Item 30: Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation.
Example 1
“Patients that are enrolled into the study are covered by indemnity for negligent harm through the standard NHS [National Health Service] Indemnity arrangements. The University of Sheffield has insurance to cover for non-negligent harm associated with the protocol . . . This will include cover for additional health care, compensation or damages whether awarded voluntarily by the Sponsor, or by claims pursued through the courts. Incidences judged to arise from negligence (including those due to major protocol violations) will not be covered by study insurance policies. The liability of the manufacturer of IL1RA (Amgen Corporation) is strictly limited to those claims arising from faulty manufacturing of the commercial product and not to any aspects of the conduct of the study.”145
Example 2
“13.6 Access to Effective Products
Should this study provide evidence of the effectiveness of TDF [tenofovir disoproxil fumarate], FTC [emtricitabine]/TDF and/or tenofovir 1% gel in preventing HIV [human immunodeficiency virus] infection, it will be critical to provide access to the effective product(s) to study participants, their communities, and the worldwide population at risk for HIV infection in a timely manner. In preparation for this study, discussions have begun with Gilead Sciences, Inc. and CONRAD [Contraceptive Research and Development Organization] to ensure such access. Considerations under discussion include licensing agreements and preferred pricing arrangements for the study communities and other resource-poor settings.
While this study is ongoing, the MTN [Microbicide Trials Network] will continue these discussions. In addition, discussions will be initiated with other public and private funding sources such as the WHO [World Health Organization], UNAIDS [Joint United Nations Program on HIV/AIDS], Gates Foundation, and appropriate site government agencies that may be able to purchase product supplies in bulk and offer them at low or no cost to the study communities and other resource-poor communities most in need of the product(s). Operations and marketing research also may be conducted to determine how best to package and distribute the products, and maximize their acceptability and use, in at-risk populations.”365
Explanation
The provision of ancillary care refers to the provision of care beyond that immediately required for the proper and safe conduct of the trial, and the treatment of immediate adverse events related to trial procedures. It is generally agreed that trial sponsors and investigators should plan to provide care for participants’ health care needs that arise as a direct consequence of trial participation (e.g., intervention-related harms). It is also important to consider whether care should be provided for certain ancillary needs that may otherwise arise during trial participation. Provision of care for ancillary needs reflects the fact that participants implicitly, but unavoidably, entrust certain aspects of their health to the research team. The scope of entrustment will vary depending on the nature of the trial (e.g., setting, health condition under study, investigations performed).366 Additional factors that influence the strength of the claim to ancillary care include participants’ vulnerabilities; uncompensated burdens and harms; the intensity and duration of the participant-researcher relationship; and the degree to which participants are uniquely dependent on the research team for health care.367
The Declaration of Helsinki states that “the protocol should describe arrangements for post-study access by study participants to interventions identified as beneficial in the study or access to other appropriate care or benefits”.1 This principle is particularly applicable – and controversial – when research enabling the development and regulatory approval of interventions is performed in countries where subsequent access to the interventions is limited by cost or lack of availability.368
The protocol should describe any plans to provide or pay for ancillary care during the trial and identify any interventions, benefits, or other care that the sponsor will continue to provide to participants and host communities after the trial is completed.369 Any plans to compensate participants for trial-related harms should also be outlined.
| 29: Access to data | 31a: Trial results |
