1. Dr. Anjum Susan John, MRC
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2. Objectives What is informed consent ?
The ethical justification of informed consent
The informed consent process
The contents of the consent form
The documentation and filing of consent forms
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3. Ethical requirements for any research
Beneficence
Autonomy
Justice
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4. Informed consent
Definition : It is the agreement of a prospective subject to participate in a study , reached after assimilation of all essential information related to the study.
Which of the ethical principles
does the informed consent justify?
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5. Essential information
Purpose of the study
Length of the study
Benefits and risks
Costs
Confidentiality
Alternative treatments
Withdrawal of participation
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6. ESSENTIAL REQUIREMENTS FOR INFORMED CONSENT
Information
Competence
Voluntariness
INFORMED CONSENT
Prospective consent + .consent in writing = Procedural issues
It is a research
Risks and benefits
Ask questions
Freedom to withdraw participation
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7. FAQ Why should we take consent ? Who provides consent ?
Who can solicit consent ?
When and where should consent be taken?
How should consent be taken ?
What is the effective period of informed consent ?
What should be the language used in consent forms ?
Where should consent documents be kept?
What types of consent forms should be used for different researches?
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8. Consent is a process not an event
The consent process
Consent is a process not an event
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9. Who provides consent ?
Consent must be provided by the prospective participant him/her self before the study has commenced
Exceptions
A child- parent/ legally authorized representative
A child able to comprehend things – assent from child in writing
Participant advocate :
Consent for vulnerable populations- prisoners, mentally challenged etc..,
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10. Who can solicit consent ?
Obtaining consent is the legal and ethical responsibility of the principal investigator.
FAQ
Can the co- investigator take consent ?
Can study nurses or nurses who help in routine clinical care take consent ?
Can the responsibility for the consent be delegated ?
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11. Where and when should consent be taken ?
Setting – where prospective participant can consider the request for participation as an autonomous individual
When – after giving adequate time for contemplating and asking questions
Except for emergency care protocols, consent must not be taken just before beginning a procedure or starting a therapeutic regimen
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12. Appropriate sites for taking consent
A quiet room where the participant can take a voluntary decision with adequate time for consideration
The research proposal must outline where and when consent would be obtained
Inappropriate sites :
Crowded waiting room, public area or operating room holding area etc..,
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13. Effective period of consent
What is mentioned in the research proposal and consent form
Consent does not require to be resigned every year.
Consent must be re- obtained if :
1. The consent document had been altered /amended after the subject signed the document
2. The subject was a minor at entry into the study and has now reached the age of maturity
3. The original consent document did not specify the duration of the subject’s participation in the study.
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14. Language used in consent forms
Simple understandable language addressing participant directly
Language level understood by a grade 6-8 student
Non English speaker : translate consent into his /her language
Type of research modifies the process of consent
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15. Where should consent forms be kept ?
Sealed signed informed consent forms along with their face sheets must be filed in the participant’s medical record files by the principal investigator
Copies of signed informed consent form must be provided to the participant
Copies of signed informed consent form must be kept in the research records of the principal investigator for 3 years after completion of the study
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16. Steps in the informed consent process
Recruitment of subjects : protocols must mention how this is done
Prescreening :
Check interest of prospective subject
Verify eligibility
Assess feasibility
Consent process
In a quiet room
Give information orally
Give consent form to them , giving adequate time
Participants sign the document, if agree
then investigator attests it
Steps in the informed consent process
Recruitment of subjects
Pre screening of prospective subjects
Consent process
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17. TYPES OF CONSENTS 1. SIGNED INFORMED CONSENT
2. WAIVER OF SIGNED INFORMED CONSENT
3. WAIVER OF INFORMED CONSENT
4. GENETIC CONSENTS A, B, C and D
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18. Signed informed consent
For prospective studies with more than minimal risk
(taken in triplicate)
One- Participant
One- with PI
One in medical record file of participant
Participant/
guardian’s name
Sign, date signed
Child’s name
Sign and date signed
Witness name
PI’s name
Sign and date signed
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Dr. Anjum Susan John ,Specialist, MRC, HMC 18

19. Waiver of signed informed consent
Where the research involves no procedure for which written consent is normally required outside research context
Or , where the consent document would be the only identifiable link
Eg: Drawing of additional blood/body secretions during routine draw, questionnaires without participant identifiers, chart reviews preliminary to studies etc..,
Waiver of signed informed consent
Where research presents no more than minimal risk of harm to the subject
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20. Waiver of signed informed consent- documentation
Taken in duplicate
Signed by the principal investigator- means he is taking the responsibility for explaining the entire consent form and signing on behalf of the participant
One copy with the PI
One copy with the participant
No need to file a copy in the file of the participant
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21. Documentation of consent: Waiver of informed consent
Waiver is provided by the RC to the principal investigator to allow him/her access to the participant’s medical record files
The research cannot absolutely be carried out without the waiver.
Collection/ study of existing data , documents, records, pathological specimens, or diagnostic specimens , if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
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22. The consent forms
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23. Patient Label HGH ⃞ WH ⃞ RH ⃞ AAH ⃞ AKH ⃞ Others ⃞M R #: PATIENTNAME:
DOB:
GENDER:
NATIONALITY:
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24. General instructions to participants
You are free to ask as many questions as you like before, during or after in this research, should you decide to give consent to participate in this research study. ( AUTONOMY)
The information in this form is only meant to better inform you of all possible risks or benefits. ( AUTONOMY)
Your participation in this study is voluntary. You do not have to take part in this study, and your refusal to participate will involve no penalty or loss of rights to which you are entitled. (AUTONOMY)
You may withdraw from this study at any time without penalty or loss of rights or other benefits to which you are entitled. (AUTONOMY)
The investigator (s) may stop your participation in this study without your consent for reasons such as: it will be in your best interest; you do not follow the study plan; or you experience a study-related injury. ( ONLY SITUATIONS WHERE INVESTIGATOR MIGHT DECIDE FOR PARTICIPANTS)
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25. Project details filled in for the benefit of the participant
Project title:
Name of Principal Investigator:
Location and phone numbers: [provide appropriate daytime contact information and after-hours or on weekends]
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26. Introduction to the research
(A brief introduction is given about the research, what it hopes to achieve, who is conducting it etc..,)
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27. Purpose of the research
( Brief, clear description of the purpose, goals and objectives of the research are provided here)
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28. Selection of research subjects
( A brief description on how research participants are selected, the inclusion and exclusion criteria used to select the sample population and an explanation of why this particular participant is being considered for inclusion in the study)
APPLICATION OF PRINCIPLE OF JUSTICE
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29. Distinction between routine care and research activities
In case the prospective participant is to be recruited from the patient clientele of treating physicians who also are investigators in the research a description is given to the participant about what parts of the treatment constitutes routine treatment and what constitutes research activities
PROVIDING ALL INFORMATION NEEDED TO TAKE AN INFORMED DECISION
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30. Explanation of the procedures to be used
(Brief, clear explanation of procedures involving the subject)
PROVIDING ALL INFORMATION NEEDED TO TAKE AN INFORMED DECISION
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31. Description of the risks and discomfort involved
(Describe physiological, psychological and social factors of discomfort or risks involved in the study
SO THAT THERE IS NO COERCION TO PARTICIPATE
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32. Description of Safety precautions in this research
Describe about the safety precautions that will be taken during study period).
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33. Descriptions of the benefits of the study
(Brief description of any direct or indirect benefits to the subject). APPLICATION OF THE PRINCIPLE OF BENEFICENCE
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34. Description of the alternative procedures or treatments for this research
( A description of all alternative procedures or treatment options available to the potential research participant , so that the participant is free to choose which treatment modality to adopt)
TO SHOW THAT THE INVESTIGATOR IS MAINTAINING EQUIPOISE BEFORE THE STUDY
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35. APPLICATION OF PRINCIPLE OF BENEFICENCE
Details of the options to remain on the research treatment after termination of the research
( A description is provided about whether the research treatment would be available to the participant even after the study has concluded)
APPLICATION OF PRINCIPLE OF BENEFICENCE
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36. Details of the person to contact in case of Injury or enquiry during the research
(In case of any types of injury or enquiry, provide name of Supervisor and office phone number to contact at any time of the day or night ).
PRINCIPLE OF AUTONOMY
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37. APPLICATION OF PRINCIPLE OF BENEFICENCE
Details of the financial or other compensation which might be provided to the research participants if any
( Provide details of any compensation which might be provided in lieu of their participation in the research).
APPLICATION OF PRINCIPLE OF BENEFICENCE
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38. Duration of the research
( Describe how long the prospective participant is expected to be in the research and what expectations the investigator might have about the participant’s time spent in the research)
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39. PROVIDING ALL INFORMATION NEEDED TO TAKE AN INFORMED DECISION
Names of the sponsors of the research (if applicable) and details about where the research is going to be conducted
( Give information to the participant about all the sponsors of the research, any issues of conflict of interest and also where the research will be conducted)
PROVIDING ALL INFORMATION NEEDED TO TAKE AN INFORMED DECISION
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40. Assurance of anonymity and confidentiality (Confidentiality about the results/specimen/laboratory or any other data)
Describe steps to protect confidentiality of data and anonymity of the participant information ) APPLICATION OF THE PRINCIPLE OF JUSTICE
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41. Non- coercive disclaimer
( A statement that there is no pressure on the prospective subject to participate in the study , that he/she is free to choose any of the treatment modalities offered and that there is no pressure on the participant to continue in the study even after enrollment)
VOLUNTARINESS, PRINCIPLE OF AUTONOMY
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42. Option to withdraw from the study without penalty
( An option is given to the potential participant to continue or withdraw from the study even after enrollment in the research)
PRINCIPLE OF AUTONOMY, FREEDOM OF CHOICE
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43. Details about termination of the study
( A description is given on when and how the study is expected to be completed, what happens when the study is completed, whether the participant is further entitled to contact the investigators after such time , whether the findings of the research will be revealed to them and if the results of the research would be applied to them or not)
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44. Details of the instances in which there might be incomplete disclosure of information
( Description of the instances in the study in which the investigator might not provide all information needed to take an informed consent at the outset of the study, why this is so and when there will be debriefing if any of the undisclosed information to the participant )
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45. Consent:
You (the participant) have read or have had read to you all of the above. Dr. Insert PI name or his/her authorized representative has provided you with a description of the study including an explanation of what this study is about, why it is being done, and the procedures involved. The risks, discomforts, and possible benefits of this research study, as well as alternative treatment choices, have been explained to you. You have the right to ask questions related to this study or your participation in this study at any time. Your rights as a research subject have been explained to you, and you voluntarily consent to participate in this research study. By signing this form, you willingly agree to participate in the research study described to you. You will receive a copy of this signed consent form. As long as the study is renewed as required by the IRB, your signature on this document is valid for the duration of the entire research study. Should any changes occur during the course of the study that may affect your willingness to participate, you will be notified.
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46. Ethical and unethical research
Research approved by the RC
Research unapproved by the RC
Accessing participant records or information without RC approval
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47. Summary
Step 1: Research proposal and consent form approval by RC
Step 2 : Sealing of consent form by MRC
Step 3 : Collecting face sheet of consent forms from MRC
Step 4 : Process of consent
Step 5 : Documentation of consent
Step 6 : File consent forms in medical record files of participants
Step 7 : Provide names and HC numbers of participants recruited each month to the Research assistants assigned for the purpose
Step 8 : Change consent forms / re consent if required
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48. Thank you
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