SOUND HEALTH RESEARCH INSTITUTE

Dedicated to the Work of Sharry Edwards, M.Ed. www.soundhealthresearch.org/

Ethics Code

The Human BioAcoustics Code of Ethics consists of two sections: (1) Code of Conduct and (2)

Procedures (Ethics Enforcement Code). It is adopted and may be amended by the Credentials Committee established by the Structure Resolution of the Board of Trustees of SHRI. The Ethics Chairperson is Judy Chambers – judyc@gate.net.

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Code of Conduct

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 SHRI IRB (Internal Review Board) or Sound Health, Inc. All questions or doubts regarding Client evaluation shall be reviewed with other certified Practitioners or with Sound Health, Inc. prior to giving a Client an appropriate Frequency or Frequency Set.
Human BioAcoustics does 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 Human BioAcoustics, informing the Client that Human BioAcoustics mission and intent is to encourage the continued investigation and development of Human BioAcoustics 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. Human BioAcoustics is defined as: “The research and study of human vocalization and low frequency sound as it relates to health and wellness.”
Practitioners shall, when performing Human BioAcoustics evaluation and presentation, always act with the written informed consent of the C1ient. All persons representing themselves as Human BioAcoustic Practitioners should not represent other modalities as Human BioAcoustics.
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.
Practitioners shall keep all required records and submit all reports in a timely fashion. All Practitioners shall keep reasonably abreast of the development of new techniques and technologies in accordance with scheduled updates for practice.
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 Subcommittee Chairperson and IRB Chairperson of any unethical conduct that comes to their attention.
Practitioners shall charge fairly and reasonably for their services.
Practitioners shall always act in a reasonably professional manner and shall avoid any impropriety or other act which may reflect negatively upon themselves or Human BioAcoustics.
Each Practitioner shall recognize and respect the Intellectual Property rights of Sharry Edwards, M.Ed. in the materials and techniques developed by her.
By becoming a Human BioAcoustics Practitioner, the Practitioner agrees to abide by this Code and to abide by the fair and timely decisions of the Ethics Subcommittee. Each Practitioner shall abide by arbitration of disputes regarding fees or ethical issues through the Ethics Subcommittee. Top

Procedures

(Ethics Enforcement Code)

Requests, Appeals and Complaints

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 Subcommittee (through the Chairperson of the Subcommittee) in writing, by any Practitioner, Client, Trustee or member of any body established by the Structure Resolution. The Subcommittee may consider any issue relating to the Structure Resolution, Code of Ethics, Peer Review Standards or Certification Standards. The Subcommittee should be guided by an honest sense of morals, ethics, sense of justice, fairness, reasonable precedents and right.
Upon receipt of a Request, Appeal or Complaint, a full copy shall be sent to each

Member of the Subcommittee and to Credentials Committee Chairperson who shall inform the Trustees thereof. Any Trustee may request a copy of any document filed with the Subcommittee.

In an emergency, the Chairperson, with the support of a majority of Subcommittee Members may issue a Temporary Ethics Order based upon a written Complaint, without a formal meeting. The Order may temporarily suspend a Practitioner or that other emergent action to preserve the status quo and the intent and integrity of Human BioAcoustics.
In all other circumstances, the parties shall have thirty (3O) days, or such lesser or greater period of time, as the Subcommittee may determine, to submit written statements regarding the matter (without separate approval of the Chairperson, no such submission, including attachments, shall exceed 25 pages).
Thereafter, the Subcommittee shall discuss the matter (by electronic or face-to-face meeting, or through individual consultations with the Chairperson). The Subcommittee may appoint one or more of its members to interview interested parties or obtain additional information.
The Subcommittee 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.

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Decisions

The Subcommittee shall issue written Decisions within a reasonable time after the closing of discussion. Copies shall be provided to each party and to the Credentials Committee Chairperson who shall so inform the Trustees or other interested persons.
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 SHRI and Human BioAcoustics.
A Fee Arbitration Decision shall determine the fair and reasonable fee and may be enforced by either party to it.
An Ethics Decision may include the temporary or permanent suspension of the right to practice, subject to Credentials Committee oversight, or such lesser requirements, including formal warnings or remedial training, as the Subcommittee may determine. In the case of any suspension of the right to practice, the Subcommittee shall require the return of any proprietary materials.
An Ethical Determination (advisory opinion) may include general advisory information on any matter within the scope of the Structure Resolution.
A copy of the Decision shall be sent each interested person and may be published or otherwise disseminated.
An Appeal of an IRB, Peer Review or Certification Subcommittee shall be determined as provided herein for a Complaint and the Chairperson of the Subcommittee or IRB being appealed shall act as representative of the Subcommittee 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.

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Reconsideration, Reinstatement, Appeal and Abuse of Process

Any interested person may Petition, in writing, the Subcommittee 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 Subcommittee 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.

Within ten (10) days after the rejection of a Reconsideration, any aggrieved party may Appeal, in writing, to the Credentials Committee, which shall consider the matter on an emergent basis.

The Committee may recommend the acceptance of the Reconsideration and refer the matter back to the Ethics Subcommittee 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.

A suspended Practitioner may submit a written Petition for Reinstatement to the Credentials Committee 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 Committee 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.

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.

rev 02/01/05 – drafted by Ralph Fucetola JD, SHRI Counsel – www.nonprofitlawyer.org.

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Back to SHRI: www.soundhealthresearch.org

Sound Health Research Institute

www.soundhealthresearch.org Credentials System Main Page

Certification Standards for Human BioAcoustic Research Associates

BARA BOARD CERTIFICATION STANDARDS – Draft 1.0 08/24/05

Introduction

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 BioAcoustics. If we are to have the most comprehensive health care options available to people, it must include research and an educational force that includes BioAcoustics.

BioAcoustics, the work founded and pioneered by Sharry Edwards, has been integrated into the research company called Sound Health Alternatives, Inc. (SHAI). Ms. Edwards provides qualified educational programs through this company. There has also been established a not-forprofit, recognized exempt organization, Sound Health Research Institute, Inc. (SHRI). The Trustees have established a Credentials System for Professional BioAcoustic Research Associate Standards in 2004. The System includes Certification, Peer Review, Research and Ethics standards. See: www.soundhealthresearch.org for details.

The Certification Board’s goal is to advance the quality of sound research, teaching, learning, and mentoring in the development of BioAcoustics by maintaining high standards for what accomplished BioAcoustic Associates should know and be able to do, and by providing a system to certify BioAcoustic Associates who meet these standards. These standards are established for BioAcoustic Associates, and for BioAcoustic Associates, is a representation of professional excellence. There are entry-level standards for beginning BioAcoustic Associates, as well as established advanced standards for experienced BioAcoustic Associates.

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

Proficiency of BioAcoustic Associates

The Board presents its view of what BioAcoustic 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.

The fundamental requirements for proficient sound 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 sound 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 BioAcoustics.

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

Seven Core Values of BioAcoustics Associates

The SHRI Trustee authorized Board for Professional Certification Standards seeks to recognize BioAcoustic Associates who demonstrate the high level of knowledge, skills, abilities and commitments reflected in the following Seven Core Values.

■BioAcoustic Associates have self-discipline. Certified and accomplished BioAcoustic Associates use good judgment and observe “do no harm” as a first rule of practice. Associates are expected to abide by the Ethics Code.

■BioAcoustic Associates are committed to being the source of their own decision making.

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

■BioAcoustic Associates utilize knowledge and creativity.

Certified and accomplished BioAcoustic Associates have a rich understanding of BioAcoustics 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.

■BioAcoustic Associates are aware and present human beings.

Certified and accomplished BioAcoustic Associates are adept at engaging people to assist their sound 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.

■BioAcoustic Associates think systematically and learn from experience. Certified and accomplished BioAcoustic Associates 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 BioAcoustics research, Certified and accomplished BioAcoustic Associates 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.

■BioAcoustic Associates are leaders within their communities. Certified and accomplished BioAcoustic Associates contribute to the effectiveness of the Sound Health by working collaboratively with other professionals on research, standards of practice, and educating. They find ways to work with people, engaging them productively in managing

their own health care choices. BioAcoustic Associates are dedicated to making BioAcoustics accessible.

■BioAcoustic Associates provide support for other human beings. Certified and accomplished BioAcoustic Associates contribute to the betterment of humankind through active support of providing options for health choices.

Certification Standards Statement of Purpose – The purpose of the Certification Standards Subcommittee (Certification Board or Board for Professional Certification Standards) is to implement 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 [both through Sound Health, Inc. and otherwise] and

professional status). Certification to cover HBA as established by the research initiated by Sharry Edwards and to include such sub-specialties as Vocal Profiling and the like. The Subcommittee consists of a Certification Chairperson appointed and removable by the Chairperson of the Credentials Committee and such Members (not exceeding six) as may be invited by the Subcommittee Chairperson. The Chairperson and Members of the Subcommittee may be removed from the Subcommittee by resignation or determination of the Board of Trustees.

Descriptions

Levels of Certification

Level I Certification (BioAcoustics Member Associate/BAMA)

This level of practitioner has received Focus course training from Sound Health, Inc and it has been mutually and contractually agreed upon that they wish to utilize the Sound Health,

Inc. technology only to conduct Vocal Profiling intake information under the auspices of a Certified Sound Health BioAcoustics Mentor. Completion time is one week, annual recertification fee is required.

Level II Certification (BioAcoustics Professional Associate/BAPA)

This level of practitioner has received Focus course and additional Lab, Merchandising training from Sound Health, Inc., submission of approved Business plan within one year of taking Focus course, and it has been mutually and contractually agreed upon that they wish to utilize the Sound Health, inc. technology to conduct Vocal Profiling and distribute and sell products commercial produced by Sound Health, Inc. Completion time is from 1-12 months, proficiency with BioAcoustics software and technical savvy is expected, annual recertification fee is required.

Level III Certification (Pre-BioAcoustics Research Associate/pre-BARA)

This level of practitioner has successfully completed the Focus course and one additional Lab training within a one year period from Sound Health, Inc., must be actively working with a Certified BioAcoustics Mentor, and is in the process of providing a minimum of one approved case study per month to Sound Health, Inc. for a consecutive period of two years, one paper must be submitted for conference presentation, and it has been mutually and contractually agreed upon that they wish to utilize the Sound Health, Inc. technology to conduct research. Completion time for requirements must be within two years, proficiency and working knowledge of BioAcoustics software is expected, annual conference attendance and presentation and re-certification fee is required.

Level IV Certification (BioAcoustics Research Associate/BARA)

This level of practitioner has successfully completed Level III, which includes having provided a minimum of one approved case study per month to Sound Health, Inc. for a consecutive period of two years, and it has been mutually and contractually agreed upon that they wish to utilize the Sound Health, Inc. technology to conduct research. Course time completion is two years, expert level of BioAcoustics software is expected, annual conference attendance and presentation and re-certification fee is required.

Level V Certification (BioAcoustics Mentor/BAM)

This level of practitioner has successfully completed Level IV for one year and submitted an approved Mentoring Agreement to Sound Health, Inc. It has been mutually and contractually agreed upon that they wish to utilize the Sound Health, Inc. technology to conduct research and to mentor Level I, II, or III practitioners. Mentoring certifications will be reviewed on a yearly basis and based on the results of the most recent year, it will be determined if Mentoring status will be maintained for the following year.

Level VI Certification (BioAcoustics Training Specialist/BATS)

This level of practitioner has successfully maintained a Level V Practitioner status for a consecutive period of five years, and it has been mutually and contractually agreed upon that they agree to teach Sound Health, Inc. classes in conjunction with and as approved by Sharry Edwards.

Level VII Certification (BioAcoustics Educator & Researcher/BAER)

This level of practitioner has successfully maintained a Level VI Practitioner status for a consecutive period of five years, and it has been mutually and contractually agreed upon that they agree to teach Sound Health, Inc. classes as approved by Sharry Edwards.

Core Educational Requirements for each level – In addition to Sound Health, Inc. requirements, each level of certification holds core educational requirements which must be fulfilled prior to beginning the Sound Health Certification Process. All degrees must be in a relevant field and from an accredited college. All core class requirements must be completed with a grade of B or higher. Sound Health, Inc. and the Certification Committee will review the applications and transcripts of each candidate and determine eligibility. Life experience credits to be taken into consideration and determined on a case-by-case basis.

Level I Core Requirements

Proficiency in basic computer skills

Level II Core Requirements

Associates degree and successful completion of Intro level courses in all of the following subjects: Business, Marketing, English, Math, Communications, Biology, Ethics 3. Level III Core Requirements

Bachelor’s degree and successful completion of Intro level courses in all of the following subjects: Anatomy, Physiology, Biology, Chemistry, Psychology, Research Methods,

English, Business Writing, Math, Law & Ethics, and Nutrition

Level IV Core Requirements

Bachelor’s degree and successful completion of Upper level courses in all of the following subjects: Pathology, Biochemistry, Genetics, Pharmacology, Immunology, Neurology,

Media Relations, Marketing, and Math

Level V Core Requirements

Masters Degree and successful completion in Upper level courses in the following subjects:

Human Development, Abnormal Psychology, Teaching & Education

Level VI Core Requirements

Doctoral degree or post-doctoral work and by permission of Sharry Edwards.

Level VII Core Requirements

By permission of Sharry Edwards only

Exemptions – Partial requirements may be satisfied through exemptions

Requirements for Exemption – Exemptions will be considered on a case-by-case basis, and with the approval of the Certification Subcommittee and the Advisory Board.

Process for Application for Exemption – To be outlined.

Proficiency Testing – International Certification by the Sound Health Advisory Board is determined with a combination of events, including but not limited to a standards-based assessment. This means there is a criterion or standard of performance that must be met by candidates in order to achieve certification, and the content of each assessment is determined by the standards document for each assessment. Applicants must complete intensive training courses and labs where they are trained to evaluate responses according to the Sound Health standards. Assessment scores are only a small portion of a candidate’s eligibility for certification. A candidate must earn a total score for all exercises that exceeds 76% or better in order to achieve International Sound Health Board Certification.

Grandfather clause – All Sound Health BioAcoustics Research Associates who are approved by Sharry Edwards, and deemed to be an active member of the Sound Health community as of [August 1, 2006] shall be grandfathered into Certification with the following requirements satisfied:
1. Case Studies –Six case studies submitted between January 1, 2006 and August 1, 2006
2. Conference Attendance – Mandatory attendance each year
3. Conference Paper presentation – Mandatory at each annual conference
4. Lab course review – Must attend one review course per four years after August 1, 2006
5. Grandfather clause exemption process – To be outlined

Certification Processes – Each person that shall receive any Certification from Sound Health, Inc. will need to follow the process outlined below.
1. Forms/Applications for Certification – To be outlined
2. Process for determining validity of Application for Certification – To be outlined Pending Certifications – To be outlined
3. Certification Renewal – To be outlined
4. Certification Rejection – To be outlined

Co-operative subcommittee functions – The Certification Subcommittee shall interact with the other subcommittees as outlined below. Credentials Committee – To be outlined
1. Ethics subcommittee – To be outlined
2. Peer Review subcommittee – To be outlined
3. Editorial Board – To be outlined
4. Advisory Board – To be outlined

Subcommittee members
1. Chair responsibilities – To create, submit, edit, and maintain Credential guidelines and policies.
2. Subcommittee member responsibilities – To be outlined

-end-

Sound Health Research Institute

Institutional Review Board Guidelines

SHRI Home Page: www.soundhealthresearch.org Credentials Committee Main Page

The Sound Health Research Institute (SHRI) Institutional Review Board (IRB) has the responsibility to review, and the authority to approve or disapprove, all research activities that use SHRI facilities, data, staff resources, or funding. Moreover, they retain the same responsibility to previously approved activities.

The IRB is established to protect the rights and welfare of human research subjects recruited to participate in Human BioAcoustics research activities.

The IRB reviews research proposals to assess the risks and benefits for the human subjects to be studied.

Each proposal is reviewed using criteria described in Human BioAcoustics Research Protection of Human Subjects. 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.

Human BioAcoustics Research Protection of Human Subjects

The SHRI 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 •People are autonomous; researchers must give them for Community 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

IRB Protocol Review Standards – Criteria for IRB approval of research IRB members are responsible for overseeing:

The proposed research design is 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 selection is 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.

IRB Review Standards Table

Regulatory review requirement

Functions of the IRB

The IRB will:

conduct initial and continuing review of research and report its findings and actions to the investigator and the institution;

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;

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.

ensure prompt reporting to the IRB of any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and any suspension or termination of IRB approval.

Operations of the IRB

Schedule meetings

Distribute complete study documentation to all members for review prior to the meeting

Vote to approve, require modifications in (to secure approval), or disapprove research activities based on compliance with IRB policies

Communicate with investigators to convey the need for additional information, IRB decisions, and criteria for appeals.

IRB Record Requirements

Maintain current list of membership, qualifications, and contact information

Record minutes of meetings

Communications to and from the IRB including annual renewal forms

Records of continuing review

IRB Review Process

The Principal Investigator (PI) must submit a complete proposal for SHRI 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.

The SHRI 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 IRB Chair will assign the proposal to a committee member who has the most experience and background in the area of study. This committee member will become the Primary Reviewer (PR). Using a detailed checklist, the PR will review the proposal.

The PR provides the Chair and IRB committee members with a summary of his or her review. Each IRB committee member receives a copy of the submitted proposal and the PR’s review two weeks prior to the next regularly scheduled IRB meeting.

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

♦ Approve as is, or Approve with Recommendations

♦ Approve with Contingencies

♦ Defer

♦ Disapprove.

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.

Once the SHRI 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 IRB Chair as soon as possible, especially in reference to adverse effects.

At the completion of the project the PI is required to submit a final report to SHRI IRB. The PI must obtain SHRI and IRB approval before any public presentation or publication of the data occurs.

Information the Investigator Provides IRB

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.
Obtain IRB approval for all manuscripts that are to be submitted for publication 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 SHRI IRB.

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

Annual progress reports

Annual progress reports are usually done at one-year intervals from the date of initial review. The IRB 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.

Publications

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

If an author is an employee of SHRI, 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 SHRI.”
A copy of the IRB approval letter.
The name of the Journal the article will appear in.
Anticipated date for submission of publication.
A copy of the manuscript including authors, title, abstract, article, and references.

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:

some or all of the research found by the reviewer to involve no more than minimal risk,
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 IRB chairperson or by one or more experienced reviewers designated by the chairperson 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.

Appendix A

Components of a Research Proposal

The SHRI 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 first principle of the code states:

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.

All subsequent codes and regulations, insofar as they pertain to competent, adult participants, follow these principles closely.

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

Human BioAcoustics^SM

REQUEST, PRIVATE LICENSE,

INFORMED CONSENT AND RELEASE

Participant: Date:

Address: Phone:

—————————————————————————————————————————–

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

First: Constitutional Request

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 Human BioAcoustics research vocal profiling evaluation.

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.

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.

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 provide Human BioAcoustic modalities that may benefit, as permitted under AMA Code 3.04.

Second: Private License

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

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.

The undersigned does hereby give Informed Consent for Human BioAcoustic, 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 energy or vocal analysis 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.

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.

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. Human BioAcoustics is a research modality.

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  2005 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

Back to SHRI homepage – www.soundhealthresearch.org

The Journal of BioAcoustic Biology (JBAB)

Submission Standards

Bringing BioAcoustics of Life

A Peer Reviewed Journal of Theory, Research and Practice of Human BioAcoustic Vocal Profiling and Sound Presentation Sound Health Research Institute, Inc.

http://www.soundhealthresearch.org

Journal Homepage: www.JBAB.org

Introduction

Human BioAcoustic Vocal Profiling & Sound Presentation, at present, is an emerging research modality that has the potential to provide pre-diagnostic assessment using a predictable

Mathematical Matrix of frequency-based protocols. JBAB strives to set forth the theoretical basis of the emerging science of Human BioAcoustic Vocal Profiling and Sound Presentation. Vocal Profiling offers interpretative information that stands independently as a valuable assessment tool. Sound Presentation provides the management phase through brain wave entrainment using low-frequency, ambient sound.

The emerging “Mathematical Model” being assembled from Human BioAcoustic research data has the potential to allow Vocal Profiling to be used to predict health issues; from the very first cries of a newborn through the frequency foundations of disease and aging.

The Journal of BioAcoustic Biology (JBAB) is sponsored by the Sound Health Research Institute, Inc., a duly recognized exempt organization (SHRI). This Journal has been established in response to the calls for a peer-reviewed venue for the publication of articles and practice notes on the subject of Human BioAcoustic Vocal Profiling.

The SHRI trustees responded by adopting, as part of the Credentials System sponsored by the

Institute, authorization for the establishment of this Journal. According to the enabling

Resolution, “The Journal publishes in the area of HBA as established by the research initiated by Sharry Edwards…” articles and practice notes subject to the oversight of the Peer Review Subcommittee.

These Submission Standards are adopted in furtherance of the Peer Review Standards adopted by the SHRI Credentials Committee and are subject thereto. Peer Review Standards. The Journal homepage is located [Here].

Instructions for Contributors

Manuscripts should be addressed to the Editor, Kathy Fucetola, 58 Plotts Road, Newton, NJ, 07860 with a copy by email to kathy.greene@usa.net. Submit an original and three (blind) copies together with a letter of transmittal including:

the name, telephone number and email of the author(s);
the title of the paper and a statement of its main point;
keywords to be used for indexing;
the total number of words (including text, references, and figure and table legends) in the manuscript;
a statement or request from the author(s) allowing publication under the auspices of the Journal
relevant manuscripts published by you in the past.

The email cover letter should also include the above information.

By submitting a manuscript, an author accepts the responsibility that all those listed as authors of a work have agreed to be so listed, have seen and approved the manuscript, and are responsible for its content. Submitted papers are reviewed in depth by two or more referees as well as other warranted parties, legal evaluation for instance, as indicated.

Reviewers are expected to return their comments within four weeks. It is the policy of JBAB that reviewers are kept anonymous. Authors are notified of acceptance, rejection, or need for revision, usually within 6 to 10 weeks. Papers cannot be resubmitted over a disagreement on interest level or relative merit.

Condition of Acceptance

When a paper is accepted for publication in JBAB, it is understood by the editors that any materials and methods necessary to verify the conclusions of the experiments reported will be made available to other investigators under appropriate conditions. The paper will remain a privileged document and will not be released to the press or the public before publication. If there is a need in exceptional cases to publicize data in advance of publication, the Journal Editor (973-300-4594 – kathy.greene@usa.net) must be consulted.

Selection of Manuscripts

In selecting papers for publication, the editor(s) give preference to those submitted by certified BARA researchers that are well written, well organized, and intelligible to lay persons as well as BioAcoustic professionals. Manuscripts containing Proprietary BioAcoustic information or nomenclature will not be published in the public version of the JBAB, without redacting such nomenclature or information. An attempt is made to balance the subject matter among theory, research and practice but any well conceived BioAcoustic based or associated topic will be considered if the premise, writing and conclusions are solidly developed.

Categories of papers include: general, experimental, clinical, theoretical, reports, correspondence, technical comments, book and software reviews, column ideas, perspectives, and policy forums. All papers should contain a title, an abstract, key words, and include, where relevant, an introduction, hypothesis, procedures, protocol, results and discussion sections with brief subheads, references, and appropriate notes and footnotes. Remember that the most read articles can tell the story and draw conclusions by the headings alone. Sometimes this is the first and last chance to interest your reader.

General Papers: General papers are expected to (i) review new developments; (ii) describe a current research problem or a technique of interdisciplinary significance; or (iii) discuss some aspect of the history, logic, policy, or administration of BioAcoustics. Readers should be able to learn from a general article what has been firmly established and what are unresolved questions.

Experimental Papers: A research paper is expected to contain new data representing a significant information for contemplation or review. Clinical papers should advance a clinical procedure or technique; include a review of relevant case studies illustrating the author(s) premise. Clinical papers should not include sufficient BioAcoustic methodology but should include information from other disciplines that support the premises.

Theoretical Papers: Theoretical papers should present a discussion of a current scientific standard as it articulates/supports understanding between BioAcoustics and other disciplines.

Perspectives: In contrast to the peer reviewed papers in the Clinical, Theoretical, or Experimental Sections, Perspectives are designed to point toward directions worth pursuing, even when there may not be enough research to fully justify or explain the insights presented. Perspectives are invitational, will appear irregularly, are not refereed, and represent the unmodified and singular view of authors selected from our community for the quality and originality of past work.

Reports: Reports are expected to contain important, but preliminary, research results. No frequencies shall be published.

Correspondence: Letters are selected for their pertinence to material published in JBAB or because they discuss general issues of interest. Letters pertaining to material published in JBAB may correct errors; provide supporter, agreement or professional

argument; or offer different points of view, clarifications, or additional information. Letters may be reviewed by outside consultants. The authors of the paper in question are usually given an opportunity to reply. Preference is given to letters that do not exceed 1250 words. Letters accepted for publication are frequently edited and shortened in consultation with the author.

Technical Comments: Technical comments, papers or explanations will be published in professional addenda to JBAB, available privately to currently certified BioAcoustic Research Associates (BARA) upon request and approval..

Book and Software Reviews: The selection of books and software packages to be reviewed and of reviewers cannot be published as a matter of course. Instructions and length specifications to accompany items to be reviewed, when they are sent to reviewers. Such reviews are best designed to be constructive, informative and relevant.

Manuscript Preparation

The guidelines for manuscript preparation are:

Use double-spacing throughout the text, tables, figure legends, and references and notes and leave margins of at least 1-inch/2.5 centimeters. Two spaces should be left between sentences, and after semi-colons and colons.

Title should be short, specific, and amenable to indexing. Chose your title based on your intent – informative or a call to action

This should explain to the general reader why the research was undertaken and why the results should be viewed as important. The abstract should convey the main point of the paper and present, if relevant, the central research findings, and outline the conclusions.

Author(s) should select keywords to be included on the abstract page.

A brief introduction should indicate the broad significance of the paper. The whole text should be intelligible to readers in different disciplines. Technical terms should be defined but we caution the author to use definitions approved by legal counsel. All tables and figures should be cited in the text in numerical order.

Symbols and Abbreviations. Define all symbols, abbreviations, and acronyms the first time they are used. At first mention any trademark or other such symbols should be designated but it is not necessary to include such marks thereafter.

Units of Measure. Authors should use the more general designation of musical notes to identify specific frequency categories for publication.

References and Notes. Number references and notes in the order in which they are cited, first through the text and then through the table and figure legends. List a reference only one time. References that are always cited together may be grouped under a single number. Use conventional abbreviations for well-known journals.

❍Reference examples follow:

■References to Papers. G. Bravo & C. Grob, Shamans, Sacraments and Psychiatrists, Journal of Psychoactive Drugs 21, 1 (1989), pp. 123-128.

■References to Books. N. Cousins, Human Options: An

Autobiographical Notebook (W. W. Norton, New York, NY, 1981).

■References to Chapters in Books. C. G. Jung, Psychological

Commentary, In The Tibetan Book of the Dead (W. Y. Evans-Wentz, Oxford University Press, New York, NY, 1957).

■References from Conference Proceedings. B. A. Rubik and D. E. Coshland, Jr., Proceedings of the National Academy of Sciences 75, 7820 (1978).

Unpublished Observations. Reference to unpublished data should be given a number in the text and placed, in correct sequence, in the references and notes.

Gather all acknowledgments into a brief statement at the end of the references and notes.

Informed Consent. Investigations on human subjects must include a statement indicating that informed consent was obtained after the nature and possible consequences of the studies had been fully explained. This is particular important for minor and/or incapacitated clients under the jurisdiction of a guardian

For each figure submit high-quality glossy prints or original drawings of sufficient size to permit relettering but not larger than 22 by 28 centimeters (8 1/2 by 11 inches). On the back of every figure write the first author’s name and the figure number and indicate the correct orientation. Manuscripts with oversized figures will be returned to the author without review. Photocopies of figures are not acceptable; transparencies, slides, or negatives cannot be used because they cannot be sent to reviewers. Digital format are acceptable and preferred.

Tables should supplement, not duplicate, the text. They should be numbered consecutively with respect to their citation in the text. Each table should be typed, with its legend (double-spaced), on a separate sheet.

Equations and Formulas. No BioAcoustic formulas or formulations should be included in any manuscript written for public review.

Uncertainties and Reproducibility. Evidence that the results are reproducible and the conditions under which this reproducibility (replication) was obtained are not always possible but every effort should be made to at least speculate as to the avenue in which the results were obtained. The effect of limitations in experimental conditions on generalizability of results should be discussed.

Permissions and Copyright. Illustrations and tables reprinted from other publications must be credited. It is the author’s responsibility to obtain written permission from the copyright owner (usually the publisher) to reprint such illustrations in JBAB. The appropriate credit line is usually supplied by the copyright owner. Papers cannot be published until copies of all permission letters have been received by the editorial office. Copyright law requires that we obtain copyright transfer from authors of each paper published in JBAB. Copyright forms are sent to all authors prior to acceptance and must be signed and returned to the editorial office immediately.

Computer Disk Submission. Computer submissions are preferred in a format that can be used universally.

Printing and Publication

Proofs and Reprints. A proof is sent to the author(s). Publication and reprints are done in PDF format.

Papers can be scheduled for publication at any time, since JBAB is electronically printed and posted. Generally, items will be accumulated and published at regular intervals in sequentially numbered Issues of the Journal.

Cover Photographs. Particularly good photographs or slides that pertain to a paper being submitted will be considered for use on the cover of JBAB. Submit digitally format pictures, drawing, graphs with the manuscript.

 2005 (10/23/05, 11/13/05) – http://www.soundhealthresearch.org Back to Journal Homepage: www.bioacousticbiology.org