Research Ethics

Introduction to Research Ethics

• Ethics are the set of rules that govern our expectations of our own and others’
behavior.
• Research ethics are the set of ethical guidelines that guides us on how scientific
research should be conducted and disseminated.
• Research ethics govern the standards of conduct for scientific researchers It is the
guideline for responsibly conducting the research.
• Research that implicates human subjects or contributors rears distinctive and
multifaceted ethical, legitimate, communal and administrative concerns.
• Research ethics is unambiguously concerned in the examination of ethical issues
that are upraised when individuals are involved as participants in the study.
• Research ethics committee/Institutional Review Board (IRB) reviews whether the
research is ethical enough or not to protect the rights, dignity and welfare of the
respondents.
Why is Research Ethics Important?
• It is a reflection of respect for those who ‘take part’ in research
• It ensures no unreasonable, unsafe or thoughtless demands are
made by researchers
• It ensures sufficient knowledge is shared by all concerned
• It imposes a common standard in all the above respects.
• It has become the norm as an expectation for research activity
• a professional requirement for practitioners in some disciplines e.g.
psychology
• a requirement for access to participants in others e.g. health
Objectives of Research Ethics:

• The first and comprehensive objective – to guard/protect human participants, their

dignity, rights and welfare .
• The second objective – to make sure that research is directed in a manner that assists
welfares of persons, groups and/or civilization as a whole.
• The third objective – to inspect particular research events and schemes for their ethical
reliability, considering issues such as the controlling risk, protection of privacy and the
progression of informed consent.
Human Subjects
• Any piece of research that involves human subjects must endeavour
to protect the rights, dignity, physical and psychological welfare of the
participants
Ethical Principles guiding research
• Respect for human dignity
• Respect for free and informed consent
• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice and inclusiveness
• Balancing harms and benefit
• Minimizing harm
• Maximizing benefit
1. Respect for human dignity

• Cardinal Principle
• Basis of ethical obligations
• Two essential components –The selection and achievement of morally acceptable ends
(The morally acceptable means to those ends Protect the multiple and interdependent
interests of the person (bodily, psychological, cultural integrity)
• It also includes:
• autonomy, which requires that those who are capable of deliberation about
their personal goals should be treated with respect for their capacity for self-
determination; and
• protection of persons with impaired or diminished autonomy, which requires
that those who are dependent or vulnerable be afforded security against
harm or abuse.
1.The right to self-determination : The right to self-determination means that prospective
participants have the right to decide voluntarily whether to participate in a study, without risking
penalty or prejudicial treatment. It also means that people have that right to ask question, to
refuse to give information, and to withdraw from the study.
2-The right to full disclosure: The principle of respect for human dignity emcompasses people’s
right to make informed, voluntary decision about study participation. Which requires full
disclosure. Full Disclosure Means that the research has fully described the Nature of the study, the
person’s right to refuse Participation, the researcher’s responsibilities, And likely risks and
benefits.
2. Informed Consent
• Informed consent means that a person knowingly, voluntarily and intelligently gives
consent to participate in a research.
• Informed consent is related to the autonomous right of the individual to participate
in the research.
• Informing the participant about the research objective, their role, benefits/harms (if
any) etc.
• Presumption that individuals have capacity and right to make free and informed decisions
• In research = dialogue, process, rights, duties, requirements for free and informed consent by
the research subject
• Your research cannot proceed without consent - Consent must be maintained throughout
• Voluntary Informed Consent is essential for research involving human
subjects -According to the APA, Informed Consent should include:
• Description of the nature of the research
• Statement that the research is voluntary and participants can withdraw at
any time
• Identification of Risks and Benefits
• Description of how confidentiality will be protected
• Description of compensation
• Description of what info researchers will share with participants
• Identification of who is responsible for research with contact information
3. Vulnerable Persons
• Ethical obligations towards vulnerable persons
• Diminished competence
• Diminished decision-making capacity
• Entitled to special protection, special procedures to protect their
interests
• Entitlement (based on grounds of human dignity, caring, solidarity,
fairness) to special protection against abuse, exploitation,
discrimination
4. Privacy & Confidentiality
• Fundamental to human dignity
• Standards protect the access, control, dissemination of personal
information
• Helps to protect mental, psychological integrity
• All data collected during the research must be protected and all
participants must be unidentifiable by anyone outside the research
project.
5. Harms and Benefits
• Balance critical to ethics of human research
• Foreseeable harms should not outweigh anticipated benefits
• Harms-benefits analysis affects welfare and rights of subjects
• Researchers have an obligation to avoid, prevent, or minimize harm in studies with humans.
Harm and discomfort can take many forms:- can be physical (eg.,injury),emotional(eg.,stress)
social (eg.,loss of social port)of financial (eg., loss of wages). Ethical researchers must use
strategies to minimize all types of harm and discomfort , even ones that are temporary.
I. Risk- Benefits Assessments

• One strategy that researchers use to protect participants is to conduct a risk-benefits

assessment. Such an assessment is designed to determine whether the benefits of participating
in a study are in line with costs be they financial physical, emotional, or social (i.e,Whether risk-
to benefits ratio is acceptable).
• The general guideline is that the degree of risk to be taken by participants should never exceed
the potential humanitarian benefits of knowledge to be gained . Thus, the selection of a
significant topic that has the potential to improve patient care is the first step in ensuring that
research is ethical.
II. Major potential benefits to participants
• Access to a potentially beneficial intervention that might otherwise be unavailable to them.
• Comfort in being able to discuss their situation or problem with a friendly objective person.
• Increased knowledge about themselves or their condition, either though opportunity for introspection and self-
reflection or through direct interaction with researchers.
• Escape from a normal routine, excitement of being part of study.
• Satisfaction the information they provide may help others with similar problems or condition.
• Direct monetary or material gain through stipends or other incentives.
• Physical harm, including unanticipated side effects.
• Physical discomfort, fatigue, or boredom.
• Psychological or emotional distress resulting from self-disclosure, introspection, fear of the unknown, discomfort
with strangers, fear of eventual repercussion, anger or embarrassment at the type of questions being asked.
• Social risks, such as the risk of stigma, adverse effects on personal relationships, loss of status.
• Loss of privacy.
• Loss of time.
• Monetary costs (e.g, for transportation, child car, time lost from work).
6. Justice and Inclusiveness
• Fairness and equity
• Procedural justice –Application process
• Distributive justice –Harms and benefits
• Enshrined within this is the notion that it would be inequitable to
provide treatment to some patients whilst withholding it from
others.
• This immediately challenges the methodological requirement for a
control group, which demands that some participants will receive
no intervention or treatment.
7. Non Maleficence
• This aims to protect participants from physical or mental danger, which may be short or long
term, permanent or temporary.
• Duty to avoid, prevent or minimize harm
• No unnecessary risk of harm
• Participation must be essential to achieving scientifically and societally important aims that
cannot be realized without the participation of human subjects
• Minimizing harm requires smallest number of human subjects that will ensure valid data
8. Beneficence
• The project/research should be able to demonstrate that there will be some benefit not only to
those participating in the study, but also to the wider population.
• The duty to benefit others
• The duty to maximize net benefits
• Produce benefits for subjects themselves, other individuals
• Produce benefits for society as a whole and for the advancement of knowledge (usually the
primary benefit)
9. Veracity
• The participants hould not be deceived at any stage of the study,
especially its aims, processes, possible outcomes, side effects etc.
• Failing to tell the participants about any key aspect of the research
may be just as unacceptable as proactively deceiving them.
• Since the use of double blinded procedures and placebos is founded
on a form of deception, there use in some cases , be unethical.
Plagiarism
• Comes from the Latin word meaning “to kidnap” *Examples of
plagiarism:
• Copying someone else’s words without proper citation
• Stealing someone else’s ideas -Stealing someone else’s intellectual
property Bottom Line: Cite sources properly and minimize
quotations in research reports
Informed Consent
• Purpose of Consent ?
• Prospective Subject Will Understand nature of research
• Be informed of purpose, risks, and benefits, and alternative
therapies
• Make a Voluntary Decision about Participation
Defining Informed Consent
• Informed consent is defined by the ICH for GCP
• “ A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been
informed of all aspects of the trial that are relevant to the subject’s
decision to participate”.
• Informed consent is documented by means of a written, signed and
dated informed consent form.
• Informed consent is the process in which a health care provider educates a patient about the
risks, benefits, and alternatives of a given procedure or intervention.
• The patient must be competent to make a voluntary decision about whether to undergo the
procedure or intervention.
• Informed consent is both an ethical and legal obligation of medical practitioners in the US and
originates from the patient's right to direct what happens to their body.
• Implicit in providing informed consent is an assessment of the patient's understanding,
rendering an actual recommendation, and documentation of the process.
• The Joint Commission requires documentation of all the elements of informed consent "in a
form, progress notes or elsewhere in the record.
• " The following are the required elements for documentation of the informed consent
discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3)
reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient's
understanding of elements.
• What is informed consents..???
Informed consent is a communication process:
• Between the researcher and the participant.
• Starts before the research is initiated .
• Continues throughout the duration of the study .
• Providing all relevant information to the volunteer/ patient
• The patient/ volunteer understanding the information provided
Voluntarily agreeing to participate
• Informed Consent allows individuals:
- To determine whether participating in research fits with their
values and interests.
- To decide whether to contribute to this specific research project.
- To protect themselves from risks.
- To decide whether they can fulfill the requirements necessary for
the research
Belmont Report
• Expanded the definition of Informed consent.
• Participants-kept informed throughout the experiment,
• Understand risks and benefits.
• Protection of vulnerable group
Basic Principles
• AUTONOMY
• BENEFICENCE
• JUSTICE
General Principles
• The information in the consent form should match the application. ™
• The written consent form should be approved by the IRB and signed by
the subject or the subject's legally authorized representative. A copy
shall be given to the person signing the form.
• The form should be written in language that is understandable to the
subjects.
• If the subject is being asked consent to various options (researchers
accessing records, future use of tissue samples, being videotaped,
audiotaped, etc) there should be one signature for overall consent for
the study and separate signatures authorizing permission for each of the
options.
 Elements In Informed Consent Form
1. Protocol number or name of study
2. Purpose of the study.
3. Duration of study and subject involvement
4. A statement that the protocol, and the informed consent were reviewed with the participant, including the risks
and benefits of the study.
5. Alternative treatment options discussed.
6. Confidentiality record
7. No of subjects
8. Compensation for injury
9. Time for questions to be asked and answered.
10. Description of the participant’s decision
11. Contact details
12. Travel reabusment
13. Subject responsibilities
14. Subject satisfaction
15. Use understandable language
16. Copy of consent was given to the participant
17. Sign copy of ICF
Information should include in informed consent form
1. Why the research is being done
2. What the researchers hope to accomplish
3. A description of what will be done during the study and how long you are expected to participate
4. The risks to you from participation in the study
5. The benefits that you can expect from participation in the study
6. Other treatments that are available if you decide not to participate in the study
7. Verification that you have the right to leave the study at any time, and that standard medical care will
be provided without penalty if you choose to withdraw from the study.
8. Although an informed consent document must be signed before enrollment in a study, it is important
to
remember that informed consent is a process that continues throughout the study.
9. You may ask questions of the health care providers at any time before, during, or after the study.
1) A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject’s
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental.
• A description of any reasonably foreseeable risks or discomforts to
the subject. The explanation of risks should be reasonable and should
not minimize reported adverse effects.
2) A description of any benefits to the subject or to others which may
reasonably be expected from the research.
• The description of benefits to the subject should be clear and not
overstated. If no direct benefit is anticipated, that should be stated.
The benefits to "others" may be an issue when benefits accruing to
the investigator, the sponsor, or others are different than that
normally expected to result from conducting research. Thus, if these
benefits may be materially relevant to the subject's decision to
participate, they should be disclosed in the informed consent
document.
3) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject.
• To enable a rational choice about participating in the research study,
subjects should be aware of the full range of options available to
them. The person(s) obtaining the subjects' consent, however, should
be able to discuss available alternatives and answer questions that
the subject may raise about them.
4) A statement describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained and that notes the
possibility that the competent authority of the Department of Health
and the Ethics Committee may inspect the records
5) For research involving more than minimal risk, an explanation as to whether any
compensation and an explanation as to whether any medical treatments are
available if injury occurs and, if so, what they consist of, or where further
information may be obtained.
• Informed consent documents should describe any compensation or medical
treatments that will be provided if injury occurs. The consent should also indicate
whether subjects will be billed for the cost of such medical treatments.
6) An explanation of whom to contact for answers to pertinent questions about the
research and research subjects' rights, and whom to contact in the event of a
research-related injury to the subject.
• The name of a specific office or person and the telephone number to contact
should be provided for answers to questions about:
• 1) the research subjects' rights;
• 2) a research-related injury; and
• 3) the research study itself. It should be considered to require that the person(s)
named for questions about research subjects' rights not be part of the research
team as this may tend to inhibit subjects from reporting concerns and discovering
possible problems.
7) A statement that participation is voluntary, that refusal to participate will involve
no penalty or loss of benefits to which the subject is otherwise entitled, and that
the subject may discontinue participation at any time without penalty or loss of
benefits to which the subject is otherwise entitled. Language limiting the subject's
right to withdraw from the study should not be permitted in consent documents. If
the subjects who withdraw will be asked to permit follow-up of their condition by
the researchers, the process and option should be outlined in the consent
document.
Additional elements of Informed Consent
1) When appropriate, one or more of the following elements of
information shall also be provided to each subject: (1) A statement that
the particular treatment or procedure may involve risks to the subject
(or to the embryo or fetus, if the subject is or may become pregnant)
which are currently unforeseeable.
(2) Anticipated circumstances under which the subject's participation
may be terminated by the investigator without regard to the subject's
consent. When applicable, subjects should be informed of
circumstances under which their participation may be terminated by
the investigator without the subject's consent.
(3) Any additional costs to the subject that may result from
participation in the research. If the subjects may incur an additional
expense because they are participating in the research, the costs
should be explained.
(4) The consequences of a subjects' decision to withdraw from the
research and procedures for orderly termination of participation by the
subject. When withdrawal from a research study may have deleterious
effects on the subject's health or welfare, the informed consent should
explain any withdrawal procedures that are necessary for the subject's
safety and specifically state why they are important to the subject's
welfare.
(5) A statement that significant new findings developed during the
course of the research which may relate to the subject's willingness to
continue participation will be provided to the subject. The IRB should
determine that a system, or a reasonable plan, exists to make such
notification to subjects.
(6) The approximate number of subjects involved in the study. If the
numbers of subjects in a study is material to the subjects' decision to
participate, the informed consent document should state the
approximate number of subjects involved in the study.
(7) The amount of remuneration/compensation, if any, that will be
provided to subjects.

(8) When appropriate, a statement concerning an investigator’s

potential financial or other conflict of interest in the conduct of the
study.