Biomagnetic Professional Ethics Code

Foundation for Magnetic Science

Biomagnetics Professional Ethics Code

Foundation Homepage: www.magnetfoundation.org

Back to PPS Main Page

The Foundation Board of Trustees has adopted this Ethics Code for the Professional Certification Program sponsored by the Foundation and for all Certified Biomagnetic Research Professionals (BmRP).

            1.            Practitioners shall be guided by the injunction, "Do no harm." Practitioners shall base all research efforts and data collection upon measurement and analysis under the Guidelines published from time to time by the Independent Review Board (IRB). All questions or doubts regarding Client evaluation shall be reviewed with other Certified Practitioners or with the Foundation prior to recommending specific use of Biomagnets or other products to a Client. The Practitioner is professionally responsible for all such professional decisions.

             2.            Biomagnetics do not, nor is it intended to, diagnose or treat any medical condition. If a Practitioner suspects any disease condition, the Practitioner should advise the Client to seek the advice of an appropriate health care professional. The Practitioner shall explain the nature of Biomagnetics, informing the Client that the intent and mission of Biomagnetics  is to encourage the continued investigation and development of Biomagnetics intervention and related technologies as a therapy that may benefit the general well being of the Client, as a companion to standard and alternative wellness practices.

             3.            Practitioners shall, when performing Biomagnetics evaluation and presentation, always act with the written informed consent of the C1ient. All persons representing themselves as Biomagnetic Practitioners should not represent other modalities as Biomagnetics.

             4.            The primary obligation of the Practitioner is to act in the best interests of the Client, based upon established techniques and IRB Guidelines.  Violations of such Guidelines is a violation of this Code.

             5.            Practitioners shall keep all required records and submit all reports in a timely fashion and in conformity, where required, with HIPPA requirements.  All Practitioners shall keep reasonably abreast of the development of new techniques and technologies in accordance with scheduled updates for practice.

             6.            Practitioners shall not violate any lawful governmental regulation relating to the research and techniques they perform.  It is the obligation of each Practitioner to inform the Ethics Board and IRB of any unethical conduct that comes to their attention.

             7.            Practitioners shall charge fairly and reasonably for their services.

8.            Practitioners shall always act in a reasonably competent professional manner and shall avoid any impropriety or other act which may reflect negatively upon themselves or Biomagnetics.

            9.            Each Practitioner shall recognize and respect the Intellectual Property rights of the Foundation in the materials and techniques developed by or through it.

            10.            By becoming a Biomagnetics Practitioner, the Practitioner agrees to abide by this Code and to abide by the fair and timely decisions of the Ethics Board. Each Practitioner shall abide by arbitration of disputes regarding fees or ethical issues through the Ethics Board.

Certified True Copy 

 Back to homepage: www.magnetfoundation.org

© 2007 02.14.07

Biomagnetics Professional Certification Program

Foundation for Magnetic Science
Certification System Rules & Standards

Foundation Homepage: www.magnetfoundation.org

Index:

Introduction
How to Become Certified
Seven Core Values
Certification System Rules
Back to PPS Main Page

Introduction to Certification Rules and Standards

Whereas the Foundation Board of Trustees has adopted a Professional Practice System Resolution that provides, in part:

"Certification Board (may also be referred to as: Board for Professional Certification Standards) - implements the Certification Standards to recommend the issuing of various degrees of certification to Research Practitioners (existing practitioners to be ‘grandfathered' and life experiences to be considered along with academics and professional status). Certification to cover Biomagnetics as established by the research initiated by Peter A. Kulish and continued by the Foundation. The Board consists of a Certification Chairperson appointed and removable by the Oversight Officer and such Members (not exceeding six) as may be invited by the Board Chairperson. The Chairperson and Members of the Board may be removed from the Board by resignation or determination of the Board of Trustees." and

Whereas the Trustees have adopted the following Seven Core Values and authorized the Oversight Officer to establish and manage a Program for Professional Certification that seeks to recognize FMS Biomagnetic Research Professionals (BmRP) who demonstrate high levels of knowledge, skills, abilities, ethics and commitments

The Board hereby adopts the following Core Values and Certification System Rules

Index

How to Become Certified

The Certification process is set forth in this document. You will need to contact the Foundation, by email, to certification@magnetfoundation.org with a brief statement setting forth you name, address, birth date, educational attainments, other licenses or certifications. The Board will then proivde you with its standard questionnaire. See the Rules and Standards, below .

Index

Seven Core Values

FMS Professionals have self-discipline and commitment.

Certified and accomplished FMS Professionals use good judgment and observe "Do no harm" as a first Rule of Practice. Professionals are expected to abide by the Professional Ethics Code and engage in the Practitioner Training Program, Professional Practices Structure and Practitioner Support Structure.

FMS Professionals are committed to being the source of their own decision making.

Certified and accomplished FMS Professionals act on the belief that all people can be responsible for their own healthcare choices. They incorporate awareness and intelligence in their practice.

FMS Professionals utilize knowledge and creativity.

Certified and accomplished FMS Professionals have a rich understanding of FMS and appreciate how knowledge is created, organized, linked to self health care and applied to real-world settings. While representing collective wisdom of our culture and upholding the value of knowledge, they also develop the critical and analytical thinking skills required for research success.

FMS Professionals are aware and present human beings.

Certified and accomplished FMS Professionals are adept at engaging people to assist their biomagnetic research and at enlisting their colleagues' knowledge and expertise to complement their own. They are also aware of ineffectual or damaging behavior and are devoted to creating a positive outcome.

FMS Professionals think systematically and learn from experience.

Certified and accomplished FMS Professionals are models of responsible and educated persons, exemplifying the virtues they also inspire in others: the desire to be healthy, whole, curious, honest, fair, and respectful of human differences. They engage in lifelong learning that they seek to be a model for all health care providers. Striving to strengthen Biomagnetic research, Certified and accomplished FMS Professionals critically examine their practice, seek to expand their repertoire, deepen their knowledge, sharpen their judgment and adapt their practice to new findings, ideas and theories.

FMS Professionals are leaders within their communities.

Certified and accomplished FMS Professionals contribute to the effectiveness of healthcare by working collaboratively with other professionals on research, standards of practice, and education. They find ways to work with people, engaging them productively in managing their own health care choices. FMS Professionals are dedicated to making Biomagnetics accessible.

FMS Professionals provide honest support for other human beings.

Certified and accomplished FMS Professionals contribute to the betterment of humankind through active support of providing options for health choices. The use of magnetism is intended to benefit normal structure and function and is not prescribed as treatment for medical or psychological conditions, nor for diagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles. Not intended to treat disease, support or sustain human life, or to prevent impairment of human health; for self-education and research purposes only.

Index

Certification System Rules
Board Certification Standards

I. Introduction

1. There exists major concern and debate about the state of health care in today's society. Many current belief systems do not entirely address giving a person domain over his or her own individual healing and health choices. Current models leave out a critical element of the health care equation: the active role of Biomagnetics. If we are to have the most comprehensive health care options available to people, it must include research and an educational force that includes Biomagnetics.

2. Biomagnetics, the work founded and pioneered by Peter A. Kulish and continued by the Foundation, is an emerging science and field of professional practice. The Trustees have established a Professional Practice System for Biomagnetic Research Associates. The System includes Certification, Peer Review, Research and Ethics standards.

3. The Certification Board's goal is to advance the quality of practice, research, teaching, learning, and mentoring in the development of Biomagnetics by maintaining high standards for what accomplished Biomagnetic Associates should know and be able to do, and by providing a system to certify Associates who meet these standards. These standards are established for Biomagnetic Associates as a representation of professional excellence. There are entry-level standards for beginning Associates, as well as established advanced standards for experienced Associates; the Board has the discretion to apply the standards to individual needs and skills.

4. Linked to these standards are reasonable and reliable processes that honor the complexities and demands of utilizing Biomagnetics. They focus on the research and work completed by Biomagnetic Associates. The Board assessments for Board Certification include having Biomagnetic Associates construct a case study research portfolio that represents an analysis of their class work and participate in exercises designed to tap the knowledge, skills, disposition, professional judgment, and research skills that represent their abilities.

II. Proficiency of Biomagnetic Associates

1. The Board presents its view of what Biomagnetic Associates should be proficient in, as well as values and beliefs regarding what should be the foundation of sound research. This expression of standards guides all of the Board's standards and assessment processes.

2. The fundamental requirements for proficient research include a broad education in the sciences, math, psychology, business, and the liberal arts; knowledge of the skills to be developed, and of the resources and equipment that manage and embody course content; knowledge of general and subject-specific methods for Biomagnetics research and for evaluating clients; the capacity to employ such knowledge prudently in the interest of research; and human qualities including expertise, professionalism, and commitment compose excellence in the field of Biomagnetics.

3. The Board's responsibility is not only to ensure that Biomagnetic Associates who become Board Certified meet its professional standards of commitment and competence, but also to maintain standards, assessments, and research data.

III. Certification Process

1. Any person who demonstrates that he or she may qualify for certification and accepts the Ethics Code and other requirements of the Professional Practice System may be certified as a Research Associate or Technicians.

2. Upon certification, such person may be known as a Biomagnetic Research Professional, BmRP. All Certifications shall be issued by the Chairperson of the Board of Trustees as Chief Executive Officer under authority of the Board. A certified health care practitioner who meets the highest standards of practice may be referred to as a Board Certified Biomagnetic Research Practitioner, or BCBmRP.

3. Each such applicant shall complete the standard questionnaire provided by the Certification Board and shall answer such other questions for which the Board may request answers, in writing. The Board may require applicants to demonstrate their knowledge of magnet placement by practical exhibition, in person, or by electronic means. When all questions are answered to the satisfaction of the Board, the Board may recommend the issuance of the appropriate Certification to the Oversight Officer.

4. All applications shall be submitted to a vote of the Board within 30 days of completion. The Members shall convey their votes to the Chairperson within ten days of receipt of the completed application package and the Chairman shall convey the results to the Oversight Officer within three days thereafter.

5. The Oversight Officer shall notify the applicant within ten days of notice by the Oversight Officer. Any appeal of a denial of Certification shall be made by complaint to the Ethics Board and under the Ethics Enforcement Rules. The appeal must be filed within ten days of receipt of notice of denial.

6. The Certification Board requires an annual recertification statement on standard questionnaire form.

Index

© 2007 1.30.07

Eithics Enforcement Code

Foundation for Magnetic Science

Foundation Home Page:  www.magnetfoundation.org

Back to PPS Main Page  

Professional Practice System
Ethics Code Enforcement Rules

 Requests, Appeals and Complaints

             1.            An Ethics Complaint, Request for Fee Arbitration, Peer Review Appeal, Certification Appeal, IRB Appeal or Request for Ethical Determination (for an advisory opinion) may be presented to the Board (through the Chairperson of the Board) in writing, by any Practitioner/Researcher, Client (or Client Representative), Trustee or member of any body established by the Professional Practice System Resolution. The Board may consider any issue relating to this Resolution, Certification Standards, Code of Ethics, Peer Review Standards or IRB Guidelines.  The Board should be guided by an honest sense of morals, ethics, justice, fairness, reasonable precedents and right.

             2.            Upon receipt of a Request, Appeal or Complaint, a full copy shall be sent to each Member of the Board and to oversight officer who shall inform the Trustees thereof.  Any Trustee may request a copy of any document filed with the Board.

             3.            In an emergency, the Chairperson, with the support of a majority of Board Members may issue a Temporary Ethics Order (TEO) based upon a written Complaint or Request, without a formal meeting. The Order may temporarily suspend a Practitioner or take other emergent action to preserve the status quo and the intent and integrity of Biomagnetics. An issued TEO shall deem  the order of an arbitrator with jurisdiction.

             4.            In all other circumstances, the parties shall have thirty (3O) days, or such lesser or greater period of time, as the Board may determine, to submit written statements regarding the matter (without separate approval of the Chairperson, no such submission, including attachments, shall exceed 25 pages).

              5.            Thereafter, the Board shall discuss the matter (by electronic or face-to-face meeting, or through individual consultations with the Chairperson).  The Board may appoint one or more of its members to interview interested parties or obtain additional information.

             6.            The Board shall have the right to determine when a matter is within its competence and when to close discussion of a matter.  It may deal with what it considers minor matters in a summary manner.

Decisions

            7.            The Board shall issue written Decisions within a reasonable time after the closing of discussion.  Copies shall be provided to each party and to the oversight officer who shall so inform the Trustees or other interested persons.

             8.            The effect of a Decision shall be that of a final Decision of an Arbitrator and may be enforced in any tribunal of competent jurisdiction.  An Ethics Code violation is deemed to cause immediate and irreparable harm to the Foundation and Biomagnetics.

             9.            A Fee Arbitration Decision shall determine the fair and reasonable fee and may be enforced by either party to it.

             10.            An Ethics Decision may include the temporary or permanent suspension of the right to practice, subject to oversight, or such lesser requirements, including formal warnings or remedial training, as the Board may determine. In the case of any suspension of the right to practice, the Board shall require the return of any proprietary materials.

             11.            An Ethical Determination (advisory opinion) may include general advisory information on any matter within the scope of the Structure Resolution.

             12.            A copy of the Decision shall be sent to each interested person and may be published or otherwise disseminated.

             13.            An Appeal of an IRB, Peer Review or Certification Board shall be determined as provided herein for a Complaint and the Chairperson of the Board or IRB being appealed shall act as representative of the Board for the Appeal.  An Appeal Decision shall be deemed the final Decision of an Arbitrator and may be enforced in any tribunal of competent jurisdiction.

 Reconsideration, Reinstatement, Appeal and Abuse of Process

             1.            Any interested person may Petition, in writing, the Board for a Reconsideration of a Determination, within fifteen (15) days of the date of the Determination. Such Petition shall state reasons for the reconsideration. The Board shall decide, within ten (10) days of receipt of the Petition, by majority vote, whether to accept the Reconsideration and shall forthwith issue a written Determination, including any terms for the reconsideration.

             2.            Within ten (10) days after the rejection of a Reconsideration, any aggrieved party may Appeal, in writing, to the Board, which shall consider the matter on an emergent basis.  The Board may recommend the acceptance of the Reconsideration and refer the matter back to the Ethics Board for Reconsideration.  It shall issue its Appeal Decision in writing and provide copies to all interested parties.  The Appeal Decision shall be deemed the final Decision of an Arbitrator and may be enforced in any tribunal of competent jurisdiction.

             3.            A suspended Practitioner may submit a written Petition for Reinstatement to the oversight officer at any time more than thirty (30) days after the period for Reconsideration would have run.  The Petition shall be notarized and shall set forth the steps taken by the suspended Practitioner to correct any defects and the grounds for reinstatement.  The Board shall consider the matter on an emergent basis, but may also seek input and information from other interested persons.  It shall issue its Reinstatement Decision in writing and provide copies to all interested parties. The Reinstatement Decision shall be deemed the final Decision of an Arbitrator and may be enforced in any tribunal of competent jurisdiction.

             4.            No one may use the process of the ethics system established in the Code for personal grudge, intimidation or other improper purpose.  A baseless Complaint that violates this provision will be rejected and may be the grounds for an Ethics Complaint for abuse of the ethics system.

© 2007- Rev 01.30.07

IRB Institutional Review Board Guidelines

Foundation for Magnetic Science
Institutional Review Board Guidelines
Foundation Home Page: www.magnetfoundation.org

Back to PPS Main Page

I. Introduction and Establishment

The Foundation for Magnetic Science, a Pennsylvania nonprofit corporation (Foundation) has established an Institutional Review Board (IRB) that has the responsibility to review, and the authority to approve or disapprove, all research activities that use Foundation facilities, data, staff resources, or funding. Moreover, the IRB retains the same responsibility to previously approved activities and final review of the research Final Report.

The Trustees of the Foundation constitute the general IRB of the Foundation. Upon recommendation of the Executive Director and consent of a majority of the Trustees, the Executive Director may appoint such specific IRBs, consisting of one to three credentialed persons, as may be necessary or convenient to provide IRB oversight of specific research activities. All research activities overseen by an IRB shall be deemed Expressive Association Protected Speech of the Foundation.

The IRB is established to protect the rights and welfare of human research subjects recruited to participate in Human BioAcoustics research activities and to oversee the conducting of research to assure its scientific validity.

The general IRB initially reviews research proposals and then either retains jurisdiction or refers to a specific IRB. The overseeing IRB reviews the proposal to assess the risks and benefits for the human subjects to be studied and the adherence of the proposal and final reports to generally accepted scientific standards. Each proposal is reviewed using criteria described herein. The research proposals are reviewed for safety, confidentiality (information about individuals is not released to anyone), degree of benefit, and the need for and quality of informed consent.

II. Research Protection of Human Subjects

The Foundation IRB ensures that all research observes three principles of ethics: (1) respect for persons; (2) beneficence (to do no harm, and to maximize benefit); and, (3) justice. The IRB looks closely at the negotiation between researcher and each potential volunteer, called the "informed consent process."

The following table shows how those three ethical principles in research apply to individual volunteers.

Ethical Principles	Individual Person
Respect for Person and Respect for Community	People are autonomous; researchers must give them required information and obtain their fully informed consent The research does only what the person consents to. For instance, people are not identified in results without their explicit consent; they can refuse or withdraw their participation without pressure Special people have special concerns. For instance, IRB should include members with expertise about such concerns.
Beneficence	Maximize benefits to individual volunteers. For instance, report their findings to them. Minimize risks to individuals. For instance, protect their privacy to avoid being stigmatized
Justice	People with less power should not be asked to undergo risky research that is of little benefit to them People with less power should be included in potentially beneficial research

 

III. IRB Protocol Review Standards - Criteria for IRB approval of research

A. IRB members are responsible for overseeing:

• Proposed research designs are scientifically sound and will not unnecessarily expose subjects to risk.
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of knowledge that may reasonably be expected to result.
• Risks to subjects are minimized.
• Subject selections are equitable.
• Informed consent is obtained from research subjects or their legally authorized representative(s).
• Additional protections are required for subjects likely to be vulnerable to coercion or undue influence.
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data

The IRB review standards table contains suggested questions that should be asked when considering if a research protocol meets regulatory requirements.

B. IRB Review Standards Table

Regulatory review requirement	Suggested questions for IRB discussion
1. The proposed research design is scientifically sound & will not unnecessarily expose subjects to risk.	(a) Is the hypothesis clear? Is it clearly stated? (b) Is the study design appropriate to prove the hypothesis? (c) Will the research contribute to generalizable knowledge and is it worth exposing subjects to risk?
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result.	(a) What does the IRB consider the level of risk to be? (b) What does the PI consider the level of risk/discomfort/inconvenience to be? (c) Is there prospect of direct benefit to subjects?
3. Subject selection is equitable.	(a) Who is to be enrolled? Men? Women? Ethnic minorities? Children (rationale for inclusion/exclusion addressed)? Seriously-ill persons? Healthy volunteers? (b) Are these subjects appropriate for the protocol?
4. Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence.	(a) Are appropriate protections in place for vulnerable subjects, e.g., pregnant women, fetuses, socially- or economically-disadvantaged, decisionally-impaired?
5. Informed consent is obtained from research subjects or their legally authorized representative(s).	(a) Does the informed consent document include the required elements? (b) Is the consent document understandable to subjects? (c) Who will obtain informed consent (PI, nurse, other?) & in what setting? (d) If appropriate, is there a children's assent? (e) Is the IRB requested to waive or alter any informed consent requirement?
6. Subject safety is maximized.	(a) Does the research design minimize risks to subjects? (b) Would use of a data & safety monitoring board or other research oversight process enhance subject safety?
7. Subject privacy & confidentiality are maximized.	(a) Will personally-identifiable research data be protected to the extent possible from access or use? (b) Are any special privacy & confidentiality issues properly addressed, e.g., use of genetic information?

The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. If the IRB determines that the research presents significant physical, social, or ethical risks to subjects, the IRB may modify, suspend, or terminate approval research that has been associated with serious harm to subjects.

IV. IRB Membership

A. General: Membership should usually consist of credentialed individuals with a diversity of members including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes; include at least one member with primary concerns in the scientific area and at least one with primary concerns in the non-scientific area; and, when necessary or appropriate, include one member otherwise unaffiliated with the Foundation.

The potential for conflicts of interest should be considered when selecting membership candidates.

B. Training: All IRB members are urged to complete a computer-based training (CBT) that provides more detailed information about their roles and responsibilities. NIH IRB on-line course:

http://ohsr.od.nih.gov/IRBCBT/intro.html

On-line course for researchers:

http://www.stanford.edu/dept/DoR/hs/

V. Functions of the IRB

A. General: The IRB will: (1) conduct initial and continuing review of research and report its findings and actions to the investigator and the institution, recommending protocols and procedures to assure the validity of the research; (2) determine which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; (3) ensure prompt reporting to the IRB of proposed changes in a research activity, and ensure that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject and (4) ensure prompt reporting to the IRB of any unanticipated problems involving risks to subjects, others, or any serious or continuing noncompliance with this policy and requirements or determinations of the IRB; and any suspension or termination of IRB approval.

B. Operations of the IRB: Under the overall supervision of the Executive Director, individual IRBs shall: (1) Schedule in- person or electronic meetings (meetings shall always be arranged so as to allow electronic attendance), (2) Distribute complete study documentation to all members for review prior to the meeting, (3) Vote to approve, require modifications in (to secure approval), or disapprove research activities based on compliance with IRB policies, and (4) Communicate with investigators to convey the need for additional information, IRB decisions, and criteria for appeals to the Board of Trustees (appeals determined by the Board are final decisions).

C. IRB Record Requirements: The Executive Director or designated Assistant for IRBs shall: (1) Maintain current list of membership, qualifications, and contact information; (2) Schedule meetings and record minutes of meetings; (3) Conduct communications to and from the IRB including annual renewal forms and (4) Maintain records of continuing review and results.

VI. IRB Review Process

A. The Principal Investigator (PI) must submit a complete proposal for Foundation IRB review. Once the IRB receives the proposal, a letter will be sent to confirm receipt of the proposal. This letter will also inform the PI if any essential components of the proposal are missing.

A Foundation IRB will review the proposal. It is the PI's responsibility, however, to submit the proposal to other IRBs, such as a university, health maintenance organization (HMO), hospital, or other federal agency (e.g., CDC, NIH) IRBs, as necessary.

The Executive Director or designated Assistant for IRBs will assign the proposal to an IRB member who has the most experience and background in the area of study. This member will become the Primary Reviewer (PR). Using a detailed checklist, the PR will review the proposal.

The PR provides the Executive Director or designated Assistant for IRBs and IRB members with a summary of his or her review. Usually each IRB member should receive a copy of the submitted proposal and the PR's review at least a week prior to the next regularly scheduled IRB meeting.

During the IRB meeting, the committee has an opportunity to discuss the research proposal. The Foundation IRB can vote to:

• ¨ Approve as is, or Approve with Recommendations
• ¨ Approve with Contingencies
• ¨ Defer
• ¨ Disapprove.

B. A letter with the decision is mailed to the PI. If the proposal is approved as is, or approved with recommendations, the work may begin once the IRB receives final letters of approval from all IRBs. If any changes are made to any part of the protocol, the changes must first be approved by all the IRBs.

If the proposal is approved with contingencies, the work may NOT begin until the PI has responded to the contingencies and has made appropriate changes to the proposal. The revised proposal must be submitted to the IRB for its review. The IRB members will review the PI's responses at the next regularly scheduled meeting and vote to either approve, approve with further contingencies, defer, or disapprove.

If the proposal is deferred, the work may NOT begin until the PI has responded to IRB requirements. Most deferrals are missing key requirements. The revised proposal must be submitted to the IRB for its review. The IRB members will review the PI's responses at the next regularly scheduled meeting and vote to either approve, approve with contingencies, defer, or disapprove.

If the proposal is disapproved the work may not be conducted. Most disapprovals are missing essential requirements.

C. Once the Foundation IRB approves a proposal, approvals will remain in effect for one year. At each anniversary of the initial approval, the PI must submit a research status report to the IRB. The annual reviews are in effect for the duration of the project. Should any changes to the protocol occur between reviews by the IRB, the PI should contact and notify the Executive Director or designated Assistant for IRBs as soon as possible, especially in reference to adverse effects.

D. At the completion of the project the PI is required to submit a Final Report to the IRB. The PI must obtain Foundation IRB approval, which shall not be unreasonably withheld or delayed, before any public presentation or publication of the data occurs. The Foundation may use the data and Final Report for its proper purposes. If the Final Report, or any interim report, is subject to Foundation Peer Review Standards and is successfully peer reviewed, it may be referred to as "Peer Reviewed Research."

VII. Information the Investigator Provides IRB

A. Overview: Procedures for IRB Review

Review IRB research guidelines to ensure compliance.

• Review IRB protocols to determine if you are eligible for exemption or expedited review.
• Submit proposal to IRB
• Renew IRB approvals annually.
• Submit annual progress reports and the Final Report.
• Obtain IRB approval for all manuscripts that are to be submitted for publication

B. Research Proposals

A research packet must contain the following items to be considered complete:

• A clear description of the research to be conducted.
• A copy of the consent form.
• Information on the consent process. See Appendix C for more information on informed consent
• If the Principal Investigator or Co-Investigator is faculty of a university or institution, a copy of the university or institution's IRB decision needs to be submitted.
• A copy of proposed procedures to maintain confidentiality and anonymity.
• If the proposal includes a survey or questionnaire, copies need to be submitted.

A complete application expedites the review process. Please submit the original protocol plus 10 copies to the Foundation IRB.

See also Appendix A - Components of a Research Proposal
Appendix B - Detailed Research Protocol

C. Annual progress reports

Annual progress reports are usually done at one-year intervals from the date of initial review. The Executive Director or designated Assistant for IRBs will send an annual renewal form to the Principal Investigator. An annual progress report is considered complete when the investigators provide the following:

• Specification as to whether or not there have been changes to the study protocol since the date of last review.
• Specification as to whether the research project has been completed since the date of last review.
• Total number of subjects enrolled.
• Total number of subjects withdrawing from the project.
• Total number of subjects withdrawing within the past 12 months of the project.
• Identification of all instances of complications or unexpected results of study activity.
• Documentation of internal review of results to date.

A complete progress report expedites the review process. If you have any questions, please do not hesitate to contact any individual in the contact lists.

VIII. Publications

A manuscript review packet must contain the following items to be considered complete:

• If an author is an employee of Foundation, the manuscript must include the standard disclaimer: "The opinions expressed in this paper are those of the author and do not necessarily reflect the views of Foundation." - The publication shall contain the standard Foundation Disclaimer: "The use of magnetism is intended to benefit normal structure and function and is not prescribed as treatment for medical or psychological conditions, nor for diagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles. Not intended to treat disease, support or sustain human life, or to prevent impairment of human health; for self-education and research purposes only."
• A copy of the IRB approval letter.
• The name and coordinates of the Journal in which the article will appear.
• Anticipated date for submission of publication.
• A copy of the manuscript including authors, title, abstract, article, and references.

IX. Expedited review procedures

Expedited review procedures may be judged appropriate for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

Research that may be reviewed by the IRB through an expedited review procedure includes: (1) Some or all of the research found by the reviewer to involve no more than minimal risk; and (2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Under an expedited review procedure, the review may be carried out by the Executive Director or designated Assistant for IRBs or by one or more experienced reviewers designated by the Executive Director or designated Assistant for IRBs from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure.

In the case of an expedited review procedure, all members shall be advised of research proposals which have been approved under this procedure.

Appeals of decisions shall be made in writing to the Board of Trustees whose decision is final and binding on all parties.

Appendix A

Components of a Research Proposal

The Foundation IRB's assessment of your research proposal involves a series of steps: (1) identifying the risks associated with the research, as distinguished from the risks the participants would experience even if not participating in the research; (2) determining that risks will be minimized; (3) identifying the probable benefits to be derived from the research; (4) determining that risks are reasonable in relation to the benefits to the participants, if any, and the importance of the knowledge to be gained; (5) ensuring that potential participants will be provided with an accurate and fair description of the risks or discomforts of the anticipated benefits; and (6) determining the intervals of periodic review.

To ensure that the IRB completes their review in a timely manner, your proposal must include the following information, as applicable:

• ¨ Cover letter with a list of all investigators and a contact person and telephone number
• ¨ Detailed protocol of study design, sampling, analyses, timelines, evaluation, and community involvement
• ¨ Informed consent and assent forms
• ¨ Other attachments, such as a copy of scripts or survey that will be used, materials that will be distributed, etc.

If your proposal is missing any required items, review of your proposal will be delayed.

Appendix B

Detailed Research Protocol

Your research protocol should discuss in detail how you plan to carry out the research, how you will analyze the data that you collect, and what you plan to do with the results. The following are points that you should address in your protocol.

Introduction and Background

• ¨ Provide relevant research background and explain why this activity is necessary or important.
• ¨ Describe the potential impact of the proposed research.

Study Design

• ¨ Provide a complete description of the study design, sequence, and timing of all study procedures that will be performed. Provide this information for pilot, screening, intervention, and follow-up phases. Include all materials that will be used in the procedure, such as surveys, scripts, questionnaires, etc. Attach flow sheets if they will help the reader understand the procedures.
• ¨ Describe how study procedures differ from standard care or procedures (e.g., medical, psychological, educational, etc.).
• ¨ If any deception or withholding of complete information is required, explain why this is necessary and attach a debriefing statement.
• ¨ Describe where the study will take place
• ¨ A letter of approval and cooperation from each participating site is needed. For example, if the study will be conducted in the local school system, an approval letter from the School Board and Superintendent are necessary.

Participants

• ¨ Explain how the nature of the research requires or justifies using the participant population.
• ¨ Provide the approximate number and ages for the control and experimental groups.
• ¨ Describe the gender and minority representation of the participant population.
• ¨ Describe the criteria for selection for each participant group.
• ¨ Describe the exclusion criteria exclusion for each participant group.
• ¨ Describe the source for participants and attach letters of cooperation from agencies, institutions, or others involved in the recruitment.
• ¨ Explain who will approach the participants and how the participants will be approached. Explain what steps you will take to avoid coercion and protect privacy. Submit advertisements, flyers, contact letters, and phone contact protocols.
• ¨ Explain if participants will receive payments, services without charge, or extra course credit.
• ¨ Explain if participants will be charged for any study procedures.

Risks and Benefits

• ¨ Describe the nature and amount of risk of injury, stress, discomfort, invasion of privacy, and other side effects from all study procedures, drugs, and devices. Describe the amount of risk the community may be subjected to.
• ¨ Describe how due care will be used to minimize risks and maximize benefits.
• ¨ Describe the provisions for a continuing reassessment of the balance between risks and benefits.
• ¨ Describe the data and safety monitoring committee, if any.
• ¨ Describe the expected benefits for individual participants, the community, and society.

Adverse Effects

• ¨ Describe how adverse effects will be handled.
• ¨ Discuss if facilities and equipment are adequate to handle possible adverse effects.
• ¨ Explain who will be financially responsible for treatment of physical injuries resulting from study procedures (e.g., study sponsor, subject, organization compensation plan, etc.).

Confidentiality of Research Data

• ¨ Explain if data will be anonymous (no possible link to identifiers).
• ¨ Explain if identifiable data will be coded and if the key to the code will be kept separate from the data.
• ¨ Explain if any other agency or individual will have access to identifiable data.
• ¨ Explain how data will be protected (e.g., computer with restricted access, locked file, etc.).

Consent Forms and Assent Forms

• ¨ If the consent form is written, submit copies of all consent and assent forms for each participant group. If an oral consent or assent script will be used, submit written scripts for each group.
• ¨ If you will not use a consent form or script, submit written justification of waiver of consent.

Drugs, Substances, and Devices

• ¨ List all non-investigational drugs or other substances that will be used during the research. Include the name, source, dose, and method of administration.
• ¨ List all investigational drugs or substances to be used in the study. Include the name, source, dose, method of administration, IND number, and phase of testing. (INDs must be registered with the appropriate institutional pharmacy.) Provide a concise summary of drug information prepared by the investigator, including available toxicity data, reports of animal studies, description of studies done in humans, and drug protocol.
• ¨ List all investigational devices to be used. Provide the name, source, description of purpose, method, and Food and Drug Administration IDE number. If no IDE is available, explain why the device qualifies as a non-significant risk. Attach a copy of the protocol, descriptions of studies in humans and animals, and drawings or photographs of the device.

Additional Information

• ¨ Describe how materials with potential radiation risk will be used (e.g., X-rays and radioisotopes).
• ¨ If you will use materials with potential radiation risk, describe the status of annual review by the Radiation Safety Committee. If the annual review has been approved, attach a copy of the approval.
• ¨ Describe the medical, academic, or other personal records that will be used.
• ¨ Describe the type of audio-visual recordings, tape recordings, or photographs that will be made.
• ¨ Explain if the Scientific Instrument Division will test all instruments. If not, describe the safety testing procedures.

Appendix C

Informed Consent

Informed consent is one of the primary ethical requirements underpinning research with human participants; it reflects the basic principle of respect for people. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or discrete moment of time. Informed consent ensures that prospective participants will understand the nature of the research and can knowledgably and voluntarily decide whether or not to participate. This protects both the participant, whose autonomy is respected, and the investigator, who otherwise faces legal hazards.

The Nuremburg Code, developed by the International Military Tribunal that tried Nazi physicians for the "experiments" they performed on unconsenting inmates of concentration camps, was the first widely recognized document to deal explicitly with the issue of informed consent and experimentation on human participants.

The Declaration of Helsinki further codified these concerns - http://www.wma.net/e/policy/b3.htm . In general, it provides:

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

Federal regulations require that certain information must be provided to each participant:

• ¨ A statement that the study involves research, an explanation of the purposes of the research and the expected duration of participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
• ¨ A description of any reasonably foreseeable risks or discomforts to the participants.
• ¨ A description of any benefits to the participant or to others which may reasonably be expected from the research.
• ¨ A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
• ¨ A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
• ¨ For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• ¨ An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury to the participant.
• ¨ A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

The regulations further provide that the following additional information be provided to participants, where appropriate:

• ¨ A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable.
• ¨ Anticipated circumstances under which the participant's participation may be terminated by the investigator without the participant's consent.
• ¨ Any additional costs to the participant that may result from participation in the research.
• ¨ The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant. If your study offers compensation for participation, specify the effects of termination of participation on that compensation. (The compensation should be prorated to reflect the duration of participation rather than an "all or nothing" so that it appears fair and non-coercive).
• ¨ A statement that significant new findings developed during the course of the research that may relate to the participant's willingness to continue.
• ¨ The approximate number of participants involved in the study.

Investigators may seek consent only under circumstances that provide the prospective participant or his or her representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. Furthermore, the information must be written in language that is understandable to the participant or representative. The consent process may not involve the use of exculpatory language through which the participant or representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence.

In your research protocol, you will need to explain the process of administering consent. The protocol should address the following questions:

• ¨ Is consent obtained in a reasonably quiet, unhurried setting?
• ¨ Is there a knowledgeable person present who can answer questions in a clear manner, using layman terms?
• ¨ Will this knowledgeable individual assess the participant's comprehension?
• ¨ Have you considered the availability of translators for those who may only speak their native language? Similarly, if you may be including participant who are illiterate, deaf, blind, etc., have you accommodated their needs?
• ¨ Do you plan to provide a copy of the consent form to each participant ?
• ¨ If children (under age 18) are involved in your study, do you have a parental consent form? If the study involves minimal risk, then consent of one parent is adequate; if it involves more than minimal risk, then you must obtain permission of both parents.
• ¨ If the child is old enough to make at least some decisions themselves (usually at least 5 or 6 years of age, but this is specific to their culture), have you set up a form and process for their assent?
• ¨ Who will explain the research to the potential participants? Should someone in addition to or other than the investigator be present?
• ¨ Should participants be reeducated and their consent required periodically?
• ¨ If a waiver of some or all of the consent requirements is requested, does the importance of the research justify such a waiver? Is more than minimal risk involved? Can the research design be modified to eliminate the need for deception or incomplete disclosure? Will participants be given more information after completing their participation? Would the information to be withheld be something prospective participants might reasonably want to know in making their decision about participation?

In addition to a detailed discussion of the components of the consent and assent forms and the administration process, you will need to include labeled copies of each form specifying its type (e.g., parental consent, child assent, regular consent), participant (e.g., community focus group members, adult vaccine recipients), and situation where it will be used (e.g., for pretest of screening instrument, administration of a provider questionnaire, etc.).

Appendix D

Sample Informed Consent

Biomagnetics

REQUEST, PRIVATE LICENSE,

INFORMED CONSENT AND RELEASE

Participant: Date:

 

Address: Phone:

 

-----------------------------------------------------------------------------------------------------------------------------

For good and valuable consideration, the undersigned agree and certify:

First: Constitutional Request

1. The undersigned individual hereby requests (1) the evaluation of the current energetic, wellness and/or nutritional state of the undersigned and (2) advice on, and use of, diet, supplements and/or energetic means, to help the undersigned achieve and maintain a healthy status, through biomagnetic research evaluation.

2. The undersigned agrees not to act on such advice until the undersigned has had an opportunity for an examination by a licensed physician chosen by the undersigned, and received the evaluation and advice of such physician.

3. The undersigned makes the above requests as an exercise of natural right, within the Right of Privacy reserved by the people under the Constitution of the United States, Ninth Amendment.

4. The Research Practitioner and agents do not diagnose or prescribe for medical or psychological conditions nor claim to prevent, treat, mitigate or cure such conditions. They do not provide diagnosis, care, treatment or rehabilitation of individuals, nor apply medical, mental health or human development principles, but rather may provide modalities that may benefit, as permitted under AMA Code 3.04.

Second: Private License

1. The undersigned does hereby privately License the Practitioner, granting same authority to assist the undersigned in any and all ways to which the undersigned gives consent. This License authorizes the services stated in the Constitutional Request, First, above.

Third: Informed Consent and Release

1. The undersigned understands that the Practitioner and any organization through which the Practitioner conducts research evaluations only, as ministration for religious, charitable, scientific research and educational purposes. The organization(s) and Practitioner(s) do not diagnose, prescribe for, or treat disease conditions; nor do they claim to prevent, mitigate or cure disease conditions.

Persons who suspect medical conditions are advised to seek an appropriate health care professional. Our research may support wellness and healing, and may support treatment, but is not a treatment of disease by itself. It is no substitute for a licensed physician's diagnosis and treatment. If the undersigned has been diagnosed by a licensed physician, the undersigned will disclose this information to the Practitioner.

2. The undersigned does hereby give Informed Consent for biomagnetic, spiritual, energetic and/or nutritional consulting, as well as such spiritual, bio-energetic and/or nutritional work as may be conducted by the Practitioner. The organization and Practitioner make no medical claims, nor assume any responsibility for any claims. In no way do they claim that any magnets, equipment or nutritional services should or can be used to treat any disease condition. The undersigned further understands that any nutritional substances recommended may be purchased from any supplier. The undersigned has studied the alternatives and personally chose the work that is to be done.

3. The organization and Practitioners do not make any representations, promises or guarantees. The recommendations and modalities used are not intended to, and will not, prevent, mitigate, treat or cure any disease condition, including, but not limited to, cancer and immune deficiency diseases.

4. The undersigned does hereby accept full responsibility for the use of these procedures and advice, releasing, indemnifying and holding the organization and Practitioners harmless from all claims arising from participation in these procedures. The undersigned acknowledges that the Practitioner does not diagnose, treat or claim to prevent, mitigate or cure human disease. The undersigned agrees that the undersigned will not bring a complaint or lawsuit against the organization or Practitioner for any reason, including, but not limited to, the grounds that these recommendations and modalities are experimental, or are not approved, accepted or acknowledged to be effective. Biomagnetics is a research modality.

5. The undersigned does hereby give the organization and Practitioners permission to use the information gathered during these procedures, with personal identification removed (anonymous data), for research and educational purposes.

 

Dated: _______________________, 200___.

 

Research Practitioner Signature Client Signature

Client Address:

 

Consent form © 2007 Ralph Fucetola JD
www.vitaminlawyer.com

 

References

http://www.npaihb.org/epi/irb.html#guidelines
http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html
http://ohsr.od.nih.gov/IRBCBT/intro.html
http://ninr.cm.net/4200-01.htm
http://www.eh.doe.gov/ohre/roadmap/achre/chap14_2.html
http://www.nihtraining.com/ohsrsite/guidelines/45cfr46.html
http://humansubjects.stanford.edu/nonmedical/IsitHS.html
http://humansubjects.stanford.edu/nonmedical/submission.html
http://www.stanford.edu/dept/DoR/hs/
http://www.fda.gov/oc/ohrt/irbs/faqs.html#IRBOrg
http://ohsr.od.nih.gov/irb/irb.html
http://ohsr.od.nih.gov/irb/OrientationGudelines_Final.pdf
http://www.fda.gov/oc/ohrt/irbs/faqs.html#IRBOrg

© 2007 - Rev 01.24.07