Declaration of Helsinki

The Declaration of Helsinki is a set of ethical principles and guidelines for conducting medical research involving human subjects. It was adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times since then, with the most recent revision occurring in 2013.

The Declaration of Helsinki outlines several key principles and considerations for researchers and physicians involved in human research, with a focus on protecting the rights, safety, and well-being of research participants. Some of the core principles and points covered in the Declaration of Helsinki include:

Informed Consent: Research participants must provide voluntary, informed, and written consent to participate in a study. They should be fully informed about the nature of the research, its purpose, risks, benefits, and alternatives.

Beneficence and Non-Maleficence: Researchers should aim to maximize the benefits of research while minimizing harm to participants. The well-being of the research subjects should be the primary concern.

Research Ethics Committee Review: All research involving human subjects should undergo ethical review by an independent committee. This review ensures that the study meets ethical and scientific standards.

Scientific Validity and Ethical Conduct: Research should be scientifically rigorous and designed to answer important questions. Researchers must conduct their work with integrity and honesty.

Privacy and Confidentiality: Participants' privacy should be protected, and their data should be kept confidential. Personal information should not be disclosed without informed consent.

Equitable Distribution of Benefits and Burdens: Research should benefit society, and the selection of research subjects should be fair, without exploitation or discrimination.

Continuing Review: Ethical review of research should continue throughout the duration of the study, with particular attention to any new information that may affect the research's ethical considerations.

Access to Medical Care: Participants should have access to medical care and treatment, and they should be compensated for any injuries resulting from their participation in research.

1. Welcome DECLARATION OF HELSINKI K. VAISHALINI Pharm D 163/082023 10/18/2022 www.clinosol.com | follow us on social media @ clinosolresearch 1

2. Index 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2 VULNERABLE GROUPS SCIENTIFIC REQUIREMENTS OF RESEARCH PROTOCOL RESEARCH ETHICS COMMITTEES PRIVACY AND CONFIDENTIALITY INFORM CONSENT USE OF PLACEBO UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE

3. I ntroduction What is declaration of Helsinki Set of ethical principles Developed by WMA for medical community –human experimentation Followed by Nuremberg code(1947) Regarded as cornerstone document of human research ethics Included within clinical trial protocols. In 1961, public opinion around the world was shocked by the thalidomide scandal.2,000 children died and 10,000 children were seriously disabled. Government authorities were then required to action and make regulatory a rrangements to oversee the testing of new medicines. In 1964, the world medical association (MWA) developed and indeed continue t o review and adapt the declaration of Helsinki as a guide for performing research in human beings. 10/18/2022 www.clinosol.com | follow us on social media @ clinosolresearch 3

4. history Adopted in June 1964 Amendments- 1975,1983,1989,1996,2000,2002,2004,2008,2013 First significant effort by medical community to regulate research. Prior to 1947 Nuremberg code only specific countries has National policies.(Germany, Russia) Forms basis of most subsequent documents 1947 declaration of the Nuremberg Code 1948 declaration of Geneva Declaration of Geneva- the WMA binds the physician with the words. “The health of my patient will be my first consideration”. 10/18/2022 www.clinosol.com | follow us on social media @ clinosolresearch 4

5. General statement Purpose - directed towards the increase of knowledge about the human condition in relation to its social and natural environment. Research is for the betterment of all. Conducted - dignity and well being. professional fair treatment and transparency no greater risk Evaluation - all stages of proposal (research design, experimentation, deceleration of results, use of results) benefits and dangers 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5 NEW KNOWLEDGE GOAL But, safeguard, protect health, rights, respect humans subjects, norms (ethical national/internationals standards), less harm, study done by qualified person, compensation treatment(if harm)

6. Risks , Burdens and Benefits In medical practice and in medical research, most interventions involve risks and burdens . Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects . Measures to minimize the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study. RISK>MODIFY/STOP STUDY 10/18/2022 www.clinosol.com | follow us on social media @ clinosolresearch 6

7. Vulnerable Groups and Individuals Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research. Scientific Requirements and Research Protocols Before human study-scientific literature, lab and animal experiment Statement-regarding funding, sponsors, institutional afflation’s, potential conflict of interest-submitted Research involving humans must confirm to generally accepted scientific principles and thorough knowledge of scientific literature and methods. Literature review and animal experiment prior conducting human research provide scientific evidence, base. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Research Ethics Committees The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions . 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8

9. Privacy and Confidentiality Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information Informed Consent Inform the human subjects of the (Aim/methods/conflicts of interest/function/general outcomes of the study/voluntary(freely agrees), withdraw consent at any time without reprisal) Informed consent in writing and participants should be informed about each intervention. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9

10. Elements in Informed Consent Form- Protocol number or name of the study Purpose of the study Duration of the study and subjects involvement A statement that the protocol, and the informed consent were reviewed with the participant, including t he risks and benefits of the study Alternative treatment option discussed Confidentiality record No of subjects Compensation for injury Time for question to be asked and answered Description of the participants decisions Contact details Travel reimbursement Subject responsibilities Use understandable language Copy consent was given to the participants sign copy of CRF. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10

11. Use of Placebo The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances : Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be taken to avoid abuse of this option. Post-Trial Provisions In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11

12. Unproven Interventions in Clinical Practice In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgment it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available . 10/18/2022 www.clinosol.com | follow us on social media @ clinosolresearch 12

13. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 13