Getting a Biobank or Registry Started

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Advocacy Organizations and Research Initiatives

The current system of academic research and rewards is fractured and unable to facilitate true collaboration and sharing. The pharma R&D pipeline has not had significant increases in the past 50 years, and the number of new submissions at the FDA is trending downward. Our current system isn’t sustainable and we, as a community, have the opportunity and the obligation to change the biomedical ecosystem. AND we can’t do this without the involvement of individual advocates, citizen scientists, and advocacy organizations.

Advocacy organizations are key stakeholders for the development of registries and biobanks, and they are vital to the advancement of collaborative science. Advocacy organizations:

  • Develop communities of trust
  • Leverage scarce resources
  • Understand the unmet research needs of the community
  • Facilitate collaboration between diverse stakeholders
  • Are committed to the cause for the long-term
  • Are appropriate and dedicated stewards of data and sample

We have many examples of successful advocacy-initiated and advocacy-managed biobanks, through Genetic Alliance Registry and BioBank and others. It is clear that advocacy organizations, individual advocates, and citizen scientists are essential partners in transforming our current system.

Interested in more information about registries and biobanks? Visit our Toolbox or attend the Registry and Biobank Track at the Genetic Alliance Annual Conference .

Resolutions for your Registry or Biobank

It's that time of year again. As we begin 2011, we are saturated with information about resolutions for the New Year and setting obtainable personal goals. Fortunately, much of this advice can be translated to your registry or biobank:

1. Think about what you have learned in the past year

Perhaps you attended a conference or webinar on biobanking that gave you useful information, or you had a conversation with someone who gave you practical advice. This is a great time to reflect about what you have learned in the past year. This exercise can also be done with others working on your biobanking initiative with you.

2. Identify a few attainable goals and one stretch goal

Instead of making one large list, consider breaking your goals into 2-3 tasks per quarter that can be achieved. Your stretch goal should be something that you strive for but is challenging. For example, if you want to improve retention rates so participants are not lost to follow-up, you will want communicate regularly with your participants. A goal could be to provide regular updates (e.g. quarterly) about your registry or biobank to your community using your newsletter, website, listservs, etc.

3. Cultivate new relationships

The New Year is a great time to meet new people and begin new relationships. We have an incredible resource of people knowledgeable about registries and biobanking in our community. Take this opportunity to reach out to a colleague or become involved in the discussion.

4. Pick one thing you want to become really good at

What skills do you want to build in 2011? Is there one thing that you would like to become really good at in the New Year? We can't be experts in everything, but if we focus on one or two things, we are more likely to build our skill set.

So, what are your biobanking goals for 2011? What new relationships will you build in 2011? How can Genetic Alliance Registry and BioBank help you achieve your goals?

These tips were adapted to biobanking from a career blog at Forbes magazine.

Planning for next year

As the year draws to a close, it is a good time to reflect on the registry and biobank resolutions you made in Week 1. How did you do?

  • Did you meet your goal?
  • Did you meet your stretch goal?
  • Did you cultivate new relationships?
  • Did you learn or improve a skill?
  • Are you ready to set registry and biobank resolutions for 2012?

Wishing you a happy and healthy new year filled with bytes and aliquots!


Setting Goals for your Registry or Biobank

Now that you´ve had a chance to think about your biobank resolutions for 2011 and identify some goals for the coming year, it´s time to make your goals a reality. You often hear businesses talk about SMART goals – SMART is an acronym for Specific, Measurable, Attainable, Realistic, and Timed. While this is a valid way to think about your goals, I like to use a simple goal setting worksheet (outlined below).

Once you have identified a goal, you should describe it as specifically as possible. Why is this goal important to you? Give reasons. Set a deadline for this goal, and identify specific steps to achieve it. It is also important to consider potential obstacles that could prevent you from reaching your goal, as well as qualities and experiences that will help you meet your goal.

  • My goal is:
  • My goal is important because:
  • My target date/deadline is:
  • Steps I´ll take to reach my goal:
  • I will know I´ve reached my goal when/because:
  • Potential obstacles that could prevent me from meeting my goal:
  • Qualities and experiences that will help me meet my goal:

You will also want to review your progress at regular intervals, such as monthly or quarterly. I also find that telling people what my goals are makes me more accountable for achieving them.

Staffing your Registry or Biobank

There are a variety of staffing models that can be used for registries and biobanks, and most advocacy-driven research initiatives utilize a combination of paid staff and volunteers. At a minimum, you will need to determine who will be responsible for managing the following:

  • Overall scientific direction of the project
  • Regulatory compliance
  • Day-to-day operations
  • Interactions with participants and potential-participants
  • Relationships with vendors and partners
  • Transactions with researchers and others accessing your collection
  • Financial oversight
  • Communications with your community, the research community and the public
  • Security and privacy

While there will likely be some overlap, it is essential that you identify roles and responsibilities for all individuals working on your registry or biobank. You may find it helpful to write job descriptions. It is also worth noting that the skill set needed for establishing the resource may be different than the skills needed to maintain the resource.

Study Design - Participants

With any registry or biobank, it is important to develop a research study design. Your study design will be influenced by the research question(s) you are trying to answer. One aspect of study design is determining from whom you will collect data and samples. For example, some organizations collect data and samples from all individuals with a disease or condition of interest (e.g. all comers). Other organizations use specific inclusion and exclusion criteria to determine who can participate. Examples can include:

  • Cases – individuals (unrelated) with the condition of interest
  • Controls – individuals without the condition of interest
  • Families – related individuals where some are affected
  • Trios – two parents and an affected child
  • Sib-pairs – two siblings and one parent

Your medical and scientific advisors can help you determine the most appropriate individuals to donate data and samples, as well as develop inclusion and exclusion criteria. You will also want to consider the budget implications of any potential study design.

Operations for your Registry or Biobank

Many organizations focus on the technical aspects of registries and biobanks, determining what data and samples will be collected and the processes for collection. While these are very important aspects of a registry or biobank, it is also essential to develop procedures to manage your day-to-day operations. You will want to separate the processes related to your research study from other organizational processes such as fundraising.


You should begin by listing all tasks related to your registry or biobank. These may include answering questions from potential participants, consenting participants, assigning participant IDs, requesting and sending sample collection kits or registry questionnaires, communicating and following-up with participants, interacting with researchers or clinicians, and sending samples to researchers. Once you have listed the tasks, you should identify which ones will be performed within your organization.


You should then develop workflows for all organizational tasks and processes related to your registry or biobank. Be sure to include the staff members or volunteers assigned to each task, as well as the tracking systems in place. Remember that these processes must be consistent with the research protocol submitted to the IRB.


Contingency Planning for your Registry or Biobank

Contingency planning is an important activity for all major initiatives. It is a planning exercise that helps you think through the “what ifs” of a situation, and in many cases the worst-case scenario. The CDC recently released a campaign to help people prepare for emergencies, using the Zombie Apocalypse as an example. While the Zombie Apocalypse is extremely unlikely, there are useful lessons to be learned about emergency preparedness.


Contingency planning is useful for your registry or biobank. It is not expected that you will identify every possible situation and outcome, but rather that you think through possible scenarios and organizational responses. Remember, the worst-case scenario is unlikely, and this exercise will help you meet your goals and respond to any challenges you may face.


Things to consider:

  • What is the worst-case scenario?
  • What if you are over budget? If funding is insufficient?
  • What if you are behind schedule?
  • What if key people leave?
  • What else should you consider?


Visit Preparedness 101: the Zombie Apocalypse

Annual Review of Policies, Protocols and Procedures

Managers of registries and biobanks should conduct an annual review of all policies, protocols and procedures. This is an opportunity to make sure everything is current, and to update things that have changed over the past year. Areas of focus should include:

  • Insurance – review any insurance policies (e.g. D&O insurance) to identify the expiration date and determine if coverage is still adequate for your current activities.
  • Vendor contracts – review all vendor contracts to determine the length of the contract and if vendors are in good standing. This is also an opportunity to evaluate if your vendors are meeting your needs and if you need to identify additional vendors for future work.
  • IRB documents – review the IRB approval letter to determine the length of IRB approval and when any reports or updates are due to the IRB. You should also review the approved study protocol and identify if there have been any changes over the past year. You will want to make the IRB aware of any changes to the study protocol.
  • Additional registry and biobank SOPs – review any additional SOPs your organization has developed around your registry and biobank. This is a great opportunity to evaluate what is currently working and identify areas that could be improved.

By entering this information in an excel spreadsheet, you can document your annual review and any follow-up items, making next year's review even easier. Excel has many useful templates for project management. This is also a good time to schedule next year's annual review on your calendar.

Good advice

Developing a registry or biobank is a rewarding yet significant undertaking. We hope these weekly tips have provided a starting point for dialogue about planning and cultivating your resource. Some final words of advice:

  • Don’t duplicate efforts - registries and biobanks are expensive and administratively burdensome
  • When possible, develop partnerships to share data and resources
  • Ensure you registry or biobank is sustainable over time

Use common data fields/ controlled vocabulary to allow comparison with multiple data sets

  • Retention is key - it is much harder to recruit new participants than to keep those that are participating
  • Sample collection is resource intensive – know what samples you need to collect and from whom
  • Prior proper planning prevents poor performance

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