20/05/2024

Vision & Mission of RMU

Informed Consent Vision

Highly recognized and
accredited center of excellence
Mission Statement
in Medical Education, using
evidence-based training To impart evidence-based
Module: III techniques for development of
research-oriented health
professional education in order
highly competent health
Endocrinology professionals, who are lifelong
to provide best possible patient
care and inculcate the values
experiential learner and are of mutual respect, ethical
socially accountable. practice of healthcare and
social accountability.

Learning Objective
a. Statement of learning outcomes (01 slide)
•Discuss the ethical principles applicable within the doctor patient relationship b. Order & Components of the session
•Describe the different types of consent and the situations in which obtaining consent is a. Core subject ( contains throughout
• Prof Umar’s Model required Sequence of the relevant clinical contents) ( 30 slides)
b. Research pertinent to enhance
• Demonstrate understanding of the elements and process of informed consent in research Session understanding o the subjects (01 slides)
• Intricate concept of vulnerability in context of research and the necessity of additional c. Vertical integration (01 slides)
safeguards to protect vulnerable population d. Horizontal integration (01 slide)
e. End of the session relevant assessments (
01 slides)
f. Suggested additional readings ( 01 slide)

Ethics and its fundamental principles Core A brief look into history Core A brief look at history Core content

content content

• Moral principles that govern a person's behaviour or the conducting of an activity

– Moral: standards of behaviour; principles of right and wrong
Fundamental principles Sulfanilamide WWII Thalidomide Tuskegee Guatemala
1. Autonomy / respect for persons 1938 1939-1945 1956-1962 1932-1972 1946-1948
Ethics in research was:
• The right for an individual to make his or her own choice
FDA Product Nuremberg Code FDA: Kefauver Harris Belmont Report Came to light in
• Protect those with diminished autonomy Authorisation 1947 Amend 1979 2005
“…born in scandal and rendered in protectionism” System EU: Directive
2. Beneficence 65/65/EEC1
• The principle of acting with the best interest of the other in mind UK: Medicines Act 68

• Maximise benefits
3. Non-maleficence
• “Above all, do no harm," as stated in the Hippocratic Oath
• Minimise risks Willowbrook Trovan MMR Asthma study TGN1412
4. Justice 1963-1966 1996 1998 2001 2006
• A concept that emphasizes fairness and equality among individuals Belmont Report Pfizer sued in US Loss of GMC Review of IRB Change in phase
• Equitable distribution of benefits and burdens of research 1979 for lack of
informed consent
registration. Still processes I trial regs
working in US

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Core Core
7 ethical requirements Regulations
content
Informed consent What is informed consent content

&
1. Social or scientific value
Guidelines a process by which a participant voluntarily • A decision to participate in research made by a competent individual
Confidentia Ethics confirms his or her willingness to participate in a
2. Scientific validity PARTICIPAN Committee • who has received the necessary information;
-lity
T review particular study, after having been informed of all
3. Fair participant selection PROTECTIO aspects of the study that are relevant to the • has adequately understood the information;
4. Favourable risk-benefit ratio N
participant’s decision to participate” • and after considering the information,
5. Independent review Informed Risk ICH GCP Section 1.28
• has arrived at a decision without having been subjected to coercion,
Consent Benefit
6. Informed consent undue influence, inducement or intimidation
7. Respect for potential and enrolled participants
Must be obtained before research participation begins

Core
Core content Core
Full Disclosure content Essential Information for patient information sheet (PIL) content

1. Trial involves research 11. Payments / reimbursements

1. The purpose of the study 2. Purpose of trial 12. Expenses, if any
2. Any reasonably foreseeable risks to the individual 3. Trial treatments and the probability 13. Free to refuse / withdraw
3. Potential benefits to the individual or others for random assignment 14. Monitors and auditors will be
4. Procedures to be followed in the study 4. Trial procedures to be followed granted access to medical records
5. Participant’s responsibilities 15. Confidentiality arrangements
5. Extent of uncertainty, or unknown effects
6. Aspects of trial that are 16. Results
6. The extent of confidentiality protections for the individual experimental 17. Contact details including who is
7. Compensation in case of injury due to the protocol 7. Foreseeable risks, pain or organising and funding the research
8. Contact information for questions regarding the study, participants’ rights, and discomfort, inconveniences 18. How/when terminated
in case of injury 8. Potential benefits 19. Expected duration
9. The conditions of participation, including right to refuse or withdraw without 9. Alternatives 20. Approx numbers of participants
penalty 10. Compensation arrangements

Core Core Core

content
Requirements for valid consent content
Points to consider content

• Who should obtain consent? • Process, not a one-off event

– PI or suitably qualified individual • Language
– Must suit level of understanding
• Must ensure: • Comprehension
– Sufficient opportunity to read and consider information – Must ensure understanding
• To reflect on implications of participation • Documentation
• To ask questions & discuss with family – Written is the gold standard
– Capacity, ie consideration of age, maturity, cognitive ability
• Intimidation / undue influence
– Invalidates consent
• Re-consent when new information arises

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Core Vertical Vertical

Voluntariness content
Case study integration
Contd… integration

• A 58 year old male patient presented in the emergency room of hospital in

•Allow participants to decide Karachi with acute urinary retention. He had been passing urine comfortably • Benign prostatic hyperplasia (BPH) is a pathology seen in elderly males
until a few days earlier. Past history revealed that the patient had undergone and can present with painful acute urinary retention warranting
TURP five years earlier at another centre and was unhappy about the minimally immediate relief through per urethral insertion of a Foleys Catheter.
•Do not coerce, convince or use undue influence to participate invasive approach adopted by the surgeon.
• ER Surgeon explained that the retention was most likely secondary to “re- Transurethral Resection of Prostate (TURP) is considered the gold
growth of prostate” or urethral stricture and added that the risk of repeat standard for the surgical treatment of BPH.2 TURP is one of the most
prostatectomy is around 5% in one year, 10-12 % in five years and 20% in 8-10 commonly performed procedures in urology.
years, he was further explained that although the incidence of repeat
prostatectomy is higher with TURP than open prostatectomy, the latter has
higher morbidity and costs.
• The patient who was now comfortable laughed and said, in Urdu, “Doctor • Comment on above mentioned scenario from ethical perspective
Sahib, for me these figures stood out as 100%. Open surgery was suitable for keeping in consideration pre requisites of valid and informed consent .
me, because in case of blockage in passing urine it takes very long from
Khuzdar to Karachi. Had I been treated with open surgery, I would not have to
go through a repeat operation on my gland.”

Points to ponder !!! Vertical

integration
Vulnerable Groups Core
content
Illiteracy Core
content

Vulnerability refers to those individuals or groups who might be in a disempowered

• Patients need to be given the information they need to make decisions. This includes position in society and are open to exploitation (whether physical, emotional or • Impartial witness signature required
explaining the prognosis, treatment options, and possible complications. International
psychological) or may not always be equipped to defend their own interests when – Must not be on delegation log or attached to study
guidelines are relevant but their application is not enough. Nor will sensitivity to cultural and
social values suffice for decision making. Decision making goes through a complex process of dealing with researchers • Witness writes in name of participant, then their own, signs and
interaction between the physician and patients or physician, patient and patient’s family • Prisoners dates
depending on the nature of the illness and the patient’s socioeconomic background and – People experiencing mental health
cultural values. So, while suggesting options, the physician needs to be patient centered, problems • Asylum seekers and refugees • Participant thumbprints
elaborating on issues which may be important to a particular patient. • Homeless people • Researcher countersigns and dates
– Brain injured individuals
• In this case, the surgeon followed international recommendations but the patient was not • Frail older persons
– Children
mentally prepared for the possibility of re-growth of the gland and retention of urine. Nor • Those experiencing forms of dementia
– People with a learning difficulty Visually impaired people
was he informed that in case of symptoms of urinary retention, he should visit the nearest •
hospital early rather than in an emergency. He should also have been told about the option – Ethnic minorities • People suffering from a life limiting
of open surgery and the reason that international recommendations were against it – Drug addicts illness
– People who cannot read or write • Healthy volunteers

Core Core Core

Age of consent content
Adult without capacity content
Waiver of consent content

• Age of majority differs country to country • Mental Illness / Mental Disability / Brain Damage / Unconscious • Research should relate directly to life-threatening condition of
– Usually 18, unless emancipated minor • Country-specific regulations
participant, eg participant is unconscious
• Legally designated person to give consent for another adult
• Consenting age to research may differ depending on type of study, for example: – Hierarchy: • Legal representative (personal or professional) to give consent
• Age <18: Not automatically deemed competent, assessment required. Parent or guardian 1. Personal legal representative • Acceptable only with ethics committee approval
can sign for minor, including them as much as possible(eg use assent form) • Suitable by virtue of relationship
• Willing
• Emergency research should seek consent from participant as soon as
• Age appropriate Information Sheets (eg <5yrs, 6-12yrs, 13-15yrs and >16yrs 2. Professional legal representative practicable
• Not connected with study
• Primarily responsible for person’s medical care OR
• Nominated by relevant health care provider

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Core Core Core

Verbal consent content
Implied consent content
Check comprehension content

• Used in minimal risk studies Open-ended questions:

• Related to data collection process
• Dependent on data collection methodology – Self-administered questionnaires  "Describe in your own words the purpose of the study."
⁻ Eg: Telephone survey – Online survey  "What more would you like to know?"
⁻ Quick face-to-face interviews
• Minimal risk study - not adversely affect rights and welfare of  "What is the possible benefit of participating in this study?
• Investigator to document the procedure participants  “Could you explain the possible risks?"
• Only with approval of the Ethics Committee Do not ask closed-ended questions:
• Only with prior approval of Ethics Committee
⁻ Scripts to be read provided to REC  "Do you understand?"
⁻ With justification for not using signed consent forms
 "Do you have any questions

Confidentiality, Data Protection & Essential Core Core Core

Documents
content
Ensuring confidentiality content
Consent to sharing data content

Privacy is... • Use codes, not names, as identifiers • Many funders and journals now require that data be added to a
• About people • Protection of records that could identify participant public repository after the end of the study
• A right to be protected – Paper data forms in locked cabinets & locked rooms • Ensure that consent has been obtained to share anonymous data for:
• Is in the eye of the participant, not the researcher or the REC – Participant identification list kept separate to clinical data – Data repository
– Use study ID only in correspondence – Data use, transfer, sharing with another group
Confidentiality... – Use of encrypted devices
• Is about identifiable data • Inform participant of the limits and possible consequences of breaches of
• Is an agreement about who has access to identifiable data confidentiality
• Password protected, restricted access to database

Core Further reading

Anonymizing data content
End of lecture assessment http://nbcpakistan.org.pk/assets/may-16-bioethics-facilitator-book---may-16%2C-
2017.pdf
• Remove direct identifiers • A researcher is conducting experimental study, two of the patients
– eg name, date of birth or address enrolled in the study develop side effects of the experimental medication
• Aggregate or reduce the precision of information or a variable and want to withdraw from the trial. What would be appropriate for the
– eg replace date of birth by age groups researcher?
– reduce precision of GPS coordinate
a) Patients would not allowed to withdraw from trial until complete
• Generalise the meaning of detailed text
– eg replace “Director of university specialising in Public Health in the UK” with “Senior staff at a b) Allowing patients to leave trial will cause financial burden for the
University in the UK” researcher
• Use pseudonyms c) Researcher can impose penalty on patients for leaving trail
• Restrict the upper or lower ranges of a variable to hide outliers
d) Patients have rights to withdraw from trial at any stage
– eg top-coding salaries
e) Patients have rights to withdraw from trial only at the start of trial

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Artificial Intelligence
Research
• European Convention of Human Rights and Biomedicine
– http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm
• International Compilation of Human Subject Research Protections
https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html
Thank you
−
• WHO TDR Ethical challenges in study design and informed consent for health research in resource-
poor settings
– http://www.who.int/tdr/publications/tdr-research-publications/ethical-challenges-study-design/en/index.html
• Casebook on ethical issues in international health research
– http://whqlibdoc.who.int/publications/2009/9789241547727_eng.pdf
• Emanuel E, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283(20): 2701-
2711
• Emanuel EJ, Wendler D, Killen J, Grady C (2004) What makes clinical research in developing
countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases 189 (5): 930-
937
Iserson K. V. (2024). Informed consent for artificial intelligence in emergency medicine: A
practical guide. The American journal of emergency medicine, 76, 225–230.
https://doi.org/10.1016/j.ajem.2023.11.022