Informed Consent: Ethical Guidelines & Requirements PDF

Informed consent By: Dr. Marwa Magdy Assistant Professor of Forensic Medicine and Toxicology Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of...

Informed consent By: Dr. Marwa Magdy Assistant Professor of Forensic Medicine and Toxicology Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of informed consent Special situations Informed consent ‫ الموافقة المبنية على العلم‬- ‫ الموافقة االختيارية المعلنة‬- ‫الموافقة المستنيرة‬ A process by which a subject voluntarily confirms his or her acceptance to participate in research after being informed of all aspects of the research that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. ‫الموافقة المستنيرة يتم توثيقها عن طريق وثيقة‬.‫مكتوبة وممضية و مؤرخة‬ Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of informed consent Special situations Informed consent in Ethical guidelines Nuremberg code 1947: “The voluntary consent of the human subject is absolutely essential.” Informed consent in Ethical guidelines Informed consent is based on the ethical principle of : ❑Respect for human subjects (autonomy) ‫احترام حق االختيار‬ Elements of respect for persons include: ◼Obtain informed consent from individuals who are capable of choosing what shall and shall not happen to them. ◼For individuals who lack decision-making capacity, extra safeguards are made to provide them with additional protection.  ‫الدستور المصرى ‪1971‬‬ ‫ (المادة ‪)43‬‬ ‫ ال يجوز اجراء أى تجربة طبية أو علمية على أى انسان بغير رضائه الحر‪.‬‬  ‫قانون التجارب السريرية ‪2021‬‬ ‫ (المــادة ‪)19‬‬ ‫ يلتزم الباحث الرئيسي قبل البدء في إجراء البحث الطبي‪ ،‬أن يتخذ اإلجراءات اآلتية‪:‬‬ ‫الحصول على الموافقة المستنيرة من المبحوث المشارك أو من الممثل القانوني له وتوثيقها‬ ‫عن طريق االستمارة المعدة لذلك والموقعة والمؤرخة من المبحوث والتي تمت مراجعتها‬ ‫والموافقة عليها من اللجنة المؤسسية‪.‬‬  ‫قانون التجارب السريرية ‪2021‬‬ ‫ (المــادة ‪)28‬‬ ‫ يعاقب بالسجن وبغرامة ال تقل عن خمسين ألف جنيه وال تزيد على مائة ألف جنيه‪ ،‬كل‬ ‫من أجرى بحث دون الحصول على الموافقة المستنيرة من المبحوث ومن الممثل القانونى‬ ‫عن الفئات المستحقة حماية إضافية من المبحوثين وموافقات الجهات المحددة بهذا‬ ‫القانون‪.‬‬ ‫ فإذا ترتب على ذلك حدوث عاهة مستديمة‪ ،‬تكون العقوبة السجن المشدد وغرامة ال تقل‬ ‫عن مائة ألف جنيه وال تزيد على خمسمائة ألف جنيه‪ ،‬وتكون العقوبة السجن المشدد‬ ‫الذي ال تقل مدته عن عشر سنين وغرامة ال تقل عن خمسمائة ألف جنيه وال تزيد على‬ ‫مليون جنيه إذا ترتب على الفعل المشار إليه موت شخص أو أكثر‪.‬‬ Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of informed consent Special situations Requirements of informed consent Requirements of a valid consent Decision making Information capacity Voluntariness /Understanding  To ensure understanding/decision making capacity the subject must be competent: ✓Adult (18 years or more) ✓No mental retardation ✓No coma ✓No dementia To ensure voluntariness: ✓No coercion ‫ال اجبار‬ ✓No undue inducement ‫ال اغراء‬ ✓No exploitation ‫ال استغالل‬ Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of informed consent Special situations Elements of informed consent  Basic elements for written informed consent document 1. A statement that the study involves research. 2. An explanation of the purpose of research and the expected duration. 3. A description of the procedures and identification of any procedures that are experimental. 4. A description of any risks or discomforts to the subject, and what steps will be taken to minimize them. 5. A description of any benefits to the subject or to others. Monetary compensation is not a benefit. 6. Any alternative procedures. 7. How records will be kept confidential.  Basic elements 8. Any compensation and any medical treatments that are available if research subjects are injured; and whom to contact in case of a research-related injury. 9. An explanation of whom to contact for answers to questions about the research. 10. A statement that participation is voluntary and that refusal to participate or withdrawal at any time will involve no penalty. Readability of the consent form Informed consent must be written in easy, simple, clear language Understandable by a child in 6th grade Avoid medical terms Must be translated to the subject’s mother language (in case of non-English speaking participants)  Requirements for a valid consent Informed Consent (DHHS 45 CFR Part 46 and FDA 21 CFR Part 50) – Eight Required Elements – Written Documentation – Language Understandable to Subjects – No Coercion or Undue Influence Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of informed consent Special situations Informed consent process Information Voluntariness Comprehension Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of informed consent Special situations  Types of consent CONSENT: An adult subject, capable of giving permission to participate in a research study, can provide consent. The subject must be 18 years of age and competent to make the decision to participate. Surrogate consent: When children/minors/mentally incompetents are included in research, the parent/guardian must sign a permission consent document. Assent: is a child’s agreement to participate in research. If the child is 7-17 years of age, assent must be obtained. The assent is verbal from 7-12 years and written from 13-17 years. Refusal shall be respected. Verbal consent: still contains all elements of written consent; however, the participant verbally obtains the information and verbally agrees to participate e.g: telephone surveys. Short form: A “short form” is generally used when there is a language barrier, the consent is translated in the subject’s native language. Agenda: What is informed consent? Informed consent in ethical guidelines Requirements of informed consent Elements of informed consent Informed consent process Types of informed consent Special situations Special situations Informed consent & Children Age >/=18 Yes No The subject sign Parent/guardian the consent sign the consent Child age 7-12 verbal assent only Child age 13-17 written assent required Informed consent & pregnant women The rule to obtain consent from the pregnant woman & her husband ✓From the woman only if: ❑The purpose of the study is to meet the health needs of the mother ❑The father is not reasonably available Informed consent & cognitive impairment ❑Cognitive impairment includes: ✓Coma ✓Dementia ✓Mental retardation ❑They can participate in research specific to their situation. ❑The informed consent is signed by their legal guardian. Informed consent & non-English speakers Get a translator Witness Understandable language A translated consent document must be submitted for the REC. Informed consent & illiterate or blind There must be a witness Read out loudly the information for them Take the thumbprint of illiterate Conclusion Informed consent is a process not just a signature on a piece of paper Informed consent is obtained before the start of the study The subject must take a copy of the consent The consent process is continuous throughout the study and doesn’t end once the participant signs. Thank you !!