370. Assessing Reasonableness of Risks in Relation to Benefits

Updated July 1, 2021

A benefit is generally defined as a desired outcome or an advantage. w88 casino benefits include anticipated or expected outcomes resulting from a w88 casino project, or what researchers hope to discover following implementation of the w88 casino plan.

w88 casino benefits fall into two categories:

• benefits to participants and
• benefits to society.

Beneficenceis identified as one of three ethical principles that should underlie the conduct of human w88 casino in theBelmont Report. The principle of beneficence involves doing no harm and maximizing possible benefits and minimizing possible harms. Beneficence requires that w88 casino participants be protected against risk of harm while consideration is given to the loss of possibly substantial benefits that might be gained from human w88 casino. Brutal or inhumane treatment of human participants is never morally justified.

Federal regulations for the protection of human participants at 45CFR46.111 item (2) specify that for the IRB to approve a w88 casino project,risks to participants must be reasonable in relation to anticipated benefit to participants (if any) and the importance of the knowledge that may reasonably be expected to result.

Investigators and the IRB have an obligation to ensure w88 casino is designed to yield useful data. While good w88 casino design may not reduce or eradicate risks to participants, poor or faulty w88 casino design diminishes the likelihood the w88 casino will achieve the desired benefits.

Given these considerations, investigators and the IRB must determine when:

• it is justifiable to seek certain benefits despite the risks involved, and
• the benefits should be foregone because of the risks.

Benefits to Participants Versus Benefits to Society

Participants may benefit when w88 casino involving evaluation of a treatment, diagnosis, or examination for an illness or abnormal condition is designed to ameliorate their conditions. However, even when a direct diagnostic or therapeutic benefit to participants is anticipated, investigators:

• must fully inform participants about both the risks and voluntary nature of participation; and
• must NOT inflate or overly emphasize possible benefits.

Society may benefit from w88 casino that is designed to increase understanding and scientific knowledge about human physiology, cognition, behavior, or educational practices. Such w88 casino may:

• not be related to treatment or diagnosis of illnesses or conditions the participants have; or
• may be related to participants' conditions but does not carry an immediate therapeutic intent.

Benefits to society include increased knowledge; improved safety; technological advances; or enhanced understanding of a behavior, disorder, or condition.

IRBs should not be overprotective of participants or dismissive of the importance of the knowledge that may result from a w88 casino project. Interests other than those of the individual participant may be sufficient to justify the risks involved in a w88 casino projectifeach participant's rights are adequately protected. If only minimal risks are involved, IRBs do not need to protect competent adult participants from participating in w88 casino that may yield concomitantly minor benefits.

Assessment of Risks in Relation to w88 casino Benefits

To determine if risks to participants are reasonable in relation to possible w88 casino benefits, investigators and the IRB must:

• consideronlythose benefits that may result from the w88 casino; and
• NOT consider possible long-range effects of applying the knowledge gained in a single w88 casino study as benefits of that study.

Analysis of risks and benefits should be as methodical and non-arbitrary insofar as possible, requiring:

• thorough accumulation and assessment of information about all aspects of the w88 casino; and
• systematic consideration of alternatives to the proposed procedures (when equally suitable and viable alternatives exist).

The IRB application requires investigators to:

• state the study purpose;
• provide background information in support of the w88 casino;
• describe study procedures (including alternative procedures);
• identify expected risks (if any) including magnitude and probability of the risks;
• explain how risks are minimized; and
• describe expected benefits to participants and to science or society.

The IRB reviews the information provided by the investigator to:

• evaluate the soundness of the w88 casino design with consideration for minimizing risk and limiting unnecessary exposure of participants to risk;
• determine if benefits are appropriately identified and consistent with the study purpose and procedures; and
• assess the reasonableness of risks in relation to the anticipated w88 casino benefits.

The IRB's evaluation of w88 casino risks and benefits requires examination of the validity of assumptions and presumptions about the w88 casino. The review will also analyze the scientific or scholarly validity of the proposed w88 casino. The IRB will carefully consider the study design and overall scientific quality of each study, particularly those studies that are investigator-initiated and/or unfunded. In evaluating the scientific design, the primary reviewer (exempt and expedited studies) or the primary reviewer and convened IRB (full board studies), will consider the following:

• clarity of the w88 casino question
• appropriateness and efficiency of design
• rigor and feasibility of methods
• qualifications and expertise of the w88 casino team
• scholarship and pertinence of background material and rationale
• adequacy of sample size and relevance of controls and
• the validity of the statistical analysis plan.

When necessary, the IRB may ask consultants with additional expertise to review the w88 casino study.

For example, the IRB may use known facts and information from available studies to evaluate the reasonableness of the investigator's:

• identification of expected harms and benefits, and
• assessment of the magnitude and probability of expected harms and benefits.

In assessing existing knowledge about the w88 casino, the IRB must exercise professional judgment in remaining cognizant that:

• information drawn from animal w88 casino may be highly suggestive of the risks and benefits to be expected for humans, but is not conclusive; and
• the absence of data concerning risks does not necessarily mean that no risks exist.

The justifiability of w88 casino should reflect at least the following considerations:

• Is it in fact necessary to use participants to achieve the w88 casino objectives?
• Are risks are reduced to include only those necessary to achieve the w88 casino objective?
• Are lower risk alternative procedures used whenever possible?
• Is the involvement of vulnerable populations appropriate and necessary given the w88 casino objective?
• Are there characteristics of the sample population that might alter perceptions of risks and benefits? (For example, the terminally ill may view risks of physical discomfort differently that would healthy participants.)
• Does the w88 casino involve interventions that have the intent and reasonable probability of providing benefit for the individual participant or is the w88 casino designed primarily to contribute to scientific knowledge?

For greater than minimal risk w88 casino, the IRB must determine the acceptable nature, magnitude, and probability of risk for w88 casino involving an intervention expected to provide direct benefit to the participant. The IRB may determine that for studies designed to evaluate therapies for life-threatening illness, risk of serious adverse effects may be acceptable. Conversely, the IRB may determine that w88 casino involving significant risk of serious impairment must provide some benefit to the individual participant. Such determinations require:

• evaluation of risks and benefits of available alternative therapies (for w88 casino involving experimental treatment/interventions);
• evaluation of the nature and degree of risk, the condition of the population involved, and the nature and level of the anticipated benefits; and
• thorough disclosure and discussion of the salient risks and benefits in the informed consent process.