# Presentation: 201916

## NIH Public Trust Initiative Update  November 10, 2005 

***Initiative Co-Chairs***
**Dr. Patricia A. Grady**
**Director, National Institute of Nursing Research**
**Dr. Yvonne T. Maddox**
**Deputy Director, National Institute of Child Health & Human Development**

**Notes:**
NIH Public Trust Initiative

Thank for this opportunity to provide an update on the NIH Public Trust Initiative. We have made a lot of progress since we first established the PTI and I’m delighted to have this opportunity to tell you what we have done so far, and what we are planning to do.  Naturally, your ideas and suggestions are most welcome!

## NIH Public Trust Initiative

- NIH cannot control the public’s perceptions in the area of research...

- ...but we at NIH can improve how we communicate and interact with the public.

**Notes:**
You may recall from when we first established the PTI, our guiding principle is that while “NIH cannot control the public’s perceptions in the area of research...[CLICK AGAIN] ..we can improve how we communicate and interact with the public.”

NOTE:  This slide requires TWO clicks, One brings in the red content, the second brings in the blue/grey content

## NIH Public Trust Initiative

**The Public Trust Initiative is based on the following assumptions:**
- Public trust is a top priority for the NIH
- The NIH has a long-term commitment to public trust
- Public input with NIH decision-making and   research planning leads to better research
- Quality research is necessary for optimal         health

**Notes:**
In our discussions, it became clear that we also needed to explicitly articulate our assumptions.

These assumptions are very consistent with one of the recommendations that came out of the COPR Workshop last fall, which suggested that NIH’s mission and philosophy explicitly express that it values involvement of the community, that this is a long term commitment, and that we believe public involvement ultimately improves research.  We believe these assumptions convey those beliefs.

## NIH Public Trust Initiative

- Mission Statement
- The mission of the NIH Public Trust Initiative (PTI) is to enable the public to understand and to have full confidence in the research that NIH conducts and supports across the country and throughout the world.

**Notes:**
With an eye toward using plain language, we have put our mission statement, overall goal, and specific objectives through several revisions.  Here is the current Mission Statement for the PTI.

## NIH Public Trust Initiative

**SPECIFICALLY, the Public Trust Initiative seeks to provide the public:**
- Information about how NIH conducts and supports research
- Opportunities to participate in priority setting and other NIH activities
- Opportunities to participate in clinical research
- Access to, and understanding of, research results

**Notes:**
Our objectives are quite straightforward and flow from our overall goal.

## NIH Public Trust InitiativeSteering Committee

**Patricia Grady**
**Yvonne Maddox**
**Lauren Aaronson**
**Barbara Alving**
**John Burklow**
**Michaele Christian**
**Lisa Colpe**
**Zeke Emanuel**
**Sharon Hrynkow**
**Lisa Kaeser**
**Raynard Kington**
**Dushanka Kleinman**
**Cliff Lane**
**Amy Patterson**
**Cliff Poodry**
**Joan Schwartz**
**Nicole Johnson Baker**

**Co-Chair, Director, NINR**
**Co-Chair, Deputy Director, NICHD**
**Senior Advisor, NIH NINR**
**Acting Director NCRR—*****Clinical, women’s health***
**Assoc. Director for Comm., NIH OD—*****Communications & education***
**Assoc. Director, Div. Cancer Treatment, NCI—*****Clinical trials, oncology***
**Acting Asst. Director for Roadmap Coordination, NIH OD **
**Chair, NIH Department of Bioethics—*****Ethics***
**Acting Director, FIC—*****International***
**Senior Program Analyst, NIH NICHD**
**Deputy Director, NIH—*****Health disparities, BSSR***
**Deputy Director, NIDCR**
**Clinical Director, NIAID—*****Clinical trials, patient advocacy***
**Director, Office of Biotechnology Activities, NIH OD**
**Director, Div. Minority Opp. & Res., NIH NIGMS—*****Special populations***
**Asst. Director, OIR—*****Women’s health, intramural***
**COPR Member—*****Public, patient advocacy***

**Notes:**
I’d like to begin by acknowledging the persons on the PTI Steering Committee.  As you can see, it is an illustrious group and they have been extremely helpful as we have discussed various activities and ideas for the PTI.

## Representatives from
Institutes
Centers
Offices of the Director

- Institutes
- Centers
- Offices of the Director

- NIH Public Trust InitiativeLiaison Group

**Notes:**
We also have a terrific Liaison group.  There is a PTI Liaison from each Institute, Center, and several of the Offices of the Director, such as the OWHR.  Many ICs also have identified an alternate to ensure their active participation in the PTI. We have been so pleased with their responsiveness and work with us.

## NIH Public Trust Initiative

- Public Trust Initiative Inventory
- Inventory of current NIH activities
- Tremendous response from all the ICs
- Over 100 pages of abbreviated info
- Categorized by types of activity
- Reviewing for target “publics”
- Identifying ‘exportable’ programs

**Notes:**
Not wanting to re-invent the wheel, and knowing that there are a lot of activities already in place that are central to building and sustaining public trust, one of the first things we did was to conduct a full inventory of current activities across NIH.  The IC liaisons were amazingly helpful in this effort and we received a fabulous response.  As a result, we have over 100 pages of abbreviated info categorized by types of activities and identified by IC.

We currently are focusing on fleshing out some minimal standard uniform data on each activity so that we can render this inventory more user friendly and take advantage of the successful experiences of our colleagues in other ICs.  The inventory itself is intended to be an internal document for use by all ICs.

*Our ultimate goal is to identify exportable programs.   We are consciously avoiding use of the term “best practices”, as we do not want this seen as something competitive or value laden.  In some respects, the concept of “best practices” isn’t really all we want to identify.  After all, some perfectly wonderful ideas and activities may be single institute specific and inappropriate to emulate in another IC.  Therefore, we think the correct label is “exportable” to capture the potential usefulness of the activity for other ICs.

## NIH Public Trust Initiative 

- Types of Activity
- Involving and Protecting Human Participants in Clinical Research
- Including the Public in IC Activities
- Promoting the Visibility of NIH Information    for the Public
- Teaching and Developing Course Materials for Science Education
- Education and Outreach Programs for Extramural and Intramural Clinical and Research Communities

**Notes:**
These are the FIVE broad categories of activities.  We have provided a handout of the table of contents from the Inventory so you can see the sub-categories of activities under each of these larger categories.

## NIH Public Trust Initiative

- Target “Publics”
- The General Public/Community
- The Research Participants
- The Research Advocacy Community
- The Extramural Scientific Community
- The Intramural Scientific Community

**Notes:**
With the help of subgroups of the PTI IC liaisons, we also sorted the activities by which “publics” they target.  For this, we identified 5 (non-mutually exclusive) publics with which the PTI is concerned.  At our recent PTI Steering Cmt meeting, some questions were raised about whether or not we should be focusing the PTI initiative on the NIH internal scientific workforce, or if this group is really just part of “us” and attention to them belongs more in the hands of the “morale” committee. 

## Examples of Exportable Activities for the Extramural Science Community

- Outreach Notebook for the Inclusion, Recruitment, and Retention of Women and Minority Subjects in Clinical Research (ORWH)
- Short courses and Summer courses (e.g., NINR Summer Genetics Institute, NIGMS summer program for college students)
- Training for PIs and IRB members (NIEHS)
- Improved Informed Consent documents/procedures (e.g., NIDDK, NEI, NIDCD, NIAID/video)

**Notes:**
Now I would like to quickly and briefly identify just a few of the examples of activities we found through our Inventory that we and our Steering Cmt thought would lend themselves well to being adapted by other ICs.  We have organized these by the targeted audience. This is not an exhaustive list, just a sampling, so please don’t be concerned if you don’t see your IC’s activity here.  While we welcome additions for the Inventory, it is quite likely that your IC’s activity is already in the Inventory, thanks to your PTI Liaison.

## Examples of Exportable Activities for Research Participants

- Consumer Advocates in Research and Related Activities (CARRA) program (NCI)
- Research Subject Advocacy Programs (e.g., NCRR, NIAMS health liaisons, NIDCR pt advocates forum, NHLBI’s Baby Hug trial)
- Educational Materials (e.g., ClinicalTrials.gov)

**Notes:**
NICHD is currently working on adapting the NCI CARRA program, on a smaller scale, to meet their needs, and possibly to serve as a model for other ICs.
Research Subject Advocacy – NCRR separately funds this position to represent the interests of the trial participants and assist scientific staff in the safe and ethical conduct of research.
Ed. Materials – NIDA’s Clinical Trials Network includes both university researchers and community providers to work together to test science-based treatments in community settings.  NIAID’s Equal Access project is targeted to minority populations to educate them about clinical trials and encourage participation.
  Again, these are just examples and we know other ICs also have similar efforts.  It is our hope that by collecting these activities across NIH, we can facilitate ICs adapting and adopting material and ideas from other ICs and reduce the need for each to develop their own materials and activities from scratch.

## Examples of Exportable Activities for the General Public

- Public Education Campaigns (e.g., NIMH/Real Men Real Depression, NHGRI/DNA Day, NICHD/Milk Matters, NINDS/Know Stroke, NIA/SeniorHealth)
- Health Fairs/Screenings/Traveling Exhibits (e.g., NEI’s The Eye Site, NHLBI’s The Heart Truth, NIMH’s Brain)
- Medicine for the Public (CC lecture series since 1978)

**Notes:**
There are many wonderful public education campaigns and traveling exhibits that the ICs do; I’ve only listed a very few examples here.
NIMH – stories of men with depression, and how they got needed help
NHGRI – know your family history/DNA
NICHD – promote calcium consumption for optimal bone growth, especially among tweens and teens
NINDS – knowing the early signs of stroke
Medicine for the Public – lecture series geared toward general public by NIH scientists on various disease topics
We also have specific activities that are designed for the Research Advocacy Community, including several specific Coalitions, e-newsletters and listservs, and Outreach Partners Networks.

Again, these are only examples of some of the wonderful activities ICs at NIH are already doing and that other ICs might find useful to adapt or adopt to  meet their own needs.  But before I end, I want to spend a little time highlighting one particular large effort that NIH undertook earlier this year.

## NIH Public Trust Initiative

**RFA-RM-06-002** Institutional Clinical and Translational Science Award
-    “The importance of overcoming the barriers to and enhancing the opportunities for public trust and participation in clinical and translational research cannot be overemphasized. The NIH's Council of Public Representatives recently explored ways to foster community involvement in clinical research and reported their recommendations (_[http://copr.nih.gov/reports/October_2004_COPR_WORKSHOP_Proceedings.pdf](http://copr.nih.gov/reports/October_2004_COPR_WORKSHOP_Proceedings.pdf)_).”

## Engaging the Public in Clinical Research is a Priority

***Enhanced access to credible health information is key to this process.***

## Health Disparities and the NIH Public Trust Initiative

**American Indians and Alaska Natives have**
**disproportionately high prevalence of the**
**following conditions and risk factors**:
- Mental health
- Diabetes
- Obesity
- Substance abuse
- Sudden Infant Death Syndrome (SIDS)

## Native American and Alaska Native Health and the NIH Public Trust Initiative

-   1.  Heart disease
-   2.  Cancer
-   3.  Unintentional injuries
-   4.  Diabetes
-   5.  Stroke
-   6.  Chronic liver disease and cirrhosis

-   7.  Chronic lower              respiratory disease
-   8.  Suicide
-   9.  Influenza and      pneumonia
-  10.  Homicide

**Ten Leading Causes of Death in the U. S. for American Indians and Alaska Natives**:

## NIH Alaska Native Outreach Effort February 2005

- IC Directors responded to invitations from the Southcentral Foundation (major Alaska Native health care provider) and former COPR member Dr.Ted Mala, to participate in their upcoming health fair in Anchorage and to visit some villages
- A delegation of public liaison officers and others from NIH, representing nearly half the ICs participated

**Notes:**
This past February, NIH undertook a massive activity that involved many ICs.  As some of you know, we have had some unfortunate situations arise in Alaska that now need attention and correction.  Historically there has been considerable mistrust and disappointment in investigators showing up, doing their research, and never being heard from again.  Because we are committed to change that, not just in perception, but in deeds, we conducted a large outreach effort to help turn this situation around.

## NIH Alaska Native Outreach Effort February 2005

- Purpose
- To better understand the culture and health care delivery system for Alaska Natives, and to build stronger bridges for carrying out research activities

## NIH Alaska Native Outreach Effort

- What we learned:
- How health care is delivered in Alaska, through meetings with hospital administrators, telehealth experts, and tribal leaders.
- The challenges of providing health care and conducting research in a largely rural, highly dispersed population.
- How traditional and complementary medicine may blend with westernized medical care.

**Notes:**
This trip was really a two-way exchange.  We learned a lot about how health care is delivered in Alaska and the unique challenges of their remote villages, often 3 hrs by puddle jumper plane to the nearest hospital.

## NIH Alaska Native Outreach Effort

-     What we shared:
- The wide range of health careers (OSE’s Lifeworks) and training opportunities available.
- Dissemination of our research-based health information through the SCF Health Fair, elementary through high school classes, and seminars for health professionals and educators.
- Tailored science education, NIH 101 and other training programs

**Notes:**
And we were able to share a lot of information with the various groups with which we met in groups and separately.  Among other things, it gave us an opportunity to identify the wide range of health careers that are options for young people, and the diverse training opportunities the NIH provides.  It was a very busy trip, a lot was accomplished, and we and they both benefited from this coordinated effort. Lisa Kaeser of NICHD (who works closely with us on the PTI) and Cindy Palace of NHLBI co-chaired this important effort.

## NIH Public Trust Initiative

- _Next Steps_
- Conduct smaller scale outreach efforts modeled after parts of the Alaska trip
- Identify incentives for ICs to adapt/adopt activities successful in other ICs
- Present to scientific directors, EPMC, clinical directors, IC Councils

**Notes:**
We had a lively discussion of “next steps” at our last Steering Committee meeting and these are some of the suggestions made.  

Dr. Kington generously offered to provide some seed money for ICs interested in adapting/adopting activities successful in other ICs

## NIH Public Trust Initiative

- _Next Steps (cont.)_
- Put exhibits around campus
- Emphasize public trust issues at all NIH events for the public and festivals
- Create a set of slides for all to use     when ‘on the road’

## NIH Public Trust Initiative

- _Next Steps (cont.)_
- Showcase activities, including community initiated, on the website on a rotating basis
- Write articles/showcase activities for the NIH Record, Catalyst, DDIR Bulletin Board, and offer to ICs for their e-newsletters
- Further encourage inclusion of communities in grant awards

## NIH Public Trust Web Site

- http://publictrust.nih.gov

**Notes:**
I’ll end my remarks today by once again showing the Public Trust website and I urge you to put a hot link from each of your IC websites to this site.