Managing and Monitoring Greater than Minimal Risk Link of the Sources:

During a Study Involving Human Participants

 https://www.solutionsirb.com/minimizing-risk/
When conducting research involving human participants,  https://ori.hhs.gov/education/products/
it is important to manage and monitor any risks that may montana_round1/human.html
arise. This is an essential part of the research process as it  https://ncsef.org/index.php/rules/src/human-
helps ensure the safety of the participants and also participants
ensures that the data collected is reliable and valid. To do
this, researchers must have a risk management plan in
place before beginning their study. This plan should
include steps for identifying, assessing, and mitigating any
risks associated with the study. Additionally, researchers
should monitor their study throughout its duration to
ensure that any risks are identified and addressed as they
arise. By taking these measures, researchers can help
ensure a safe and successful research experience for all
involved.
• Adopting methods that follow a sound research design
• Avoid exposing them to needless risk
• Using existing techniques on the participants for
diagnostic or therapeutic goals.
• Prescreening to identify and weed out persons at high
risk,
• Giving participants as much information as feasible
during debriefing and informed consent.

Researchers must ensure that any risks associated with

the study are acceptable given the expected benefits of
the procedure.

“Must use information to determine
the level of risk involved in a study
involving human participants”
Human Subject "means a living individual about whom an
investigator conducting research obtains data through
intervention or interaction with the individual, or identifiable
private information."
Intervention "includes both physical procedures by which data
are gathered (for example, venipuncture) and manipulations of
the subject or the subject's environment that are performed for
research purposes."
Interaction "includes communication or interpersonal contact
between investigator and subject.”
All human participant projects are considered to have some
level of risk.
Project risk levels fall into one of two categories:
 No more than minimal risk occur when the possibility and
degree of any injury or pain anticipated in the research are
not greater than what would typically be experienced in daily
life or when undergoing routine physical and psychological
examinations or testing, and that confidentiality is
sufficiently maintained.
 Greater than minimal risk means that the probability and
magnitude of harm or discomfort anticipated in the research
is greater in and of themselves than those ordinarily
encountered in daily life or during the performance of
routine physical or psychological examinations or tests.
Jhenybee N. Agaloos
10- STE A
Group 5
What are some examples of types of risks?
1. Examples of Greater than Minimal Physical Risk
- Something carries an increased possibility of physical
harm as opposed to what may typically occur in everyday life.
- Examples of greater than minimal physical risk in
research include experiments involving hazardous materials, extreme
temperatures, or dangerous environments.
- involves activities that could cause harm to the
participants such as ingestion, tasting, smelling or application of a
substance. this kind of substances will be evaluated by the Institutional
Review Board (IRB) which determine risk level based upon the nature
of the study and the local norms.
- Example case is the Willowbrook School for Mentally
Retarded Children Staten Island, NY; 1956-1971, whereas the
residents are purposely infected with hepatitis through injection.
Experimental vaccines are administered, and risks are not fully
explained to the parents.
2. Examples of Greater than Minimal Psychological Risk
- Something carries an increased possibility of
psychological harm as opposed to what may typically occur in everyday
life.
- Research activity (e.g. hypnosis, questionnaire, survey).
that can result in emotional stress such as depression, shock, guilt,
etc.).