Adequate SOC v “undue inducement”
| “Reasonable to conclude that providing medical care to participants iswarranted, appropriate, and proper” (Chapter 3: 47) | Warns against over-large payments that could be undue inducement to participate (Guideline 10) | Silent | “Care should be taken [not to] … unduly influence freedom of choice in participation” (Guidance point 10) | Dividing line is fine between inducement and benefit (Paragraph 44) |
| Researchers should indicate how they would minimise therapeuticmisconception(Recommendation 3.10) | | | | |
Protecting vulnerable populations
| The US Government should not sponsoror conduct trials that do not ata minimum provide … a minimumof risk to participants … and… equal regard for all participants (Recommendation 1.1) | In populations with limited resources, researchers must make every effort toensure interventions will be madeavailable (Guideline 10) | Particular needs of the economicallyand medically disadvantaged must berecognised (Paragraph 8) | Limited availability of care and treatment can increase risk and harm to participants(Guidance point 7: 23) | Developing country participants more vulnerable to exploitation because of limited access to basic health care, lack of knowledge about research, cultural differences (Paragraph 11) |
| … a vulnerable population should not be the focus of research unless the potential benefits of the research will accrue to that group after the trial (Chapter 1: 7) | If [vulnerable persons] participate, means of protecting rights and welfare must be strictly applied (Guideline 13) | | | |
Universal v best locally available care
| An RCT must provide “establishedeffective treatment” in controlarm whether or not available in host country(Recommendation 2.2) | In RCTs, subjects should generally receivean “established, effective intervention”(Guideline 11) | In RCTs, must provide “best current SOC” (Paragraph 29) | Need to achieve equity in care andtreatment globally; minimum is best proven locally (Guidance point 16: 42–3) | In RCTs there is a strong case for current standard local treatment (Paragraph 36) |
Capacity building for SOC
| Potential problems exist maintaining SOC established during a trial … sponsors could undertake training of personnel, maintenance of equipment post-trial; ultimate goal is to improve welfare of those in host country (Section 5: 77) | Sponsors are ethically obliged to ensure availability of services to make intervention reasonably available (Guideline 21) | Every participant in trial should be assured access to the best proven methods identified by study(Paragraph 30). This implies building capacity though not explicitly mentioned | Sponsors should contribute to health care capacity-building integrated into community infrastructure (Guidance point 16: 42–3) | The ethical obligation to provide improved care when trial over and by whom is unclear (Paragraph 17) |
Treatment of research related injury
| Adequate care and compensation for injuries directly sustained during research must be provided (Recommendation 1.1) | “Sponsors obliged to ensure treatment for subjects who suffer injury as consequence of research interventions”(Guideline 21) | Silent | Sponsors need to ensure care andtreatment for those who become HIV+(Guidance point 16) | “Provision of care for seroconverters may be a function of what is locally available” (Paragraph 54) |
Community participation
| Researchers/sponsors should involve community throughout trial design and implementation (Recommendation 2.3) | Important to involve community members in decisions around benefit/risk,informed consent, responsiveness to health needs (Guidance 1, 10) | Silent | Comprehensive care and treatment package should be developed by community (Guidance point 5, 16) | Silent |
Pre-trial agreements
| Whenever possible, preceding start of research, agreements should benegotiated to makebenefits/intervention available to host country after research is completed (Recommendation 4.3) | Sponsor obligations should be clarifiedbefore research begins(Guidance 21) | Silent | Plans to make vaccines, other knowledgeand care available should be developedat initial stages (Guidance point 2, 16) | Researchers can demand pre-trial discussions with pharmaceutical companies (Paragraph 57, 64) |