INFORMED CONSENT

As new medical products are being developed, no one knows for sure how well they will work, or
what risks they will find. The main purpose of clinical trials is to “study” new medical products in
people. It is important for people who are considering participation in a clinical trial to understand
their role, as a “subject of research” and not as a patient.
Informed consent of all subject involved in clinical trial must be submitted to IRB for
documentation.
Impairments to reasoning and judgment that may prevent informed consent include basic
intellectual or emotional immaturity, high levels of stress such as posttraumatic stress
disorder (PTSD) or a severe intellectual disability, severe mental disorder, intoxication,
severe sleep deprivation, Alzheimer's disease, or being in a coma.

Obtaining informed consent is not always required. If an individual is considered unable to give
informed consent, another person is generally authorized to give consent on his behalf, e.g.,
parents or legal guardians of a child (though in this circumstance the child may be required to
provide informed assent) and conservators for the mentally disordered, or consent can be
assumed through the doctrine of implied consent, e.g., when an unconscious person will die
without immediate medical treatment.
In cases where an individual is provided insufficient information to form a reasoned decision,
serious ethical issues arise. Such cases in a clinical trial in medical research are anticipated and
prevented by an ethics committee or Institutional Review Board.

Definition:
“Informed consent is a process for getting permission before conducting a healthcare intervention
on a person, or for disclosing personal information. A health care provider may ask a patient to
consent to receive therapy before providing it, or a clinical researcher may ask a research participant
before enrolling that person into a clinical trial. Informed consent is collected according to guidelines
from the fields of medical ethics and research ethics.”
GOAL OF THE INFORMED CONSENT:

 Provide sufficient information so that a participant can make an informed decision about
whether or not to enroll in a study or to continue participation.
The informed consent document must be written in language 4 easily understood by the
participant, it must minimize the possibility of coercion or undue influence, and the subject
must be given sufficient time to consider participation.
TYPES OF INFORMED CONSENT:
1. Consent – An adult subject, capable of giving permission to participate in a research study,
can provide consent. The subject must be 18 years of age and competent to make the
decision to participate.
2. Parental Permission – When children/minors are included in research, the parent/guardian
must sign a parental permission consent document. Some situations require permission
from at least one parent, while other situations require permission from both parents.
3. Verbal – Verbal consent still contains all elements of written consent, however, the
participant is verbally read the elements and verbally agrees to participate.
4. Short Form – A “short form” is generally used when there is a language barrier and an
English IRB-approved consent is orally translated in the subject’s native language.
5. Information/Fact Sheet – An information sheet many be used as a form of consent in
certain circumstances where a signature could compromise the participant or in studies
where signed consent is not required by regulations.
ELEMENTS OF INFORMED CONSENT:

Before enrolling in a clinical trial, the following information must be given to each potential
research subject:

1. A statement explaining that the study involves research.

2. An explanation of the purposes of the research.
3. The expected length of time for participation.
4. A description of all the procedures that will be completed during enrollment on the clinical
trial.
5. Information about all experimental procedures the will be completed during the clinical
trial.
6. A description of any predictable risks.
7. Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as
a result of the research.
8. Any possible benefits that may be expected from the research.
9. Information about any alternative procedures or treatment (if any) that might benefit the
research subject.
10. A statement describing:
a. the confidentiality of information collected during the clinical trial,
b. how records that identify the subject will be kept
c. the possibility that the FDA may inspect the records.
11. For research involving more than minimal risk information including
a. an explanation as to whether any compensation or medical treatments are
available if injury occurs,
i. what they consist of, or
ii. where more information may be found.
iii. questions about the research,
b. research subjects' rights,
12. Research subject participation is voluntary
13. Research subjects have the right to refuse treatment and will not losing any benefits for
which they are entitled,
14. Research subjects may choose to stop participation in the clinical trial at any time
without losing benefits for which they are entitled.
15. Contact information will be provided for answers to any query or problem.
A potential research subject must have an opportunity to:

o read the consent document,

o ask questions about anything they do not understand.

Usually, if one is considering participating in a clinical trial, he or she may take the consent
document home to discuss with family, friend or advocate. The information must be in language
that is understandable to the research subject.
 CONFIDENTIALITY:
Privacy and confidentiality are also supported by two principles of the Belmont Report:

1. Respect for persons – Individuals should be treated as autonomous agents able to exercise
their autonomy to the fullest extent possible, including the right to privacy and the right to
have private information remain confidential.

2. Beneficence – Maintaining privacy and confidentiality helps to protect participants from

potential harms including psychological harm such as embarrassment or distress; social
harms such as loss of employment or damage to one‘s financial standing; and criminal or
civil liability.

Federal regulations require that research records identifying the participant be kept confidential
to the extent permitted by applicable laws and regulations. For example, if the results of a clinical
study are published, participants’ identities must remain confidential.

Federal law also protects the confidentiality of individually identifiable health information for all
research participants. Other federal laws and regulations protect the records and identity of
vulnerable populations as well as study participants receiving alcohol and drug abuse treatment.

WHAT RECORDS MUST BE KEPT CONFIDENTIAL?

USFDA - provides protections for the confidentiality of research participants as follows:

 Subpart A – Basic protections of human research participants

 Subpart B – Additional protections for research participants that are pregnant women,
fetuses, neonates
 Subpart C – Additional protections for participants that are prisoners involved biomedical
and behavioral research
 Subpart D – Additional protections for research participants that are children

Health Insurance Portability and Accountability Act (HIPAA) mandates privacy protections for
individually identifiable health information under 45 CFR 160 and 164.

“All records of the identity, diagnosis, prognosis, or treatment of any person in a clinical
trial must be maintained. This includes any record in connection with alcohol or drug abuse
prevention, education, training, treatment, rehabilitation, or research must be kept confidential.
“Identity” includes not only the participant’s name but also any other information that could be
readily linked to the participant. Additionally, applicable information may be in any form (e.g.,
paper, electronic, verbal).

For example,
  Clinical research staff may not disclose that a participant is enrolled in an HIV study. This
type of disclosure would be in violation of the participant’s confidentiality and can make
things difficult for the participant given the stigma associated with the disease in certain
communities.

 an alcohol or drug abuse treatment program may not disclose to anyone outside the
program that a particular person attends the program, or disclose any information that
identifies a person as an alcohol or drug abuser.

INFORMATION IN A PARTICIPANT'S MEDICAL RECORD CAN BE DISCLOSED IN FOLLOWING

CONDITIONS:
1. Law enforcement officers when the participant has committed or threatened to commit a
crime.
2. suspected child abuse or neglect to state
3. Given to medical personnel in a medical emergency for the purpose of treating a condition
that poses an immediate threat to the health of any person and requires immediate
medical intervention.
4. for management audits, financial audits, or program evaluation activities
5. Danger to Self
6. Danger to Others
7. the participant has a disease that poses a risk to public health
8. Court Order

The following routine practices are recommended to ensure the confidentiality of research
participants:

1. Substitute codes for information that identifies the participant (e.g., use numbers instead
of names to identify participants).
2. Remove face sheets that contain identifiers, such as names and addresses.
3. Properly dispose of all paper documents that contain identifiers.
4. Limit access to all data that identifies participants.
5. Educate research staff on the importance of maintaining confidentiality.
6. Store paper records in locked cabinets.
7. Assign security codes to computerized records.
Control and resolution
To ensure that appropriate ethical values are being applied within hospitals, medical research
requires that ethical considerations are taken into account, for example with respect to physician
integrity, conflict of interest, research ethics and organ transplantation ethics.
Guidelines
There is much documentation of the history and necessity of the Declaration of Helsinki. The first
code of conduct for research including medical ethics was the Nuremberg Code. This document
had large ties to Nazi war crimes, as it was introduced in 1947, so it didn’t make much of a
difference in terms of regulating practice. This issue called for the creation of the Declaration.
There are some stark differences between the Nuremberg Code and the Declaration of Helsinki,
including the way it is written. Nuremberg was written in a very concise manner, with a simple
explanation. The Declaration of Helsinki is written with a thorough explanation in mind and
including many specific commentaries.
In the United Kingdom, General Medical Council provides clear overall modern guidance in the
form of its 'Good Medical Practice' statement. Other organizations, such as the Medical Protection
Society and a number of university departments, are often consulted by British doctors regarding
issues relating to ethics.
Ethics committees
Often, simple communication is not enough to resolve a conflict, and a hospital ethics
committee must convene to decide a complex matter.
U.S. recommendations suggest that Research and Ethical Boards (REBs) should have five or more
members, including at least one scientist, one non-scientist, and one person not affiliated with the
institution. The REB should include people knowledgeable in the law and standards of practice and
professional conduct. Special memberships are advocated for handicapped or disabled concerns,
if required by the protocol under review.
The European Forum for Good Clinical Practice (EFGCP) suggests that REBs include two practicing
physicians who share experience in biomedical research and are independent from the institution
where the research is conducted; one lay person; one lawyer; and one paramedical professional,
e.g. nurse or pharmacist. They recommend that a quorum include both sexes from a wide age
range and reflect the cultural make-up of the local community.
In India – IRB
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical
review board (ERB), or research ethics board (REB), is a type of committee that applies research
ethics by reviewing the methods proposed for research to ensure that they are ethical. Such
boards are formally designated to approve (or reject), monitor, and
review biomedical and behavioral research involving humans.
Composition o IRB
≥ 5 members
≥ 1 member whose primary area of interest is in a nonscientific area
≥ 1 member who is independent of the trial site
IRB/IEC FUNCTIONS
• Determining its composition
• Conducting its meetings
• Approval of minor change(s) in ongoing trials
• Specify that, no subject should be admitted to a trial before the IRB/IEC approval
• Specify that, no deviation from protocol
Documents submitted to IRB to get permission to conduct clinical trial
• Protocol
• Informed consent form
• Investigator's Brochure (IB)
• Subject recruitment procedures
• Available safety information
Cultural concerns
Culture differences can create difficult medical ethics problems. Some cultures have spiritual or
magical theories about the origins and cause of disease, for example, and reconciling these beliefs
with the tenets of Western medicine can be very difficult.

Truth-telling
Some cultures do not place a great emphasis on informing the patient of the diagnosis, especially
when the diagnosis is serious. American doctors rarely used truth-telling especially in medical
cases, up until the 1970s.
In medicine, the principle of informed consent now takes precedence over other ethical values.
Additionally, The WMA International Code of Medical Ethics explicitly states, "A physician
shall...report to the appropriate authorities those physicians who practice unethically or
incompetently or who engage in fraud or deception." There is also the conflict with physicians who
are tempted to report made up incidents or make an incident worse than what it was for their
own personal motives. In vice versa, a physician might be hesitant to report an incident because
of personal friendship he or she may have with his or her colleague.

Online business practices and privacy

Healthcare websites have the responsibility to ensure that the private medical records of their
online visitors are secure from being marketed and monetized into the hands of drug companies,
occupation records, insurancers. The delivery of diagnosis online leads patients to believe that
doctors in some parts of the country are at the direct service of drug companies, finding diagnosis
as convenient as what drug still has patent rights on it.
Physicians and drug companies are found to be competing for top ten search engine ranks to
lower costs of selling these drugs with little to no patient involvement.
With the expansion of internet healthcare platforms, online practitioner legitimacy and privacy
accountability face unique challenges such as e-paparazzi, online information brokers, industrial
spies, unlicensed information providers that work outside of traditional medical codes for profit.
The American Medical Association (AMA) states that medical websites have the responsibility to
ensure the health care privacy of online visitors and protect patient records from being marketed
and monetized into the hands of insurance companies, employers, and marketers. [40]With the
rapid unification of healthcare, business practices, computer science and e-commerce to create
these online diagnostic websites, efforts to maintain health care system’s ethical confidentiality
standard need to keep up as well. Over the next few years, the Department of Health and Human
Services have stated that they will be working towards lawfully protecting the online privacy and
digital transfers of patient Electronic Medical Records (EMR) under The Health Insurance
Portability and Accountability Act (HIPAA).

Humanitarian medical volunteerism

One concern regarding the intersection of medical ethics and humanitarian medical aid is how
such assistance can be as harmful as it is helpful to the community being served. One such example
being how political forces may control how foreign humanitarian aid can be utilized in the region
it is meant to be provided in. This would be congruous in situations where political strife could
lead such aid being used in favor of one group over another. Another example of how foreign
humanitarian aid can be misused in its intended community includes the possibility of dissonance
forming between a foreign humanitarian aid group and the community being
served.[41] Examples of this could include the relationships being viewed between aid workers,
style of dress, or the lack of education regarding local culture and customs.[42]
Conflicts of interest
Conflicts of interest:

1. Referral
2. Vendor relationships
3. Treatment of family members
4. Sexual relationships

Physicians should not allow a conflict of interest to influence medical judgment. In some cases,
conflicts are hard to avoid, and doctors have a responsibility to avoid entering such situations.
Research has shown that conflicts of interests are very common among both academic
physicians and physicians in practice.

Referral
Doctors who receive income from referring patients for medical tests have been shown to refer
more patients for medical tests. This practice is proscribed by the American College of Physicians
Ethics Manual. Fee splitting and the payments of commissions to attract referrals of patients is
considered unethical and unacceptable in most parts of the world.

Vendor relationships (Pharmaceutical marketing to health care providers)

Pharmaceutical marketing, sometimes called medico-marketing or pharma marketing in some
countries, is the business of advertising or otherwise promoting the sale of pharmaceutical drugs.
Pharmaceutical company spending on marketing far exceeds that of its research budget. In
Canada, $1.7 billion was spent in 2004 to market drugs to physicians; in the United States, $21
billion was spent in 2002.
In U.S. pharm marketing spend
56% was free samples, 25% was pharmaceutical sales representative "detailing" (promoting drugs
directly to) physicians, 12.5% was direct to user advertising, 4% on detailing to hospitals, and 2%
on journal ads.[6] There is some evidence that marketing practices can negatively affect both
patients and the health care profession.

PhRMA Code – activity of sales representative

The Pharmaceutical Research and Manufacturers of America (PhRMA) released updates to its
voluntary Code on Interactions with Healthcare Professionals on 10 July 2008.
a. The use of gifts, including pens and coffee mugs embossed with pharmaceutical
product names, has been prohibited by PHRMA ethics guidelines since 2008.
b. Prohibits company sales representatives providing restaurant meals to healthcare
professionals, but allows them to provide occasional modest meals in healthcare
professionals’ offices in conjunction with informational presentations"
c. Includes new provisions requiring companies to ensure their representatives are
sufficiently trained about applicable laws, regulations, and industry codes of practice
and ethics.
d. Continuing medical education to all staff of industry and marketing person.
e. Provides additional guidance and restrictions for speaking and consulting
arrangements with healthcare professionals.

To health care providers

Marketing to health-care providers takes three main forms:

1. activity by pharmaceutical sales representatives,
2. provision of drug samples, and
3. sponsoring continuing medical education (CME)

1. Pharmaceutical representatives
 Representatives often have a call list of about 200-300 physicians with 120-180 targets
that should be visited in 1-2 or 3 week cycle.
 The United States has 81,000 pharmaceutical representatives or 1 for every 7.9 physicians.
 Physicians are perhaps the most important component in sales. They write the
prescriptions that determine which drugs will be used by people. Influencing the physician
is the key to pharmaceutical sales. Historically, this was done by a large pharmaceutical
sales force. A medium-sized pharmaceutical company might have a sales force of 1000
representatives. The largest companies have tens of thousands of representatives around
the world. Sales representatives called upon physicians regularly, providing clinical
information, approved journal articles, and free drug samples. This is still the approach
 today; however, economic pressures on the industry are causing pharmaceutical
companies to rethink the traditional sales process to physicians.
 The industry works on laptops and more recently tablets. The new age pharmaceutical
representative is armed with key data at his fingertips and tools to maximize the time spent
with physicians.

2. Free samples
 Free samples have been shown to affect physician prescribing behavior. Physicians with
access to free samples are more likely to prescribe brand name medication over equivalent
generic medications. Other studies found that free samples standard of care practices.
 It is argued that a benefit to free samples is the “try it before you buy it” approach. Free
samples give immediate access to the medication and the patient can begin treatment
right away. Also, it saves time from going to a pharmacy to get it filled before treatment
begins. Since not all medications work for everyone, and many do not work the same way
for each person, free samples allow patients to find which dose and brand of medication
works best before having to spend money on a filled prescription at a pharmacy.

3. Journal articles and technical documentation

 Activities once considered independent of promotional intent, including continuing
medical education and medical research, are used, including paying to publish articles
about promoted drugs for the medical literature, and alleged suppression of unfavorable
study results.

To consumers

1. Advertisement
o Only two countries as of 2008 allow direct to consumer advertising (DTCA): the
United States and New Zealand. The rhetorical objective of direct-to-consumer
advertising is to directly influence the patient-physician dialogue. Many patients
will inquire about, or even demand a medication they have seen advertised on
television
2. Drug coupons
o In the United States, pharmaceutical companies often provide drug coupons to
consumers like health insurers for prescription medication. These coupons are
generally used to promote medications that compete with non-preferred products
and cheaper, generic alternatives by reducing or eliminating the extra out-of-
pocket costs that an insurers typically charge a patient for a non-preferred drug
product.
Treatment of family members
 The American Medical Association (AMA) states that "Physicians generally should not treat
themselves or members of their immediate family".
 This code seeks to protect patients and physicians because professional objectivity can be
compromised when the physician is treating a loved one. Studies from multiple health
organizations have illustrated that physician-family member relationships may cause an
increase in diagnostic testing and costs. Many doctors still treat their family members.
Doctors who do so must be vigilant not to create conflicts of interest or treat
inappropriately.
 Physicians that treat family members need to be conscious of conflicting expectations and
dilemmas when treating relatives, as established medical ethical principles may not be
morally imperative when family members are confronted with serious illness.

Sexual relationships
 Sexual relationships between doctors and patients can create ethical conflicts, since sexual
consent may conflict with the fiduciary responsibility of the physician.
 Out of the many disciplines in current medicine, there are studies that have been
conducted in order to ascertain the occurrence of Doctor-Patient sexual misconduct.
Results from those studies appear to indicate that certain disciplines are more likely to be
offenders than others.
o Psychiatrists and Obstetrician-Gynecologists for example, are two disciplines noted
for having a higher rate of sexual misconduct. The violation of ethical conduct
between doctors and patients also has an association with the age and sex of
doctor and patient. Male physicians aged 40–49 and 50–59 years are two groups
that have been found to be more likely to have been reported for sexual
misconduct, while women aged 20–39 have been found to make up a significant
portion of reported victims of sexual misconduct. Doctors who enter into sexual
relationships with patients face the threats of losing their medical license and
prosecution.
o In the early 1990s, it was estimated that 2-9% of doctors had violated this
rule. Sexual relationships between physicians and patients' relatives may also be
prohibited in some jurisdictions, although this prohibition is highly controversial.
Futility

 The concept of medical futility has been an important topic in discussions of medical ethics. What
should be done if there is no chance that a patient will survive but the family members insist on
advanced care? Previously, some articles defined futility as the patient having less than a one
percent chance of surviving. Some of these cases are examined in court.

 Advance directives include living wills and durable powers of attorney for health care. In many cases,
the "expressed wishes" of the patient are documented in these directives, and this provides a
framework to guide family members and health care professionals in the decision-making process
when the patient is incapacitated. Undocumented expressed wishes can also help guide decisions in
the absence of advance directives, as in the Quinlan case in Missouri.

 "Substituted judgment" is the concept that a family member can give consent for treatment if the
patient is unable (or unwilling) to give consent themselves. The key question for the decision-making
surrogate is not, "What would you like to do?", but instead, "What do you think the patient would
want in this situation?".

 Courts have supported family's arbitrary definitions of futility to include simple biological survival, as
in the Baby K case (in which the courts ordered a child born with only a brain stem instead of a
complete brain to be kept on a ventilator based on the religious belief that all life must be
preserved).

 In some hospitals, medical futility is referred to as "non-beneficial care."

 Baby Doe Law establishes state protection for a disabled child's right to life, ensuring that this right is
protected even over the wishes of parents or guardians in cases where they want to withhold
treatment.