Unit 11 p2

Biomedical research

• Analyze biological material in laboratories in hospitals, clinics or as part of research teams

• A document that describes the background, rationale, objectives, design, methodology and organization of a clinical research project

Research on therapies (e.g., drugs, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans, prenatal diagnosis through amniocentesis) preventive measures (e.g., vaccines, diet, or fluoridated toothpaste)

• Legal Regulations

• Biomedical research

Research protocols

• The level of uncertainty in a given situation

• the detailed plan of the study

This is a ______

• Research protocol

• Degree of risk

Research participants or study volunteers

• Research subjects

• Informed consent

The probability that actual experience will be different from what is expected

• Informed consent

• The degree of risk

In a/an __________, the patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention

• Informed consent

• Multi-centre study

This covers how personal data should be processed e.g Identifiers, data, and keys should be placed in separate password-protected/encrypted files

• Preclinical testing

• data protection

_____can be either positive (e.g. cure, survival) or negative (e.g. death)

• A trial outcomes

• Social benefits

The positive effects that a particular treatment or service can have on society as a whole

• Proposed trial

• Societal benefits