Frequently Asked Questions about the STARR Site Certification

We recognize that mental health clinical research is a particularly challenging area within research so we’ve brought together stakeholders from pharma, CRO’s, and sites to identify some obstacles and challenges unique to CNS research.

The STARR Site Certification is a result of these conversations.

Why should my site be STARR Certified?

The main reason to be STARR Certified is to be part of a network of stakeholders that are employing standardized best practices within their organizations and are advancing mental health clinical research by:

  • cultivating community engagement;
  • promoting research as an option for all;
  • strengthening communication between research site staff and patients, caregivers, and advocacy groups;
  • providing ongoing support for best practices around a few areas identified by the stakeholders of The STARR Coalition as being areas that could use some support.

Everything The STARR Coalition does comes from our stakeholders looking to make positive change. 

How does the STARR Site Certification advance mental health clinical research?

The STARR Certification advances mental health clinical research through a series of certification elements including the following:

  • Engaging with Advocacy – Sites that are engaging advocacy and building trusting relationships within local advocacy branches are likely to have better relationships with the patients, higher staff morale and job satisfaction, lower staff turn-over, and overall more successful trials. The STARR Coalition has established relationships with advocacy organizations and will help open the doors for mutually beneficial relationships.

     

  • Engaging with the Community — Successful community engagement will raise your site’s profile within the community, while educating the public on the benefits of clinical research.
    To that end, The STARR Coalition has created a simple Community and Advocacy Assessment process to identify community assets and areas of opportunity. This may include local treatment centers, life skills and employment centers, hospitals, clinics, and schools, in addition to the local advocacy organizations like NAMI, DBSA, and MHA. We’re happy to work with sites to complete the Assessment and provide tools to engage with the community.

     

  • Workgroup Participation – The workgroups include Project RockSTARR, STARR 911, Community Education and Engagement, and Research Parity workgroups, and we’re currently working on setting up a Site-Support Network and a workgroup on Diversity. If you have any ideas for a workgroup that you think would be relevant and worthwhile, please let us know!

     

  • STARR 911 Implementation – The STARR Coalition has created a straightforward process to provide support to inbound callers that express suicidal ideation. Site staff is given very simple and specific instructions on referring callers to the Suicide Lifeline for support or conduct a warm handoff to a suicide prevention specialist. The idea here goes beyond simply preventing suicide and saving lives — it is that if even one site staff member turns away someone that has suicidal thoughts because they don’t meet study criteria, that undermines all mental health research credibility and reinforces that idea that researchers don’t really care and will only use the ‘subjects’ that meet criteria. It erodes public trust and perpetuates the stigma against mental health research.

     

  • Auditory Hallucination Simulation – This empathy training provides staff with a better understanding of what it’s like to experience this relatively common mental health symptom. Empathy not only makes for better site staff, but data shows that clear understanding the bigger picture (finding a cure) helps improve site morale. A link to the Simulation is available on the website under the Auditory Hallucination Simulation module.

     

  • Project RockSTARR Implementation – This program has multiple benefits: (1) it gives sponsors the opportunity to support local advocacy; (2) it empowers volunteers to give back to their community; and (3) it builds a stronger relationship between local advocacy and research sites. When (and only when) Sponsors implement Project RockSTARR is for specific trials, The STARR Coalition will train the relevant staff to provide potential subjects with the information.

The certification is an evolving process – we welcome any suggestions for new topics, changes to the existing elements, and/or ideas to improve this process.

What does my site have to do to be STARR Certified?

We know that you are busy and have kept the certification requirements as simple as possible:

  • 40 hours of Community/Advocacy outreach each year: this is something that many of you are already doing. Simply let us know what you’ve done to meet this criteria. If you worked a mental health fair, did a training/talk at a community event, or participated in a NAMI Walk, let us know when and what you did.

     

  • Suicide prevention training – it’s an 11 minute video training for each of your staff people. And we’ll provide the 3-minute script and lifeline numbers for your staff to give to suicidal callers that don’t meet study criteria. This is one of the certification elements that no one can afford NOT to do.

     

  • Empathy and stigma reduction training – the stigma reduction training is simply a 15 minute read and the auditory hallucination simulation takes at most 30 minutes and gives your patient-facing staff a clearer understanding of what some of your patients experience. Again, it’s a simple thing with possible game-changing repercussions.

     

  • The community assessment element does require filling out a form that may take a bit longer, but it is information that you likely already have. And if you don’t have the information, it would be beneficial to you and your staff to collect it and have it available because:
    1. it provides a list of your community’s resources that you have access to;
    2. it provides a list of your community’s resources that can offer their contacts access (and awareness) to you;
    3. it gives your site staff a big-picture view of your place within your community, which data strongly indicates creates a happier, more satisfied workplace culture, which data strongly indicates makes for a more productive team.

I’m busy and don’t have time for more paperwork.

There is minimal paperwork involved with your site certification. And if the 30-60 minutes a year is too burdensome, we’ll help you with that by collecting your info on a quick call and we’ll handle the re-certification paperwork for you.

What if I already know the advocacy people in my community and I don’t need your help with that?

Great – we need experienced people like you to join us in helping others work with the advocacy organizations within their communities. Share some of the benefits of developing a relationship with advocacy and some ideas on how to go about nurturing those relationships and leveraging them to educate the public on clinical research and the benefits of participating in a mental health clinical trial.

Maybe you can help us by doing a podcast with us or sharing some training material you’ve used.

We need you in the STARR Coalition.

How are sponsors and CROs supporting the STARR Site Certification?

Many sponsors are part of The STARR Coalition and have worked together to create the STARR Site Certification. They are supporting this initiative with funding and, more importantly, time. New sponsors and CROs are joining The STARR Coalition every day and putting resources toward the STARR Site Certification and the certification elements like Project RockSTARR and STARR 911.

Sponsors are working on adding “Are you STARR Certified?” to their site feasibility forms because they want to be reassured that site staff has all of the tools available to operate at peak performance, with respect to the people they serve and building credibility for clinical research.

Sponsors continue to join us to work with thought-leaders from across the research industry, advocacy, treatment, regulatory agencies and those living with CNS disorders to work collaboratively to identify areas we need to improve for patient care in research, research education, reducing stigma around diseases and promotion of research as an option for all. Everything The STARR Coalition does comes from our stakeholders looking to make positive change.

How is the STARR Site Certification going to have any real impact on mental health clinical research when nothing has changed despite millions of dollars in marketing efforts over the last 15 years?

It’s true: despite years of effort, the disparity between mental health research and other disease research is vast and the stigma around mental health disorders and clinical research persists. Years of marketing effort and millions of dollars has gone toward making mental health research a trusted treatment option, just as it is with oncology, but the needle hasn’t moved much in our direction.

That’s precisely why we’re doing this.

We need to start from a place of trust to lay the foundation. That is why the site certification endorses building relationships with local mental health advocacy organizations and engaging with the community — because change has to come from the inside – from trusted sources within each community, then growing outwards to spread throughout the whole system.

What is the annual fee to be STARR Certified?

The $2,500 annual certification fee can (and maybe should) be considered a donation to a worthy cause and we would welcome an even larger donation, if you are inclined and could use the tax break. This money helps support the STARR Coalition, which exists to support YOU. And yes, it is tax-deductible.

I’m happy to DONATE $2,500 to STARR because it’s a worthy cause (and I get the tax break), but not happy to be told that I am now expected to pay for something that I already do as standard practice.

The STARR Site Certification is OPTIONAL. The certification fee can (and maybe should) be considered a donation to a worthy cause: this money helps support The STARR Coalition, which exists to support YOU.

Again, your STARR site certification provides you with assurances that ALL of your staff is on point and employing standardized best practices. You may think that your staff would respond appropriately in any given situation, but without actual procedures in place and some training, you can’t be sure.

You might be thinking…

“I already do all of the things that the certification offers – I am empathetic; I’ve handled and helped people in crises; I promote research within my community. I don’t need help with any of that.”

 

That’s great! In your case, the STARR Site Certification provides you with assurances that ALL of your staff is on point. You may think that your staff would help someone in suicide crises, but without actual procedures in place and some training, you can’t be sure.

If even just one of your staff people turns away someone that has suicidal thoughts, that undermines your credibility and reinforces the idea that research doesn’t care and only “uses” the “subjects” that meet criteria. It erodes trust.

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The objective is to provide help, build trust, and save lives, but unless there are real systems and procedures in place, with training and follow-up spot checks, how can you know for sure that everyone on your staff is responding the right way?