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Research Trans Slay
Research Trans Slay
Research Trans Slay
Purposes of Research
Description
Exploration
Explanation
Prediction and Control
Identification
Characteristics of Research
Orderly and Systematic
Control
Empiricism ( From the patient and people)
Generalization
2
OVERVIEW OF RISK AND BENEFITS
To avoid confusion, speak of risk and benefits in terms of
probabilities
Researchers should provide detailed information about
potential risks and benefits associated with the research, as
well as probability, magnitude and potential harms
associated with each risk
RESEARCH ETHICS COMMITTEES SHOULD:
Evaluate potential risk
Weight the probability of the risk occurring
Weight the magnitude of harm that may result
Judge whether the anticipated benefit (either new
2. Value the research participant knowledge or of improved health for the research
Indispensable for the research ( partner ) participant) justifies inviting any person to undertake the
Choose to join risk.
Cannot be worse off by joining research Identify the risk associated with research as
“Considerations of well being of research participants take distinguished from the risks of therapies the participants
precedence over the interest of science or society” ( would be receive even if not participating in research
helsinski , 2008) Determine that the risk will be minimized to the extent
Protection of research participants is a universal concern possible
Foremost responsibility of investigator is protection of rights, Identify the probable benefits to be derived from the
safety and welfare of study participants research
As a person with inherent dignity who should be: Determine that the risk are reasonable in relation to the
A. An end and not as means benefits to participants, if ant and the importance of the
B. Protected against harm and wrong knowledge to be gained.
C. Respected as a person Assure the potential participants will be provided with an
D. Equal to other person accurate and fair description ( during consent) of the risk
3. Value Self or discomfort and the anticipated benefits.
As honorable and trustworthy TYPES OF RISK
4. Value Community 1. PHYSICAL
Impact on community which participants represent both during 2. PSYCHOLOGICAL
after research 3. SOCIAL
5. Value environment 4. ECONOMIC
PHYSICAL RISK
THE PRINCIPLES OF NON-MALEFICENCE AND Usually minor discomfort or pain
BENEFICENCE: WEIGHING BENEFITS AND RISK Potentially serious or disabling
BACKGROUND: Transient or permanent
Two of the required criteria of REC approval of a research PSYCHOLOGICAL RISK
Risk to participants are minimized
Stress, feeling of guilt or embarrassment, depression, loss of
Risk to participants are reasonable
self- esteem, confusion etc.
Risk must be reasonable in relationship to:
From minimal or transient to serious
Anticipated benefits, if any, to participants themselves
INVASION OF PRIVACY - access to a person’s body or
The importance of the knowledge that may reasonably
behavior without consent
be expected to results
BREACH OF COFIDENTUALITY - inability to safeguard
DEFINITIONS
information that has been given voluntarily by one person to
another
BENEFICENCE SOCIAL HARM
Labeled or stigmatized
is action that is done for the benefit of others
May cause embarrassment or criminal prosecution
Beneficent actions can be take to help prevent or
ECONOMIC HARM
remove harms or to simply improve the situation of
others Actual cost
It is a concept in research ethics states that researchers Loss of employment
should have the welfare of the participants as a goal of WAYS TO MINIMIZE RISK
any research. Provide complete information in the research proposal
NON-MALEFICENCE regarding the experimental design and scientific rationale
Means to “ do not harm” underlying the proposed research
The pertinent ethical issue is whether the benefits Assemble a research team with sufficient expertise and
outweigh the burden / risks experience to conduct a research
BENEFIT: a valued or desired outcome; an advantage Ensure that the projected sample size if sufficient to yield
RISK: the probability and magnitude of harm or injury useful results
occurring as a result of participation in research study Collect data from standard-of-care procedures to avoid
MINIMAL RISK unnecessary risk, particularly for invasive or risky procedures
Where the probability and magnitude of harm or discomfort (e.g spinal taps. Cardiac catheterization )
anticipated in the proposed research are not greater, in and Incorporate adequate standards into the research design such
of themselves, that those ordinarily encountered in daily as an appropriate data safety monitoring plan, the presence of
lives of the general population or during the performance of trained personnel who can respond to emergencies and
routine physical or psychological examination or test. procedures to protect the confidentiality of the data (e.g.
encryption, codes and passowrds )