Certificate of Confidentiality Application

Attachment 16
Certificate of Confidentiality

July 19,2013

Dr. Nadine Rogers
Scientific Review Officer
NJDA
Office of Extramural Affairs

Dr. Rogers:
We are requesting a Certificate of Confidentiality for the project titled Quantification of Behavioral and
Physiological Effects of Drugs Using a Mobile Scalable Device. If anything further is needed, please contact
Timothy Brown at 319-335-4785 or [email protected] u.

I.

Name and address of applicant research institution:
National Advanced Driving Simulator, University of Iowa
2401 Oakdale Blvd
Iowa City, TA 52242

2.

Sites where the research will be conducted and a brief description of the facilities available for the
conduct of the research:
National Advanced Driving Simulator, University of Iowa
240 I Oakdale Blvd
I owa City, lA 52242
The National Advanced Driving Simulator is a research facility with secure building access. There are three
fully enclosed prep rooms separated from administrative offices in which participant briefing and
debriefing occurs. Another room holds the simulator used for the study and is adjacent to the hallway in
which the prep rooms are located.

3. Title of the research project: Quantification of Behavioral and Physiological Effects of Drugs Using a
Mobile Scalable Device
4.

Source and number of the supporting grant: NIDA N44DA-12-1206

5.

IRB Approval:See Attached Approval and Assurance

6.

Name and address of applicant and key personnel.
Timothy L. Brown, Ph.D.
National Advanced Driving Simulator, University oflowa
240 I Oakdale Blvd.
Iowa City, lA 52242
[email protected]
phone:319-335-4785
fax:319-335-4658
Dr. Brown received his Doctorate of Philosoph y from the University oflowa in 2000 in the area ofHuman
Factors Engineering. He has worked at the Iowa Driving Simulator, Cognitive Systems Laboratory and
National Advanced Driving Simulator studying multiple facets of driving, including impairment. He has
prior experience studying the impacts of alcohol and drugs on driving.

Gary R. Gaffney M.D.
National Advanced Driving Simulator, University oflowa Hospital and Clinics, University oflowa
240 I Oakdale Bl vd.
Iowa City, lA
Dr. Gaffney received his Doctorate of Medicine from the University of Iowa in I 981. Dr. Gaffney has 23
years in the practice of child and adolescent psychiatry and is currentl y the Director of the Autism Cl inic at
the University oflowa Hospitals and Clinics, Iowa City, Iowa. Dr. Gaffney has numerous publications in
Autism, Tourette's Syndrome, Psychopharmacology, Genetics, and Brain Imaging. He has prior experience
studying the impacts of alcohol and drugs on driving.
Gary Milavetz, Pharm.D.
National Advanced Driving Simulator, College of Pharmacy, University oflowa
2401 Oakdale Blvd.
Iowa City, lA
Dr. Milavetz received his Doctorate of Pharmacy from the University of Minnesota in 1980. He has worked
with the National Advanced Driving Simulator on prior studies investigating alcohol and drugs on driving.
His research interests include the pharmacotherapeutics of respiratory medications. He has numerous
original research publications on the pharmacokinetics, pharmacodynamics and clinical efficacy of
medications used to treat respiratory disease.
7.

Beginning date and expected end da te of the project: August 1 5, 2013- 30 September 2014

8.

Concise description of the study aims and research methodology; include number, source and
description of the human subjects.
The overall study is designed to characterize the effects of common recreat ionally used prescription drugs
(Xanax and Adderall) with well-known stimulant and sedating effects, as well as cannabis, and their
relationship to results from the Mobile Alertness Memory Profiler (M-AMP) which includes a set of
vigilance and memory tasks..
The aim of this research is to assess drug effects on driving and to explore the utility of the Mobile
Alertness Memory Profiler (M-AMP) assessment in detecting drug effects that effect driving.
Subjects will be 18-40 years of age. A total of twenty su bjects are needed to complete the study. It is
anticipated that up to twenty-six wi ll need to be enrolled to reach this target. Although an equal sample of
males and female subject are desired for completing this study, some imbalance will be allowed.
The studies involve three visits -a screening visit and two dosing visits. The dosing visits include a clean
(placebo) visit and a drugged visit. Participants wi ll be enroll ed into one of three studies (Xanax, Adderall,
or Cannabis) depending upon the timing of recruitment. The screening visit will last about 45 minutes and
wi ll include drug and pregnancy testing as well as screening for physical/psychological health. A simulator
drive is also done. Each of the dosing visits will last approximately five to six hours and will involve
baseline M-AMP assessment, a baseline drive, M-AMP assessment after dosing, a dosed drive, and dosed
M-AMP assessment. There wi ll also be blood sampl i ng before dosing, before driving, and after
driving. Multiple questionnaires are administered at each dosing visit, including demographic, well ness,
sleepiness, realism, and a sleep and food intake.

9.

Mea ns used to protect subjects' identities (e.g., coded by number, kept in locked files).
All stud y documents with the exception of the Consent Documents will be identified only by an assigned
subject number. The master list linking the subject to their assigned number will be kept by the research
coordinator in a password protected file on a secure network. During data collection and analysis,
paper/hard documents will be kept in a locked cabinet within a secure building that can only be entered by
personnel with a marlock key. After completion of analysis, all hard copies except the Informed Consent
Documents will be scanned, placed on a CD and placed into the NADS archival room that has limited
access by designated archival personnel. The original Informed Consent Documents will be stored in the
NADS archival room that has limited access by designated archival personnel. The Consent Documents
and other study documents identified by subject number are stored separately.

Electronic study documents, identified onl y by subject 10 number, will be coded by research staff onto a
computer. Electronic study data is collected and recorded onto data storage media and will be password
protected and can onl y be accessed by in vestigator, study personnel, or system admi n istrator. A ll
vi deota pes and questionnaires wi ll be locked in filing cabinets d uring the data analysis phase and wi ll only
be accessible by stud y personnel. Data will be transferred to a perma nent data storage area at the end of the
project where it wi ll only be available to the funding agency, principal investigator, or research team
members. Simulator data is captured and initially stored on a mirrored RAID system located within a
limited access area of the NADS facility. This data is behind a hardline firewall. Access to study data i s
controlled through validated user login, au thentication protocols and access permi ssions establ ished on a
per-study basis. Data backups are maintained as dual copies on ph ysical hard dri ve devices. One drive is
stored within a secured location on-site, and the other is stored off-site under the auspices of The U niversity
of Iowa Information Technology Services. All backup drives are inventoried and access to stud y data
requires a request for access and authorization from a designated authority.
I0. Reasons for requiring confidentiality.
A certificate is being req uested because we will be administering prescri ption drugs to subjects enrolled in
this study, and will be collecting data on what drugs are in their system while enrolled in the study.
II. Drug Enforcement Administration Certificate of Registration: See Attached
1 2. Assurances of the following:See Attached

Assurances
This institution agrees to use the Certificate of Confidentiality to protect against the
compelled disclosure of personally identifiable information and to support and defend the
authority of the Certificate against legal challenges.
The institution and personnel involved in the conduct of the research will comply with the
applicable Federal regulation for the protection of human subjects or, if no such Federal
regulation is otherwise applicable, they will comply with 45 CFR Part 46.
This Certificate of Confidentiality will not be represented as an endorsement of the project
by the DHHS or NIH or used to coerce individuals to participate in the research project.
All subjects will be informed that a Certificate has been issued, and they will be given a
description of the protection provided by the Certificate.
Any research participant entering the project after expiration or termination of the
Certificate will be informed that the protection afforded by the Certificate does not apply to
them.

Signature of Principal Investigator

Name and Title of Institutional Official

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lOWA BOARD OF PHARMACY
400 S.W.EIGIITH STREETSUITE E
DES MOINES" lA 50309-4688
515/281-5944

· FAX 515/281-4609
http://www.state.ia.us/ibpe ·

CEll.TIFICA_TE OlR EGIS fRATION

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. IOW1\ CONTR()LJ.JED SUBSTA_NCES ACT

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REGISTRATION NUl\'IBER

4100964
122N33N45

DRUG SCHEDULES REGISTERED

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REGISTRATION ISSUED

02/03/2012

REGISTRATION EXPIRES

09/30/2013

NAME, MAILING ADDRESS

NAME, REGISTERED LOCATiON

GAFFNEY"GARY R MD
NAT ADVANCED DRIVING SIMULATOR .
UNIVERSITY OF IOWA
2401 OAKDALE BLVD
IOWA CITY IA 52242-

GAFFNEY GARY R MD
NAT ADVANCED DRIVING SIMULATOR
UNIVERSITY OF IOWA
2401 OAKDALE BLVD
IOWA CITY IA 52242COUNTY 52
DEA REGISTRATION NO. AG2791362

Researcher

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RESPONSffiLE INDIVIDUAL. . Gary R Gaffney, Medical Doctor

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