Fairness in Recruitment

4 ethical paradigms in research

Aids our ethical decision-making

1. research paternalism

2. protectionism

3. participant access

4. collaborative partnership

Research paternalism

Where researchers or research institutions make decisions on behalf of research participants, consent, or nature of the study w/o involving participants autonomy

• social over individual interests (informed consent not prioritized)

• was caused by the jewish chronic disease hospital, Tuskegee syphilis experiment, and hepatitis experiments at willowbrook

Willowbrook Hepatitis Experiment

Reserachers intentially infected mentally disabled children with hepatitis to study the diseease’s progression & effectivitness of gamma globulin

• children weren’t given choice to particpate & some were even denied appropriate medical care

Belmont Report

Bioethics document that specifies in 3 major ethical principles

• respect for persons

• beneficence

• justice

Has the purpose of protecting participants in clinical trials or resarch studies

Common Rule (Research Protectionism)

It is the protection of human subjections (set of regulations that protects human participants in research)

• protects vulnerable populations like:

  • pregnant women & neonates

  • chidlren

  • captive populations (students, military, prisoners)

  • those without decision-making capcaity

  • educationally or economically disadvantaged populations

HIV 1980/Participant Access

Aids epidemic had protectionism of research regulations questioned

• fairness argument now extended to the benefits of research

• participants decided whether they accept the research risks

• compassionate access where patients allowed to use a drug that hasn’t gone through clinical research phases

Trials for HIV mostly recruited white, homosexual men which was wrong because the research was bias and limited findings by excluding individuals from other racial, ethnic, & gender groups

Representation in Research

Rebeca dresser showed the lack of women & racial minorities was constant in research

• seen in heart disease investigating trails

• trials didn’t explicityly target men

• children and elderly research was rare

Why was underrepresentation ongoing?

seen with racial & other minorities (like elderly)

• occured due to legacy of mistrust

• lack of access to academic research centers

• prejudice about ability to adhere to research protocols

Case #1 Participant refuses further participation

Early onsent alzheimer patient no longer has decision-making capacitiy and explicity refuses further participation

• they should automatically be disenrolled from the study because of

1. respect for authonomy

   • individuals retain certain rights so even with diminshed capacity, they expressed clear refusal

   • continuing the suty with them would violate ehtical principles

2. Ethical guidelines & regulations

   1. common rule & belmont report emphasizes voluntary participation & ongoing informed consent

   2. once participant doesn’t want to take part, has to agree and not breach those standards

3. Vulnerability & protection

   1. pt with dementia is part of a vulnerable pop

   2. extra percuatstions must be taken to protect from harm, explotion, etc.

Case #2 Conducting trial in underdeveloped country

AZT regimen reduces likelihood of mother-to-child HIV transmission

• AZT can’t be implement in developing countries in 1990s because of cost of drugs and need for 12 week prenatal treatment

Conducting a trial with shorter course of AZT is a study somewhat fair research recruitment

• the trial adress pressing health need & results will directly benefit local pop

• no other effect treattment alternative available

• there is informed consent & community engagment as participants volunteer and are fully informed

Case #3 Homeless Participants are vulnerable pop? And is study ethical?

Study bout relationship between diabetes & schizophrenia

• homeless pts in a mental facility are enrolled

• these pts lack awareness of their illness and deny having schizophrenia

• participants not asked for their consent to review their medical records & aren’t told the study is about schizophrenia & diabetes

1. These homeless pts are a vulnerable pop becuase they lack awareness of their illness & lack of consent

2. The study cannot be conducted ethically as currently designed because pts do not give consent

3. pts need to be aware of real purpose of the study and asked for consent to access medical records