Ethical Research Practices

Ethical Concerns in Research

• Research ethics involve the treatment or conduct related to using human participants or animal subjects.
• It also includes research conduct related to scientific integrity and communication.

Learning Objectives: Research Involving Humans Aim

• To name and describe the historical events that have shaped current ethical guidelines.
• To describe the major elements of ethical guidelines for human participant research.
• To name and understand the agencies governing human research in Canada and the US.
• To describe the purpose and responsibilities of Research Ethics Boards (REB) or Institutional Review Boards (IRB)

Lessons from History: Ethical Issues in Human Research

• Following WWII, inhumane "medical" experiments on Nazi concentration camp prisoners were revealed, including breaking and re-breaking bones, and exposure to extreme elements.
• In 1947, 20 physicians were tried for these crimes in Nuremberg.
• The Nuremberg Code with 10 Guidelines, served as the groundwork for ethical standards.

The Nuremberg Code Key Points

• Voluntary consent is essential.
• Research should yield fruitful results for society unobtainable by other means.
• Studies must be designed on animal experimentation and other knowledge.
• Avoid unnecessary physical and mental suffering and injury.
• No experiment should be conducted if death or disability injury is likely to occur.
• Risk should not exceed potential gain.
• Participants should be protected from every possibility of injury, disability, or death.
• Research should be conducted by scientifically qualified persons.
• Voluntary withdrawal is essential.
• Scientists should be prepared to terminate the experiment if there is potential for injury, disability, or death.

Timeline of Ethical Guideline Development

• 1964: The World Medical Association adopted the Declaration of Helsinki.
• Late 1960s: The Surgeon General required institutions receiving federal funds to review research proposals to protect participants.
• 1974: US Congress passed the National Research Act.
• 1979: The Belmont Report identified basic principles by the National Commission.
• Autonomy of persons involves respect for individuals, informed consent, and protection for those unable to provide informed consent.
• The principle of beneficence states the researcher should not cause harm, must minimize risk, and maximize benefit.
• The principle of justice seeks fair and nonexploitative procedures in selection and treatment.

Importance of Names and Dates in Research Ethics

• Troubled history of unethical research exists even after guidelines are in place, such as nutrition research on children in residential schools from 1942-1952 by the Canadian federal government.
• Milgram's obedience study (1963) deceived participants by making them believe they were causing pain.
• The Tuskegee study (1972) monitored men with syphilis for 40 years without treatment.
• Zimbardo conducted the Stanford Prison experiment in 1973.

Ethical Guidelines and Standards for Research Conduct

• Guidelines depend on the type of research (human or animal), the research team’s location/affiliation, and the location of the research.
• The American Psychological Association (APA) maintains a set of ethical principles for research.
• The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans - TCPS 2 (2022).
• The Canadian Council for Animal Care has guidelines standards.

Principles Dictating Ethical Guidelines

• Measurement techniques for certain individuals and behaviors.
• How researchers select individuals.
• Research strategies used with certain populations and behaviors.
• How studies are carried out.
• How data are analyzed.
• How results are reported.

American Psychological Association (APA) Guidelines

• Committee formed in 1952.
• Code discussion began after Milgram's study (Mid '60s).
• The first code developed in 1973, included updates and amendments.
• 10 ethical standards apply to all researchers before engaging in human research.

Development of Canadian Guidelines

• 1978: The Medical Research Council (now CIHR) provided first guidelines.
• 1981: The Social Sciences and Humanities Research Council (SSHRC) set own guidelines.
• 1998: Federal agencies (CIHR, SSHRC, and NSERC) developed TCPS for research involving humans.
• Updated and amended several times, with the most recent (2022) version called TCPS 2.
• Those conducting research with humans complete an online Course On Research Ethics (CORE 2022).
  • Previous version was a TCPS or TCPS:2 certificate

TCPS II Core Principles

• Respect for Persons.
• Concern for Welfare.
• Justice.

APA and TCPS II Guidelines Elements

• APA (Table 4.2): No Harm, Confidentiality, Institutional Approval, Competence, Record Keeping, Informed Consent, Dispensing with Informed Consent, Inducements, Deception, Debriefing.
• TCPS 2 (2022): Ethics Framework, Scope and Approach, The Consent Process, Fairness and Equity in Participation, Privacy and Confidentiality, Governance of Research Ethics Review, Conflicts of Interest, Multi-Jurisdictional Research, Research Involving First Nations, Inuit and Métis Peoples, Qualitative Research, Clinical Trials, Human Biological Materials, Human Genetic Research.

No Harm

• Duty to anticipate and disclose reasonable risks to protect from harm.
• Clinical equipoise occurs when clinicians do what is best for patients.
• Principle of clinical equipoise requires only 2 equally preferred treatments should be compared.

Confidentiality

• Participants are more likely to share truthful information.
• It is achieved by keeping research records anonymous via assigned participant IDs.

Informed Consent Elements

• Information about the general purpose, what is involved, and risks and benefits.
• Understanding occurs via a 2-way discussion. Those lacking capacity to consent can only agree via assent.
• Voluntary Participation depends on free will in absence of potential coercion. Withdrawal without negative consequence must be possible at any time.

Informed Consent Procedure

• Specifics vary by institution.
• Be mindful of local preferred language and language to avoid, such as “You are invited to participate”.
• It involves written documentation.

Common Elements of Consent Forms

• Overview: Purpose and goals of the study, who is conducting the work.
• Description of Procedures: What will be done and what is being requested of the participants.
• Risks and Inconveniences: Physical and psychological risks and demands placed on participants
• Benefits: Personal benefits (if any) to participants.
• Costs and Economic Considerations: Charges to participants (e.g., in treatment) and payment (e.g., for participation).
• Alternative Treatments: Only if applicable, usually for clinical trials.
• Voluntary Participation: A reminder participation can be withdrawn at any time.
• Questions and Further Information: Laboratory and ethics office contacts are listed for questions.
• Signature: By both the participant and the researcher

Confidentiality in Consent

• How it is maintained.
• Caveats in which sensitive information can be subpoenaed or reported.

Deception

• Purposeful withholding or misleading.
• Passive Deception omits information.
• Active Deception is the commission or presentation of misinformation.
• Explicit lie about the study, false information, false feedback, and use of confederates. Consideration of placebo studies.

Deception Guidelines: APA vs TCPS II

• APA: Must be justified regarding benefit outweighing risk:All alternatives must have been considered. Cannot conceal potential pain or emotional distress. Should have debriefing as soon as possible afterwards with an explanation
• TCPS II (2022), Covered in Article 3.7A. No more than minimal risk. Unlikely to adversely affect participants. Impossible to carry out research otherwise. Debriefing that may offer participants the opportunity to withdraw consent and samples

Purposes of Debriefing

• Conveying true purpose.
• Explaining educational value.
• Counteracting / minimizing negative effects, as deception can cause skepticism.
• Explaining and justifying the use of deception.
• Answering questions.

Institutional Review Boards (IRB) or Research Ethics Boards (REB)

• Research involving human biological materials must be locally reviewed. This is a requirement for administrations of funding and academic journals.
• Some research needs review and approval from more than one board.
• Based on location of research, affiliations of researchers and participant recruitment location

IRB/REB Composition

• They are made up of several members.
• Guidelines from TCPS II dictate a minimum of 5 members, with men and women
• Institutions will include 2 members with relevant experience, 1 member knowledgeable in ethics, 1 member knowledgeable in law, and 1 community member.
• Institutional senior administrators cannot serve.

Institutional Review Boards (IRB) or Research Ethics Boards (REB) Responsibilities

• Evaluate research proposals for adherence to ethical guidelines.
• Minimization and assessment of risk.
• Equitable selection and informed consent via documentation.
• Data monitoring.
• Privacy and confidentiality.

IRB Assessment of Risk Levels

• Assessed based on risk level to determine the extent of review.
• Full REB review has become the default for human research. Delegated REB review makes a review by a proportion of the committee for minimal risk, deemed no greater than that experience in day-to-day activities.

Research Exempt from Review

• Publicly available information.
• Studies in public spaces where there is no intervention and no reasonable expectation of privacy.
• Secondary use of anonymous biological materials.

TCPS II (2022) Guidelines: Research Involving Indigenous Peoples

• Historically, research must involve non-Indigenous researchers.
• Guidelines must create a framework for building dialogue between researchers and Indigenous communities.
• A reciprocal, trusting relationship is necessary to develop research questions.
• Engagement must involve community governing authorities, service organizations, elders, and knowledge holders.
• Values, cultures, traditions, histories must be recognized and integrated.
• Customs and codes of research practice must be respected, while tools/methods usually used must be adapted for the population.
• Research should benefit the community through reciprocity of learning and transfer of knowledge and skills.

Learning Objectives: Research Involving Animals

• Aim to describe the major elements of ethical guidelines for nonhuman subjects in research.
• To name and understand the body that governs ethical conduct of non-human research in Canada.
• To describe the purpose and responsibilities of the Institutional Animal Care and Use Committee (IACUC)

Ethical Issues in Nonhuman Research

• Use of nonhuman "subjects" in research, consent can not be given
• Animal models are used to understand systems within those species, processes within humans, and conduct research impossible within human models.

History of Animal Treatment

• Organizations campaigned and lobbied and increased awareness of fair treatment of animals.
• The Society for the Prevention of Cruelty to Animals (SPCA) formed in 1866.
• People for the Ethical Treatment of Animals (PETA) formed in 1980

Government Guidelines in the USA

• They state researchers must follow local animal ethics committee guidelines, US Department of Agriculture guidelines, State guidelines, and established guidelines within the academic discipline like the APA.

Government Guidelines in Canada

• Falls within provincial jurisdiction, not federal.
• The Canadian Council for Animal Care (CCAC) publishes guidelines based on the 3 Rs.
• Replacement methods should avoid or replace animal models.
• A reduction strategy must result to fewer animals being used.

Institutional Animal Care and Use Committee (IACUC)

• It is referred to as the Animal Care Committee (ACC) in Canada.
• Responsible for reviewing and approving research proposals using nonhuman subjects.
• Criteria are based on the guidelines by the governing agency.
• Committees include: a veterinarian, a scientist experienced in animal models, and a member of the public.

Ethics Reviews: Final Notes

• Any changes to methodology undergo review via an amendment.
• All approved protocols undergo annual renewal.
• Research activity in the last year, changes to protocol and any unanticipated events must be disclosed.
• Statements regarding current state of data analysis.
• Budgets can be frozen without ethics approval.

Learning Objectives: Research Conduct and Scientific Integrity

• Aim to name and understand the threats to academic and scientific integrity.
• To identify fraud and plagiarism prevention measures.

Ethics in Research Conduct and Scientific Integrity

• Two main issues: fraud and plagiarism.
• The APA has a code of ethical standards that address these issues.
• Reporting Research Results states psychologists do not fabricate data.
• Any significant errors in published data must be corrected through correction, retraction, or erratum.
• Psychologists do not present another's work or data as their own, even if cited occasionally.

Fraud

• Error is an honest mistake versus fraud, which is intentional manipulation to falsify or misrepresent data
• Could be blatant or less obvious misrepresentation of data
• Due to pressure and funding success, or if partners have their own agendas

Avoiding Fraud Recommendations

• Keep excellent lab records.
• Pre-register hypotheses and planned analysis.
• Replication is key to revealing discrepancies.
• Peer review provides judgement by educated peers.
• There must be data sharing via Open Science.

Plagiarism

• Presenting someone else's words without appropriate credit.
• Can be direct copy/paste or gradual internalization of works by others.

Tips to Avoid Plagiarism

• Take detailed notes with citations.
• Flag and cite ideas from elsewhere within writing via quotes to identify where you have taken things word for word
• Be careful when paraphrasing.
• Be sure reference list is complete.
• When in doubt, cite the work.
• Use citation software