What is the definition of minimal risk? (2024)

FAQs

What is the definition of minimal risk? ›

Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected.

The federal regulations define “minimal risk” as: “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” This offers some ...

Minimal Risk is defined in TCPS2 as follows: “research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research”.

The Belmont Report has defined minimal risk as “the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical or psychological examination, of healthy children.”

'Minimal' and 'minimum' both mean the same – the smallest or least amount possible. But the word 'minimum' is used both as a noun and an adjective whereas 'minimal' is used only as an adjective.

minimal. / (ˈmɪnɪməl) / adjective. of the least possible; minimum or smallest.

A minimum-risk route is a temporary corridor of defined dimensions recommended for use by high-speed, fixed-wing aircraft that presents the minimum known hazards to low-flying aircraft transiting the combat zone (JP 3-52).

A minimum variance portfolio is an investing method that helps you maximize returns and minimize risk. It involves diversifying your holdings to reduce volatility, or such that investments that may be risky on their own balance each other out when held together.

Types of Risks

Widely, risks can be classified into three types: Business Risk, Non-Business Risk, and Financial Risk.

Definitions of minimal risk

102(i)). Specific to child participants: Minimal risk are those risks encountered during daily life by normal, average, healthy children living in safe environments or during the performance of routine physical or psychological examinations or tests.

What is the purpose of distinguishing between minimal risk research? ›

What is the purpose of distinguishing between minimal risk research and research that is more than minimal risk?  Minimal risk research does not require REB review.  The distinction helps the REB to determine the appropriate level of ethics review.

Minimal risk research exposes participants to risks that are no greater than those encountered by healthy people in daily life or during routine physical or psychological examinations.

Three basic ethical principles are outlined in The Belmont Report to serve as a guide for research involving human subjects. These are respect for persons, beneficence and justice.

Often investigators refer to a clinical study as “minimal risk” while pointing to the side effects as being minor or acceptable for the given condition, and/or that the procedures in the study are common in medicine and rarely have severe complications.

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice. 1.

Less Than Minimal Risk

Consent is not required for most of these studies BUT IRBs must ensure subjects are treated, and data/specimens are used, ethically. Examples include: Education/classroom research. Surveys, interviews, educational tests, public observations (that do not involve children)

Risk level: The risk level can be low, moderate or high. Each enterprise risk has a risk level based on the impact and likelihood ranking of the risk. The risk level provides the basis for prioritization and action.