PIHMA Institutional Review Board (IRB)

About the Institutional Review Board (IRB)

Welcome to the Phoenix Institute of Herbal Medicine Human Subjects Protection Program (HSPP) Web Page. The mission of the FPRE Institutional Review Board is to Protect the Rights and Welfare of the Human Research Subject. The IRB covers both acupuncture and homeopathic medicine.

External vs. Internal Submissions

The IRB accepts both external and internal submissions to both its homeopathic and acupuncture arms of its IRB.  The total cost for external submission is $1250 which is broken down as follows:

  • $100 for initial project review
  • $1150 for comprehensive project review

Note that external submissions are required to submit a IRB-2016 Summary Form with the initial project review fee before beginning the formal comprehensive review process.

History of IRB

AMCH applied for federal IRB status in June of 2007. It is now registered as an IRB with designation assurance IRB00006144 and parent organization IORG0005118. The name was changed to the Foundation for PIHMA Research and Education IRB #1 in 2016.

The FPRE HSPP partners with academic and non-academic institutions in their human subject protections programs.  FPRE can serve as an institution’s sole IRB or one of an institution’s IRBs for human subjects research, through inclusion on an institution’s Federalwide Assurance. The AMCH IRB meets all requirements of the U.S. Department of Health and Human Services (HHS) regulations on human subject protection (45 CFR §46).

Vision

FPRE has long held a vision of establishing an IRB which will serve the needs of the FPRE research community and the larger homeopathic community. To our knowledge, there has never been a homeopathic IRB in the United States. With the establishment of the FPRE Research Committee in 2005, this began to become possible. For more information, call 602-274-1885 and ask for the Human Subjects Protection Program.

Mission and Purpose

The mission of the FPRE Institutional Review Board is to Protect the Rights and Welfare of the Human Research Subject. To accomplish our mission, we strive to:
A. Ensure that the risks of scientific advancement shall never outweigh the value of human life
B . Follow our traditions while embracing new technologies and practices
C. Maintain appropriate ethical conduct and regulatory compliance
D. Honor our hallmark of respect for all persons
E. Engage in a continuing quest for excellence

Federal Wide Assurance

Under the Department of Health and Human Services (DHHS) human subjects protection regulations at 45 C.F.R. 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP).
Historically, OHRP has approved three basic types of assurances: Multiple Project Assurance (MPA), Cooperative Project Assurance (CPA), and Single Project Assurance (SPA). All MPAs approved by OHRP were designated for federal wide use.

In December 2000, OHRP developed an Institutional Review Board (IRB) Registration and a new Federal wide Assurance (FWA) intended to: 1) create a new registry of IRBs, and 2) streamline the assurance process to significantly reduce the administrative burden on individual institutions, other federal departments and agencies, and OHRP. A notice regarding the IRB Registration and the FWA was posted by DHHS in the Federal Register, and the forms themselves were made available on the OHRP website, for public comment. Since that time, many institutions have elected to submit FWAs and to register their IRBs using these forms.

A. Federal Wide Assurance (FWA): #FWA00004218
B. Name of IRB Organization: AMCH
C. IRB Registration or Sequence Number: IRB00000291
D. Effective Roster Date: December 10, 2007

FPRE IRB Members
Bonnie Phelps PhD (Chair)
Kim Arcoleo (Member)
Brigit Ciccarello (Member)’
Melanie Grimes (Member)
Amy Loschert (Member)
Sharon McDonnough-Means (Member)
Anna Vakil (Member)
Ambika Wauters (Member)
John Reed (Member)
Muhammed Rafeeque (Member)

Application Materials

Applications should be submitted electronically to researchcoordinator@AMCofH.org.

Preliminary Summary Form for External Submissions
Project Review Form
IRB Authorization Agreement
Subject Consent Form
Guidelines for Subject Consent Form
Parent Legal Guardian Permission Form
Minor’s Assent Form
Guidelines for Minor Assent
HIPAA Guidelines
Continuing Review Form
Continuing Review Guidelines
Continuing Review Report Template
Request for Amendment Form
Study Related Problem Form

 

Human Subject Training (NIH)

Documentation that all study personnel have completed the required Human Subjects training program must accompany all research proposals submitted for IRB review.

Checklist

Use the investigator checklist to review the approval process.

Forms

Many different forms, guidelines, and templates are available in the forms section.

Certificate of Confidentiality

Investigators may request a certificate of confidentiality for the collection of sensitive data.

HIPAA

HIPAA is the Congressional act for covered entities requiring the protection of individually identifiable health care information. Research projects using this type of data must follow HIPAA guidelines found under the forms section of this site.

Policies and Procedures

Please click on the section below for a downloadable PDF:
AMCH HSPP Policies and Procedures Section I
AMCH HSPP Policies and Procedures Section II
AMCH HSPP Policies and Procedures Section III
AMCH HSPP Policies and Procedures Section IV
AMCH HSPP Policies and Procedures Section V
AMCH HSPP Policies and Procedures Section VI
AMCH HSPP Policies and Procedures Section VIII
AMCH HSPP Policies and Procedures Section IX
AMCH HSPP Policies and Procedures Section X

Information for the Public

The AMCH Human Subjects Protection Program office has developed this web page to provide you with additional information regarding participation in research. Please use the links below to find answers to questions about participation in research.

Research involving human participants (often referred to as subjects) may take place in many locations. Research with human participants is conducted by many colleges and departments.

If you are considering participating in a research study, remember that participation is completely voluntary you can choose not to participate, or, if you do decide to participate, you can choose to stop participating at any time. The Bill of Rights summarizes the rights you have as a research participant. The National Institutes of Health sponsors a web site, called Clinical Trials. This web site provides information to the public about clinical research studies. There are other sources of information about ongoing research known as clinical trials that can acquaint you with research about special topics. One Online document is entitled. If you would like to contact our office for information about your rights as a research subject, you can call us at 602-347-7950.

Contact Us

Foundation for PIHMA Research and Education
Institutional Review Board
301 E. Bethany Home Road, #A100
Phoenix, AZ 85012
602-274-1885; bphelps10@cox.net

Important Links

Homeopathic Pharmacopeia of the United States
National Institutes of Health
Food and Drug Administration
Office for Human Research Protections
National Bioethics Committee