Dr. Vajira H. W. Dissanayake MBBS (Colombo), PhD (Nottingham) Senior Lecturer, Human Genetics Unit & Joint-secretary, Ethics review committee Faculty of.

Risk Benefit AnalysisRisk Benefit Analysis

Dr. Vajira H. W. Dissanayake MBBS (Colombo), PhD (Nottingham)

Senior Lecturer, Human Genetics Unit&

Joint-secretary, Ethics review committee

Faculty of medicine, university of Colombo

Dr. Vajira H. W. Dissanayake MBBS (Colombo), PhD (Nottingham)

Senior Lecturer, Human Genetics Unit&

Joint-secretary, Ethics review committee

Faculty of medicine, university of Colombo

1.1.Collaborative PartnershipCollaborative Partnership

2.2.Social ValueSocial Value

3.3.Scientific ValidityScientific Validity

4.4.Fair Subject SelectionFair Subject Selection

5.5.Favourable Risk Benefit Favourable Risk Benefit

RatioRatio

6.6.Independent ReviewIndependent Review

7.7.Informed ConsentInformed Consent

8.8.Respect for Research Respect for Research

ParticipantsParticipants

1.1.Collaborative PartnershipCollaborative Partnership

2.2.Social ValueSocial Value

3.3.Scientific ValidityScientific Validity

4.4.Fair Subject SelectionFair Subject Selection

5.5.Favourable Risk Benefit Favourable Risk Benefit

RatioRatio

6.6.Independent ReviewIndependent Review

7.7.Informed ConsentInformed Consent

8.8.Respect for Research Respect for Research

ParticipantsParticipants

Requirements for Evaluating the Ethics of Requirements for Evaluating the Ethics of Research Research

““Minimal Risk”Minimal Risk”““Minimal Risk”Minimal Risk”

2. Research involving greater than minimal 2. Research involving greater than minimal risk,risk,

but presenting the prospect of direct benefit but presenting the prospect of direct benefit to the individual subjects.to the individual subjects.

2. Research involving greater than minimal 2. Research involving greater than minimal risk,risk,

but presenting the prospect of direct benefit but presenting the prospect of direct benefit to the individual subjects.to the individual subjects.

1. Research involving no more than minimal 1. Research involving no more than minimal risk.risk.

1. Research involving no more than minimal 1. Research involving no more than minimal risk.risk.

3. Research involving greater than minimal 3. Research involving greater than minimal risk and risk and no prospect of direct benefit to individual no prospect of direct benefit to individual subjects, subjects, but likely to yield generalizable knowledge but likely to yield generalizable knowledge about the subject’s disorder about the subject’s disorder or condition.or condition.

3. Research involving greater than minimal 3. Research involving greater than minimal risk and risk and no prospect of direct benefit to individual no prospect of direct benefit to individual subjects, subjects, but likely to yield generalizable knowledge but likely to yield generalizable knowledge about the subject’s disorder about the subject’s disorder or condition.or condition.4. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of the participants.

4. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of the participants.

““Minimal Risk ?”Minimal Risk ?”““Minimal Risk ?”Minimal Risk ?”

For research involving greater than minimal For research involving greater than minimal riskrisk

1. the potential 1. the potential risks to individual subjects risks to individual subjects should be minimized,should be minimized,

2. the potential benefits to individual subjects 2. the potential benefits to individual subjects should be enhanced, andshould be enhanced, and

3. the potential benefits to individual subjects 3. the potential benefits to individual subjects and society should be proportionate to and society should be proportionate to or or outweigh the risks.outweigh the risks.

For research involving greater than minimal For research involving greater than minimal riskrisk

1. the 1. the potentialpotential risks to individual subjects risks to individual subjects should be should be minimizedminimized,,

2. the 2. the potentialpotential benefits to individual subjects benefits to individual subjects should be should be enhancedenhanced, and, and

3. the 3. the potentialpotential benefits to individual subjects benefits to individual subjects and society should be and society should be proportionateproportionate to to or or outweighoutweigh the risks. the risks.

For research involving greater than minimal For research involving greater than minimal riskrisk

1. the 1. the potentialpotential risks to individual subjects risks to individual subjects should be should be minimizedminimized,,

2. the 2. the potentialpotential benefits to individual subjects benefits to individual subjects should be should be enhancedenhanced, and, and

3. the 3. the potentialpotential benefits to individual subjects benefits to individual subjects and society should be and society should be proportionateproportionate to to or or outweighoutweigh the risks. the risks.

““Benefits”Benefits”““Benefits”Benefits”

only benefits that accrue toonly benefits that accrue toparticipants from the interventions participants from the interventions

necessarynecessaryto achieve the research objectives to achieve the research objectives

ororthose deriving from the knowledge those deriving from the knowledge

to beto begained by the research should be gained by the research should be

used toused tojustify risks to participantsjustify risks to participants

only benefits that accrue toonly benefits that accrue toparticipants from the interventions participants from the interventions

necessarynecessaryto achieve the research objectives to achieve the research objectives

ororthose deriving from the knowledge those deriving from the knowledge

to beto begained by the research should be gained by the research should be

used toused tojustify risks to participantsjustify risks to participants

Two benchmarks unique to developing Two benchmarks unique to developing countries.countries.

1. 1. the risk-benefit ratio for individuals must the risk-benefit ratio for individuals must be favorable in the context in which they live.be favorable in the context in which they live.

2. the risk-benefit ratio for the community 2. the risk-benefit ratio for the community should be favorable (look at benefits from should be favorable (look at benefits from collaborative partnership, social value, collaborative partnership, social value, respect for study population).respect for study population).

““Minimal Risk Research”Minimal Risk Research”““Minimal Risk Research”Minimal Risk Research”

Minimal risk researchMinimal risk research

Research involving materials (data, documents, Research involving materials (data, documents, records, or specimens) that have been collected, or will records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as be collected solely for nonresearch purposes (such as medical treatment or diagnosis).medical treatment or diagnosis).

Minimal risk researchMinimal risk research

Research on individual or group characteristics or Research on individual or group characteristics or behavior (including, but not limited to, research on behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral behavior) or research employing survey, interview, oral history, focus group, program evaluation, human history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. factors evaluation, or quality assurance methodologies.

Minimal risk researchMinimal risk research

Collection of data from voice, video, digital, or image Collection of data from voice, video, digital, or image recordings made for research purposes.recordings made for research purposes.

Minimal risk researchMinimal risk research

Clinical studies of drugs and medical devices only when Clinical studies of drugs and medical devices only when condition a or b is met:condition a or b is met:a.a.Research on drugs for which an investigational new Research on drugs for which an investigational new drug drug application is not required (exception: application is not required (exception: research on marketed research on marketed drugs that significantly drugs that significantly increases the risks or decreases the increases the risks or decreases the acceptability of the risks associated with the use of the acceptability of the risks associated with the use of the product)product)

b.b.Research on medical devices for which the medical Research on medical devices for which the medical device is cleared/approved for marketing and the device is cleared/approved for marketing and the medical device is being used in accordance with its medical device is being used in accordance with its cleared/approved labeling.cleared/approved labeling.

Minimal risk researchMinimal risk research

Collection of blood samples by finger stick, heel stick, Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:ear stick, or venipuncture as follows:a.a. from healthy, nonpregnant adults who weigh at from healthy, nonpregnant adults who weigh at least 110 least 110 pounds. For these participants, the pounds. For these participants, the amounts drawn may not exceed amounts drawn may not exceed 550 ml in an 8 550 ml in an 8 week period and collection may not occur more week period and collection may not occur more frequently than 2 times per week; orfrequently than 2 times per week; or

b.b. from other adults and children2, considering the from other adults and children2, considering the age, weight, and age, weight, and health of the participants, the health of the participants, the collection procedure, the amount of collection procedure, the amount of blood to be blood to be collected, and the frequency with which it will be collected, and the frequency with which it will be collected. For these participants, the amount drawn collected. For these participants, the amount drawn may not exceed may not exceed the lesser of 50 ml or 3 ml per kg in the lesser of 50 ml or 3 ml per kg in an 8 week period and collection an 8 week period and collection may not occur may not occur more frequently than 2 times per week.more frequently than 2 times per week.

Minimal risk researchMinimal risk research

Prospective collection of biological specimens for research Prospective collection of biological specimens for research purposes by noninvasive means.purposes by noninvasive means.Examples: Examples: a.a. hair and nail clippings in a nondisfiguring manner; hair and nail clippings in a nondisfiguring manner; b.b. deciduous teeth at time of exfoliation or if routine patient deciduous teeth at time of exfoliation or if routine patient

care indicates a need for extraction; care indicates a need for extraction; c.c. permanent teeth if routine patient care indicates a need for permanent teeth if routine patient care indicates a need for

extraction; extraction; d.d. excreta and external secretions (including sweat); excreta and external secretions (including sweat); e.e. uncannulated saliva collected either in an unstimulated uncannulated saliva collected either in an unstimulated

fashion or stimulated by chewing gumbase or wax or by fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; applying a dilute citric solution to the tongue;

f.f. placenta removed at delivery; placenta removed at delivery; g.g. amniotic fluid obtained at the time of rupture of the amniotic fluid obtained at the time of rupture of the

membrane prior to or during labor; membrane prior to or during labor; h.h. supra- and subgingival dental plaque and calculus, provided supra- and subgingival dental plaque and calculus, provided

the collection procedure is not more invasive than routine the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic accomplished in accordance with accepted prophylactic techniques; techniques;

i.i. mucosal and skin cells collected by buccal scraping or swab, mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; skin swab, or mouth washings;

j.j. sputum collected after saline mist nebulization.sputum collected after saline mist nebulization.

Minimal risk researchMinimal risk research

Collection of data through noninvasive procedures (not Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not and effectiveness of the medical device are not generally eligible for expedited review, including generally eligible for expedited review, including studies of cleared medical devices for new indications.)studies of cleared medical devices for new indications.)Examples: Examples: a.a.physical sensors that are applied either to the surface of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of the body or at a distance and do not involve input of significant amounts of energy into the participant or an significant amounts of energy into the participant or an invasion of the participant’s privacy; invasion of the participant’s privacy; b.b.weighing or testing sensory acuity; weighing or testing sensory acuity; c.c.magnetic resonance imaging; magnetic resonance imaging; d.d.electrocardiography, electroencephalography, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; doppler blood flow, and echocardiography; e.e. moderate exercise, muscular strength testing, body moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where composition assessment, and flexibility testing where appropriate given the age, weight, and health of the appropriate given the age, weight, and health of the individual.individual.

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Chairperson’s ReviewChairperson’s ReviewChairperson’s ReviewChairperson’s Review