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The committee that advises the Secretary of the Department of Health and Human Services (HHS) has made the recommendation to exclude “surveillance activities” for intelligence agencies. Surveillance activities does not typically pertain to research. This would provide a loophole for the intelligence community, which has been one of the primary offenders of the Common Rule. vi. Intelligence Surveillance Activities (NPRM at §ll.101(b)(1)(vi)) The sixth category of excluded activities that will not be considered research involves surveys, interviews, surveillance activities and related analyses, or the collection and use of bio specimens where these activities are conducted by a defense, national security, or homeland security authority solely for authorized intelligence, homeland security, defense, or other national security purposes. The rationale for excluding the defense or national security-related activities is similar to that described above regarding public health surveillance activities. The lawful conduct of the departments’ and agencies’ mandated missions for actively protecting national security, homeland security, and homeland defense are fundamentally not research.

These activities may incorporate the collection and analysis of identifiable information, but they are not information, but they are not designed to develop or contribute to generalizable knowledge; rather, they are solely conducted to fulfill a department or agency’s legal mandate to ensure the safety and protection of the United States, its people, and its national security interests.

This exclusion codifies the current interpretation of the Common Rule. Research conducted or sponsored by Federal departments and agencies using this exclusion will continue to be subject to this regulation.

Throughout the United States people are complaining of unrelenting Cointelpro, Red Squad, and State Secret Style Operations. These covert operations are conducted against activist, political group, whistleblowers, everyday citizens under the guise of National Security. Yet, some of these individual latter find out, that they are non-consensual experimentees. Elements of the United States government are using various nano technology, sensors, tracking devices for experimentation purposes and control.

The above named operations are a smoke screen to shield the misconduct. When the victims of government sponsored technological abuse complain, often they find themselves in a mental institution to affect their credibility. Tell the congress we do not want the intelligence agencies to have any exclusion. On the contrary, we seek stronger human protections from their research, and we would like them enforced.

Tell Congress to conduct an investigation into modern day Cointelpro, RedSquad, and State Secret Style Operations; which are covertly being implemented against the public. Please submit your ………….. (create a link for this information- from the above information) The Nuremberg Code was developed in 1947 to set out principles for human medical experimentation in response to what had been uncovered during the Nuremberg trials about experiments performed by Nazi doctors on Jews in concentration camps and other prisoners. The Helsinki Declaration 1964 was produced by the World Medical Association to be a universally accepted set of ethics principles governing the behavior of doctors and other researchers doing studies with human subjects, and it included many of the same principles set out in the Nuremberg Code. In the United States the Tuskegee Syphilis Study, a controversial 40-year study of nearly 400 poor black farmers with syphilis, led to the establishment in the early 1980s of regulations to protect human subjects and later to the creation of the Office of Protections from Research Risks and to the requirement that federally funded human subjects research be overseen by institutional review boards. Federal Policy for the Protection of Human Subjects (‘Common Rule’) The current U.S. system of protection for human research subjects is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human

Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations. The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A.

For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.

The list below displays the agencies and departments that have signed onto the Common Rule and their CFR numbers. Hyperlinks are to areas of a department or agency Web site that have been suggested to HHS as entry points for those interested in human subject protection activities of the department or agency.

7 CFR Part 1c – Department of Agriculture

10 CFR Part 745 – Department of Energy

14 CFR Part 1230 – National Aeronautics and Space Administration

15 CFR Part 27 – Department of Commerce – National Institute of Standards and Technology

16 CFR Part 1028 – Consumer Product Safety Commission

22 CFR Part 225 – Agency for International Development (USAID)

24 CFR Part 60 – Department of Housing and Urban Development

28 CFR Part 46 – Department of Justice – National Institute of Justice

32 CFR Part 219 – Department of Defense

34 CFR Part 97 – Department of Education

38 CFR Part 16 – Department of Veterans Affairs – Office of Research Oversight – Office of

Research and Development

40 CFR Part 26 – Environmental Protection Agency – Research and Development

45 CFR Part 46 – Department of Health and Human Services

45 CFR Part 690 – National Science Foundation

49 CFR Part 11 – Department of Transportation

Although they have not issued the Common Rule in regulations, three other departments and agencies comply with all subparts of 45 CFR part 46. These include:

 The Central Intelligence Agency, by executive order, must comply with all subparts of 45 CFR

Part 46. (Executive Order 12333, paragraph 2.10)

 The Department of Homeland Security, created after issuance of the Common Rule, has chosen

to apply all subparts of 45 CFR part 46 to its human research activities. (6 U.S.C. section 112)

 The Social Security Administration was separated from HHS in 1994 and, absent action by the Administrator, must apply all regulations that applied to SSA before the separation. (42 U.S.C. section 901)

Several non-HHS federal departments and agencies have additional regulations in place for research involving special populations or for human subjects research in general. The federal department/agency that conducts or supports research retains final authority for determining whether an institution has complied with its regulations for the protection of human subjects. If HHS receives an allegation or indication of noncompliance related to human subject research that is conducted or supported solely by a Common Rule department/agency other than HHS, HHS will refer the matter to that department/agency for review and action as appropriate. Investigators are encouraged to review the regulations of the funding agency to determine whether additional regulations apply. Also, many agencies have not adopted subparts B, C, or D and grantees of those agencies are not necessarily bound by them. Grantees should consult their funding agency for guidance.

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