Recognizing the Value of Ethics and the Ethical Review Process

1906: FDA Established

HISTORY OF RESEARCH ETHICS: Prior to \____, when the Pure \____ was passed, there were no regulations regarding the ethical use of human subjects in research. There were no consumer regulations, no \___ (\___), no Common Rule, and no institutional Review Board (IRB).

1948: The Nuremberg Code

HISTORY OF RESEARCH ETHICS: stating that "the voluntary consent of the human subject is absolutely essential," making it clear that subjects should give consent and that the benefits of research must outweigh the risks

1950s: Thalidomide Incidence

HISTORY OF RESEARCH ETHICS: was approved as a sedative in Europe; it was not approved in the United States by the FDA. Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babes were born with severe deformities due to 1932-1972: Tuskegee Syphilis Study HISTORY OF RESEARCH ETHICS: 600 low-income African-American males, 400 were infected with syphilis, monitored for 40 years. Subjects were not told about their disease. Even though a proven cure, penicillin, became available in the 1950s, the study continued until 1972 with participants being denied treatment

1954: Declaration of Helsinki

HISTORY OF RESEARCH ETHICS: research with humans should be based on the results from laboratory and animal experimentation, research protocols be reviewed by an independent committee, informed consent is necessary, research should be conducted by qualified individuals, risks should not exceed benefits

1979: The Belmont Report

HISTORY OF RESEARCH ETHICS: established three basic ethical principles: (1) Respect for persons, (2) Beneficence, (3) Justice

RESEARCH ETHICS

Rules for "proper" behavior during the thinking and action processes of research and particularly to the protection of human participants (DePoy & Gitlin, 2016), Proper way to plan and implement research that does not cause harm or compromise the safety and autonomy of those who are participating

RESEARCH ETHICS

The application of moral principles and professional codes in the conduct of scientific research

To protect the rights and welfare of research participants, To protect intellectual property rights, To ensure the accuracy of scientific knowledge (research integrity)

MAIN GOALS OF RESEARCH ETHICS

Nazi Medical Experiments (1933-1945)

Conducted during the holocaust, all for the glory of science, Human subjects are subjected to various tortures that led to death in some cases, euthanasia, severe starvation, extreme temperatures of water to know the limits of hypothermia

Nuremberg Code (1949)

Developed while the trials were conducted, Biggest contribution is placing emphasis on the voluntary consent of the human subject is absolutely essential

Nuremberg Code (1949)

10 guidelines for: Voluntary consent (should be based on information regarding the purpose, procedure, and potential hazards that the participant should be well- informed in), Withdrawal of subjects from the study, Protection of subject from physical and mental suffering, injury, disability, and death, The balance benefits and risks in the study (risks should not exceed the humanitarian benefits)

Declaration of Helsinki (1964)

Greater care can be exercised to protect subjects from harm, Strong, independent justification for exposing a healthy volunteer to substantial risk of harm (independent review board), Investigators must protect life and health of research subjects, This established the role of an independent review board that determines ethical compliance, Research that did not adhere to the declaration were not accepted for publication

Tuskegee Syphilis Study (1932-1972)

Despite the developments in research ethics, this experiment continued on that lasted for 6 months to 40 years , Subjects were deceived during recruitment, Afro-american men, 400 of them had syphilis, They were not given medication and treatment for their sickness that they didn't know that they had, Even after the discovery of penicillin which can serve as treatment, the subjects were not given treatment at all

1972

Tuskegee syphilis study: media exposed the study

1977

Tuskegee syphilis study: clinton administration gave a public apology to the survivors

Willowbrook Hepatitis Study (1956-1980)

Another study that did not comply to the codes and declaration, Natural course of hepatitis and effect of vaccination, Children with Mental Retardation were deliberately exposed to the virus & the parents were not informed about it

Belmont Report (1979)

Ethical principles and guidelines for the protection of human subjects of research, Outlined 3 basic ethical principles, Respect for Persons, Beneficence, Justice

Philippine Council for Health, Research, and Development (PCHRD)

NATIONAL GUIDELINES: National Ethics COmmittee (NEC, 1984), Made first set of guidelines for ethical conduct of biomedical research (1985)

Philippine National Health Research System (PNHRS)

NATIONAL GUIDELINES: Philippine Health Research Ethics Board (PHREB), National Ethics Guidelines (2006)

DOST Administrative Order 001 series of 2007

NATIONAL GUIDELINES: Requirements for review of researches involving human participants

Respect for persons

GUIDING PRINCIPLES: groups together autonomy & confidentiality

Beneficence & non-maleficence

GUIDING PRINCIPLES: \__ \___ \__ can be grouped as one

Justice

GUIDING PRINCIPLES: includes individual & social justice

Veracity

GUIDING PRINCIPLES: is expected in everything

Autonomy

RESPECT FOR PERSONS: "Refers to the capacity of individuals to make decisions affecting their lives and to act on those decisions", Right to self-determination, Right to full disclosure

worth and dignity

Autonomy: A person's \___ \__ \___ as intrinsic, incomparable and unconditional

destroyed or denatured

Autonomy: A person cannot be

means

Autonomy: A person must be an end and not merely a \___ to another's end

destiny

Autonomy: A person can & should decide his/her own

equal

Autonomy: All persons are of \___ worth with the same fundamental inviolable rights and freedoms: to life, truth, minimum healthcare, justice, etc.

respectful courteous

Autonomy: A person must be attended to in a \___ \___ manner

AUTONOMOUS

Autonomy: Bottomline in research: Individuals should be treated as \___ agents (own mind)

informed consent

Respect for Persons: Autonomy: The key to this principles is the notion of \___ \___ as a required prerequisite for most kinds of research

Autonomy

they can decide for themselves, they are informed, they are participation is voluntary

protection

Respect for Persons: Autonomy: Individuals with diminished autonomy are entitled to \___

most familiar

Respect for Persons: Autonomy: Deliver of information: Language that should be used in a consent form is the one that is \__ \___ to the human subject

consent

Respect for Persons: Autonomy: Include a process of obtaining \___ : \___ is given by a competent adult, Must be given adequate information before deciding to voluntarily join a study

RESPECT: Voluntary participation

Right to choose to participate or not, prior to the conduct of the study, Right to withdraw at any time, Right to refuse to answer any particular question or participate in a particular set of questions

Initial enrolment, continuation in study, right to refuse

RESPECT: Voluntary participation: Protection at 3 points in the study:

Concealment of information, Coercion

Violation of RESPECT: Voluntary participation:

Permission

RESPECT: \___ is the agreement of the guardian or parent to allow the child to participate in the study, Legally authorized representative of a legally incompetent individual (physically or mentally incapable of giving consent) or a legally incompetent minor must provide informed consent

Assent

is a child's affirmative agreement to participate in the study

Without their assent the study won't continue, this shows the respect to the child's decision as well

RESPECT: Assent with surrogate permission

For children and, adolescents, Parental permission and active assent, For the incapacitated, Permission of surrogate or legal guardian and active assent

7

RESPECT: Assent with surrogate permission: Any child with an intellectual age of \__ (American Academy of Pediatrics)

RESPECT: Privacy and confidentiality

Protect the privacy of participants and ensure confidentiality of data, Evaluation of privacy involves consideration of how a researcher will have access to information about the potential participants

Privacy

is once controlled over the extent, timing, and circumstances of sharing information about oneself with others

Confidentiality

refers to the treatment of information that the individual has already disclosed to the researcher

BENEFICENCE

"Refers to the obligation to attend to the well being of individuals"

Maximize benefits and minimize harm

BENEFICENCE: If there are potential risks, they should be reasonable & should be minimized. Researchers must take the precaution to prevent discomfort or harm

Stop rules should be enforced, researcher should know when to stop the study from going further

Freedom of exploitation

BENEFICENCE: Participants are free from any form of exploitation (mental, physical, psychological, economic)

Belmont Report

"Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. The term beneficence is often understood to cover acts of kindness or charity that go beyond strict obligation" -

Risks and Benefits

Beneficence: \__ \__ \___ should be clearly stated in informed consent form, the institutional review board will assess if the benefits are maximized,

justified

Beneficence: risks vs. benefits: Brutal or inhumane treatment is never

justification

Beneficence: risks vs. benefits: If study shows risks, insist of a good \___,

justify

Beneficence: risks vs. benefits: If vulnerable population are involved, need to strongly

informed consent form

Beneficence: risks vs. benefits: Risks and benefits should be clearly stated in the

JUSTICE

"Refers to fairness in the research process, or the equitable distribution of the benefits and burdens", Right to fair treatment, Right to privacy, Ensuring justice involves examining the composition of subjects who have been enrolled in the study, looks into who benefits and who bears the burden

vulnerable group

Justice: Unacceptable to to take advantage of a \__ \__ & others to reap the benefits of research (e.g., stipend)

Individual justice

Selecting "undesirables" for studies with high risks, Selecting participants in your favor for highly beneficial studies, Harm should not be designated to those who are at a disadvantage already

Social justice

Never make distinctions among social classes that should or should not be included in the study, Equal opportunity, Upholding social justice

order of preference

There is an \___ \__ \___ in the selection of classes of subjects (e.g., adults before children)

potential subjects

Some classes of \___ \__ (e.g., the institutionalized or prisoners) may be involved as research subjects, if at all, only on certain conditions

Cannot give consent

children, mentally-incapacitated

situational vulnerability

low ses, prisoners

relational vulnerability

siblings, students

cognitive vulnerability

by virtue of cognitive impairment

juridic vulnerability

by virtue of formal authority relationship

deferential vulnerability

cultural and social influences

medical vulnerability

participant with health condition for which no other remedy is available

allocational vulnerability

allocational disadvantage on socially distributed goods

infrastractural vulnerability

discriminated against because of loack of a certain resource/infrastracture

Cannot give consent

cognitive vulnerability

Situational vulnerability

medical, allocational, infrastructural vulnerability

Relational vulnerability

juridic, deferential vulnerability

vulnerability

Strategies must be employed in consideration of the \___ of study participants, especially when obtaining consent

INFORMED CONSENT

Adequate information about the research, Language must be understandable to the person being recruited, May decline or discontinue voluntarily

chance to choose

Participants of any research to the degree that they are capable must be given \___ \__ \___ what shall or shall not happen to them

adequate information

For an adult or an incompetent individual to provide consent, they should be given \___ \__ and competent enough to make that decision to voluntarily join the study

FREE AND INFORMED CONSENT

Subject information should be confidential/ anonymous, Researcher must ensure that all questions of the subject are answered, Subject may withdraw consent at any point, Special considerations are given to subjects that are "vulnerable", Must be easy to understand & allow the participants to ask questions,

Consent

is an ongoing process; participant can withdraw at any time

Coercion

Informed Consent: Violation if There is: Intentional threat to harm in order to obtain compliance

Undue influence

Informed Consent: Violation if There is: Offer an unwarranted, excessive, improper reward for compliance (use of power, bias, incentive)

purpose

elements of informed consent: The \__ of the study

risks

elements of informed consent: Any reasonably foreseeable \__ to the individual

benefits

elements of informed consent: Potential \__ to the individual or others

Alternatives

elements of informed consent: to the research protocol (if any)

confidentiality

elements of informed consent: The extent of \__ protections for the individual

Compensation

elements of informed consent: in case of injury due to the protocol

Contact

elements of informed consent: information for questions regarding the study, participants' rights, and in case of injury

conditions

elements of informed consent: The \__ of participation, including right to refuse or withdraw without penalty

minimal risk

Can consent be waived: The research involves no more than \__ \__ to the participants;

adversely affect

Can consent be waived: The waiver or alteration will not \__ \__ the rights and welfare of the participants;

waiver or alteration

Can consent be waived: The research could not practicably be carried out without the \__ __; and

additional pertinent

Can consent be waived: Whenever appropriate, the participants will be provided with \__ \__ information after participation

Institutional Review Boards (IRBs) or Ethics Review Board (ERB)

In charge of monitoring the ethical conduct of research (based on Belmont Report)

Full review

3 levels of review: high risk classification involving a vulnerable population, drug testing, invasive procedures

Expedited review

3 levels of review: researcher has to show that their study does not involve a vulnerable population, there are no invasive procedures, minimal risks, and use of secondary data

Exempted status

3 levels of review: Justification for exempted status