IRB Approval Letter

April 2, 2014
Joanne Vega
Strategic Research Associates, LLC
25 West Cataldo, Suite D
Spokane, WA 99201
Re: National Institute on Drug Abuse (NIDA), Protocol Number PEERx, Strategic Research Associates,
LLC “Customer Feedback Information for NIDA PEERx Videos”
Dear Ms. Vega:
The above-referenced study has been determined by M. Alexander Kenaston, Ph.D., M.S., R.N., CIP to
be exempt according to 45 CFR 46.101(b) (1):
Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as (i) research on regular and special education instructional strategies, or (ii)
research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
management methods. Additionally, the research must meet the following:
•
•

The research is not FDA-regulated
The research does not involve prisoners as subjects

Although you chose category 2 the reviewer indicated the above category more appropriately meets your
project.
RESPONSIBILITIES OF PRINCIPAL INVESTIGATOR:
(1)

Submit for review by IntegReview all modifications to the protocol or consent form(s), when
applicable, prior to the implementation of the change;

(2)

Protect the confidentiality of all personally identifiable information collected and train your staff and
collaborators on policies and procedures for ensuring confidentiality of this information;

(3)

For funded projects, submit a copy of renewals/continuations and advise whether the study of
specimens, records, or human subjects has changed from the original submission; and

(4)

Submit notification if planned changes to an exempt study might make that study non exempt from
human subject’s research

3001 S. Lamar Blvd., Suite 210, Austin, TX 78704
Tel. 512.326.3001 Local Fax. 512.697.0085 http://www.integreview.com
IRB Registration Numbers: IRB00008463, IRB00003657, IRB00004920, IRB00001035, IRB00006075

Joanne Vega
National Institute on Drug Abuse (NIDA), Protocol No. PEERx
Page 2

If you have any questions please feel free to contact our office at 512-326-3001.
Sincerely,

Rosa S. Sandoval, B.S., CCRP
Senior IRB Coordinator, Co-chair

MEMBERSHIP ROSTER
As of April 1, 2014
NAME
M

Susan Parker Ginnings,
Chairman

Th,

BOARD
POSITION
Scientific

EXPERIENCE
Retired; Hospital Pharmacy Supervisor

AFFILIATION
WITH IRB
Non-affiliated

ALTERNATE
FOR
Scientific members

IntegReview
Employee

Non-scientific
members

Susan Parker Ginnings

M

Levi Machado, Co-chair

M

Olga Obrda

M

M

NonScientific

IRB Coordinator,
IntegReview

B.S.
(Chemistry)

Scientific

BD Representative; previously employed as Project
Management and Business Development for CRO

Non-affiliated

Scientific members

Jennifer Christensen

Pharm. D.,
BCPS

Scientific

Internal
Medicine,
Investigational
Neuropharmacology research scientist

Non-affiliated

Scientific members

Susan Krivacic

B.A. (German),
M.P.Aff (Public
Affairs)

Scientific

Consultant and patient advocate for oncology trials;
previously employed as Senior Executive and
Executive Director for CRO

Non-affiliated

Scientific members

Charles F. Ryan, Chairman
Charles F. Ryan

Ph.D., M.S.
(Pharmacology
& Toxicology),
R.Ph.

Scientific

Retired; representative for first time in human studies;
Pharmacology, Toxicology, Radiation Safety,
Radioisotope, Nutritional/Food supplements and
Medical Foods

Non-affiliated

Scientific members

T

Valerie Nelson, Co-chair

B.A. (History
and French),
M.A. (History),
CCRP

Nonscientific

IRB Coordinator, administrative support for
IntegReview; previously employed as Lead Project
Assistant and a Research Assistant for CRO

IntegReview
Employee

Non-scientific
members

T

Sara Bartos

M.D.

Scientific

Licensed physician, Internal Medicine

Non-affiliated

Scientific members

Ph.D., M.S.
(Toxicology),
R.N., CIP

Scientific

Toxicology Research Scientist, representative for first
time in human studies, Pharmacology/ Toxicology,
Licensed Registered Nurse; previously employed as
Project Manager, CRA and CRC for CRO

Non-affiliated

Scientific members

T

W

T

M. Alexander Kenaston

M
F

DEGREES/
CERTS.
R.Ph.

Denotes regular Monday board members T Denotes regular Tuesday board members
Denotes regular Friday board members
Other members are alternates

W

administrative

support

for

Drugs,

Denotes regular Wednesday board members

Th

Denotes regular Thursday board members

All regular Board members can serve as alternates on other Boards as specified by their positions (e.g. Scientific for Scientific)
Non-scientific members represent the general perspective of study participants
Page 1 of 4

NAME
T

Christine du Castel

DEGREES/
CERTS.
M.D.

T

Marcy Goodfleisch

B.S., M.A.
(Liberal
Studies)

EXPERIENCE
Medical Advisor; previously licensed to practice
General Medicine in France

AFFILIATION
WITH IRB
Non-affiliated

ALTERNATE
FOR
Scientific
members

Nonscientific

Mediator (civil, family & workplace dispute resolution);
previously employed as Management & Communication
Consultant, Clinic Administrator for nationally
recognized HIV Clinic and large FQHC community
health center, Ethicist

Non-affiliated

Non-scientific
members

Nonscientific

Quality Assurance and Quality Control Administrator
for CRO; previously employed as a Clinical Research
Monitor; and Project Manager

Non-affiliated

Non-scientific
members

Nonscientific

IRB Coordinator, administrative support for
IntegReview; previously employed as a Project
Assistant for CRO

IntegReview
Employee

Non-scientific
members

W

Carolyn Hensler, Chairman

W

Tonya Reed, Co-chair

W

Karen Haslund

M.D.

Scientific

Licensed physician, Pediatrics

Non-affiliated

Scientific
members

W

Raymond Carr

R.Ph.

Scientific

Staff Pharmacist

Non-affiliated

Scientific
members

W

Christopher P. Martin

Pharm.D., M.S.
(Pharmacy),
BCPS

Scientific

Clinical Assistant Professor, Division of
Pharmacotherapy UT ; Clinical Pharmacy Coordinator;
Assistant Professor University of Oklahoma Health
Sciences Center, College of Pharmacy

Non-affiliated

Scientific
members

Th

Frederick Kopec, Chairman

J.D. , B.A.
(Philosophy)

Nonscientific

Licensed, Practice of Law, Ethicist

Non-affiliated

Non-scientific
members

Th

Rosa S. Sandoval, Co-chair

B.S.
(Chemistry),
CCRP

Scientific

Administrative support for IntegReview; previously
employed as Clinical Research Coordinator and Medical
Research Assistant for University

IntegReview
Employee

Scientific
members

Th

Michael Romain

M.D.

Scientific

Licensed physician, Internal Medicine

Non-affiliated

Scientific
members

M
F

BOARD
POSITION
Scientific

B.S. (Physical
Education)

Denotes regular Monday board members T Denotes regular Tuesday board members
Denotes regular Friday board members
Other members are alternates

W

Denotes regular Wednesday board members

Th

Denotes regular Thursday board members

All regular Board members can serve as alternates on other Boards as specified by their positions (e.g. Scientific for Scientific)
Non-scientific members represent the general perspective of study participants
Page 2 of 4

NAME
Th

Mary O’Connell

Th

Dario Kuzmanovic

DEGREES/
CERTS.

EXPERIENCE
Quality & Regulatory Affairs Manager; previously
employed as Clinical Research Recruiter, Data Associate,
Coordinator and QC Auditor for CRO, IRB Administrator,
Emergency Medical Technician Paramedic

AFFILIATION
WITH IRB
Non-affiliated

ALTERNATE
FOR
Scientific
members

B.A., MHSc, CRA

Scientific

Research Ethics Manager; serves as a member on HIV
Research Ethics Board, Research Ethics Policy &
Advisory Committee, U of T REB Chairs Committee and
the Research Ethics & Research Education Committee,
Ethicist

Non-affiliated

Scientific
members

F

Mary Ruwart, Chairman

Ph.D.
(Biophysics); B.S.
(Biochemistry)

Scientific

Research Scientist, Drug Delivery Systems, Diabetes, GI
Diseases, Drug Metabolism

Non-affiliated

Scientific
members

F

Jami Brackeen, Co-chair

CST, CCRP

Nonscientific

IRB Coordinator; former Quality Control Associate for
IRB Regulatory Compliance department; Certified
Surgical Technologist

IntegReview
Employee

Non-scientific
members

F

Laurajo Ryan

Pharm.D., MSc,
(Clinical
Investigations),
BCPS, CDE

Scientific

Clinical Assistant Professor of Pharmacy, Division of
Pharmacotherapy UT, Department of Medicine
UTHSCSA, Clinical Pharmacy Specialist STX VA

Non-affiliated

Scientific
members

F

Dennis Brannon

R.Ph. , B.S.
(Animal Science)

Scientific

Clinical Research Consultant, Director of Pharmacy;
Executive Director Clinical Development; previously
employed as Senior Project Manager and CRA for CRO

Non-affiliated

Scientific
members

F

Ashley Hutson

Nonscientific

Unemployed; previously volunteered as research subject
in clinical trials

Non-affiliated

Non-scientific
members

Scientific

Clinical Research Consultant; previously employed as
Medical Affairs/Medical Officer, Regional Senior Clinical
Research Associate, Quality Assurance Auditor, Clinical
Research Manager

Non-affiliated

Scientific
members

F

Eduardo E. Sandoval

M.D., MBA
(Healthcare
Administration)

M
F

BOARD
POSITION
Scientific

Denotes regular Monday board members T Denotes regular Tuesday board members
Denotes regular Friday board members
Other members are alternates

W

Denotes regular Wednesday board members

Th

Denotes regular Thursday board members

All regular Board members can serve as alternates on other Boards as specified by their positions (e.g. Scientific for Scientific)
Non-scientific members represent the general perspective of study participants
Page 3 of 4

NAME

DEGREES/
CERTS.

AFFILIATION
WITH IRB

ALTERNATE
FOR

Victoria Govea

CCRP

Nonscientific

Management support for IntegReview; former IRB
Coordinator, Co-chair for IntegReview

IntegReview
Employee

Non-scientific
members

Erik Guerra

B.S., CCRP

Scientific

Former IRB Coordinator, administrative support for
IntegReview; previously employed as Clinical Research
Recruiter for CRO, Research Assistant, and Medical
Technician for a globally-recognized cancer center

IntegReview
Employee

Scientific
members

Nonscientific

Former IRB Coordinator, administrative support for
IntegReview

IntegReview
Employee

Non-scientific
members

Scientific

Management support for IntegReview; former IRB
Coordinator, administrative support for IntegReview;
previously employed as Research Coordinator, Health
Care Administration and Education, Clinical Nutrition,
Registered Dietician/Certified Pediatric Nutrition
Specialist

IntegReview
Employee

Scientific
members

(Biochemistry)
Angelica Martinez
Lynn Goldman

M
F

EXPERIENCE

BOARD
POSITION

B.S. (Nutrition),
MSHP
(Healthcare
Administration),
RD, LD, CCRP

Denotes regular Monday board members T Denotes regular Tuesday board members
Denotes regular Friday board members
Other members are alternates

W

Denotes regular Wednesday board members

Th

Denotes regular Thursday board members

All regular Board members can serve as alternates on other Boards as specified by their positions (e.g. Scientific for Scientific)
Non-scientific members represent the general perspective of study participants
Page 4 of 4