1. We are pleased to launch this newsletter. We hope
it will be an informative link to our partners in the
Washington metropolitan community. GHUCCTS is
a partnership among five organizations:
Georgetown University, Howard University, Wash-
ington Veteran‟s Affairs Medical Center, MedStar
Health Research Institute, and the Oakridge Nation-
al Laboratories.
Each year, GHUCCTS supports about 170 research
studies and nearly 2,000 research participants visit
our sites. We invest over $350,000 annually to pro-
mote research to advance medical knowledge and
improve health. We have provided seed money for
research led by community-based organizations.
Ten young investigators have received start-up
funds and mentoring to support their careers and we
have provided summer research experience to over
50 students. We have a highly engaged board of
Community Advisors who help to promote diversity
within research and inclusion of community per-
spectives.
We are beginning to
realize the potential
that was envisioned
with the formation
of GHUCCTS. By
using our various
strengths, we have
seen our theme of
“Discovery through
Diversity” take
shape. Histori-
cally, ethnic and
racial minorities
have not been well-represented in the research that is
done to improve health. Not so with GHUCCTS.
More than half of our research participants are Black
or African American. Through our teamwork and
partnerships, GHUCCTS is changing history.
Message from the Principal Investigators
Fighting Heroin Addiction One STRIDE at a Time
Heroin is one of the most commonly used drugs
among individuals admitted for drug addiction treat-
ment in the District of Columbia. It can have devas-
tating consequences including the risk of spreading
HIV by sharing needles or through unprotected sex.
Drug abuse treatment programs help drug users
change the behaviors that put them at risk for HIV.
However, research often excludes people who are
already living with HIV. Researchers at Howard
University seek to change this. With partners from
George Mason University and Yale School of Medi-
cine, this GHUCCTS-supported project is the first in
the country to test the use of a medicine called bu-
prenorphine as a way to reduce the chance that HIV+
heroin users will spread the infection to others.
Georgetown Howard Universities Center for Clinical and
Translational Science
April 1, 2014Volume 1, Issue 1
The GHUCCTS -e- Reporter
Supporting the Community Through Research
Special points of
interest:
 GHUCCTS Realizes
Mission: Discovery
Through Diversity
 Making STRIDEs
Against Addiction and
HIV
 Meet our Community
Advisors: Listening to
Our Hispanic Elders
 Seeing Research
Through the Patient’s
Eyes
Inside this issue:
Meet our Community
Advisors
2
Research Through the
Patient’s Eyes
3
STRIDE continued pg. 2
Thomas Mellman, MD, Howard
University (left) and Joseph
Verbalis, MD, Georgetown
University (right)

2. The study is called project STRIDE which stands
for Seek, Treat, Reach, and Identify, pretrial De-
fendant Enhancement. Led by Dr. William Law-
son, Chairman of the Department of Psychiatry at
Howard University, this study aims to help people
maintain consistent treatment for HIV. Vince Wal-
ford, a therapist at Howard University Hospital is
the lead counselor for project STRIDE. Walford
states, “It's challenging for those addicted to heroin
to remain drug free, as oftentimes, they are also
addicted to the lifestyle, in addition to environmen-
tal factors that may cause a barrier for one to want
to live a sober life.”
Dr. Suneeta Kumari, Clinical Project Director of
STRIDE adds, “We know opiate-addicted persons
are also at high risk for developing [other] medical
conditions stemming from poor nutrition, sharing
needles, and lack of preventive care. If additional
treatment is needed, we refer the patient right
away. In a way, this study is a gateway allowing
study participants to access medical services they
may not ordinarily seek or know they need.”
STRIDE participants receive comprehensive care
as needed including medicine to treat HIV, case
management for drug dependence, and detox ser-
vices. Therapist Vincent Walford states, “We have
seen good outcomes with some participants re-
maining sober longer times.”
To learn more about project STRIDE, contact
Terry Wilkins at 202-599-0287 or Project Director,
Marissa Kiss at 703-993-5222.
lenges faced by older Hispanic adults in the D.C.
Metropolitan Area and throughout the nation. Yanira
Cruz, a CAB member of three years, assumes a piv-
otal role on the board by bringing the Hispanic per-
spective on public health and research needs. As
President & CEO of the National Hispanic Council
on Aging (NHCOA), Dr. Cruz and her team work
tirelessly to empower older Hispanic adults in ac-
quiring advocacy skills to voice their own concerns
and influence policy.
The organization's age-sensitive empowerment train-
ings, as well as other NHCOA programs and re-
sources, are culturally and linguistically tailored to
better serve this population. Moreover, their pro-
grams are designed based on the very needs ex-
pressed by the population they serve. One of
NHCOA's program participants states, “Even though
most people here are older adults, these are problems
for the entire Hispanic community. We all need to
develop a solution that involves the entire communi-
ty.”
Oftentimes, older Hispanic adults face many road-
blocks when accessing services like Medicare and
Social Security. Low educational attainment, low
English proficiency, and other cultural and linguis-
tic barriers present great obstacles. Lack of famili-
arity with local, state and federal government ser-
vices can also result in older Hispanic adults ac-
cessing far few services than those for which they
may be eligible. Likewise, service providers fre-
quently lack cultural and linguistic competence to
better serve this population. According to an older
Hispanic adult, “Many of the services do not have
employees that have the capacity or the patience to
help us. There is a huge lack of respect to seniors.”
Yet, older Hispanic adults are eager to advocate for
better conditions within their own communities
and increased access to much needed housing,
health, and economic security services.
GHUCCTS Community Advisory Board (CAB)
member, Yanira Cruz, DrPH, MPH brings a rich
understanding on the strengths, needs, and chal-
STRIDE (continued)
Meet our Community Advisory Board Members:
Supporting Older Hispanic Adults to Use Their Voices
Page 2
The GHUCCTS -e- Reporter
“This study is a
gateway allowing
study participants to
access medical
services they may
not ordinarily seek
or know they need.”
NHCOA continued pg. 3
NHCOA National Summit
Yanira Cruz, DrPH, MPHYanira Cruz, DrPH, MPH

3. As a result, NHCOA has been offering an Empow-
erment & Civic Engagement Training (ECET) initi-
ative, where older Hispanic adults, their families,
and caregivers are mobilized to play an active role
in advocating for policy issues that directly impacts
their lives. This two-day training teaches partici-
pants how to identify issues in their community,
build support to resolve an issue, and hold a suc-
cessful meeting with an elected official. Dr. Cruz
states, “The two-day training gives them confidence
in themselves . . . that they actually have the capaci-
ty to voice their opinion. We give them a frame-
work on how to build an advocacy campaign.”
Annually, the training prepares approximately 50
older Hispanic adult community advocates and
leaders for a visit to Capitol Hill, and to be active
participants in NHCOA‟s annual summit in Wash-
ington, D.C. - events and forums to which they
would not usually have access. These forums pro-
vide opportunities for older Hispanic adults to share
their concerns with business owners, policy mak-
ers, service providers, and academic scholars with
the aim of enacting policy change and improving
needed services. “The summit is a way of putting a
face to the problem, and making it more personal,”
states Dr. Cruz. “Many policy makers and service
providers addressing housing, health care, and
other issues, don‟t understand the challenges faced
by older Hispanic adults,” she adds.
Empowerment programs like those offered by
NHCOA present an avenue for older Hispanic
adults to become civically engaged, giving them
the tools necessary to advocate for their needs and
those of their communities. Dr. Cruz brings to the
GHUCCTS CAB a concrete perspective on the
reality of a population whose voice would other-
wise go unheard.
For more information about NHCOA,
visit http://nhcog.org
NHCOA (continued)
Clinical Research in Vulnerable Populations: The
Patient’s Perspective
guidelines. It involves a thorough understanding by
the research team of how participants perceive a
study and what reasons they might have for partici-
pation. Are the participants sufficiently informed?
Have their questions been answered to their satisfac-
tion? Do they enroll because they wish to contribute
to the advancement of medical science, or are they
hoping to find a cure for their particular disease?
Knowing the answers to such questions and under-
standing why people chose to participate or not
participate helps to ensure that the interests and
choices of the research participants are protected. It
also helps in a successful implementation of the
study.
The informed consent process is critical for the
protection of human participants in clinical studies.
It allows researchers to provide potential partici-
pants with essential information about a particular
study, including its aims, procedures as well as pos-
sible risks and benefits to those who enroll. This
process enables an individual to decide freely
whether to take part in a given study. Before enrol-
ling in a study, all potential participants receive an
informed consent form (ICF) to sign with the under-
standing that they can withdraw from the study at
any time and for any reason without repercussions
to them. Ethical practices and guidelines for the
protection of human participants in research have
been well established. Yet, ensuring genuine in-
formed consent extends beyond following required
Page 3
Volume 1, Issue 1
Community Leaders
Assya Pascalev, PhD
“Empowerment programs
like those offered by
NHCOA present an avenue
for older Hispanic adults to
become civically engaged,
giving them the tools
necessary to advocate for
their needs and those of
their communities.”
MEDIC continued pg. 4
Assya Pascalev, PhD
Alexander V. Libin , PhD

4. For more information, please contact us at:
Georgetown Howard Universities Center for Clinical and Translational Science
Dr. Libin and Dr. Pascalev stress that, “persons faced with a chronic
disease such as cancer, heart disease, or diabetes are particularly
prone to therapeutic misconceptions because the chronic condition
often influences a person‟s choices and may reduce the patient‟s
perceived or actual range of treatment options. Because of this, indi-
viduals with chronic illness may be more willing to participate in
research than they would be otherwise” (Libin et al, 2012).
Another ethical consideration in research involving participants with
chronic illness is that they tend to develop strong emotional connec-
tion with their health care providers. As a result, patients with
chronic conditions may feel obligated to participate in studies, which
are recommended or conducted by their clinician. “This perceived
obligation may also undermine a participant‟s ability to decide freely
whether to participate in a study,” notes Dr. Pascalev.
The study involves presenting patients and clinicians with scenarios
involving hypothetical patients with chronic conditions. The partici-
pants in MEDIC are asked to respond whether the patient in the
scenario should participate in a study and what their motivation is to
participate or not.
With findings from this study, the research team will be able to de-
velop educational modules to help clinicians and providers better
understand the informed consent process in vulnerable populations.
According to Dr. Pascalev, “The idea is to develop a training tool for
clinical researchers and anyone involved in the conduct of clinical
studies so that patients, but also re-
searchers and the public, benefit because
the quality of informed consent and thus
the quality of research will improve.
Individuals will go into studies for the
right reasons.”
However, at present, very little is known about the motivation of
participants to enroll in clinical studies, and the concept of in-
formed consent has not been studied from the perspective of the
participant‟s experiences.
According to Assya Pascalev, Ph.D, bioethicist and Associate
Professor of Philosophy and Community and Family Medicine at
Howard University, “This is an important area of study because,
although we talk a lot about informed consent and its importance,
the point of view of the participants has not been well under-
stood.” Dr. Pascalev is a co-investigator (with Dr. Alexander Libin
from Georgetown Medical Center) of a new GHUCCTS pilot re-
search project currently underway at Howard and Georgetown
Universities, which aims to contribute to a better understanding of
the research participant‟s perspective. The project is titled
“Medical Health Ethics in Vulnerable Populations: Clinical Re-
search through the Patient‟s Eyes” (MEDIC).
The research focus of MEDIC is to gain the perspective of re-
search participants who are also patients with a chronic disease.
Dr. Libin and Dr. Pascalev believe that, “greater care is needed to
ensure that such vulnerable individuals understand the risk and
benefits of participation in research as well as their rights to freely
choose participation or other treatment options” (Libin et al,
2012).
As an ethicist, Dr. Pascalev is concerned that, “some individuals
may decide to participate in research under the wrong assumption
that the studied treatment, procedure, or devise will improve their
health or may cure their illness.
This problem known as „the therapeutic misconception‟ represents
a major ethical concern because it interferes with a person's ability
to make sound decisions regarding participation in research and
hampers a participant‟s ability to give meaningful informed con-
sent.”
MEDIC (continued)
Primary Business Address
4000 Reservoir Road
Washington, DC 20007
Phone: 855-338-4293
www.georgetownhowardctsa.org
For Research Participants
24 Hour Phone:
202-681-2872
Page 4