Ethics in Health & Biomedical Research

Ethics in Health & Biomedical Research. Dr.CH.Padmavathy Senior Resident Dept. of Community Medicine.

In Medical profession oldest prescribed practical guidelines of ethics are in Charaka samhitha and S usrutha samhitha ..

Why this concept?. Nazi experimentation during World War II was forceful, without consent of the participants, and collected data that involved the unnecessary and willful harm of human subjects..

Code of conduct in research. Development of the Nuremberg Code in 1947 Helsinki Declaration in 1964. Belmont report . CIOMS-The Council of International Organizations of Medical Sciences. International Council on Harmonization- ICH..

Purpose of these guidelines. To ensure highest professional and ethical standards.

Any research involving human subjects should follow international standards of ethics. Indian national standards were developed by ICMR ICMR guide lines are the gold standard ethical guidelines for India which were based on international standards..

ICMR POLICY. Applies to All ICMR scientific/technical staff and students involved in research at ICMR Headquarters or at ICMR Research Institutions, Centers or field units across the country. ( irrespective of source of funding )..

All stakeholders. R esearchers, I nstitutions, S cientific review committees and E thics committees involved in the conduct, review or reporting of research. ..

Research Integrity Unit (RIU). RIU at ICMR Headquarters, New Delhi would facilitate and guide research integrity . T hrough a designated Research Integrity Officer (RIO) at Institutional/ Divisional level..

ICMR Bioethics Unit (IBU). Unit will be responsible for development and timely updation of policy on research integrity, misconduct and publication ethics. Research Integrity Officer (RIO)-- facilitate implementation of this policy..

Before initiating research . A pplicable guidelines and regulations must be followed and required approvals be obtained . Institutional Animal Ethics Committee (IAEC), Institutional Committee for Stem Cell Research (IC-SCR), Genetic Engineering Approval Committee (GEAC), Review Committee on Genetic Manipulation (RCGM), Health Ministry’s Screening Committee (HMSC), Central Drug Standard Control Organization (CDSCO), Institutional Biosafety Committee (IBSC), Atomic Energy Regulatory Board (AERB) etc ..

Research should be undertaken by persons who are competent with qualifications, having relevant experience/training to collect reliable data, undertake accurate analysis, interpretation and publication. All raw data should be available and securely kept by the lead investigator for at least 3-5 years after study completion..

Completed research irrespective of results must be published and shared on public databases such as CTRI, institute websites or other available relevant platforms ..

What is unethical. 1.Plagiarism—Copying. 2.fabrication-The intentional act of making-up data or results. 3. falsification--changing or omitting/-giving completely wrong information. 4.manipulation of data ..

Authorship should be duly given to all those who have substantially scientifically contributed to the research ..

Before publication The researcher/corresponding author should submit- The final draft along with details of authorship, 1. undertaking (Annexure I) 2. plagiarism check report. 3.Researcher is also required to submit continuing review/ (Common form for EC review - Annexure 3)..

Approved only if The research documents with acceptable level of plagiarism (<10%) without identified misconduct shall be forwarded by RIO to Director/ Head for approval before publication/dissemination..

I n case of research misconduct. R espondent who will be given an opportunity to provide explanation within a limited time period (15 days). enquiry committee to evaluate misconduct and explanation by respondent to investigate credibility of evidence, extent/nature of misconduct, personnel involved and intentions to suggest further course of action, including punitive/ disciplinary action will be taken by Director..

Guidelines for avoiding Plagiarism. “Acknowledgment ” is the ethically right manner of crediting someone else’s work. In case of verbatim text is being taken from another source, it must be enclosed in quotation marks and by providing citation to indicate its origin ..

Types of Plagiarism – by ICMR. Direct copying or word by word copying of a someone’s work without acknowledging the original author- Direct Plagiarism A situation where the person duplicates his previous works-- Self-Plagiarism. Copying of idea- Mosaic Plagiarism Accidental Plagiarism 'salami' publications/ Redundant publications..

D on’t publish in. In India, ICMR, UGC and other agencies have recommended the academic as well as scientific community to avoid publication in predatory journals and conferences . Any publication in predatory/dubious journals or presentations in predatory/dubious conferences shall not be considered for academic credit for selection, confirmation, promotion, performance appraisal, award of scholarship or academic degrees or credits in any form..

R eference List of Quality Journals. The Consortium for Academic and Research Ethics (UGC-CARE) reference List of Quality Journals across various disciplines was posted at https://ugccare.unipune.ac.in/site/website/index.aspx ..

International level. Office of Research Integrity (ORI)- to tackle scientific misconduct. Committee on Publication Ethics (COPE)- COPE developed Guidelines on Good Publication Practice. International Committee for Medical Journal Editors (ICMJE)-- ethical standards in the conduct and reporting of research and other material published in medical journals. CONSORT-- to alleviate the problems arising from inadequate reporting of randomized controlled trials (RCTs). National Institutes of Health (NIH)- A Guide to the handling of research misconduct Allegations.

National level. Department of Biotechnology (DBT). ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants 2017. University Grants Commission (UGC) Regulations for promotion of academic integrity and prevention of plagiarism in Research..

Establishing and Constituting the Institutional Ethics Committee (IEC).

T he IEC meetings are held once in every three months or in accordance with the need of the work load. All the proposals will be received at least three weeks before the meeting, checked for completeness as per the check list initially by the office clerk(Form II), subsequently by the member secretary (through a nominated person) using the evaluation form (Form III)..

Procedure for submission of research project for review by Ethics Committee.

A certificate of approval At the end of each meeting, every member must return all the research proposals and documents to IEC office staff. It will be sent to the applicant within 2 weeks and a ll the approvals will be valid for only three years..

Format for submission of Research proposal to IEC.

Format for submission of Research proposal to IEC.

Research Protocol. Rationale of the study (in less than 100 words) Research design & methodology . Please include number of subjects, Research methods to calculate sample size. Attach all relevant enclosures like proforma , questionnaires etc Informed consent process, including patient information sheet and informed consent form in local language, if applicable. For any drug / device trial, mention all relevant pre-clinical animal data and clinical trial data from other centers within the country /other countries, if available-. If applicable - Name and signature of Principal Investigator and co-investigator/s on research protocol with date. Signatures of HOD and principal of institute..

Checklist for attached documents. 1.Project proposal – 10 Copies 2.Curriculum Vitae of Investigators 3.Brief description of proposal 4.Patient information sheet 5.Informed Consent form 6.Investigator’s brochure for recruiting subject 7.Copy of advertisements/Information brochures 8.Copy of questionnaire / data collection sheet . Place ,date and finally the HOD’s remark with Name & Signature..

Name Of the participant; Of Primipal investigator: Of the Of the : _ _ . Wag in my language about the project in detail. have understood. Wag to ask any they been 1 S years Of age and exercising my power Of hereby give 2) 3) 6) 7) S) my to be included as a participant in this study." have and understood this Consent the provided to I had the Consent explained to me I have been explained about the nature Of study My rights to by the investigator been advised the rigkS With participation in the Study I agree to With the investigator and if not in study the past _ I am a Ware Of the fact that r Can opt out Of the study at any Without giving also a-vvare that the investigators may terminate my the study at any any without my I O) give • to the me result Of in this study to the I My identity be kept if my data are publicly presented. 12) have my 13) to in the study that if have any questions this I should any addresses listed. By Signing this Consent I that the information given in this been c explained to me apparently understood by I be given a copy Participant •s.

Protocol No Investigator Title Information to participants . complete address with contact NO. You are invited to take part in this research study _ The information on this document is meant to help you decide whether you want to participate or not Please feel free to ask if you have any queries or concerns. You are asked to participate in this study that is to be conducted in Shri Sathya Sai Medical College &RI because you satisfy our eligibility criteria: 6. What is the purlN»se of research? The study design Study procedures Possible risks to you Possible benefits to you Possible benefits to other people The Alternatives you have What should you do in case of injury or a medical problem during this research study? Confidentiality of the information obtained from you How will your decision not to participate in the study affect you? Can you decide to stop participating in the study once you start?.

24 Can the investigator take you off the study? Right to new information Participant's initial. (Explanation under each above said title in easy language should be made and a copy in English and local language should be included ).

All research proposals must be submitted in English language only. M ust be submitted at least three weeks in advance from the scheduled date of IEC meeting ..

Receipt of the application will be acknowledged by the IEC office. Every application will be allotted an IEC registration number to be used for all future correspondence and reference ..

Organization of the IEC. 1.Chairman – from outside the institution 2.one-two persons from basic medical science area 3.One –two clinicians from various institutions 4.One legal expert or retired judge 5.One social scientist /representative of NGO 6.One philosopher/ethicist 7.One lay person from the community 8.Member secretary.

When should we apply to IEC?. I t is Before initiation of your research For all research activities you must take approval from EC. NOTE : Even when we are using available data where we say that there is no risk involved to human participants , ethics review is required. Even in these situations ethics review is considered important and mandatory..

General principles of research are. Autonomy Beneficence non maleficence Justice Confidentiality..

Autonomy. It represents a patient's right to determine his or her own health-care decisions. Patient autonomy is the most fundamental principle underlying all health-care ethics..

For example, patients have the right to refuse undesired therapy, and they have the right to choose whether or not they will participate in experimentation. Each patient has the right to have his wishes carried out even in the event that he loses consciousness or the capacity to make decisions for himself..

Autonomy is similar to. F reedom of religion, F reedom of speech, F reedom of assembly. The concept of patient autonomy is similar to that of voting ..

Minor(< 18 years). Minors are generally not considered competent to make their own decisions. Only a parent or a legal guardian can give consent for a minor . Neighbors, aunts, uncles, and grandparents cannot give consent for treatment of a minor..

All adult patients are considered competent unless specifically proven otherwise A patient with mental illness or mental retardation that might be considered incompetent for other areas of life may still retain the right to refuse medical procedures..

B eneficence. Doing what is good for people­ is a high aim and ethical principle, autonomy is considered more important and takes precedence. You cannot treat him or her against his or her will even if the treatment is for her benefit ..

confidentiality. You cannot release medical information to anyone about a patient unless the patient gives you permission to do so. confidentiality is breached in case of HIV, tuberculosis, or a sexually transmitted disease because these are legally notifiable to public health authority and also these conditions can harm an innocent third party. The patient has an absolute right to freely access the information it contains..

Lets us know. .. 9/27/2022. 48.

Let us know some of the ethical issues in health biomedical research 1.Can you do? Automatic HIV testing of patients without their specific informed consent that you will be testing for HIV..

You cannot do. When a patient enters the hospital there is general consent given that allows the routine testing of blood for chemistry and hematology and so on. An additional HIV-related consent required to test for HIV..