The procedures in many studies will involve only minimal risks such as drawing blood. Taking large volumes of blood or blood sampling in children will need justification in the protocol and mention of why this is acceptable in the ethics section. Other procedures may be more invasive such as tissue biopsies, lumbar punctures, or excessive exposure to multiple x-rays or CAT scans. These should be appropriate and acceptable. Element 5: ←Essential → Non-physical harm: Risks can also involve non-physical harm, such as breach of confidentiality and privacy, damage to reputation, monetary harm, legal risk, loss of insurance coverage, emotional stress, genetics issues such as paternity, and discrimination. Information might be published that could stigmatize a group or expose its members to discrimination. For example, the information gained from a study could indicate, rightly or wrongly, that the group has a higher than average prevalence of alcoholism, mental illness or sexually transmitted disease, or is particularly susceptible to certain genetic disorders. There may be risks to family members from knowledge gained in genetics studies. Benefits Potential benefits to the individual subject: Ethically, considerations for the well-being of the subject should take precedence over the interests of science and society (CIOMS 2002, Declaration of Helsinki 2000, para 5). If there is lack of potential benefit, this should be stated. Benefits to subjects might include positive response to the study intervention (both products and procedures), additional medical care and oversight, possibility of life-style modifications (e.g., programs for diabetes or obesity), coverage of costs of additional medical care, payment for participation, or post-study continued access to study interventions. Potential benefits to others including the community and society: Knowledge: The knowledge that results from a study and the application of that knowledge may benefit society. The kinds of knowledge may be the resolution of a safety issue or the proof that a new mechanism of action is relevant in a hard-to-treat disease. In spite of societal benefit, there may be some risks to the individual that are too great to support conducting the study, so how the balance is achieved is properly discussed in the ethical section.
The procedures in many studies will involve only minimal risks such as drawing blood. Taking large volumes of blood or blood sampling in children will need justification in the protocol and mention of why this is acceptable in the ethics section. Other procedures may be more invasive such as tissue biopsies, lumbar punctures, or excessive exposure to multiple x-rays or CAT scans. These should be appropriate and acceptable. ←Essential Element 5: → Non-physical harm: Risks can also involve non-physical harm, such as breach of confidentiality and privacy, damage to reputation, monetary harm, legal risk, loss of insurance coverage, emotional stress, genetics issues such as paternity, and discrimination. Information might be published that could stigmatize a group or expose its members to discrimination. For example, the information gained from a study could indicate, rightly or wrongly, that the group has a higher than average prevalence of alcoholism, mental illness or sexually transmitted disease, or is particularly susceptible to certain genetic disorders. There may be risks to family members from knowledge gained in genetics studies. Benefits Potential benefits to the individual subject: Ethically, considerations for the well-being of the subject should take precedence over the interests of science and society (CIOMS 2002, Declaration of Helsinki 2000, para 5). If there is lack of potential benefit, this should be stated. Benefits to subjects might include positive response to the study intervention (both products and procedures), additional medical care and oversight, possibility of life-style modifications (e.g., programs for diabetes or obesity), coverage of costs of additional medical care, payment for participation, or post-study continued access to study interventions. Potential benefits to others including the community and society: Knowledge: The knowledge that results from a study and the application of that knowledge may benefit society. The kinds of knowledge may be the resolution of a safety issue or the proof that a new mechanism of action is relevant in a hard-to-treat disease. In spite of societal benefit, there may be some risks to the individual that are too great to support conducting the study, so how the balance is achieved is properly discussed in the ethical section.
toolkit_essentialelementsofethics_108_pg_11-24-14_revised_clean1.docx