Free, Prior and Informed Consent

US Government Proposes to Weaken Informed Consent

Three section of the United Nations Declaration on the Rights of Indigenous Peoples (2007) state that indigenous peoples–indigenous nations–have a legitimate expectation that no legislative, administrative or juridicial action, policy or practice may be carried out by a state or its subdivisions without first obtaining their free, prior and informed consent. Inclusion of this principle in this Declaration attests to the fundamental importance states approving the Declaration are presumed to attach to international common law. Insertion of the principle of “free, prior and informed consent” was promoted and advocated by political and legal representatives of Fourth World nations and organizations during the development of the Declaration in the 1980s and 1990s. Perhaps more than any other principle, the mandate to obtain the free, prior and informed consent of Fourth World nations in advance of actions taken by states, international bodies and substate parties is now part of common international law.

To recognize the principle in common international law or even in statutory international law is not the same thing as implementing the principle and enforcing the principle’s application. 

The United States Department of Health and Human Services is responsible in that country for administering regulations concerned with human subject research–particularly in conjunction with obtaining “informed consent” from participants or subjects. This principle was encoded in US law thirty years after the Nuremberg trials in Germany concluded that experimentation on human subjects by the Nazi German government must be considered a violation of human rights–even perhaps a crime against humanity when applied to “a people in whole or in part.” Beginning in 2011 the US Department began developing and has now published for comment (period to end 16 January 2016) fundamental changes in the application of “informed consent” requirements involving human subject research.

The current proposed changes appear in proposed rulemaking to “Revise the Federal Policy for the Protection of Human Subjects (the “Common Rule”). The “common rule.” The common rule embraces three principles emphasized in the Belmont Report (resulting from the Nuremberg Trials)– justice, beneficence, and respect for persons – to protect living human participants in research. Subpart A is often referred to as the Federal Policy or the “Common Rule”, and it outlines basic requirements for Institutional Review Boards (IRBs), informed consent processes, and assurances of compliance with research regulations. Subparts B, C, and D provide further protections for pregnant women, fetuses, neonates, prisoners, and children.

Under the UN Declaration, one can readily see that the principle of “free, prior and informed consent” is essentially embodied in the “common rule.” So, what is the problem?

The US Department’s proposed changes that will affect all US government agencies, research in many countries around the world since they follow US human subjects regulations and Fourth World nations since many nations have sought to regulate access to native peoples by researchers who fail to obtain free, prior and informed consent.

1. No Fourth World government has been consulted by the United States government in the development of its proposed rule change.
2. The rule change proposes “broad consent” that allows unspecified use of biospecimens (bodily fluids, blood, tissue, genetic material, etc) leaving the source without prior or informed consent. This is very serious since native peoples the world over have been the subjects of biospecimen collections. Since native peoples around the world have been experimented on using radioactive materials their tissues and samples even now would not necessarily be protected under informed consent.
3. The new rule would not protect the use of biospecimens taken from individuals even after they have died.
4. The rule calls for the use of a single Institutional Review Board to oversee research which fundamentally conflicts with the authority of Fourth World governments and any guiding or oversight bodies created in the community.
5. The proposed rule suggests the exclusion of consent coverage over oral histories, biographies, sacred knowledge, without out Fourth World governmental or community oversight directly conflicts with the principle of free, prior and informed consent.

Informed consent is fundamental to the right of personal autonomy and the protection of small and large Fourth World Nations from depredations and unscrupulous researchers, agencies and governments. Here is an instance when the principle of free, prior and informed consent is clearly essential.

The US government must immediately employ that principle and exempt an Fourth World nation from its ruling. If the US government does not, each concerned Fourth World government must enact enforceable laws to protect their people and prevent this potential invasion.