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Institutional Review Board
(IRB)
AMCH Institutional Review Board
Welcome to the American Medical College of Homeopathy Human Subjects Protection Program (HSPP) Web Page. The mission of the AMCH Institutional Review Board is to Protect the Rights and Welfare of the Human Research Subject.
Establishment of AMCH 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 is American Medical College of Homeopathy IRB #1.
Click here for a link to additional details.
Future Plans for AMCH IRB
The AMCH HSPP partners with academic and non-academic institutions in their human subject protections programs. AMCH 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. WIRB meets all requirements of the U.S. Department of Health and Human Services (HHS) regulations on human subject protection (45 CFR §46).
History
AMCH has long held a vision of establishing an IRB which will serve the needs of the AMCH 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 AMCH Research Committee in 2005, this began to become possible.
For more information, call 602-347-7950 and ask for the Human Subjects Protection Program or contact
info@AMCofH.org.
Mission and Purpose
The mission of the AMCH Institutional Review Board is to Protect the Rights and Welfare of the Human Research Subject.
To accomplish our mission, we strive to:
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Ensure that the risks of scientific advancement shall never outweigh the value of human life
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Follow our traditions while embracing new technologies and practices
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Maintain appropriate ethical conduct and regulatory compliance
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Honor our hallmark of respect for all persons
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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.
Federal Wide Assurance (FWA): #FWA00004218
Name of IRB Organization: AMCH
IRB Registration or Sequence Number: IRB00000291
Effective Roster Date: December 10, 2007
AMCH IRB Members
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Iris Bell MD, MD(H), PhD (Chair)
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Rob Bannan, LH, LCH, HMA: (Member)
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Joie Rowles, PhD, HMA
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Dan Peitzmeyer: (Member)
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Bonnie Phelps PhD: (Member)
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Marilyn Gradov, HMA (IRB Administrator)
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Amy Kahn PhD, MBA: (Alternate)
Application Materials
Human Subject Training (CITI)
Training is now available for individuals conducting research through the Collaborative Institutional Training Initiative (CITI). Simply go to
www.citiprogram.org
and register with a user name and a password of your choice. Read the required modules for either and answer the 3-6 questions in the quiz at the end of each module. The system automatically keeps track of your progress. The system also updates the Human Subjects Protection Program regarding your completion of the CITI training.
Investigator Information
Training
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.
HIPPA
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:
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 on-line 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
Administrative Office:
American Medical College of Homeopathy
Attn: Marilyn Gradov HMA, IRB Administrator
2001 W. Camelback, Suite 150
Phoenix, AZ 85015
602-347-7950; 602-864-2949(fax)
www.AMCofH.org
Important Links
Homeopathic Pharmacopeia of the United States
National Institutes of Health
Food and Drug Administration
Office for Human Research Protections
National Bioethics Committee
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