Informed Consent Process

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Presentation Transcript

Slide 1: 

A presentation on………. Informed Consent Presented By Amol Khedkar B,Pharm M.Tech(Biotech) Email: amolkhedkar@gmail.com Contact: +91-9763921244

Defining Informed Consent : 

2 Defining Informed Consent Informed consent is definied by the ICH for GCP “ A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are revelent to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.”

Why? : 

3 Why? Informed Consent

Research Done The Wrong Way – IThe Tuskeegee Syphilis Study * : 

4 Research Done The Wrong Way – IThe Tuskeegee Syphilis Study * Longest non-therapeutic experiment on human beings in medical history: The progress of untreated syphilis (1932-72). 399 poor African-American sharecroppers in rural Macon County, Alabama, USA. The men were told they were being treated for “bad blood”. Even after penicillin was discovered and found to be a miracle cure, the men were not treated or even told what they had. US government officials went to extreme lengths to insure that they received no therapy from any source. Presidential apology, May 1997 * Tuskegee Syphilis Study Legacy Committee Final Report of May 20, 1996

Research Done The Wrong Way – IINazi Prisoner Research During World War II : 

5 Research Done The Wrong Way – IINazi Prisoner Research During World War II Objectives of various trials: Effect of cold, heat, chemicals on men, women and children “Time to death” testing in response to stressors in healthy “volunteers” Organ transplant experiments on healthy “volunteers” Any information given (some?) is irrelevant because prisoners were forced to participate Outcome: 23 German scientists taken to court, 7 acquitted, 9 imprisoned, 7 given death sentence Nuremberg Code of 1947

Informed Consent in Human ResearchThe Origins : 

6 Informed Consent in Human ResearchThe Origins Before the 20th century, guidelines required physician’s need to adhere to acceptable medical standards Issue of patient’s agreement to the research never discussed Most requirements arose after the Nuremberg trials

Informed Consent in Human ResearchThe Origins : 

7 Informed Consent in Human ResearchThe Origins Emerges from the ethical principle of Respect for Persons Individuals be treated as capable of taking decisions for themselves (“autonomy”) Those with diminished autonomy be protected

What is informed consent? : 

8 What is informed consent? Informed consent is a PROCESS Involves Providing all relevant information to the volunteer/ patient The patient/ volunteer understanding the information provided Voluntarily agreeing to participate A basic right

Slide 9: 

9 Biomedical Research in HumansGuidelines for Informed Consent The Nuremberg Code, 1947 The Declaration of Helsinki, 1964 (2000) The Belmont Report, 1979 ICH GCP, 1997 ICMR Guidelines, 2000

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10 Informed Consent Various terms Patient Information Sheet Provides only the information Informed Consent Form Used to document consent Both integrated in to one document called the informed consent form

WHAT IS INFORMED CONSENT ? : 

11 WHAT IS INFORMED CONSENT ? Informed consent is … “consent given by a competent individual who has received the necessary information has adequately understood the information after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation”.

INFORMED CONSENT AS A PROCESS : 

12 INFORMED CONSENT AS A PROCESS Informed consent is a communication process between the researcher and the participant starts before the research is initiated continues throughout the duration of the study

Information in informed consent : 

13 Information in informed consent Provided in writing The informed consent form Discussed with the subject Consent must be in a language the subject understands

Counseling : 

14 Counseling Who does the counseling.? Clinical Investigator—Preferably a senior who has experience or at least trained in counseling .

PROCESS OF INFORMED CONSENT : 

15 PROCESS OF INFORMED CONSENT Timing Before screening Nature of research project Explicitly state that it is research How subjects will be recruited Purpose / aim of research Investigators’ names & affiliations

Slide 16: 

16 What must a subject know?Treatments Trial treatment(s) Treatments Investigational product and placebo Investigational product and active comparator Investigational product in different doses Probability for random assignment of treatments “flipping a coin”/ “drawing a card” What chance that the subject would be assigned to a particular treatment “equal chance”

Study procedures : 

17 Study procedures What is subject’s involvement Duration of study Explain about sample collections (not just names of tests) Procedures which are research / experimental If treatment, how different from conventional Randomization / blinding No. of subjects in study

Slide 18: 

18 Medical, social, psychological, economic Probability, magnitude Participation Voluntary Can withdraw No penalty, no loss of benefits Potential risks : Benefits

Slide 19: 

19 No coercion No statement / information that causes subject / subject’s legally acceptable representative to waive any legal rights or release investigator / sponsor /institution from liability for negligence Circumstances for termination of subject’s participation by investigator Any questions, further information

Slide 20: 

20 Clear, simple, non technical Sufficient time to make decision Give written information Translations written / verbal Thumb impressions allowed All signatures should be dated Language

Slide 21: 

21 Confidentiality, privacy adverse consequences of information eg. psychiatric illness, sexual preferences, substance abuse, to employers, insurance, legal authorities, HIV stigma Monitor / auditor/IRB/IEC/ regulatory authority have direct access to records without violating confidentiality to extent permitted & subject authorizes such access by signing consent Publication, identity will remain confidential

Documentation of Consent : 

Documentation of Consent Documentation of “legally effective informed consent” usually involves the use of a written consent form signed by the subject or the subject’s legal representative. The consent form is merely the documentation of informed consent and does not, in and of itself, constitute informed consent. Informed consent from parents is generally required. One exception!! 22

Basic Informed Consent/Study Information Sheet Elements : 

23 Basic Informed Consent/Study Information Sheet Elements Explain: Research Purpose Procedures Risks and benefits Compensation Confidentiality Contacts Termination and Withdrawal

IRB Flexibility : 

24 IRB Flexibility Written informed consent is not necessarily appropriate for all research, especially research in the social & behavioral sciences IRBs have flexibility and authority to waive or modify the consent process

Waiver of Documentation : 

Waiver of Documentation An IRB may waive the requirement for the PI to obtain a signed consent form for some or all subjects if it finds The research presents no more than minimal risk; AND The research involves procedures that do not require written consent when performed outside of a research setting. 25

Waiver of Documentation : 

Waiver of Documentation An IRB may waive the requirement for the PI to obtain a signed consent form for some or all subjects if it finds The principle risks are those associated with a breach of confidentiality concerning the subject’s participation in the research; AND The consent document is the only record linking the subject with the research. 26

Slide 27: 

27 SPECIAL PROTECTIONS FOR VULNERABLE POPULATIONS

Special Protections forVulnerable Populations : 

28 Special Protections forVulnerable Populations Federal regulations involving human subjects research include specific protections for children, pregnant women, and fetuses, and prisoners In addition, the IRB expects the investigator to provide additional information regarding cognitively impaired individuals in research or others who are likely to be vulnerable to coercion or undue influence

Children : 

29 Children “Children” are persons who have not attained the legal age for consent to treatment or procedures Parental permission is generally required Assent from children is required when, in the judgment of the IRB, the children are capable of providing assent. If there is any risk at all involved there must be a direct benefit to the minor subjects

The informed consent-Short Form : 

The informed consent-Short Form The short form supplements & documents an oral presentation of the information that is provided to study subject as part of consent process. If this method is used: The form must state that all elements of consent required by regulation have been presented orally to the subject or subjects’s legally authorized representative. There must be a witness to the oral presentation. The IRB must approve a written summary of what is to be said to the subjects or his or her representative.

The informed consent-Short Form….. : 

The informed consent-Short Form….. Only the short form itself is to be signed by the subject or his or her representative. The witness will sign both the short form and copy of the written summary. The person obtaining the consent will sign a written copy of the summary. A copy of the short form and the summary will bw given to the subject or his or her representative.

The informed Consent-Long Form : 

The informed Consent-Long Form The main difference between the two forms is that the long form spells out in writing everything that is presented orally when the short form is used, the subject reads the written long form. The subject signs and dates two copies, one to keep and one for investigator. The only signature required on the long form is that of the subject. However, many IRBs also require investigator and/or witness signatures.

Exceptions from Consent : 

Exceptions from Consent An occasional circumstances will arise where an investigator feels there is a subject who whould benefit form the use of an investigational product, but who is not in a study or who would not qualify for the study. Individual Exceptions e.g. Patient suffering from severe infection, where all marketed antibiotics have been tried.

Exception form informed consent requirement for Emergency Research Studies : 

Exception form informed consent requirement for Emergency Research Studies Frequently, these studies have a relatively short window of opportunity for treatment e.g. treatment must commence within two hours of the injury.

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35 THANK YOU