Research ethics By Dr Zaryab Khalid Class BS

Research ethics By Dr. Zaryab Khalid Class: BS Botany Semester: 7 th Subject: Research Methodology

1. Introduction to ethics in research you must accept the responsibility to behave • ethically toward those who will be affected by your research ethics is the study of proper action • research ethics concerns the responsibility of • researchers to be honest and respectful to all individuals who may be affected by their research studies or their reports of the studies’ results

Ethics: principles for guiding decision making • and reconciling conflicting values People may disagree on ‘ethics’ because it is based – on people's personal value systems What one person considers to be good or right – may be considered bad or wrong by another person

What is human research? Human research is: 1 -research conducted with people 2 -research conducted about people research dealing in their data or tissue. 1

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

Why is Research Ethics Important *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 *… and a requirement to comply with external REF’s to obtain funding e. g. ESRC

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. 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)

2. Consent - 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

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

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

6. Justice and Inclusiveness i. e. , fairness and equity • Procedural justice • Application process – Distributive justice • Harms and benefits –

7. Non-malfeasance 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 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)

ETHICAL PRINCIPLES ACORDING TOBelmont Report The Belmont Report identified three principles essential to the ethical conduct of research with humans: 1. Respect for persons 2. Beneficence 3. Justice These three basic principles serve as the foundation of the current HHS regulations and guidelines for the ethical conduct of human subjects research supported by HHS. •

Respect for human dignity This Principle includes • 1 -The right to self-determination • 2 -The right to full disclosure •

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.

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.

The Right to Full Disclosure Summary The right to self determination and the right to full disclosure are the tow major elements on Which informed consent – discussed.

Beneficence One of most fundamental ethical principles in research is that of beneficence which imposes a duty on researchers to minimize harm and to maximize beneficence. This principle covers multiple dimensions -The right to freedom from harm and discomfort. - The right to protection from exploitation.

The right to freedom from harm and discomfort 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.

The right to protection from exploitation Involvement in a study should not place participants at a disadvantage or expose them to situations for which they have not been prepared. Participants need to be assured that their participation, or information they might provide, will not be used against them in any way.

The right to protection from exploitation For example • Person describing his or her economic circumstances to researcher should not be exposed to the risk of losing public health benefits; a person reporting drug abuse should not fear exposure to criminal authorities.

cont, - Qualitative, Quantitative Data in qualitative research, the risk of exploitation my become especially acute because the psychological distance between investigators and participants typically declines as the study progresses. On other hand , qualitative researchers typically are in better position than quantitative researchers to do good, rather than just to avoid doing harm, because of the close relationships they often develop with participants

JUSTICE. The third broad principle articulated in the Belmont Report concerns justice, which includes participants 'right to fair treatment and their right to privacy -the right to fair treatment -the right to privacy

The Right to Fair Treatment One aspect of the justice principle concerns the equitable distribution of benefits and burdens of research. The selection of study participants should be based on research requirements and not on the vulnerability or compromised position of certain people.

The Right to Fair Treatment cont The right to fair treatment encompasses other obligations. It means that researchers must treat people who decline to participate in a study or who withdraw from it in a non prejudicial manner they must honor all agreements made with participants, including the payment of any promised stipends; demonstrate sensitivity to [and respect for] thebeliefe, habits, and lifestyles of people from different backgrounds or cultures; and afford participants courteous and tactful treatment at all times.

the right to privacy Virtually all research with humans involves intruding into personal lives; researchers should ensure that their research is not more intrusive than it needs to be and that participants’ privacy is maintained throughout the study. Participants have the right to expect that any data they provide will be kept in strictest confidence.

Procedures for protecting study participants Now that you are familiar with fundamental ethical principles for conducting research, you need to understand the procedures researchers follow to adhere to them. It is these procedures that should be evaluated in critiquing the ethical aspects of a study.

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).

Cont. , 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.

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.

Major potential benefits to participants *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.

Major Potential Risks to Participants *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.

Major Potential Risks to Participants *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).

Research Ethics: Areas of Focus *Harm *Informed Consent *Confidentiality *Deception *Reporting Results and Plagiarism

Harm -As mentioned before, researchers should • take every precaution to ensure that participants are not subjected to undue harm or stress -Harm and discomfort can take many forms • ; can be physical[eg, injury], emotional[ eg , stress]social[eg, loss of social port]or financial[eg, loss of wages]. Ethical -researchers must use strategies to minimize all types of harm and discomfort, even ones that are temporary •

Informed Consent -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

Confidentiality *All information collected in a research project should remain confidential -Participants should be assigned a HIPAA compliant code -Data should be locked away in a secure setting -Electronic Databases should also be protected What do you do if you bump into a research participant in Wal-Mart?

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

Treatment of Vulnerable groups Adherence to ethical standards is often • straightforward. The rights of special vulnerable groups, however, , may need to be protected through additional procedures and heightened sensitivity. Vulnerable subjects may be incapable of living fully informed consent, or may be at high risk of unintended side effects because of their circumstances You should pay particular attention to the ethical dimensions of study when people who are vulnerable are involved as being vulnerable are the following

cont. , 1 -Children legally and ethically. 2 -Mentally or emotionally disabled people. • 3 -Severely ill or physically disabled people. • 4 -The terminally ill • 5 -Institutionalied people •

1 - Children legally and ethically. Children do not have the competence of give • informed consent and so the consent of children’s parents or guardians shoud be obtained. However , it is appropriate especially if the child is at • least 7 Years of age-to obtain the child’s assent as well Assent refers to the child’saffirmative agreement to participants. If the child is development mature enough to • understand the basics of informed consent evidence of respect for the child’s right to self-determination.

2 - Mentally or emotionally disabled people. Individuals whose disabiity makes it • impossible for them to weight the risk and benefits of participation and make informed decisions. (peopelaffected by cognitive important, • mental illness, coma and so on) Also can not legally provide informed • consent. In such cases, researchers should obtain the written consent of lgal guardin.

3 -Severely ill or physically disabled people For patients who are very ill or undergoing • certain treatment (e. g. , mechanical ventilation) it might be necessary to assess their ability to make reasoned decisions about study participation. Another issue that for certain disabilities , • special procedures for obtaining consent may be required.

CONT For example : With people who cannot read and write or • who have a physical impairment preventing them from writing alternative procedures for documenting informed consent should be used.

4 -The terminally ill Terminally ill people can seldom expect to benefit personally from research, and thus the risk-to- benefit ratio needs to be carefully assessed researchers must also take steps to ensure that if the terminally ill do participate in a study , their health care and comfort are not compromised.

5 -Institutionalied people Nurses often conduct studies with hospitali ed • or institutionalized.

References Beecher, H. K. 1966. “Ethics and Clinical Research. ” New England Journal of Medicine 274(24): 1354– 1360. Faden, R. R. , and T. L. Beauchamp. 1986. A History and Theory of Informed Consent. New York: Oxford University Press. Institute of Medicine (IOM). 2001. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, D. C. : National Academy Press. • • Jonas, H. 1969. “Philosophical Reflections on Experimenting with Human Subjects. ” Daedalus 98: 219– 247. Jones, J. H. 1981. Bad Blood: The Tuskegee Syphilis Experiment. • •

New York: The Free Press. • Katz, J. 1972. Experimentation with Human Beings. New York: Russell Sage Foundation. • • National Bioethics Advisory Commission (NBAC). 1997. Cloning Human Beings. 2 vols. Rockville, MD: U. S. Government Printing Office. National Bioethics Advisory Commission • ———. 1998. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. 2 vols. Rockville, MD: U. S. Government Printing Office. • ———. 1999 a. Ethical Issues in Human Stem Cell Research. 3 vols. Rockville, MD: U. S. Government Printing Office. • ———. 1999 b. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. 2 vols. Rockville, MD: U. S. Government Printing Office. • ———. 2001. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. 2 vols. Bethesda, MD: U. S. Government Printing Office. • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). 1979. • Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D. C. : U. S. Government Printing Office. Tuskegee Syphilis Study Ad Hoc Advisory Panel. 1973. Final Report. Washington, D. C. : U. S. Department of Health, Education, and Welfare. 19 • • •