Call for Comments: (the participation of dozens of victims of Non-Consensual Hi-Tech, or other, Surveillance, Monitoring, and/or Harassment ('TI's), or 50 to 200 or more victims ('TI's), is needed)

      On September 8, 2015, a Notice of Proposed federal Rulemaking was published,  AFTER 4 years of government DELIBERATIONS about possible rule changes to the Federal Policy for the Protection of Human Research Subjects.  Among its few dozen proposals published on September 8, is, all of a sudden, out of no-where, and with ZERO prior discussion:
     -   A proposal to Exempt, unspecified, "U.S. Intelligence Surveillance Activities" from being concerned with any federal rules or regulations from the federal Policy for Protection of Human (Research / Experimentation) Subjects.
 
       [ September 8, 2015 "Notice of Proposed Rulemaking [NPRM]: Federal Policy for Protection of Human Subjects",  has  NPRM subpart: ]
      "vi. Intelligence Surveillance Activities (NPRM at § __.101(b)(1)(vi))(1) NPRM Proposal
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 biospecimens 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 Public Comments for this federal Rulemaking are due early January 2016.

    One can only imagine dozens or (over the coming years) hundreds, of strange, or 'ambitious' (ambitious to push the edge of borderline rights violations, or worse), or 'mad-science' (as in: 'mad' for acquiring scientific knowledge), Human Research proposals which, plausibly, someone in the Defense/Intelligence Community is 'JUST WAITING' to be given 'license' to attempt! 

     It is Critically Important that individual victims, and victims collectively (such as via: an FFCHS community wide comment; and/or FFCHS Regional groups, and/or other groups of victims) file a "Public Comment" to the federal Rulemaking Public Comment period for the proposed change in federal policy.
     Because the Public Comments are due by early January 2016, individuals and groups filing comments should compose their comment, research it, proof read it (and have other 'aware' TI's or others read it), and file it, before mid-to-late December [December 15 - 30, 2015] (if possible).
[ On November 24, 2015, the Rulemaking Public Comment period was extended 30 days to early January 2016. ]

  Additional Information:
      What TI's should know about this federal rulemaking:
      Excerpts from the September 8, 2015 NPRM which concern us:
      Information, tips, and suggestions on submitting Public Comments:


    What TI's should know about this federal rulemaking:

-   TI's / FFCHS members should realize that we are 'stakeholders' here, in that many of us, if not nearly all of us, are citizens who have been alleging (often for years or longer) that we are being subjected to non-consensual human experimentation, and technology testing and development and evaluation, regarding advanced technology, and/or assorted 'low tech', intelligence related surveillance methods and technologies; [ The name of our National Group: 'Freedom from Covert Harassment and Surveillance' obviously speaks for itself! ]

-   TI's / FFCHS members should know (if they don't already know it) that: Bad federal regulations can cause, or enable, or encourage, governmental violations of Civil Liberties, and/or basic U.S. Constitutional Rights, and/or Human Rights.  It is not just federal and state laws which govern our Country, but, at the federal level, Federal Regulations play an important role in controlling what the government can and cannot do;

-   TI's / FFCHS members should know that Federal Rulemaking, and the Public Comment process of Federal Rulemaking, legally obligates the U.S. Government to conduct an Honest Process. If the agencies conducting the rulemaking hear loud and clear from stakeholders, and even from ordinary citizens, and it is apparent that there are strong objections to a new federal rule proposal, then THOSE IN CHARGE OF THE RULEMAKING ARE LEGALLY OBLIGATED to not ignore significant objections to proposed rule changes. Very often, Public Comments to a Rulemaking public comment period cause the Government to either abandon a proposed rule change, or to significantly revise and restrict a proposed rule change, which (if there still is a possible adverse impact upon the public) then may result in a re-proposal of the modified proposed rule change.

-   It is arguably important to inform all stakeholders here to consider appending  to their Public Comment   a statement of the form:
     'The October 1995 Final Report of ACHRE (Advisory Committee on Human Radiation Experiments) recommended, at their recommendation 15, “the adoption of a federal policy requiring the informed consent of all human subjects of classified research and that this requirement not be subject to exemption or waiver". Thereupon, on March 27, 1997, President Clinton issued an Administrative Order “Strengthened Protections for Human Subjects of Classified Research”, [Federal Register, May 13, 1997, pp. 26367-26372], which attempted to institute that protective rule.  For 18 years since that attempted Rulemaking (an NPRM was never completed), victims of alleged and actual Non-consensual Classified Human Research, notably including Research involving Intelligence Surveillance-related technologies, have suffered from violations, often horrible violations, of their basic rights.  Without delay, that March 1997 protection proposal should be implemented as an Interim Federal Rule, and an NPRM should be published, and Public Comment should be sought, and a rule should be appropriately finalized.'

     The internet Homepage of the Policy Change Proposal [NPRM, "Notice of Proposed Rulemaking"] is:
http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html .
[ Note:  that webpage has a link to a 'brief summary' of proposed changes, but their summary omits mentions of the NPRM-subpart which concerns us.]
The Notice of Proposed Rulemaking itself is at:
https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects ;
or, in PDF format: http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf ;

    [ As the NPRM Homepage states:
          "You may submit comments in one of three ways [a Public Comment submission should only be on record as submitted by only 1 of these 3 methods]:

  1. Electronically. You may submit electronic comments on specific issues in this regulation. (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.)

  2. By mail., or else,      3.  In person or by courier:
    You may mail, or hand deliver, written comments (one original and two copies) to the following address ONLY: Office for Human Research Protections (OHRP), 1101 Wootton Parkway, Suite 200,Rockville, MD 20852.
    [ If Submitting a Comment by mail:]  Please allow sufficient time for mailed comments to be received before the close of the comment period." ]

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Footnotes:
1. ACHRE Recommendation 15: https://ehss.energy.gov/ohre/roadmap/achre/chap18_3.html .
2.. Clinton Administrative Order:  http://fas.org/sgp/clinton/humexp.html .
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    Excerpts from the September 8, 2015 NPRM which concern us:

[ Note: The NPRM, besides from seeking general Public Comments on the proposals, requests that Comments consider (if applicable) the Question number headings, which appear below: ]
(The Question numbers which apply to our concern are: Questions number 1., 9., 10., 11., 12., 13., (14.), and 15. )
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"Public comment is sought not only on the provisions outlined below, but on whether the proposals strike a reasonable balance among the core ethical principles. A better balance among the core principles should increase the strength of the partnership between the research enterprise and the public, and even greater scientific understanding and innovation will be fostered.

Finally, it is important to note that, to the extent appropriate, the intent is to eventually amend the other subparts of the HHS human subjects protection regulations in 45 CFR part 46 (subparts B, C, D, and E), and consider the need for updates to FDA regulations and other relevant Federal departmental or agency regulations with overlapping scope.

1. Question for Public Comment

1. Public comment is sought on whether the proposed changes will achieve the objectives of (i) decreasing administrative burden, delay and ambiguity for investigators, institutions, and IRBs, and (ii) strengthening, modernizing, and making the regulations more effective in protecting research subjects."
...
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"Three of the exclusions seek to eliminate any uncertainty about whether certain internal program improvement activities, historical or journalistic inquiries, or quality assurance or improvement activities satisfy the definition of research. The other three exclusions include some activities that fall into to a gray area that encompasses some activities that arguably might be judged to be research, but that are part of inherently governmental functions that have purposes other than research, such as responsibilities to protect public health and welfare (see exclusions for criminal investigations, public healthy surveillance, and intelligence surveillance). These activities promote recognized specific goods that are crucial to the public welfare, and should be carried out without any hindrances that satisfying regulatory requirements might impose. For these activities, the principles of beneficence and justice outweigh any intrusions on individual autonomy that the regulations might have prevented."
...
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"vi. Intelligence Surveillance Activities (NPRM at § __.101(b)(1)(vi))
(1) NPRM Proposal
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 biospecimens 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 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."
...
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" .. Questions for Public Comment
["Questions for Public Comment" for the NPRM Section which includes the above proposed Exclusion of "Intelligence Surveillance Activities" [that is, to exclude the Policy for Protection of Human Subjects from being applicable to such activities]. ]

9. Public comment is requested on the extent to which covering any of these activities under the Common Rule would substantially add to the protections provided to human research subjects.
10. Public comment is sought on whether this exclusion should only apply to research activities in which notice is given to prospective subjects or their legally authorized representatives as a regulatory requirement. If so, please comment on what kind of information should be included in the notice such as the research purpose, privacy safeguards, contact information, ability to opt-out, etc. Would requiring notice as a condition of this exempt research strike a good balance between autonomy and beneficence?
11. Public comment is sought regarding whether it is reasonable to rely on investigators to make self-determinations for the types of research activities covered in this particular exclusion category. If so, should documentation of any kind be generated and retained?
12. Public comment is sought regarding whether some or all of these activities should be exemptions rather than exclusions.
13. Public comment is sought regarding whether these exclusions should be narrowed such that studies with the potential for psychological risk are not included. Are there certain topic areas of sensitive information that should not be covered by this exclusion? If so, please provide exemplary language to characterize such topic areas in a manner that would provide clarity for implementing the Rule.
14. For activities captured under the third element of this exclusion, do the statutory, regulatory, and other policy requirements cited provide enough oversight and protection that being subject to expedited review under the Common Rule would produce minimal additional subject protections? If so, should the exclusion be broadened to also cover secondary analysis of information collected pursuant to such activities?
15. Public comment is requested on the extent to which excluding any of these research activities from the Common Rule could result an actual or perceived reduction or alteration of existing rights or protections provided to human research subjects. Are there any risks to scientific integrity or public trust that may result from excluding these research activities from the Common Rule?"

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    Information, tips, and suggestions on submitting Public Comments:
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Online Submissions:

Note:     When submitting a Public Comment online, you are asked for:
First Name; Last Name;
       You are provided with a text box to type text into or to Paste text into (their text box has approximately a 4988 character limit). [ If your text exceeds the character limit, then you should submit your complete text in a file attachment. In that case, you should put a brief Summary, or a detailed Summary (and/or outline, and/or index), of your Comment in the text box, and/or the first 4988 characters of your larger comment in the text box. Its up to you. ]
       And, you are provided with an option to upload 1 or more files as an enclosure(s) to your Public Comment and/or as containing your Public Comment. As the NPRM states: "Attachments should be in Microsoft Word [format], WordPerfect [format], or Excel [format]; however, we prefer Microsoft Word." Most word processors allow you to save to a file to Word format. Avoid the use of unusual special characters or any form of encryption.
       There is a check box provided to give your email address and your zip code (checkbox: 'I want to provide my contact information'). The preference is that a Public Comment contains your name and address (and many comments contain email addresses, and telephone numbers), in the same way that formal Petitions to the U.S. Government ought to have signers' names and addresses. Of course, its up to you. Independently, if you CHECK their checkbox and enter your email address and zipcode, that email and zipcode entry will not be viewable online by the Public.


     Advice: Putting at least a Summary of your Public Comment in the text box makes it easy for others to be aware of, and to more easily notice, the subject matter of your comment. Consider making even a little extra effort to make the text in the text box (whether Summary text, or your main Comment): easy to understand, well written, and rational (and true).
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from http://www.archives.gov/federal-register/tutorial/online-html.html


"Writing effective comments?

Type neatly and cite rulemaking by docket number and other identifying information (subject heading; FR cite)

Include your name and address

Follow directions -- agency may ask you to respond to specific questions or label comments with CFR parts or section numbers

Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes "

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also consider reading the suggestions at:
      http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf ;
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also consider reading the suggestions at:
     http://www.foreffectivegov.org/node/4059
which includes the following:

     "[A Public Comment] can be brief or in-depth and well researched. [It] can address only specific aspects of the proposed rule, fully address all aspects, or address the subject at-large. Often, the agency will ask the public to comment on specific aspects of the proposed regulation, but you may comment on any part or the whole regulation."