{"id":3833,"date":"2017-01-20T12:26:46","date_gmt":"2017-01-20T12:26:46","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Presentation_on_DoH-_Mfutso-Bengo.pdf"},"modified":"2017-01-20T12:26:46","modified_gmt":"2017-01-20T12:26:46","slug":"presentation_on_doh-_mfutso-bengo-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/presentation_on_doh-_mfutso-bengo-2\/","title":{"rendered":"Presentation_on_DoH-_Mfutso-Bengo"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Presentation_on_DoH-_Mfutso-Bengo<\/a><\/p>\n

Prof. J. Mfutso-Bengo, PhD
\nCenter of Bioethics (CEBESA)
\nUniversity of Malawi College of Medicine
\nCapeTown \u2013 South Africa
\nDecember 2012
\nwww.medcol.mw
\nJoseph-matthew@gmx.net
\nRevisions on the Declaration of
\nHelsinki
\nIntroduction
\n\uf097 TheWorld Medical Association (WMA)was
\nestablished after theWW2 in reaction to the
\natrocities committed by physicians
\n\uf097 It was meant to be a global representative body for
\nphysicians
\n\uf097 Currently, there are 48 National Medical
\nAssociations and approximately 7 million physicians
\n\uf097 WMA adopted the Declaration of Helsinki (DoH) in
\n1964
\nThe Roles of the WMA in Biomedical
\nResearch
\n\uf097 Establishment of high-level global ethical
\nstandards for biomedical research
\n\uf097 Bridge between physicians and researchers
\n\uf097 Advocate for patients serving as human
\nsubjects
\n\uf097 Participant in capacity-building initiatives
\nBrief History of DoH
\n\uf097 First adopted in 1964
\n\uf097 Significant additions in 1975
\n\uf097 Minor amendments in 1983, 1989 and 1996
\n\uf097 Major revision and reorganization 2000
\n\uf097 Notes of clarification in 2002 and 2004
\n\uf097 Another revision in 2008
\nInfluence of DoH
\n\uf097 CIOMS guidelines follow the DoH quite closely
\n\uf097 ICH-GCP guidelines require adherence to \u201cprinciples
\nthat have their origin in the DoH\u201d
\n\uf097 The UNESCO Declaration on Bioethics and Human Rights
\ncites the DoH
\n\uf097 The EC Directive on ClinicalTrials and the US FDA
\nrequire adherence to the principles of DoH
\n\uf097 DoH is the most cited research ethics document by
\nresearch ethics committees
\nProposed Amendments in the 2012
\nConsultation Draft
\n\uf097 Paragraph 11: It should be revised to read;\u201cIt is the duty of
\nthe researcher in medical research to protect the life,
\nhealth, privacy, confidentiality and dignity of the
\nhuman subject\u201d
\n\uf097 Paragraph 12: It should be revised to read;\u201cAppropriate
\ncaution must be exercised in the conduct of research which
\nmay affect the environment, and the welfare of human
\nsubjects and animals used for research must be respected.\u201d
\nProposed Amendments in the 2012
\nConsultation Draft
\n\uf097 Article 14 the ethics committee should provide the
\nresearchers with a checklists of documentation and
\nrequirements for independent scientific and ethical review
\nprocess
\n\uf097 The researcher should also submit to the committee, for
\nreview, information regarding funding, sponsors, institutional
\nAffiliations, other potential conflicts of interest and
\nincentives for subjects. I propose to add \u201cPost trial access
\nplan if appropriate and community engagement
\nplan.\u201d
\nProposed Amendments in the 2012
\nConsultation Draft cont\u2019d
\n\uf097 Paragraph 28: It should be revised to read:\u201c
\nWhen a subject deemed legally incompetent,
\nsuch as a minor child, is able to give assent to
\ndecisions about participation in research, the
\ninvestigator must obtain that assent in addition to
\nthe consent of the legally authorized
\nrepresentative. However, emancipated
\nminors should be allowed to give their
\nown informed consent.\u201d e.g., minors who
\nare mothers.
\nProposed Amendments in the 2012
\nConsultation Draft cont\u2019d
\n\uf097 Paragraph 31: It should be revised to read;\u201cThe physician
\nshould fully inform the patient which aspects of the care
\nare related to the research.The refusal of a patient to
\nparticipate in a study must never interfere with the
\npatient-physician relationship. And if a conflict of
\ninterest (CoI) exists between a physician cum
\nresearcher and a patient, the physician must
\ndisclose the CoI to the patient and recuse
\nhim\/herself from recruiting the patient as a
\nhuman subject.\u201d
\nProposed additional principle
\n\uf097 Paragraph : \u201cHuman subjects who
\nparticipate in clinical trials involving
\ninvestigational products whose safety
\nprofiles are unknown should be
\nprovided with clinical trials
\ninsurance\u201d
\nExportation and importation of clinical
\nand research samples
\n\uf097 There is growing trend of exporting human tissues from developing countries to laboratories in
\ndeveloped countries for clinical diagnosis or clinical research. Especially for clinical samples have
\nthe potential for abuse and lack of accountability
\n\uf097 There is need to create safeguards to avoid the abuse of those human tissues.
\n\uf097 Hence we propose that there is a need to have a material transfer agreement(MTA).
\n\uf097 The MTA agreement form should have a clear description of namely:
\n1. The destination
\n2. Ownership
\n3. The intention of export\/import
\n4. Access and control of the samples
\n5. Safety and security of the samples
\n6. Capacity building issues
\n7. Justification
\n8. Permission
\n9. Signatures
\nHow to resolve conflicting decisions
\nbetween ethics committees in multi-
\ncentered clinical trial
\n\uf097 Incase of conflict between a remote and a local ethics
\ncommittee.The voice of the local ethics committee ought to be
\ntaken into consideration
\n\uf097 The scientific and ethical justification should not be ignored
\nConditions for supporting local ethical
\njurisdictions
\n1. Members of the local population and, in this situation, the local ethical
\ncommittee is the best judge of what is appropriate
\n2. Exception: local review is sufficient only if the host country\/institution
\nhas a system of substantive protections that are equivalent to international
\nacceptable standards.
\n3. The basis of this argument is the principle of justice: that equals should be
\ntreated equally. Local ethical committees should be allowed to adjudicate
\nconflicts between remote and local committees, One approach to
\nresolving the impasse could be to distinguish between fundamental,
\nqualitative and non-arguable principles and more relative, quantitative and
\ncircumstantial applications.
\n\uf097 (6) Ethical principles cannot be universal without being contextual
\nConditions for supporting local ethical
\njurisdictions
\n\uf097 (1)The local committee must be constituted and its deliberations
\nexecuted according to internationally recognized ethical standards
\n(e.g.TheWorld MedicalAssociation’s Declaration of Helsinki;The
\nBelmont Report: Ethical Principles*).
\n\uf097 A clear SOPs of decision-making process
\n\uf097
\nConclusion
\n\uf097 Developing countries are vulnerable to
\nunscrupulous researchers
\n\uf097 Collective responsibility in protecting the rights,
\nsafety, and welfare of human subjects is critical.
\n\uf097 This calls for fair and objective regulations and
\nguidelines that aim at promoting research and
\ndevelopment while at the same time not
\ncompromising the protection of human subjects<\/p>\n"},"caption":{"rendered":"

Presentation_on_DoH-_Mfutso-Bengo Prof. J. Mfutso-Bengo, PhD Center of Bioethics (CEBESA) University of Malawi College of Medicine CapeTown \u2013 South Africa December 2012 www.medcol.mw Joseph-matthew@gmx.net Revisions on the Declaration of Helsinki Introduction \uf097 TheWorld Medical Association (WMA)was established after theWW2 in reaction to the atrocities committed by physicians \uf097 It was meant to be a global representative […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Presentation_on_DoH-_Mfutso-Bengo.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3833"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3833"}]}}