Dr. Anjum Susan John, MRC 4/13/2017

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 4/13/2017

Ethical requirements for any research Beneficence Autonomy Justice 4/13/2017

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? 4/13/2017

Essential information Purpose of the study Length of the study Benefits and risks Costs Confidentiality Alternative treatments Withdrawal of participation 4/13/2017

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 4/13/2017

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? 4/13/2017

Consent is a process not an event The consent process Consent is a process not an event 4/13/2017

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.., 4/13/2017

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 ? 4/13/2017

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 4/13/2017

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.., 4/13/2017

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. 4/13/2017

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 4/13/2017

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 4/13/2017

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 4/13/2017

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 4/13/2017

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 4/13/2017 Dr. Anjum Susan John ,Specialist, MRC, HMC 18

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 4/13/2017

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 4/13/2017

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. 4/13/2017

The consent forms 4/13/2017

Patient Label HGH ⃞ WH ⃞ RH ⃞ AAH ⃞ AKH ⃞ Others ⃞M R #: PATIENTNAME: DOB: GENDER: NATIONALITY: 4/13/2017

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) 4/13/2017

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] 4/13/2017

Introduction to the research (A brief introduction is given about the research, what it hopes to achieve, who is conducting it etc..,) 4/13/2017

Purpose of the research ( Brief, clear description of the purpose, goals and objectives of the research are provided here) 4/13/2017

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 4/13/2017

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 4/13/2017

Explanation of the procedures to be used (Brief, clear explanation of procedures involving the subject) PROVIDING ALL INFORMATION NEEDED TO TAKE AN INFORMED DECISION 4/13/2017

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 4/13/2017

Description of Safety precautions in this research Describe about the safety precautions that will be taken during study period). 4/13/2017

Descriptions of the benefits of the study (Brief description of any direct or indirect benefits to the subject). APPLICATION OF THE PRINCIPLE OF BENEFICENCE 4/13/2017

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 4/13/2017

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 4/13/2017

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 4/13/2017

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 4/13/2017

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) 4/13/2017

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 4/13/2017

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 4/13/2017

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 4/13/2017

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 4/13/2017

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) 4/13/2017

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 ) 4/13/2017

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. 4/13/2017

Ethical and unethical research Research approved by the RC Research unapproved by the RC Accessing participant records or information without RC approval 4/13/2017

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 4/13/2017

Thank you 4/13/2017