With much anticipation, the Office of Human Research Protections (OHRP) released the final version of the 2018 Common Rule on January 19, 2017. However, with the issuance of an Interim Final Rule on January 22, 2018, the changes are not to be implemented until July 19, 2018.
OHRP plans to provide additional instruction, guidance, and templates on new initiatives such as broad consent, reasonable person standard, and the new/expanded exempt categories, but these materials are not yet available. In the meantime, institutions and independent IRBs must move forward with the planning and development of processes and procedures with the goal of implementation this summer. This is a challenging task for IRBs and for the research community, which has grown accustomed to set parameters within which to plan their studies. The uncertainty surrounding the revised Common Rule was met by IRBs in a variety of ways. Some held off with the development of major process changes citing the lack of guidance and the tight timeline to reprogram systems, rewrite procedures and policies, and adequately educate the community. Others, relying on their current interpretation of the rule, moved forward and created new templates, policies, and online applications ready to launch at midnight on January 18th. However, the January 17, 2018 announcement by OHRP that the implementation and effective dates would be delayed at least 6 months caused a reversal of these plans and left many institutions with questions about how to prepare for the new July 19, 2018 deadline.
Therefore, the Human Research Protections Program at Wake Forest University Health Sciences has developed a short survey to assess the time and effort put forth in preparation for the 2018 Common Rule. The results of the survey may be useful as IRBs prepare to allocate resources for the future effective date. Please consider accessing and completing the survey to provide feedback on the amount of time spent preparing for the 2018 Common Rule, strategies that your institution plans to employ, and what additional guidance would be most helpful.
The survey will take less than 5 minutes to complete, and can be accessed by clicking here, or by pasting the following URL into your browser: https://redcap.wakehealth.edu/redcap/surveys/?s=3LK8T8EHXM
Thank you for time and input into this important question.
Director, Human Research Protections Program and IRB
Wake Forest University Health Sciences
Winston-Salem, NC 27157