Ethical Terminologies and Research Ethics Flashcards
Theme One: Ethical Terminologies
Regulatory Framework & Purpose:
Ethics board members and investigators must share a standardized understanding of ethical terms as defined in the National Code for Health Research Ethics.
Definitions of Key Research Terminologies:
Anonymized Data: Data or biological samples that completely lack identifiers or codes that could link a specimen or record back to a specific individual or identified human being.
Assent: An affirmative agreement by an individual (such as a child or cognitively impaired person) to participate in research. Mere failure to object, in the absence of explicit affirmative agreement, does NOT constitute assent. Assent is obtained from individuals who are legally or decisionally incapable of providing full informed consent.
Autonomous Person: An individual capable of deliberating about personal goals and acting intentionally under the direction of such deliberation.
Children: Persons who have not reached the legal age of consent for medical treatments or research procedures under the applicable local laws. For individuals under of age, consent must be obtained from a legal guardian or parent.
Clinical Trial: A prospective biomedical or behavioral research study involving human subjects designed to evaluate specific biomedical or behavioral interventions (including drugs, therapies, medical devices, or novel uses of existing treatments).
Distinction from Clinical Research: A clinical trial explicitly utilizes a comparative design involving a study arm (participants receiving the intervention) and a control arm (participants receiving standard care, placebo, or no intervention but otherwise identical).
Coded Data: Data where direct personal identifiers are removed and replaced with unique alphanumeric codes. The key linking codes to personal identifiers is stored separately and securely from the primary dataset.
Coercion: Influencing a person's decision regarding research participation through explicit or implicit threats, such as loss of employment standing, reduced academic grades, or loss of community support.
Compensation: Financial payments, material items (e.g., coupons, gift certificates), or non-monetary rewards provided to participants to offset time, travel, or inconvenience.
Deception: Purposefully misleading research participants regarding the true objectives, nature, or procedures of a study.
Diminished Autonomy: A state where an individual has restricted capacity to deliberate about personal goals or limited physical/mental ability to act according to those deliberations.
Equipoise: A state of genuine scientific uncertainty or lack of professional consensus regarding which of two or more medical interventions provides superior therapeutic benefit.
Foetus (Fetus): The product of human conception from the time of uterine implantation until complete delivery.
Incomplete Disclosure: Withholding specific details about study hypotheses or procedures during consent to prevent bias, where full knowledge could materially affect a subject's decision to join.
Informed Consent: A legally effective, voluntary agreement provided by a prospective participant after comprehending and weighing all relevant information regarding study participation.
Investigator: Any individual actively involved in designing, conducting, or analyzing research.
Exclusion: Merely supplying coded private data or biological specimens without further involvement does not constitute being an investigator.
Involvement Criteria: Collaboration in analyzing, interpreting, presenting, or co-authoring papers based on coded data/specimens elevates an individual to investigator status.
Legally Authorized Representative (LAR): An individual, judicial entity, or legal body empowered under applicable law to grant substituted consent on behalf of a prospective study participant (typically a parent or court-appointed legal guardian).
Minimal Risk: A baseline where the probability and magnitude of anticipated physical or psychological harm/discomfort do not exceed those ordinarily encountered in daily life or during routine physical or psychological examinations.
Neonate: A newborn infant.
Permission: The agreement of parent(s) or legal guardian(s) for their child or ward to participate in research.
Placebo: An inactive substance or sham intervention designed to physically resemble an active drug or intervention as closely as possible.
Pregnancy: The period from implantation of a fertilized ovum until complete delivery. Presumptive signs (such as missed menses) establish presumed pregnancy until a negative test or delivery occurs. Delivery is defined as complete separation of the foetus from the womb.
Prisoner: Any individual involuntarily detained or confined in a penal facility, including those sentenced under civil/criminal statutes, detained in pre-trial holding, or placed in alternative commitment facilities.
Therapeutic Misconception: The tendency of research subjects to misinterpret experimental protocols as customized personal medical care, holding an unshakeable belief that all research procedures are designed solely for their personal therapeutic benefit.
Undue Burden: Systematically targeting or selecting specific populations for research participation based on easy accessibility, vulnerability, or ease of manipulation rather than scientific relevance.
Undue Influence: Offering an excessive, unwarranted, or inappropriate reward or inducement to persuade individuals to comply with research procedures.
Theme Two: Respect for Persons
Core Ethical Foundation:
Based on the Belmont Report, respect for autonomy requires acknowledging an autonomous person's choices and refraining from impeding their self-directed actions.
Implemented primarily through voluntary, comprehended, and fully disclosed informed consent.
Three Essential Pillars of Informed Consent:
Voluntariness: Decision to participate must be entirely free from overt or subtle coercion by research personnel.
Comprehension: Participants must possess adequate decisional and cognitive capacity to process and evaluate study details.
Disclosure: Mandatory minimum disclosure elements must be conveyed in a manner understandable to a reasonable person.
Mandatory Disclosure Requirements (Section F(f)5):
Statement that the project involves scientific research, detailing explicit purposes, procedures, experimental aspects, and duration.
Reasonably foreseeable risks or discomforts.
Potential benefits to the individual participant or broader society.
Available alternative medical treatments or procedures, if applicable.
Extent to which confidentiality of personal records will be maintained.
Availability of medical treatments or financial compensation in the event of research-related injury (for greater than minimal risk studies).
Contact details for queries regarding the study, subject rights, or injuries. Must include both the Principal Investigator's contact info AND the independent Chairman of the Health Research Ethics Committee (HREC).
Explicit statement that participation is voluntary, refusal carries no penalty or loss of benefits, and withdrawal can occur at any time without penalty.
Explanation of post-research outcomes and provisions for participants and local communities once the study concludes.
Additional Consent Elements (When Applicable):
Unforeseeable risks to participants, embryos, or foetuses.
Conditions under which an investigator may terminate a subject's participation without prior consent.
Additional financial costs to the participant resulting from research.
Procedures for orderly termination and consequences of voluntary withdrawal.
Obligation to inform subjects of significant new findings that might alter their willingness to continue.
Statements regarding commercial benefit sharing among researchers and participants.
Disclosure of actual or potential conflicts of interest.
Diminished Autonomy Protections:
Autonomy is dynamic and affected by age, illness, cognitive impairment, or pharmacological treatments.
Capacity assessment depends on both individual cognitive capacity and the analytical complexity/risk of the study.
Substituted consent from a Legally Authorized Representative (LAR) is required under Section F(f)13 of the 2006 Code when capacity is compromised.
Even when an LAR signs, the investigator must seek direct participant consent or assent to the maximum extent feasible.
For temporary or intermittent incapacity (e.g., acute trauma or sedation), recruitment must be delayed until full decisional capacity returns. If capacity is regained mid-study, re-consent must be obtained directly.
Consent Format & Technical Standards:
Reading level must not exceed what is understandable by an individual with of standard education in Nigeria (Section F(f)1).
Consent documents must not exceed in length (Section F(f)3).
Documents and presentations must be translated into the participant's primary spoken language.
Waiver or Alteration of Informed Consent (Section F(f)13):
HRECs may alter or waive consent elements under specific conditions:
Study evaluates public benefit/service programs, payment methods, or administrative procedures administered by public officials, AND the study cannot practicably be conducted without the waiver.
Study involves no more than minimal risk, waiver will not adversely affect subject rights/welfare, study is impracticable without waiver, and pertinent post-study debriefing is provided when appropriate.
Practicability: Financial cost or time constraints alone do NOT satisfy the criteria for impracticability. HREC makes the sole binding determination.
Documentation Requirements:
Written consent forms signed by the subject or LAR (Section F(f)1-5, F(f)12).
The National Code does NOT allow complete waiver of consent documentation (Section F(f)12).
Illiterate or physically incapacitated participants: HREC-approved alternative process required, such as witnessed thumb-printing or witnessed audio recording (Section F(f)8).
Records retention: Copies of signed forms must be archived and available for audit by subjects, sponsors, institutions, HREC, and NHREC (Section F(f)10).
Case Study: Sleeping Sickness Protocol (Campus Recruitment):
Study Design: Trypanosomiasis vaccine research measuring surface antigen expression. Requires daily human blood draws.
Blood Donor Criteria: Healthy, weight , no whole blood donation of () in the last (). Maximum per subject over an period, drawing per session. Compensation: per draw. Duration: .
Recruitment Analysis: Recruiting directly from the researcher's clinical class creates an unethical power dynamic prone to coercion. Campus-wide recruitment via public fliers across students, staff, and faculty is ethically acceptable provided class time is not used and authority is not exerted.
Consent Form Evaluation: Consent Document 1 is unacceptable because it omits risk descriptions, confidentiality safeguards, HREC contact info, and explicit withdrawal terms. Consent Document 2 is fully compliant with Section F(f)5.
Theme Three: Beneficence
Core Principles & Obligations:
Obligation to protect participant well-being, defined by two complementary rules:
Do no harm (non-maleficence).
Maximize anticipated benefits while minimizing potential risks.
Taxonomy of Research Risks:
Physical: Pain, physical injury, sensory loss (touch, sight); ranges from acute/transient to chronic/permanent.
Psychological: Anxiety, grief, guilt, emotional distress, or psychological trauma.
Social: Harm to personal reputation, social status, stigmatization, or exposure to political/social retaliation.
Legal: Unintentional disclosure of illegal activities exposing subjects to civil liability or criminal prosecution.
Economic: Job termination, reduced employability, loss of health insurance, increased premiums, or out-of-pocket medical/transportation costs.
Risk-Benefit Balancing & Study Design (Section F[d,b,a]):
Protocol design must minimize risks (Section F[d]), justify unavoidable risks as scientifically necessary (Section F[b]), and ensure potential knowledge advances public health (Section F[a]).
Risk-benefit ratio must be strictly favorable. Risks must be reasonable in relation to the societal importance of knowledge gained.
Undue Inducement:
Excessive monetary or material offers that obscure objective assessment of risk or encourage participants to lie about medical history/eligibility criteria.
Compensation plans must account for financial background, employment status, and local resource dynamics.
Therapeutic Misconception Mitigation:
Research interactions, physical exams, and diagnostic monitoring can lead subjects to confuse experimental protocols with personalized therapy.
Consent must explicitly clarify that procedures are experimental research, not tailored clinical treatment.
Equipoise & Clinical Trials:
Defined as genuine scientific uncertainty or lack of consensus within the expert medical community regarding the comparative effectiveness of interventions.
Essential prerequisite: If standard treatment is known to be superior, randomizing subjects to an inferior arm is unethical.
Case Study (Autism Interventions): Comparing Cognitive Behavioral Therapy against Dietary/Biomedical intervention is in full equipoise because clinical evidence for both standard options is equivalent.
Privacy vs. Confidentiality:
Privacy: An individual's right to control physical and informational intrusion into their personal domain.
Confidentiality: The duty of researchers to prevent unauthorized disclosure of participant data.
Confidentiality Protections: Encrypted databases, double-locked cabinets, restricted physical access, and identifier removal.
Case Study (Rural HIV Trial): Publishing aggregate demographic data (age, sex, state, zone) in small rural settings is unacceptable if local identities can be deduced. Example: Hantavirus study on a US Indian Reservation exposed deceased individuals' identities, violating cultural taboos.
Coded Private Information Safeguards:
Research involving coded samples/data involves human subjects if:
Information was collected specifically for the proposed project via direct interaction, OR
Investigators can readily identify subjects through access to the code key.
Secondary data use is NOT human subject research if data was collected independently AND the investigator cannot access identity keys.
Health Research Ethics Committees (HRECs):
Institutional governance bodies operating under Section E to safeguard human subjects.
Structure: Minimum representing diverse professional backgrounds (Section D[b]).
Composition: Must include legal expertise (lawyer when feasible, Section D[d]) and at least one non-scientific layperson who is unaffiliated with the institution and not an immediate family member of staff (Section D[e,f]).
Review Types:
Full Board Review: Mandatory for studies involving greater than minimal risk.
Expedited Review: Permitted for minimal risk studies or minor administrative protocol changes. Conducted by the Chair or designated senior HREC members (Section E[f]). Rejection of a protocol cannot occur under expedited review; full board evaluation is mandatory for disapproval.
Continuing Oversight: Mandatory annual re-evaluation (Section E[e]). Protocol expiration causes immediate administrative lapse: all recruitment, data collection, interventions, and data analysis must halt immediately.
Data and Safety Monitoring Boards (DSMBs):
Independent panels of clinical experts without conflicts of interest tasked with monitoring interim unblinded safety and efficacy data in multi-site clinical trials exceeding minimal risk.
Principal Investigators must remain blinded to interim data to preserve scientific objectivity.
Case Study (Mercury Exposure): Behavioral trial conducted across Nigeria, Benin, and Ghana funded by the NIH requires a DSMB per National Code and NIH regulations.
Theme Four: Justice
Conceptual Foundations:
Demands fairness in participant selection and equitable distribution of research benefits and burdens.
Individual Justice: Prohibits selecting vulnerable or disfavored individuals for risky studies, or reserving beneficial studies only to favored patients.
Social Justice: Requires equitable burden distribution across societal classes, protecting burdened groups (e.g., welfare recipients, institutionalized individuals, racial minorities) from exploitation.
Equity vs. Equality:
Equality: Treating everyone in the exact same manner.
Equity: Treating individuals fairly based on risk profiles, health prevalence, and scientific relevance. Representation must reflect proportional burden of disease.
Applied Selection Case Studies:
Migraine Trial: Enrolling as many female participants as male participants across diverse ethnic groups is equitable because women experience severe migraines at the rate of men.
Esophageal Cancer Trial: Sampling exclusively from a local Yoruba population for genetic analysis of a disease affecting all ethnic groups is unethically restrictive and creates scientific knowledge gaps.
Inclusion and Exclusion of Children:
Historically excluded, resulting in unverified off-label drug usage in pediatric populations.
Rule: Children MUST be included in clinical trials unless explicit ethical/scientific justification is provided.
Justified Exclusion Criteria: Disease irrelevant to children, legal prohibition, existing redundant pediatric data, age-specific trial preferred, or insufficient adult safety data.
Legal Mandate: Section 64(2) of the Child Rights Act (2003) establishes that adolescents aged and older possess legal capacity to independently consent to scientific research without parental permission. Children under require parental permission plus child assent.
Ethical Use of Placebos:
Permissible only when: no standard effective treatment exists, genuine uncertainty surrounds standard treatment efficacy, placebo risk is minor without risk of permanent harm, or major public benefit is expected with minimal placebo risk.
Consent forms must explicitly explain what placebos are and state the statistical likelihood of receiving a placebo.
Deception and Incomplete Disclosure:
Permitted only when research cannot be conducted without it, study involves no more than minimal risk, subject rights/welfare are preserved, and post-study debriefing is conducted.
International Research & Local Sustainability:
Post-trial access: Investigators and sponsors must make good-faith efforts to ensure local participants retain post-study access to effective experimental treatments.
HIV/AIDS Trials: Guaranteed post-trial access to antiretroviral agents (ARVs) must be established with local health authorities prior to trial launch.
Local Context Review: International studies must be reviewed by an HREC embedded in the local host setting or informed by local cultural experts.
Local Cultural Norms & Informed Consent:
Community leader consent or head-of-family permission must be sought where culturally expected.
Crucial Rule: Community or family consent can never replace individual voluntary informed consent; it operates solely as an additional preliminary step.
Translation Standards for Consent Documents:
Language barriers cannot be used to exclude non-English speaking populations.
Standard Translation: Certified translator translates text; editor reviews.
Back-Translation Protocol: A second independent medical translator translates the local language document back into English without reference to the original text. Side-by-side comparison reveals discrepancies.
Short Form Consent Process (Only for minimal risk or direct benefit):
PI presents HREC-approved English consent orally via an in-person medical interpreter.
Participant reads written short-form translation.
Process is witnessed by an independent fluent individual (interpreter can act as witness).
PI and witness sign English consent form.
Participant and witness sign translated short form.
Participant receives signed copies of both documents.
Originals are archived together in participant research records.
If a non-English language group is systematically targeted, a full written translation of the entire consent document is legally required.
Theme Five: Vulnerable Populations
Definition of Vulnerable Groups:
Individuals susceptible to coercion, undue influence, or harm, including pregnant women, foetuses, neonates, children, adolescents, prisoners, People Living with HIV/AIDS (PLWHA), commercial sex workers, men who have sex with men (MSM), injection drug users, economically/educationally disadvantaged women, and students.
Pregnant Women & Foetuses (Section 5.1):
Gestation defined from implantation to delivery. Presumptive pregnancy assumed upon missed menses until negative pregnancy test.
Protocols must minimize maternal and foetal risks; risks to foetus must be scientifically justified by direct health benefits or minimal risk thresholds.
Children and Adolescents (Section 5.2 & 5.3):
Assent requires affirmative agreement. Refusal to object does not equal assent.
Parental permission required for subjects under . Under Section 64(2) of the Child Rights Act (2003), youth aged and older can grant independent legal consent.
Prisoners (Section 5.4):
Involuntarily confined in criminal/civil facilities. Consent must be protected against coercive institutional rewards, sentence reductions, or guard pressures.
Stigmatized & High-Risk Groups (PLWHA, Sex Workers, Drug Users - Section 5.5 & 5.6):
Excluded populations face extreme legal, social, and economic risks (criminal prosecution, violence, societal ostracization).
Requires heightened confidentiality safeguards, certificate of confidentiality, and anonymized data collection.
Students as Research Subjects (Section 5.8):
Vulnerable to coercive power dynamics from professors/instructors (fears of grade penalty or lost favor).
Direct classroom recruitment by course instructors is prohibited; broad multi-departmental recruitment fliers must be used.
Emergency Research Consent Exemptions (Section 5.10):
Special provisions allow research without prior consent during life-threatening emergencies where subjects are incapacitated, no LAR is available, and the intervention must be administered immediately.
Theme Six: Community Engagement
Key Principles:
Establishing collaborative partnerships with target populations prior to protocol initiation.
Engaging local health leadership, advisory boards, and community structures to foster trust, ensure cultural appropriateness, and facilitate transparent dissemination of research findings.
Disseminating results back to participating communities, particularly in HIV-related research as mandated by National HIV Research Policy.