Governor Rick Scott Why our Are Children Being Used For Research?

I am not a research subject I am a child

I was online and came across this DCF article that goes into the correct procedures to use our children as human research subjects, even to manipulate the environment they are in,

I need to know, we the human race needs to know why in God’s name are you using CHILDREN as guinea pigs?

I call on each and every one who reads this to please Stop this madness!

 Call upon our Governor Rick Scott and the First Lady Ann Scott who is the child advocate for Florida to Stop this, please notice the schools and companies listed on the link, how are they benefiting and how is the state of Florida benefiting?”Governor Rick Scott” <rick.scott@eog.myflorida.com>

 Even if you are not from Florida please let Rick Scott know that you are not interested in living in a state that uses children as research and if you planned on visiting tell him you will not spend your tourist dollars to help pay for this barbaric practice.

 God Bless everyone who will not tolerate this form of abuse. Please pray for our children, and for our Governor Rick Scott and Ann Scott to have an open mind and not be hard hearted, that they will do the right thing.

CFOP 215-8

This operating procedure supersedes CFOP 215-8 dated March 11, 2008.

OPR: PDMH

DISTRIBUTION: B

STATE OF FLORIDA

DEPARTMENT OF

CF OPERATING PROCEDURE CHILDREN AND FAMILIES

NO. 215-8 TALLAHASSEE, June 11, 2010

Safety

INSTITUTIONAL OVERSIGHT OF HUMAN SUBJECT RESEARCH

AND INSTITUTIONAL REVIEW BOARD DESIGNATION

1. Purpose. The intent of this operating procedure is to provide a structured framework within which

Department staff and contracted providers proposing or conducting research can ensure that the rights

of the individuals that the Department serves, and its employees, are protected. It is the policy of the

Department of Children and Families to uphold its assurance as filed with the federal Department of

Health and Human Services’ (HHS) Office for Human Research Protections (OHRP).

2. Scope. This policy is applicable to all Department and contracted provider staff that engage in, plan

to engage in, or are asked to authorize or support research using human subjects within the

Department’s areas of responsibility.

3. References.

a. 45 Code of Federal Regulations Subparts 46, 160, 162, and 164.

b. 21 CFR Subparts 50, 56, 312 and 812.

c. Health Insurance Portability and Accountability Act of 1996 (HIPAA).

d. Terms of Assurance, Office of Human Research Protections, Department of Health and

Human Services (http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm).

e. The Belmont Report, 1978 (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm).

4. Definitions. For the purposes of this operating procedure, the following definitions shall apply:

a. Agents. Agents of the Department include all individuals performing institutionally

designated activities or exercising institutionally delegated authority or responsibility.

b. Assent. The affirmative agreement to participate in research. Assent is required even if the

individual’s parent (of child) or legally authorized representative (for child or adult) provides consent.

Failure to voice objection to participate in research does not qualify as assent.

c. Assurance. An agreement that establishes standards for human subjects’ research as

approved by the Office for Human Research Protections.

d. Belmont Report. A report that was issued in 1978 by the National Commission for Protection

of Human Subjects of Biomedical and Behavioral Research to explain the fundamental ethical

principles that should guide the conduct of research involving human subjects.

e. Child. As per s. 39.01 (12), Florida Statutes, a child or youth means an unmarried person

under the age of 18 years old who has not been emancipated by order of the court.

June 11, 2010 CFOP 215-8

2

f. Department. Department of Children and Families.

g. Dissent. An individual’s negative expressions, verbal and/or non-verbal, that he/she objects

to participation in the research or research activities.

h. Human Subject.

(1) An individual about whom an investigator (whether professional or student)

conducting research obtains:

(a) Data (of any kind) through intervention or interaction with the individual; or,

(b) Private identifiable information (see definition below) even in the absence of

intervention or interaction with the individual.

(2) For purposes of this operating procedure, human subjects also include any

Department employees, or persons being served by the Department or by one or more of its contracted

providers, whose relevance to the research is based on his or her connection with the Department or

who is otherwise within the Department’s areas of responsibility and authority.

i. Intervention. Physical procedures by which data are gathered and/or manipulations of the

subject or the subject’s environment that are performed for research purposes.

j. Interaction. Communication or interpersonal contact between investigator(s) and the

research participant, or review of their private identifiable information.

k. Institutional Review Board (IRB). A review body established or designated by an

organization to protect the rights and welfare of human subjects recruited to participate in biomedical or

behavioral/social science research. To be used by a project covered in this operating procedure, an

IRB must be in good standing with the Office for Human Research Protections of the U.S. Department

of Health and Human Services.

l. Legally Authorized Representative. An individual authorized under applicable law to grant

permission for services, treatment, benefits or other activities as determined by the court on behalf of

another person.

m. Memorandum of Understanding. A formal written agreement between the Department of

Children and Families and another institution.

n. Private Identifiable Information. This includes any information that may be linked to the

identity of the subject as defined by HIPAA (e.g., Social Security Number, birth date, agency case

number, address, health plan number, other demographic information, etc.). For the purposes of

human subject research, it also includes information about any behavior that occurs in a setting in

which an individual can reasonably expect that no observation or recording is taking place.

o. Provider. Any service provider that contracts with the Department to provide services to

populations of individuals or families on behalf of the Department. A contracted provider is an agent of

the Department for the purposes of this operating procedure.

p. Research. A systematic investigation, including research development, testing and

evaluation, designed to develop or contribute to generalizable knowledge.

June 11, 2010 CFOP 215-8

3

5. General.

a. Institutional Commitments.

(1) The Department shall safeguard the rights and welfare of human subjects in

research by ensuring that all human subject research receives approval through a federally approved

Institutional Review Board(s), consistent with general policy established in Florida Public Law 381.86

and 45 CFR 46, 160, 162 and 164.

(2) The Department shall safeguard the rights and welfare of human subjects in clinical

research (of Food and Drug Administration regulated products, including drugs, devices, or biologics)

through rule set forth by the U.S. Food and Drug Administration’s Human Subject Regulations (21 CFR

50, 56, 312, 812) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

(3) The Department shall uphold the ethical principles of the Belmont Report found at

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm and apply Health and Human Services

regulations (45 CFR 46, including subparts A, B, C and D) to all proposed research which is funded or

supported by the Department of Health and Human Services or any other funding source. The ethical

principles set forth in the Belmont Report are summarized as follows:

(a) Respect for Individuals. Recognition of the personal dignity and autonomy of

individuals and the special protection of those persons with diminished autonomy or vulnerability.

(b) Beneficence. The term is often understood to cover acts of kindness or

charity that go beyond strict obligation. Persons are treated in an ethical manner not only by respecting

their decisions and protecting them from harm, but also by making efforts to secure their well-being.

Such treatment falls under the principle of beneficence.

(c) Justice. Persons are treated with fairness in the distribution of research

benefits and burdens. For example, the selection of research subjects needs to be scrutinized in order

to determine whether some classes (e.g., recipients of financial assistance, racial and ethnic minorities,

or persons confined to institutions) are being systematically selected simply because of their easy

availability, their compromised position, or their manipulability, rather than for reasons directly related to

the problem being studied. Finally, whenever research supported by public funds leads to the

development of therapeutic devices and procedures, justice demands that these not provide

advantages only to those who can afford them, and that such research should not unduly involve

persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

(4) The Department shall offer annual training free of charge for Department employees

and provider staff who engage in research. The training certification is required annually for

investigators and is offered through the Collaborative Institutional Review Board Initiative (CITI) on-line

course hosted by the University of Miami at http://www.miami.edu/citireg/.

b. Human Subject Research/Non-Research Determinations.

(1) The Department’s Human Protections Administrator has the authority to determine

whether activity represents “human subject research” or not in accordance with federal regulation.

(2) Investigators do not have the authority to make an independent determination of

what activity qualifies as not being human subject research. Investigators shall submit a request in

writing to the Department’s Human Protections Administrator to make this determination.

June 11, 2010 CFOP 215-8

4

c. Enrollment of Vulnerable Populations in Research (specifically, children, pregnant women,

individuals with mental illness or mental retardation, or prisoners).

(1) Consistent with federal regulations in 45 CFR 46 and 21 CFR 50 and 56, all

research involving vulnerable populations as listed above require special assurances. The Institutional

Review Board is required to ensure that these special assurances are met.

(2) Children will only be enrolled in research with the signed consent of parents or a

legally authorized representative, such as a guardian or the court. Where appropriate, there must also

be an indication of the child’s own assent to participate (when the child is capable of providing such

assent). A waiver of assent can only be granted by the Institutional Review Board.

(3) At no time shall a child in the custody of the Department be allowed to participate in

a clinical trial that is designed to develop new psychotropic medications or evaluate the suitability of

providing medications previously approved for adults to children. This paragraph does not preclude

research that evaluates the consequences of administration of psychotropic medications to children in

state care.

(4) Adults who have a legally authorized representative will only be enrolled in research

with signed consent from the legally authorized representative and assent from the individual. A waiver

of assent can only be granted by the Institutional Review Board.

(5) It is the responsibility of any Department employee or provider agency aware of

proposed research involving children or adults in any way to alert the appropriate Department program

office and the Department’s Human Protections Administrator as soon as it is known. The intent is to

ensure that the investigator(s) are aware of policy and Institutional Review Board requirements, and

that research does not begin until approval is received from the Institutional Review Board and the

Department’s Human Protections Review Committee, as described below.

d. Florida Statewide Advocacy Council.

(1) The Florida Statewide Advocacy Council has access to Institutional Review Board

meetings and to the Department’s Human Protections Review Committee for all research proposed

involving any adult or child served by the Department or its providers, per Section 402.166(7)(d),

Florida Statutes. If the Florida Statewide Advocacy Council has any concerns, the Council may

express those concerns to the Human Protections Administrator or to the Institutional Review Board

directly.

(2) The Human Protections Administrator will serve to resolve any issues that the

Florida Statewide Advocacy Council may have with the proposal concerning constitutional or human

rights.

6. Procedures.

a. Maintenance of a Federal-Wide Assurance (FWA).

(1) The Department’s Federal-Wide Assurance # FWA00004629 shall be maintained by

the Deputy Secretary who is the signatory official for the Department and registered with the Office for

Human Research Protections.

(2) The Deputy Secretary shall appoint a Department employee to function as the

Human Protections Administrator. The primary role of the Human Protections Administrator is to

ensure that Department employees, providers, and anyone acting as an agent of the Department

comply with the Assurance and this operating procedure.

June 11, 2010 CFOP 215-8

5

(3) The Human Protections Administrator shall renew the FWA every three years and

ensure that any Memoranda of Understanding (or interagency agreement(s)), when warranted, are

maintained.

(4) The Signatory Official and Human Protections Administrator shall complete the

OHRP Training Modules (see http://137.187.172.153/CBTs/Assurance/login.asp).

b. Institutional Review Board (IRB) Designation.

(1) In lieu of its own IRB, the Department shall agree with and designate one or more

Institutional Review Boards outside of the Department that have valid designations as active

Institutional Review Boards with the Office of Human Research Protections. These IRBs shall be listed

on the Department’s Federal-Wide Assurance (FWA). Current agreements are listed in Appendix A to

this operating procedure.

(2) The Department requires that any person or entity that wants to conduct research

involving individuals who are receiving services from, or on behalf of, the Department, or involves

Department employees, have written approval from an IRB and must provide a copy of the approval

notification to the Department’s Human Protections Administrator.

(3) In addition to IRB approval, the investigator must also have Department approval to

conduct human subject research. While both approvals are required, the investigator should consider

obtaining the Department’s approval before proceeding with an IRB application (see paragraph 6.c.

below regarding Department approval process), as the Department is not obligated to allow IRB

approved research.

(4) A contracted provider is considered to be an agent of the Department, and as such,

is covered under the Department’s Federal-Wide Assurance.

(5) When a contracted provider receives federal funding for research as a result of a

grant from the Department of Health and Human Services (HHS) either through a contract with the

Department of Children and Families, or directly from HHS, the investigator is required to seek approval

from an IRB listed on the Department’s FWA. However, if the provider has their own IRB (and thus,

has their own FWA) in good standing with the Office of Human Research Protections, the investigator

may seek IRB approval through the provider’s designated IRB. If this designated IRB is not listed on

the Department’s FWA, the investigator must work with the Human Subjects Administrator to ensure its

addition to the FWA.

(6) When the research is unfunded or funded by any source other than the Federal

government, the investigator may use any IRB as long as the institution has a valid and active IRB

designation by the OHRP.

(7) If the investigator is not an employee or agent of the Department, he/she shall

complete an Individual Investigator Agreement (Appendix B to this operating procedure) prior to

approval from the Department’s Human Protections Review Committee (see paragraph 6.c. below). If

the investigator does not have access to an IRB through his or her own institution, the Department has

an agreement with Western Institutional Review Board (WIRB) which enables any DCF-approved

investigation to be reviewed for the relevant fee. Information about WIRB, including instructions for

submission of proposals, may be found on their web site at http://www.wirb.com/. The Department’s

Human Subjects Administrator can provide additional information. .

(8) The investigator is responsible for any fees charged by an IRB unless the research

project is specifically requested or designed by the Department. In this case, the Department will pay

June 11, 2010 CFOP 215-8

6

the fees through contract or agreement with the IRB, or through a payment mechanism with the

investigator, such as a contract or Direct Order.

(9) Investigators must comply with the principles established in the Belmont Report, this

operating procedure, the policies and procedures of the Institutional Review Board, and all references

herein.

(10) The Department shall execute a Memorandum of Understanding with each

Institutional Review Board listed in its FWA.

c. Establishment of the Department’s Human Protections Review Committee (HPRC) and

Submission of Research Proposals for Department Review.

(1) The HPRC shall be established by the Department’s signatory official to review and

approve all human subject research activity prior to the research beginning to ensure that the scope of

the research falls within the mission of the Department. This committee is not an Institutional Review

Board and does not replace the need for IRB approval; however, its permission to conduct the

proposed research is required. This committee shall include appropriate program office personnel

designated to serve on the committee by the Deputy Secretary of the Department. At a minimum, the

HPRC shall include the Assistant Secretary for Programs, or his or her designee authorized to approve

research proposals, and the Assistant Secretary for Mental Health and Substance Abuse, or his or her

designee authorized to approve research proposals.

(2) The HPRC shall be chaired and coordinated by the Human Protections

Administrator. The HPRC shall meet as needed to review all research proposals submitted.

(3) This internal review serves the purpose of alerting the appropriate program office of

the proposed research and giving the appropriate personnel the opportunity to express support,

withhold support, and discuss concerns. The concerns will be communicated to the investigator

through the Human Protections Administrator as soon as possible following the meeting. The

Department shall provide the investigator with a written statement of approval or disapproval within 5

days of the HPRC meeting, or following the resolution of any concerns.

(4) The Department reserves the right to disallow any research proposal, regardless of

IRB approval. However, all research must receive HPRC and IRB approval prior to commencement.

Program offices of the Department may require additional review and approval processes, but

authorization is subject to final decision by the Human Protections Review Committee.

(5) All research proposals, regardless of funding source and IRB approval, must be

electronically submitted via email to the Department’s Human Protections Administrator. The contact

information for the Human Protections Administrator can be found on the Department’s website at

http://www.dcf.state.fl.us/admin/publications/humanResearch.shtml.

(6) The research proposal submitted to the Human Protections Administrator by the

investigator shall include a narrative description that includes the following:

(a) The name, address, email addresses, and phone numbers of all investigators

involved in the proposed research;

(b) The name of the organization(s) involved in the research project;

(c) The funding source(s) for the research;

June 11, 2010 CFOP 215-8

7

(d) The specific subject population served by, or working for, the Department

and a list of the specific locations where the research will take place;

(e) A description of the research proposal and its purpose;

(f) A discussion of the level of risk associated with the research and how the

risks will be minimized;

(g) Name and FWA number of Institutional Review Board that applies to this

research project; and,

(h) Any other relevant documentation related to the research project that is

requested by the Department.

(7) Once received, the IRB approval letter shall be sent to the Human Protections

Administrator prior to commencement of the research.

(8) The investigator may submit a copy of the research proposal and application that the

investigator plans to submit to the designated IRB in lieu of the above narrative description as long as

the aforementioned documents contain all of the information described above in paragraph 6.c.(6).

f. Reporting of Adverse Events. The Human Protections Administrator will ensure prompt

reporting of the following events to the Department’s Deputy Secretary, the HRPC, the IRB who

approved the research project, and the Office of Human Research Protections:

(1) Unanticipated problems involving risks to subjects or others;

(2) Serious or continuing noncompliance with the federal regulations or the

requirements or determinations of the IRB; and,

(3) Suspension or termination of HRPC or IRB approval.

BY DIRECTION OF THE SECRETARY:

(Signed original copy on file)

DON WINSTEAD

Deputy Secretary

June 11, 2010 CFOP 215-8

Appendix A to CFOP 215-8

Institutional Review Boards

Listed on Department of Children and Families’

Federal-Wide Assurance

FWA # Institution Name

FWA00001669 University of South Florida 01A

Medical A, 02 Behavioral A, 01B

Medical A, 01C Medical A, 01D

Medical (IRB) (IRB00000362,

IRB00000363, IRB00001786,

IRB00001787, IRB00001884)

FWA00005790 University of Florida #1 A, #2 A, #3 A

(IRB00000335, IRB00000336,

IRB00000337)

FWA00003331 Research Triangle International #1A,

#2A, #3 A (IRB00000653, IRB00000654,

IRB00000655)

FWA00000340 Public/Private Ventures (IRB #1 A

(IRB00000830)

FWA00005897 Western IRB #1-8, #11-14, & #35 A

(IRB00000533)

FWA00004801 U of North Carolina at Chapel Hill

IRB #8 – Behavioral A (IRB00000543)

FWA00005551 Westat Inc. #1A (IRB00000695)

Not applicable Independent Review Consulting, Inc.

(IRC) IRB #1 A ( IRB00000762)

June 11, 2010 CFOP 215-8

Appendix B to CFOP 215-8

Individual Investigator Agreement

Name of Institution with the Federal-wide Assurance (FWA): Florida Department of Children

and Families

Applicable FWA #: FWA00004629

Individual Investigator’s Name:_______________________________________________________

Specify Research Covered by this Agreement:___________________________________________

Institutional Review Board:___________________________________________________________

(1) The above-named Individual Investigator has reviewed: a) The Belmont Report: Ethical Principles

and Guidelines for the Protection of Human Subjects of Research (or other internationally

recognized equivalent; see section B.1. of the Terms of the Federal-wide Assurance (FWA) for

International (Non-U.S.) Institutions); b) the U.S. Department of Health and Human Services (HHS)

regulations for the protection of human subjects at 45 CFR part 46 (or other procedural standards;

see section B.3. of the Terms of the FWA for International (Non-U.S.) Institutions); c) the FWA and

applicable Terms of the FWA for the institution referenced above; and d) the relevant institutional

policies and procedures for the protection of human subjects.

(2) The Investigator understands and hereby accepts the responsibility to comply with the standards and

requirements stipulated in the above documents and to protect the rights and welfare of human

subjects involved in research conducted under this Agreement.

(3) The Investigator will comply with all other applicable federal, international, state, and local laws,

regulations, and policies that may provide additional protection for human subjects participating in

research conducted under this agreement.

(4) The Investigator will abide by all determinations of the Institutional Review Board

(IRB)/Independent Ethics Committee (IEC) listed above and will accept the final authority and

decisions of the IRB/IEC, including but not limited to directives to terminate participation in

designated research activities.

(5) The Investigator will complete any educational training required by the Institution and/or the

IRB/IEC prior to initiating research covered under this Agreement.

(6) The Investigator will report promptly to the IRB/IEC any proposed changes in the research

conducted under this Agreement. The investigator will not initiate changes in the research without

prior IRB/IEC review and approval, except where necessary to eliminate apparent immediate

hazards to subjects.

(7) The Investigator will report immediately to the IRB/IEC any unanticipated problems involving risks

to subjects or others in research covered under this Agreement.

June 11, 2010 CFOP 215-8

B-2

(8) The Investigator, when responsible for enrolling subjects, will obtain, document, and maintain

records of informed consent for each such subject or each subject’s legally authorized representative

as required under HHS regulations at 45 CFR part 46 (or any other international or national

procedural standards selected on the FWA for the institution referenced above) and stipulated by the

IRB/IEC.

(9) The Investigator acknowledges and agrees to cooperate in the IRB/IEC’s responsibility for initial

and continuing review, record keeping, reporting, and certification for the research referenced

above. The Investigator will provide all information requested by the IRB/IEC in a timely fashion.

(10) The Investigator will not enroll subjects in research under this Agreement prior to its review and

approval by the IRB/IEC.

(11) Emergency medical care may be delivered without IRB/IEC review and approval to the extent

permitted under applicable federal regulations and state law.

(12) This Agreement does not preclude the Investigator from taking part in research not covered by this

Agreement.

(13) The Investigator acknowledges that he/she is primarily responsible for safeguarding the rights and

welfare of each research subject, and that the subject’s rights and welfare must take precedence over

the goals and requirements of the research.

http://www.dcf.state.fl.us/admin/publications/policies/215-8.pdf

Randy Kluge

941-915-1046

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2 comments to Governor Rick Scott Why our Are Children Being Used For Research?

  • Why would anyone write such crap? It sounds like the writings of a pharmaceutical company trying to “protect” those who are “assigned” to test the new DRUGS on unsuspecting individuals who have somehow gotten themselves in the “system” and somehow seemed to “need” help. What other purpose would there be to doing this? SOMEONE, SOMEWHERE HAS A LOT TO GAIN by creating such a process and the writing to go with the process proves it… Why, Why, Why? what is wrong with this country that people believe that EVERYTHING can be cured with drugs? Do you know what the cure for ADHD is – a thousand acres of wilderness and a wild pony to ride. KIDS NEED TO PLAY and we have taken that away from them. Put them in buildings with no windows, no butterflies, no ponies, no kittens, no puppies, no playmates… apartments are where ADHD is born, grows, thrives and children grow up into adults never knowing what it feels like to PLAY. love to all… lonely nanna in florida

  • La'Cher Groomes

    I certaintly do not agree with the use of children in research benefots. I think it is unethical and quite harming. It also is in violation of children. Children are a gift from God and should not be mistreated in any form of a way. To allow this procedure to happen is unethical and quite ludicris in my opinion. There is no way that one who loves and cares for children would allow this. This action of torture should be stopped IMMEDIATELY. As of right now!

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