370. Assessing Reasonableness of w88 slot online in Relation to Benefits

Updated July 1, 2021

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

Research w88 slot online fall into two categories:

• w88 slot online to participants and
• w88 slot online to society.

w88 slot online is identified as one of three ethical principles that should underlie the conduct of human w88 slot online in the Belmont Report. The principle of beneficence involves doing no harm and maximizing possible w88 slot online and minimizing possible harms. Beneficence requires that research participants be protected against risk of harm while consideration is given to the loss of possibly substantial w88 slot online that might be gained from human research. 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 slot online project, w88 slot online 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 research is designed to yield useful data. While good research design may not reduce or eradicate w88 slot online to participants, poor or faulty research design diminishes the likelihood the research will achieve the desired benefits.

Given these considerations, investigators and the w88 slot online when:

• it is justifiable to seek certain benefits despite the w88 slot online involved, and
• the benefits should be foregone because of the w88 slot online.

w88 slot online to Participants Versus w88 slot online to Society

Participants may benefit when w88 slot online 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 w88 slot online and voluntary nature of participation; and
• must NOT inflate or overly emphasize possible w88 slot online.

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

• not be related to treatment or diagnosis of illnesses or conditions the w88 slot online have; or
• may be related to w88 slot online' conditions but does not carry an immediate therapeutic intent.

w88 slot online 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 research project. Interests other than those of the individual participant may be sufficient to justify the w88 slot online involved in a research project if each participant's rights are adequately protected. If only minimal w88 slot online are involved, IRBs do not need to protect competent adult participants from participating in research that may yield concomitantly minor benefits.

Assessment of w88 slot online in Relation to Research Benefits

To determine if w88 slot online to participants are reasonable in relation to possible research benefits, investigators and the IRB must:

• w88 slot online w88 slot online those w88 slot online that may result from the research; and
• NOT consider possible long-range effects of applying the knowledge gained in a single research study as w88 slot online of that study.

Analysis of w88 slot online 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 slot online; and
• systematic consideration of alternatives to the proposed procedures (w88 slot online equally suitable and viable alternatives exist).

The w88 slot online application requires investigators to:

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

The w88 slot online reviews the information provided by the investigator to:

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

The IRB's evaluation of research w88 slot online and benefits requires examination of the validity of assumptions and presumptions about the research. The review will also analyze the scientific or scholarly validity of the proposed research. 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 slot online question
• appropriateness and efficiency of w88 slot online
• rigor and feasibility of methods
• qualifications and expertise of the w88 slot online team
• scholarship and pertinence of background material and rationale
• adequacy of w88 slot online size and relevance of controls and
• the validity w88 slot online statistical analysis plan.

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

For example, the IRB may use known facts and information from available studies to evaluate the reasonableness w88 slot online investigator's:

• identification of expected harms and w88 slot online, and
• assessment of the magnitude and probability of expected harms and w88 slot online.

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

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

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

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

For greater than minimal risk w88 slot online, the IRB must determine the acceptable nature, magnitude, and probability of risk for w88 slot online 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 slot online involving significant risk of serious impairment must provide some benefit to the individual participant. Such determinations require:

• evaluation of w88 slot online and benefits of available alternative therapies (for research 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 w88 slot online; and
• thorough disclosure and discussion of the salient w88 slot online and benefits in the informed consent process.