Submitting a Monograph

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Guidelines for Homeopathic Drug Provings

Approved April 2015

8. Legal / Ethics

Proving will be designed and conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki ⁽¹⁾, and that are consistent with Good Clinical Practice and the applicable regulatory requirements ⁽²⁾.

Ethics or Institutional Review Board

Review and approval is required for all Provings on human subjects.

Informed Consent

Documentation of Informed Consent is required for all Proving subjects, and should include:

a) Documents should meet the general requirements for Informed Consent of 45CFR 46.116 (3) and 21 CFR 50.20 (4)
b) Informed Consent should contain the information required by each of the eight basic elements,
c) And, if appropriate to the Proving, any of the six additional elements as listed in those regulations.
d) Be presented in a form that is understandable by all subjects.

Subject Withdrawal Criteria

Voluntary subject withdrawal must be permitted at any time during the Proving at the request of the subject.

Subjects may be removed at any time during the Proving so long as the criteria are adequately recorded and approved by the Principal Investigator.

Reasons for removal of a subject from the proving (either voluntary or involuntary) must be reported in the monograph submission. Removal of subject(s) by the Principal Investigator without sufficient cause will result in disqualification of the Proving.

Insurance coverage

Insurance coverage for test subjects sufficient to permit Ethical or Institutional Review Board approval is required.

Financial Disclosure Certification

Financial Disclosure certification must be completed by the Principal Investigator and Clinical Coordinator/ Subject Supervisors (if not employed directly by the Principal Investigator) including acknowledgement of any of the following ⁽⁵⁾:

Any financial remuneration by the sponsor or manufacturer of the tested medicine beyond the cost of the study.

Any grants or honoraria paid by the sponsor or manufacturer

Any proprietary interest in the tested product

Any significant equity interest in the sponsor or manufacturer

(1) WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
As adopted by the World Medical Association in 1964 with subsequent amendments. Last downloaded April 27, 2023 from online at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
(2) Universal Declaration on Bioethics and Human Rights adopted by the United Nations Educational, Scientific, and Cultural Organization (UNESCO) in October 2005. Last downloaded April 01, 2012 from online at http://unesdoc.unesco.org/images/0014/001461/146180E.pdf
(3) Code of Federal Regulations Title 45 Department of Health and Human Services Part 46: Protection of Human Subjects. Last downloaded April 01, 2012 from online at
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subparta
(4) Code of Federal Regulations Title 21 Food and Drug Administration Part 50 Protection of Human Subjects. Last downloaded April 01, 2012 from online at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1
(5) Code of Federal Regulations Title 21 Food and Drug Administration PART 54 Financial Disclosure By Clinical Investigators. Last downloaded April 01, 2012 from online at http://www.acc