Submitting a Monograph

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Guidelines for Clinical Verification

Approved July 2020

8. Legal / Ethics

The gathering of clinical data for monograph review must take place in accordance with the ethical principles that have their origin in the Declaration of Helsinkiⁱ and other applicable regulatory requirements.ⁱⁱ

Ethics or Institutional Review Board

The monograph sponsor must assess requirement for Ethics Committee or IRB oversight.

All prospective studies involving therapeutic use of an unapproved IHMP must undergo Ethics Committee or IRB evaluation.

Ethics Committee or IRB evaluation is recommended for all retrospective clinical data gathering for monograph purposes.

Informed Consent

Informed consent for acquisition or use of human patient data for monographing purposes is required unless the Ethics Committee or IRB has granted a waiver of informed consent.

If access to additional de-identified original patient case data is requested by the HPCUS, this shall be authorized by written informed consent.

When used, documentation of informed consent shall include:

a) Documents must meet the general requirements for informed consent as given in the U.S. federal regulations 45 CFR§46.116ⁱⁱⁱ and 21 CFR §50.20^iv of the U.S. Code of Federal Regulations (CFR)
b) Informed consent shall contain the information required by each of the eight basic elements as delineated in U.S. federal regulation 45 CFR §46.116(a)²⁸
c) If appropriate to the investigational study, any of the six additional elements as listed in U.S. federal regulation 45 CFR §46.116(b)²⁸
d) And informed consent must be presented in a form that is understandable by all subjects

Subject Withdrawal

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

Subjects may be removed at any time during the prospective studies so long as the criteria are adequately recorded and approved by the PI.

Reasons for removal of a subject from a study (either voluntary or involuntary) must be reported in the monograph submission. Removal of subject(s) by the PI without sufficient cause will result in disqualification of the relevant data.

Insurance Coverage

Insurance coverage in prospective studies shall be provided, if required to comply with applicable regulatory requirements.

Absence of insurance coverage due to lack of regulatory requirement must be justified via the provision of adequate documentation.

Insurance coverage

Insurance coverage in prospective studies shall be provided, if required to comply with applicable regulatory requirements.

Absence of insurance coverage due to lack of regulatory requirement must be justified via the provision of adequate documentation.

Financial Disclosure Certification

Financial disclosure statements must be completed by the sponsor and/or investigator(s), including acknowledgement of any of the following:

a) Any financial remuneration by the sponsor or manufacturer of the tested medicine beyond the cost of the study
b) Any grants or honoraria paid by the sponsor or manufacturer
c) Any proprietary interest in the tested product
d) Any significant equity interest in the sponsor or manufacturer

Ethics Training

Requirements and recommendations for ethics training are located in Section 2 Personal Qualifications & Training.

i) World Medical Association (WMA). WMA Declaration of Helsinki ‒ Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th World Medical Association in Helsinki, Finland, June 1964. Last amended at the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed September 10, 2020.
ii) United Nations Educational, Scientific, and Cultural Organization (UNESCO). Universal Declaration on Bioethics and Human Rights. Paris, France: UNESCO; 2006. http://unesdoc.unesco.org/images/0014/001461/146180E.pdf. Accessed September 10, 2020.