Introduction to research ethics in microbiology

INTRODUCTION
 Ethics is study of morality – careful & systematic reflection
on & analysis of moral decisions & behavior, whether past,
present or future.
 Medical ethics
 To recognize difficult situations & to deal with them
rational & principled manner.
 to safe guard humanity

HISTORY
 1947 - Nuremberg Code
 1947 - World Medical Association established
 1948 -Universal Declaration of Human Rights (General Assembly UN)
 1954 –Principles for Research and Experimentation (WMA)
 1966 -International Covenant on Civil and Political Rights
 1964 - Declaration of Helsinki (1975, 1983, 1989, 1996, 2000, 2008)
 1980 - Policy Statement on Ethical Considerations involved in Research on
Human Subjects ( ICMR)
 1982 - International Guidelines for Biomedical Research involving Human
Subjects (WHO & CIOMS )
 1991 - International Guidelines for Ethical Review in Epidemiological
studies (CIOMS)
 1993 - International Ethical Guidelines for Biomedical Research Involving
Human Subjects (revised 2002) (CIOMS)
 2000 - 'Ethical guidelines for Biomedical Research on Human Subjects
(ICMR)
 2003 - The International Declaration on Human Gene Data (UNESCO)
 2005 -Universal Declaration on Bioethics and Human Rights (UNESCO)
 In 2006, ICMR published “Ethical guidelines for biomedical research on
human participants”

ETHICS IN MEDICAL PRACTICE &
RESEARCH
Basic principles
 Non-maleficence
 Beneficence
 Autonomy
 Justice
 Declaration of Geneva - “The health of my patient will be
my first consideration”
 International Code of Medical Ethics - “A physician shall
act in the patient's best interest when providing medical care.”

DECLARATION OF HELSINKI, 2008
 3)6) …duty to safe guard participants….well being of research subject…..
 7)21)…..primary purpose…improve present knowledge…..outweighs risk
 10) …consider.. National & international norms…….
 14) ….Protocol…..ethical issues…..
 16) …by scientifically trained & qualified……………
 17)…..vulnerable & disadvantages…………fulfill their health needs…..
 19)…..trials must registered…..public database……………
 22) …..participation …..voluntary……..
 25)…..human material & data……consent for collection, analysis, storage,
reuse …if not possible…..from research ethics committee….
 28 ) ….incompetent research subject…….consent from legal authority….
 30 )…Authors, publishers & publisher……results available publicly……
 31) …….medical practice & research ….combined…if justified.
 32) …new intervention..against best current proven intervention …except in
….no treatment…..or compelling & sound methodological reason ..not
subjected to any risk………
 33) …if beneficial….then post intervention access………….

RIGHTS AND RESPONSIBILITIES OF
RESEARCHERS
 Qualification and competent
 Research should improve of knowledge on the subject
 No secret research – bring to public domain
 Should follow ethical guidelines
 honesty and transparency
 Respect, Protection & Promotion of rights of participants
 Unethical study, then can quit
 Right to publication
 Peer review

INSTITUTIONS
 Respect autonomy of researchers
 Support ethical guidelines
 Should have Institutional Ethical committee
 Observance of ethical guidelines for research

INSTITUTIONAL ETHICS COMMITTEE
(IEC)
Functions
 To resolve ethical dilemmas
 To safeguard dignity, rights, safety & well being of
actual & potential participants
 Taking care of principle of ethics
 To support the researcher in ethical issues
 To examine compliance with all regulatory
requirements, applicable guidelines and laws
 Ethical clearance irrespective of funding agency

COMPOSITION OF IEC
7-9 members
1. Chairperson
2. 1-2 basic medical scientists.
3. 1-2 clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist / representative of NGO
6. One philosopher / ethicist / theologian
7. One lay person from the community
8. Member-Secretary
Subject expert/ Independent consultants
 Duration of Membership – 2-3 years

APPLICATION PROCEDURES & DOCUMENTS
 Prescribed application form
 Name of applicant with designation
 Name of Institute/ Hospital / Field area where research will be conducted.
 Approval of HOD/ Institution
 Protocol of proposed research
 Ethical issues in study & plans to address these issues.
 Proposal should be submitted with all relevant enclosures like proformas, case report
forms, questionnaires, follow - up cards, etc.
 Informed consent process, including patient information sheet and informed consent form
in local language(s).
 For any drug / device trial, all relevant pre-clinical animal data and clinical trial data
from other centres within country / countries, if available.
 Curriculum vitae of all the investigators with relevant publications in last five years.
 Any regulatory clearances required.
 Source of funding and financial requirements for the project.
 Other financial issues including those related to insurance
 An agreement to report only Serious Adverse Events (SAE) to IEC.
 Statement of conflicts of interest, if any.
 Agreement to comply with the relevant national and applicable international guidelines.
 A statement describing any compensation for study participation (including expenses and

REVIEW PROCEDURES:
 Proposals sent to members at least 2 wks in advance
 Meetings on scheduled intervals
 Minimum 5 member for decision
 Decision by meeting not by circulation
 Researchers will be invited to offer clarifications if need
 Minute & notification by member secretary
 Communicating decision
 Record keeping & Archiving
 Updating IEC members

SELECTION OF AS RESEARCH
PARTICIPANTS
 be completely voluntary
 should give informed written consent
 no inducement but compensation( risk benefits, out of pocket expenses)
 No unjustifiable assurance
 Anonymity & confidentiality
 Selection of special groups as research participants
 Pregnant or nursing women
 Children - after phase III
 Vulnerable groups

RIGHTS OF PARTICIPANTS
INFORMED CONSENT
1. Patient information sheet---Nature and purpose of study
2. Duration of participation with number of participants
3. Procedures to be followed
4. Investigations, if any
5. Foreseeable risks and discomforts
6. Benefits to participant/ community /medical profession
7. Policy on compensation
8. Medical treatment for injuries or risk
9. Alternative treatments if available
10. Steps taken for confidentiality
11. No loss of benefits on withdrawal
12. Benefit sharing in event of commercialization
13. Contact details of PI or local PI/Co-PI in Multicentric
14. Contact details of Chairman of IEC for appeal against violation of rights
15. Voluntary participation
16. If test for genetics & HIV, counseling for consent for testing must be given
as per national guidelines
17. Storage period of biological sample and related data
18. Copy to participant

 Written consent not possible?
Third person, audio-visual but needs approval of IEC
 Age?

Fresh or re-consent
 Deviation of protocol
 Regains consciousness from unconscious
 Change in treatment modality, procedures, site, visits
 Before publication
Waiver of consent
 Not more than minimal risk
 Do not come into contact
 When it is necessitated in emergency situations
 Research on anonymised biological samples from deceased individuals

RELATIONSHIP AMONG
RESEARCHERS
Principal researchers are responsible
 Ethical conduct but juniors, assistants, students & trainees have an
equally responsibility
 Training to junior, assistants
 No discrimination
 Researchers should not mislead or force other researchers
 Co-operative, responsive, honest and respectful about the
interest, opinion/view, capability and work of other
researchers

 Epidemiological studies
 Drug trials
 Vaccine trial
 Herbal extracts/ Unani/ Siddha
 Medical device/diagnostic devices
 Tissue/organ transplants
Ethical issues in various research setting

ETHICAL ISSUES IN EPIDEMIOLOGICAL
STUDIES
 Consent from community &Community participation
 Inducements are not permissible
 All risks involved – explained to individual & community
 Maintaining confidentiality
 Minimize harm, maximum benefit for individuals and
communities taking part in study
 Committees -- epidemiologists, clinicians, statisticians, social
scientists, philosophers, legal experts and representatives from
community/ voluntary groups
 Should not raise false hopes.

ETHICAL PRINCIPLES FOR DRUG
TRIAL
 Drugs Controller General of India (DCGI),
(Drugs and Cosmetics Act, 1940)
 Approval of IEC
 All guiding principles -irrespective of place of discovery of drug
 Risk-benefit should be favorable.
 It should registered as per International standard RCT
 Should be carried out in equipped center, m/m ASE
 Preferably clinical pharmacologist involved.
 Use of a placebo in drug trials/ sham surgery
i. self limited disease;
ii. where no proven prophylactic, diagnostic or therapeutic method
exists

DRUG TRIAL …….
 Post trial benefit
 Criteria of termination
 Breaking of code
 Partner notification -HIV/ AIDS related trial
New drug (India)- Phase I to IV
New drug (outside India)- Phase I data required

DRUG TRIAL………….
Phase I
Change in protocol -approval of IEC must
Started from lowest dose
Sub-populations
Duration between 2 trials in same volunteer - 3 mths
Compensation is given by the sponsors or insurance
Phase II
The dose used is lesser than the highest dose used in phase I
Phase III
 Drug in Indian patients
 Open non-comparative trials are unethical.
Phase IV
 doesn’t require approval from DCGI

Multicentric Trials
 Acceptance of the protocol
 Approval IECs
 Meetings at initial & intermediary stages – Central monitoring committee
 Training – uniformity procedures, data entry in the case record forms, ethics &
GCP
Trial involving contraceptive
 Information about alternatives available
 Implant- proper follow & removal
 Failure of contraceptives
Monitoring and reporting adverse reactions or events
 unexpected AE/ADR & all SAE (Indian Good Clinical Practice(GCP) Guidelines)
Investigator to sponsers -24 hrs
Investigator to EC - < 7 days
Death information to Ec – 24 hrs
Sponsor to Licensing Authority &Investigator(s) of other site -14 calendar days
 Evaluated and discussed
 Medical management of adverse event
 financial plan for trial related injury

VACCINE TRIALS
 Contain active or live – attenuated
 Standard vaccine -if no – community involvement
 Control groups- Post trial access
 Certification of vaccination

CLINICAL TRIALS WITH SURGICAL
PROCEDURES / MEDICAL DEVICES
 Safe procedures
 Indian Medical Devices Regulatory Authority (IMDRA)- Health
Ministry
 Indian Standard Institute, Board of Indian Standards, Drug
Controller General of India, and Nuclear Medicine Board of the
BARC
 Informed consent as in drug trials
 Patient information sheet- information on follow-up if withdraw from
trial.

DIAGNOSTIC AGENTS - USE OF RADIO-
ACTIVE MATERIALS AND X-RAYS
 Participants & investigators are exposed
 Bhabha Atomic Research Centre, Mumbai
 Informed consent must- possible genetic damage to offspring
& other risk
 Safety measures
 Event of death of a participant with radiological implant
 Done on patients undergoing diagnostic or therapeutic purposes.
 Substitute Ultrasound
 Non-radioactive diagnostic agents considered as drugs

CLINICAL EVALUATION OF TRADITIONAL
AYURVEDA, SIDDHA, UNANI (ASU) REMEDIES
& MEDICINAL PLANTS
“Operational Guidance: Information needed to
support clinical trials of herbal products (2005)”
---WHO
 Drugs Controller General of India
 Categories of drugs
 Cat I – No Phase I
 Cat II & III – Phase I -IV

ETHICAL ISSUE ORGAN
TRANSPLANTATION RESEARCH
 Institutional Committee for Stem Cell Research and Therapy (IC-
SCRT) & National Apex Committee for Stem Cell Research and
Therapy (NAC-SCRT)
 Centers registration with NAC-SCRT & Equipped institutions
 No deliberate conception and /or subsequent abortion
 No research is permitted on the live aborted foetus.
 Voluntary, informed, written consent from mother 2 stages –
1st
for the abortion 2nd
for donation of tissue from the foetus.
 Termination of pregnancy for financial or therapeutic benefits
 Intact embryos or foetuses will not be kept alive artificially
 Cells obtained from fetuses will not be patented for commercial

REPORTING OF RESULTS OF
RESEARCH
 support ?or contradict ?
 Cource(s) of funding and sponsors
 Report explain methodology, how ethical guidelines
followed, ethical dilemmas encountered and resolved,
etc.
 No any keep secrete results.
 Who will? Investigators? Institution? Sponser?
 Ensure easy availability & accessibility
 Conflict of interest

INTERACTING WITH MEDIA
 Avoid dissemination till published
 No false hopes or expectations or unnecessarily scare
raise

RIGHTS AND RESPONSIBILITIES OF PEER
REVIEWERS/REFEREES
 Encouraged to improve and advance research
 Peer reviewer in expertise field
 Undertaking objectively, impartially and constructively
 Actual or potential conflicts of personal or professional
interest
 Malpractices in research or violation of ethics

PUBLICATION IN SCIENTIFIC
JOURNAL
 Clear consent for publication from participants
 Confidentiality
 Authorship - International Committee of Medical
Journal Editors (ICJME)
 Consolidated standards of reporting trials (CONSORT)
guidelines

RIGHTS & RESPONSIBILITIES OF EDITORS &
PUBLISHERS
 Ensure that such material is, duly reviewed by referees
 As journalists & as researcher
 Fabricated, falsified or plagiarized information - not be
entertained
 After publication - doubt is raised about its ethical
status or ethical conduct of the study
 Misconduct

FUNDERS AND SPONSORS
 Right to expect progress of work & final report
 Right to get a copy of ethical guidelines for research
 Respect ethical guidelines for research & should not
expect researchers and institutions to undertake
research or conduct it in any way contrary to ethical
guidelines.

CHALLENGES
 Use of placebo or standard?
 Paying researcher: Motivation Or Inducement?
 Training of IEC members

REFERENCES:
 World medical association. Medical ethics manual. 2nd
Ed. UK: The
World Medical Association Inc; 2009.
 World Medical Association. Declaration of Helsinki: 2008. Seoul:
TheWorld Medical Association Inc; 2008.
 ICMR. Ethical guidelines For Biomedical research On Human
participants. New Delhi: ICMR; 2006.
 WHO. Operational Guidelines for Ethics Committees That Review
Biomedical Research. Geneva: World health organization; 2000.
 Amnesty International. Ethical codes & declarations relevant to the
health professions. 4th
Ed. London: Amnesty international; 2000.
 CM Francis. Medical Ethics. 2nd
ed . New Delhi: Jaypee brothers, 2004.
 Ravindran GD. Medical ethics education in India. Indian journal of
medical ethics 2008 Jan-Mar;5(1):18-26.

Introduction to research ethics in microbiology

Introduction to research ethics in microbiology

More Related Content

Similar to Introduction to research ethics in microbiology

More from bharathimmurugavel

Recently uploaded

Introduction to research ethics in microbiology