Ask SCB: How Does SCB Promote Broad Community Participation in Standards?
In this series, SCB staff answer common questions about standards and the standards development process from the regenerative medicine community.
Diverse and comprehensive input from the community is critical to the development of consensus-based standards. Below are some of the strategies we use to make sure that standards have the right input to represent the needs of the stakeholders they will impact.
How does SCB determine what expertise is needed for a standard effort?
We use the following process to identify the different areas of expertise needed to develop an effective standard:
We consider who would be impacted by the standard, including those who are likely to use the standard directly (e.g., in regulatory submissions) and those who may be involved upstream and downstream. For example, the stakeholders making equipment or materials involved in a standard are often impacted indirectly.
We reach out to those who will be impacted and request their involvement in the standards development working group. Upon the identification of the initial group of individuals involved in the relevant topic areas, we engage with them to make sure we have successfully captured the opinions of all relevant stakeholders. As these experts often have unique insights into the key stakeholders through their immersion in the technical topic areas and workflows related to the standard, their input is invaluable.
We then invite the recommended experts/stakeholders to join the working group and continue the process until all the expertise gaps have been identified.
How does SCB reach out to potential participants?
Once we have identified expertise gaps, we solicit input in several ways:
Continue to encourage the stakeholders in our working groups to reach out to their peers who have relevant skills and expertise
Contact partner organizations (e.g., scientific and professional organizations) and ask them to share the participation opportunity with their stakeholders
Make public calls to action to increase awareness of the standard effort on our various communication channels.
How does decision-making work in standards working group meetings?
After we have sought out stakeholders representing all the key areas of expertise and perspectives, SCB’s role is to facilitate discussion and help the group reach an agreement. Decisions are then made through consensus of the group. We don’t implement formal quora or voting during our meetings, instead focusing on encouraging conversation and collaboration; however, as the standard advances to a standards development organization (SDO) for development, the SDO will often use these formal processes.
How do you resolve disagreements about how to move forward?
Many times, when the experts have a disagreement, their positions are much more similar than they initially recognize. To help align the expert perspectives and articulate the similarities of views, we will request the experts to share their opinions and reasons in writing. If that doesn’t resolve the issue, we’ll ask the group to provide written input; this can lead to productive discussion of concrete changes to make. From there, the group will make a consensus decision on how to move forward. If no clear consensus can be found, we’ll develop a new draft that takes both perspectives into account.
How can I help SCB raise awareness of opportunities to provide input into standards?
The quality and relevance of standards ultimately depend on the people who write them, and your support is critical to help us make sure all the expert opinions are captured.
There are several ways to stay up to date on new standards participation opportunities and help us spread the word:
Follow SCB on Twitter or LinkedIn and share relevant posts with your network
Share our monthly calls for experts with your colleagues
Be a champion of the importance of standards within your organization
Help connect subject matter experts you know to standards efforts that could use their support by introducing them to SCB staff
Find the latest updates and calls to action on the SCB Regenerative Medicine Standards Portal
Join the mailing list to receive our quarterly newsletter
Get Involved
Whether you are new to standards or an industry expert, SCB offers a variety of ways to engage. Contact us and let us know how you’d like to get involved.