Clinical research is getting with the times!  Good Clinical Practice, the BIMO manuals, and EMA guidelines on computerizes systems have undergone significant "renovations" in the past few years (to use that delightful ICH term). Now the Declaration of Helsinki replaces its marble counter tops in its first update since 2013. Let's see what's new:

• Terminology.  Like Good Clinical Practice, the Declaration of Helsinki now uses "participants" in place of "subjects," "researchers" to encompass non-physician investigators, and the more inclusive "they" in place of "he/she." 
• Risk/benefit for underrepresented populations.  Although the prior version emphasized protections for vulnerable subjects, Section 6 of the update emphasizes the need to consider the risks and benefits of inclusion in/exclusion from research for under-represented populations.  The update points out that research takes place in the context of "various structural inequities"; when vulnerable populations are included in research, per Section 12, they should receive "specifically considered support and protections."  Researchers are urged to engage with participants and their communities to design research and share results. 
• Public health emergencies.  The update cautions that ethical principles must be upheld even in public health emergencies.
• Quality by design and environmental sustainability. The update nods to this principle of ICH E8 by adding that research should be designed (not just conducted) to minimize harm to the environment and adds that research should strive for environmental sustainability.
• Misconduct. Section 12 now specifically states that researchers must not engage in misconduct.
• Protocol.  The update now states that the protocol should include aims, methods, anticipated benefits, potential risks and burdens, and provisions to protect participant privacy and confidentiality.  
• Ethics Committees.  Section 23 now states that Ethics Committees must not only be independent of the researcher but should also have the authority to resist undue influence. This section also adds that Ethics Committees must have sufficient resources to perform their role; must be familiar with local circumstances and context; and must include at least one member of the general public. 
• Ethics Approval.  Section 23 specifies that Ethics Committees must have the right to monitor, recommend changes to, withdraw approval for, or suspend ongoing research. adds a statement that international trials must be approved by Ethics Committees in all countries where the research is conducted. 
• Informed consent.  The update adds an introductory statement that "free and informed consent is an essential component of respect for individual autonomy." In addition to other requirements for informed consent, participants must be informed about the qualifications of the researcher (previously, the "institutional affiliations"); provisions to protect privacy and confidentiality; and provisions for treating or compensating participants who are harmed during research. Section 27 on participants who are initially incapable of providing informed consent adds that consent should be sought from a participant if they regain capacity to give it.
• Consent for use of biological samples. In cases where participants are asked to consent to collection and storage of samples for "multiple and indefinite uses," an Ethics Committee must approve and monitor the ongoing use of databases and biobanks.  Such consent must be consistent with the WMA Declaration of Taipei. 
• Post-research follow-up.  An Ethics Committee must approve any case where post-trial provisions for participants who require additional interventions cannot be made.