing and
  interview rooms, participant overnight rooms and
  lounge, toxicology lab, observed lavatories,
  staff offices and a separate dedicated entrance
  for staff and participants.
• Establish and perform a high number of
  collaborative clinical and translational
  protocols.
• Establish the NIDA Clinical informatics system at
  MPRC

15
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Enhance supervision of the contract with the
  Maryland Psychiatric Research Center (continued)
• Actions
• MPRC has awarded a sub-contract to the Matthew
  Media Group to design and establish a major NIDA
  -MPRC participant recruitment initiative from the
  Spring Grove campus. 
• An established recruitment base on the west side
  of Baltimore will allow NIDA and MPRC the
  opportunity to target a different socio-economic
  population than our current east Baltimore base.

16
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Enhance supervision of the contract with the
  Maryland Psychiatric Research Center (continued)
• Actions
• Clinical protocols - 12 collaborative protocols
  addressing a dual-diagnosed population are
  currently being conducted at MPRC
• INFLUENCE OF NICOTINE ON COGNITIVE FUNCTION IN
  SCHIZOPHRENIC PATIENTS WITH AND WITHOUT COMORBID
  DRUG DEPENDENCE (E. HONG-C. MYERS)
• QUITTING MARIJUANA USE SELF-REPORT STUDY OF
  QUITTING STRATEGIES AND WITHDRAWAL (D. KELLY-D.
  GORELICK)
• DOPAMINE FUNCTION AND REWARD PROCESSING IN
  SCHIZOPHRENIA (E. HONG-E. STEIN)
• NEUROIMAGING STUDIES OF NEUROPHYSIOLOGICAL
  PHENOTYPES IN SCHIZOPHRENIA (E. HONG-E. STEIN)
• A COMPARISON OF VARENICLINE AND PLACEBO FOR
  SMOKING CESSTATION IN SCHIZOPHRENIA (E. WEINER-A.
  COFFAY)
• KNOWLEDGE OF SMOKING CONSEQUENCES AND VIEWS OF
  SMOKING AND CESSATIONAMONG PEOPLE WITH
  SCHIZOPHRENIA (D. KELLY-S. HEISHMAN)
• ANTAGONIST-ELICITED CANNABIS WITHDRAWAL (D.
  KELLY-M. HUESTIS)
• PREVENTATIVE HEALTH CARE SERVICES AND FREQUENCY
  OF MEDICAL DISORDERS IN WOMEN WITH SCHIZOPHRENIA
  AND SUBSTANCE ABUSE (D. KELLY-C. MYERS)
• RASAGILINE IN THE TREATMENT OF PERSISTENT
  NEGATIVE SYMPTOMS OF SCHIZOPHRENIA (R.
  BUCHANAN-D. GORELICK)
• ALLELIC LINKAGE IN SUBSTANCE ABUSE (D. BOGGS-G.
  UHL)

17
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Enhance supervision of the contract with the
  Maryland Psychiatric Research Center (continued)
• Actions
• 14 more are in the hopper awaiting some level
  of approval (IRB, budget, scientific review)
• EFFECTS OF SMOKING CUES ON TOBACCO CRAVING
  RESPONSES AND THE REINFORCING EFFICACY OF
  CIGARETTES IN SMOKERS WITH AND WITHOUT
  SCHIZOPHRENIA (D. KELLY-S. HEISHMAN)
• THE EARLY TIME COURSE OF SMOKING WITHDRAWL IN
  SCHIZOPHRENIC AND HEALTY SMOKERS THE EFFECTS OF
  VARENICLINE (K. WARREN-C. MYERS)
• RISK PERCEPTION IN DRUG-DEPENDENT ADULTS WITH AND
  WITHOUT SCHIZOPHRENIA (K. PRENTICE-D. GORELICK)
• TRANSCRANIAL MAGNETIC STIMULATION (TMS)
  INTERFERENCE WITH CUE-INDUCED NICOTINE CRAVING
  (H. HOLCOMB-D. GORELICK)
• PILOT STUDY OF REPETITIVE TRANSCRANIAL MAGNETIC
  STIMULATION (RTMS) IN THE TREATMENT OF MAJOR
  DEPRESSIVE SYMPTOMS IN SCHIZOPHRENIA (D. BOGGS-D.
  GORELICK)
• PILOT STUDY OF TRANSCRANIAL MAGNETIC STIMULATION
  (TMS) INTERFERENCE WITH CUE-INDUCED COCAINE
  CRAVING (H. HOLCOMB-D. GORELICK)
• PILOT STUDY OF TRANSCRANIAL MAGNETIC STIMULATION
  (TMS) INTERFERENCE WITH CUE-INDUCED CANNABIS
  CRAVING (H. HOLCOMB-D. GORELICK)
• NEUROBIOLOGY AND PHARMACOKINETICS OF ACUTE MDMA
  ADMINISTRATION (H. HOLCOMB-M. HUESTIS)
• OXYTOCIN AND COGNITIVE-BEHAVIORAL THERAPY IN DRUG
  DEPENDENCE (D. KELLY-M. LEE)
• OXYTOCIN IN THE TREATMENT OF SCHIZOPHRENIA WITH
  COGNITIVE BEHAVIORAL THERAPY (D. KELLY-M. LEE)

18
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Enhance supervision of the contract with the
  Maryland Psychiatric Research Center (continued)
• Actions
• Translational protocols - recently undertaken
  through the contract. The impetus for this
  undertaking was a desire to take advantage of
  wealth of scientific personnel available between
  the two programs to implement basic science proof
  of principal studies for eventual clinical
  applications.
• To date, seven basic science protocols have
  received approval to be conducted via the
  contract.
• ROLE OF PEDUNCULOPONTINE AND LATERODORSAL
  TEGMENTAL ACETYLCHOLINE NEURONS IN REWARD
  PROCESSING (G. ELMER-R. WISE)
• TRANSLATIONAL NEUROIMAGING OF HABENULOMESENCEPHALI
  C REWARD PATHWAYS IN THE RAT (P. SHEPARD-E.
  STEIN)
• METHAMPHETAMINE NEUROTOXICITY AND GENE EXPRESSION
  IN BCL-2 TRANSGENIC MICE (M. VOGEL-J. CADET)
• TESTING GENE BY ENVIRONMENT INTERACTIONS IN AN
  AMIMAL MODE OF SCHIZOPHRENIA (J. KOENIG-M. LEE)
• PHENOTYPING COMORBIDITY (G. ELMER-B. HOFFER)
• INVOLVEMENT OF ALPHA-7 NICOTINIC ACETYCHOLINE (7
  nACh) RECEPTORS IN CANNABANOID REWARD (R.
  SCHWARTZ-S. GOLDBERG)
• QUANTIFICATION OF N-ACETYL-ASPARTYL-GLUTAMATE
  (NAAG) IN THE BRAIN (L. ROWLAND-Y.YANG)

19
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• Extend collaborations with clinical investigators
  at other NIH Institutes for more effective use of
  the NIH Clinical Center.
• Actions
• Clinical Director participating in the NIH PET
  cGMP and Radiochemistry Research Executive
  Steering Committee looks at how NIH ICs can
  fund and utilize a facility built in the NIH
  Clinical Center
• NIDA IRP participating with NIMH and NIAAA in a
  protocol at the NIH CC - Chronic Cocaine Use,
  Metabotropic Glutamate Receptor 5 Density,
  Genetics and Craving
• Developing a collaboration with NIDDK on a
  project at the clinical center which looks at
  addiction in relation to obesity
• Clinical Director attends monthly meetings of the
  NIH Medical Executive Committee (MEC) composed of
  all NIH Clinical Directors
• Clinical Director involved with the NIH Deputy
  Director of Intramural Research in a project to
  explore Barriers to Clinical Science
• Regular attendance by Clinical Director, Deputy
  Clinical Director and/or staff from their office
  at lectures, meetings and grand rounds at the NIH
  Clinical Center in the area of Radiology and
  Imaging Sciences

20
Conducting Human Research on Drug Abuse
(continued)

• Recommendation
• 8. Consider alternative venues for clinical
  research.
• Actions
• The SD has encouraged collaboration between the
  clinical research program and NIDA extramural
  programs. He has supported the Deputy Clinical
  Director (DCD) as she is detailed to work on a
  Center for Clinical Trials Network (CCTN) project
  on Post-Traumatic Stress Disorder (PTSD) and
  Substance Use Disorders (SUD) in Operation
  Enduring Freedom/Operation Iraqi Freedom
  (OEF/OIF) warriors and veterans.
• As a research administration mentor, he is
  encouraging the DCD to explore possibilities of
  organizational collaborations (DoD, VA, NIH,
  NIDA) to develop a broad, translational research
  program to study co-occurring mild Traumatic
  Brain Injury (mTBI), PTSD, and SUD in OEF/OIF
  warriors and veterans.
• In order to broaden the numbers of patients with
  co morbid substance abuse disorder liaisons with
  the Baltimore Veteran Administration Hospital are
  developing to recruit certain with substance
  abuse and psychiatric conditions such as PTSD and
  anxiety and major depressive disorders.
• Working with NIDA Director on a project involving
  collaboration with the Johns Hopkins Medical
  Institution involving PET and MRI imaging of
  tobacco users
• Study with US Naval Hospital, San Diego
  University of Pittsburgh and Ionworks, Inc. to
  develop innovative field-deployable tools that
  measure exposures to PTSD and mTBI.
• Studies using field-deployable hand-held computer
  devices
• With Johns Hopkins Unviersity, School of Medicine
  to measure exposures to psychosocial stress and
  addictive substances
• With Johns Hopkins Bloomberg School of Public
  Health to study the relationship between
  self-reported emotions, behavior, influences,
  environment and weight change.

21
Cultural Diversity among IRP Researchers

• Recommendation
• The committee wishes to emphasize that Dr. Hoffer
  has done a tremendous job at supporting the
  scientific success of minority researchers within
  the IRP. Still, given lingering perceptions
  regarding cultural diversity at the NIH, it is
  important that he continues to maintain a high
  level of vigilance on this delicate issue.
• Actions
• Secured funding for 4 additional minority
  trainees
• Continue to invite a representative from OEODM
  and a minority representative to serve on our
  scientific search committees.
• Continue to support a minority summer student
  program
• Supports Women Scientist Advisory council
• Combining with NIA
• Sponsored a tea as a way to discuss future
  plans
• Created honorary award which will be distributed
  along with a series of lectures in March, 2009
• Combine with NIDA Extramural to do the following
• Utilize the NIH Office of Equal Opportunity
  Diversity Managements Special Emphasis Program
  Managers when advertising appropriate positions
• Continue our relationship with the Society for
  Advancement of Chicanos Native Americans in
  Science (SACNAS) to post our scientific
  vacancies.
• Establish contracts with other minority-focused
  professional societies to post our vacancies on
  their websites (i.e., the National Association of
  Asian American Professionals and the National
  Organization for the Professional Advancement of
  Black Chemists and Chemical Engineers.)
• Utilize the new Diversity Notification service
  being offered by NIH HR. HR has developed a
  listing of 444 diversity organizations (HBCUs,
  professional associations and societies, etc.)
  and during the recruit process we can specify
  which ones wed like to contact about our vacancy
  and HR will send an email to them.  
• Establish a relationship with Gallaudet
  University and periodically host a hearing
  impaired student.
• Identify minority scientific/professional
  societies that will be meeting in the
  D.C./Baltimore area and sponsor booths or
  otherwise disseminate information on our
  vacancies.
• Send representatives to the Blacks in Government
  annual meeting