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Dr. Anjum Susan John, MRC

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Objectives 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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• 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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1. It is a research2. Risks and benefits

3. Ask questions 4. Freedom to withdraw

participation

•Prospective consent + .consent in writing = Procedural issues

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• 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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Consent must be provided by the prospective participant him/her self before the study has commenced

Exceptions 1.A child- parent/ legally authorized

representative2.A child able to comprehend things – assent

from child in writing 3.Participant advocate : 4.Consent for vulnerable populations-

prisoners, mentally challenged etc..,

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Obtaining consent is the legal and ethical responsibility of the principal investigator.

FAQCan 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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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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• 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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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 document2. The subject was a minor at entry into the study

and has now reached the age of maturity3. The original consent document did not specify

the duration of the subject’s participation in the study.

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• 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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• 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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Recruitment of subjects Pre screening of prospective

subjects Consent process

Recruitment of subjects : protocols must mention how this is done

Prescreening :1.Check interest of prospective subject

2.Verify eligibility3.Assess feasibilityConsent process 1. In a quiet room2. Give information orally3. Give consent form to them , giving adequate time 4. Participants sign the document, if agree5. then investigator attests it

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1. SIGNED INFORMED CONSENT2. WAIVER OF SIGNED INFORMED

CONSENT 3. WAIVER OF INFORMED CONSENT 4. GENETIC CONSENTS A, B, C and D

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For prospective studies with more than minimal risk

(taken in triplicate)One- ParticipantOne- with PIOne in medical

record file of participant

Participant/guardian’s name

Sign, date signed

Child’s name

Sign and date signed

Witness name

Sign and date signed

PI’s name

Sign and date signed

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Where research presents no more than minimal risk

of harm to the subject

1. Where the research involves no procedure for which written consent is normally required outside research context

2. Or , where the consent document would be the only identifiable link

3. Eg: Drawing of additional blood/body secretions during routine draw, questionnaires without participant identifiers, chart reviews preliminary to studies etc..,

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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 PIOne copy with the participantNo need to file a copy in the file of the

participant

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• 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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• HGH WH RH AAH AKH ⃞� ⃞� ⃞� ⃞� ⃞�Others

•⃞�M R #: • PATIENTNAME:• DOB:• GENDER:• NATIONALITY:

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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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• 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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(A brief introduction is given about the research, what it hopes to achieve,

who is conducting it etc..,)

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( Brief, clear description of the purpose, goals and objectives of the

research are provided here)

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( 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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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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(Brief, clear explanation of procedures involving the subject)

PROVIDING ALL INFORMATION NEEDED TO TAKE AN INFORMED DECISION

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(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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Describe about the safety precautions that will be taken during study

period).

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(Brief description of any direct or indirect benefits to the subject).

APPLICATION OF THE PRINCIPLE OF BENEFICENCE

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1. ( 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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( 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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1. (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 ).

2. PRINCIPLE OF AUTONOMY

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1. ( Provide details of any compensation which might be

provided in lieu of their participation in the research).

2. APPLICATION OF PRINCIPLE OF BENEFICENCE

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1. ( 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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1. ( 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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Describe steps to protect confidentiality of data and

anonymity of the participant information )

APPLICATION OF THE PRINCIPLE OF JUSTICE

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( 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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1. ( 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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1. ( 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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1. ( 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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• 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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• Research approved by the RC

• Research unapproved by the RC

• Accessing participant records or information without RC approval

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