DECLARATION OF HELSINKI

The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:

Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.

Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.

Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.

Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.

Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.

Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.

Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.

1. PRESENTED BY HEMA PRIYANKA Bpharm RAGHAVI Bpharm

2. Preamble. General Principles. Risks and burdens. Vulnerable groups and individuals. Scientific requirements of research protocol. Research ethics committees. Privacy and confidentiality. Informed consent. Use of placebo. Post trail provisions. Research registration and publications and dissemination of results. Unproven interventions in clinical practice. CONTENTS

3. INTRODUCTION:- The declaration was originally adopted in June 1964 in Helsinki. The declaration is an important document in the history of research ethics as it is the significant effort of the medical community to regulate the research itself and forms basis of the sub-sequent documents, Prior to the 1947 Nuremberg code, there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries Germany and Russia has national policies. The declaration developed principles first stated in Nuremberg code later tied them to declaration of Geneva. A Notable change from Nuremberg code was a relaxation of conditions of consent, which was essential under Nuremberg. Now the doctors were asked to obtain consent were a proxy consent such as legal guardian was available.

4. PREAMBLE:- WMA has developed the declaration of Helsinki as a statement of ethical principles for medical research involving human subjects. The declaration should read as whole and each of its constituent paragraph should be applied with consideration of all other relevant paragraphs. The declaration is addressed primarily to the physicians. The WMA encourages others who are in medical research involving human subjects to adopt these principles.

5. GENERAL PRINCIPLES 1. The declaration of Geneva of WMA binds the physician with the words like “ The health of my patient will be my first consideration” . And the International code of medical ethics declares that, “ A physician shall act in the patients best interest when providing medical care”. 2. It is the duty of physician to promote safeguard the health, well being and rights of patients who are involved in medical research and all of his knowledge and conscience (moral sense of right and wrong) are dedicated to the fulfillment of this duty. 3. Medicinal progress is based on research that ultimately must include studies involving human subjects. 4. The primary purpose of medical research involving human subjects is to understand the cause, the development and effects of disease and improve preventive, diagnostic and therapeutic interventions .Even the proven interventions must be evaluated continually for their safety, effectiveness, efficiency, accessibility and quality .

6. 5. The medical research is subject to ethical standard that promote and ensure respect for all human subjects and protects there health and safety. 6. The primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interest of the individual research subjects. 7. It is the duty of physicians to safeguard or protect the health, life, integrity, dignity, right to self determination, privacy and confidentiality of personal information of research subjects. The responsibility always lies with the physician and never with the subjects even though they have given consent. 8. Physician must consider ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as international norms and standards. No national, international, ethical, legal or regulatory requirements should eliminate/reduce the protection for research subjects. 9. Medical research should conduct in manner, that minimizes possible harm to environment.

7. 10 . The medical research on subjects should be conducted only by individuals with appropriate ethics, and scientific education training and qualification. The research on the patients or healthy volunteers req quires supervision of a qualified physician/other health care professional. 11. Groups that are underrepresented in medical research should be appropriate access to participation in the research. 12. The physicians should believe that participation of research subjects in the research study will not adversely effect the health of the patients. 13. Appropriate compensation and treatment for the subjects who are harmed as a result of participating in research must be ensured.

8. RISKS, BURDENS AND BENFITS Most interventions involve risks and burdens. Medical research only be conducted if the importance of objective only be conducted if the importance of objective outweighs the risks and burdens to research subjects. Measures to minimize risk must be implemented, they must be continuously monitored, assessed and documented by the researches. physicians may not involved in a research unless they are confident that risks been adequately assessed and satisfactorily managed. when the risks are more than benefits, or there is a conclusive proof of definitive outcomes, the physician must assess whether to continue, modify or immediately stop the study.

9. VULNERABLE GROUPS AND INDIVIDUALS

10. S SCIENTIFIC REQUIREMENTS 0F RESEARCH PROTOCOLS Medical research must conform to accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information & adequate laboratory and animal experimentation. The welfare of animals used for research must be respected. The design & performance of research involving human subjects must be clearly described & justified in a research protocol. The protocol should contain ethical consideration & should contain how principles in this declaration have been addressed. The protocol should also contain information regarding Funding Sponsors Institutional affiliations Potential conflict of interest Inventive for subjects Information regarding provisions for treating & compensating subjects who are harmed as a consequence of participation in research study

11. RESEARCH ETHICS COMMITTEE The research protocol must be submitted for consideration guidelines & approval to the concerned REC before the study begins. The committee must be transparent in functioning and independent of sponsor, researcher and must be qualified. It must also take into consideration the laws and regulations of country or countries in which research is to be performed as well as international norms and standards, but these must not eliminate or reduce the protection of research subjects. The committee have rights to monitor and the researcher should provide information about any (serious AE) to committee. At the end of trial, final report must be submitted to the committee containing summary of study PRIVACY AND CONFIDENTIALITY The privacy and confidentiality of the subjects should be maintained /protected.

12. All the individuals should be voluntarily participated and should given informed consent. The subjects who are capable of giving informed consent of funding, possible conflicts of interests, risks and benefits, discomfort of the study. They can with draw consent/eliminate at any time. After ensuring that subject has understood the information, the physician takes freely given consent in a written manner, then it should be formally documented and witnessed. The physician must be independent to the subject and should not have any relationship with subject. The subject who is incapable of giving informed consent the physician must seek informed consent from the legally authorized representative(LAR) If a subject is illiterate then ICF was signed by impartial witness(any social worker) he then signs by saying that he explained all the matters to the subject. The physician must fully inform the patients which aspects of their care are related to the research. The patients decision to withdraw from the study must never adversely effect the patient-physician relationship For medical research using human material/data contained in bio banks or similar repositories, physician must seek informed consent for its collection, storage and reuse. In exceptional situations where consent is impossible, the research may be done only after consideration and approval of research ethics committee.

13. Elements In Informed Consent Form Protocol number or name of study Purpose of the study Duration of study and subject involvement A statement that the protocol, and the informed consent were reviewed with the participant, including this risks and benefits of the study Alternative treatment options discussed Confidentiality record No of subjects Compensation of injury Time for questions to be asked and answered Description of the participants decision Contact details Travel reimbursement Subject responsibilities Subject satisfaction Use understandable language Copy of consent was given to the participant Sign copy of ICF

14. US E OF PLACEBO: The risk, benefits and effectiveness of new interventions must be tested against those of the best proven interventions, expect in following 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 less proven one, placebo, or no intervention will not subject to the additional risks of serious or irreversible harm as a result of not receiving the best proven intervention Extreme care must be taken to avoid the abuse of this opinion 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

15. Research Registration and publication and Dissemination of Results Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject Researches, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of results of research Researchers have to make publicly available the results of their research on human subjects and are responsible for complete accuracy of their reports Negative, as well as positive results, sources of findings should also be made Reports of research not in accordance with the principles of this declaration should not be accepted for publication

16. Unproven Interventions In Clinical Practice In the treatment of an individual patient, where proven intervention do not exit or other known interventions have been ineffective, the physician after seeking expert advice, LAR may use an unproven intervention, if in the physician judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should be designed to evaluate its safety and efficacy. In all cases, new information must be recorded and made publicly available.