Frequently Asked Questions: HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required)

The U mechanism, or cooperative agreement, is a support mechanism intermediate between a grant and a contract in how it is handled. It is used when there will be substantial Federal scientific or programmatic involvement in the initiative once the award is made. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. Awards made to this funding opportunity will be cooperative agreements.

The NIH Helping to End Addiction Long-term^® Initiative, or NIH HEAL Initiative^®, is an effort to speed scientific solutions to stem the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the NIH HEAL Initiative is available at heal.nih.gov. The overall goal of this program is to inform clinicians about the effectiveness of interventions such as coordinated, multidisciplinary management strategies that reduce acute and/or chronic SCD pain and that continue to provide access to opioid pain management as needed. Clinical trials in this program will be conducted within the infrastructure of the HEAL Pain Management Effectiveness Research Network (HEAL ERN).

Clinical efficacy or effectiveness research aims to evaluate whether interventions improve clinical and/or functional health outcomes in ways that are significant for patients, clinicians, and other decisionmakers. These research studies may utilize various control groups including, but not limited to, placebo, sham conditions, time and attention, active comparison, or usual care controls.