Difference between revisions of "Theme:F72dcd0f-c164-4604-83c1-17cbf52ca717"
From The Embassy of Good Science
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{{Theme | {{Theme | ||
|Theme Type=Good Practices | |Theme Type=Good Practices | ||
| + | |Has Parent Theme=Theme:B14a910a-3bc4-40ff-a0e6-eb7119f51ed9 | ||
|Title=Informed assent | |Title=Informed assent | ||
| − | |Is About=Informed assent is a process through which minors agree to participate in clinical trials. This is different from informed consent, because minors cannot provide consent in the full meaning of the word, as they don’t meet the legal age requirements. For minors, consent is provided by parents or legal guardians, and this process of acquiring both consent and assent is called a dual consent procedure (1). | + | |Is About=Informed assent is a process through which minors agree to participate in clinical trials. This is different from informed consent, because minors cannot provide consent in the full meaning of the word, as they don’t meet the legal age requirements and are considered to be a vulnerable population. For minors, consent is provided by parents or legal guardians, and this process of acquiring both consent and assent is called a dual consent procedure.<ref>Hein IM, De Vries MC, Troost PW, Meynen G, Van Goudoever JB, Lindauer RJ. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research. BMC Med Ethics. 2015;16(1):015-0067.</ref> |
| − | |Important Because=In order to conduct clinical research in an ethical manner, informed assent from children and informed consent from their legal guardians must be sought. Respecting both children’s wishes and asking parents’ permission is necessary in order to respect laws and rules of good clinical practice, and to respect patients’ autonomy, despite the fact that the patient is a minor ( | + | <references /> |
| − | |Important For= | + | |Important Because=In order to conduct clinical research in an ethical manner, informed assent from children and informed consent from their legal guardians must be sought. Respecting both children’s wishes and asking parents’ permission is necessary in order to respect laws and rules of good clinical practice, and to respect patients’ autonomy, despite the fact that the patient is a minor. <ref>Poston RD. Assent Described: Exploring Perspectives From the Inside. J Pediatr Nurs. 2016;31(6):e353-e65.</ref> |
| + | <references /> | ||
| + | |Important For=Junior researchers; Senior researchers; Supervisors; PhD students; Graduate students; Early career researchers | ||
| + | |Has Best Practice=Throughout the world, different practices have been developed to protect the interest of children participating in clinical trials. In the United States, researchers have to ask permission from both minors and their parents or legal guardians. Permission from minors has to be definitive and the lack of objections cannot be defined as assent. When asking for assent, researchers should present all relevant information in a simple and understandable language, according to the child’s level of understanding (1). In the European Union, different practices exist, and some countries provide different legal and mandatory or recommended ages for assent (review of practices provided in tools section). In some situations, giving informed consent is not necessary. For example, when the only treatment for a disease is only available through clinical trials.<ref>American Academy of Pediatrics Committee on Bioethics: Guidelines on foregoing life-sustaining medical treatment. Pediatrics. 1994;93(3):532-6.</ref> | ||
|Has Reference=a | |Has Reference=a | ||
}} | }} | ||
| − | {{Related To}} | + | {{Related To |
| − | {{Tags}} | + | |Related To Resource=Resource:F7ed25ad-cfab-4040-b52f-596accc3c317;Resource:E9cd7ee1-bd54-4d5c-bdd9-786ef1c9f603 |
| + | |Related To Theme=Theme:0d054575-ca21-4209-b7c5-6120fc0ed647;Theme:E5629f68-81f6-490d-84d6-fd1e63b8dbc7;Theme:D0ad4326-4faa-47bf-85ab-a3eb78cb6540 | ||
| + | }} | ||
| + | {{Tags | ||
| + | |Has Virtue And Value=Honesty; Autonomy; Respect | ||
| + | |Has Good Practice And Misconduct=Informed consent; Vulnerable and non-competent subjects | ||
| + | }} | ||
Latest revision as of 17:50, 20 October 2020
ThemesInformed assent
What is this about?
Informed assent is a process through which minors agree to participate in clinical trials. This is different from informed consent, because minors cannot provide consent in the full meaning of the word, as they don’t meet the legal age requirements and are considered to be a vulnerable population. For minors, consent is provided by parents or legal guardians, and this process of acquiring both consent and assent is called a dual consent procedure.[1]
- ↑ Hein IM, De Vries MC, Troost PW, Meynen G, Van Goudoever JB, Lindauer RJ. Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research. BMC Med Ethics. 2015;16(1):015-0067.
Why is this important?
In order to conduct clinical research in an ethical manner, informed assent from children and informed consent from their legal guardians must be sought. Respecting both children’s wishes and asking parents’ permission is necessary in order to respect laws and rules of good clinical practice, and to respect patients’ autonomy, despite the fact that the patient is a minor. [1]
- ↑ Poston RD. Assent Described: Exploring Perspectives From the Inside. J Pediatr Nurs. 2016;31(6):e353-e65.
For whom is this important?
Junior researchersSenior researchersSupervisorsPhD studentsGraduate studentsEarly career researchers
What are the best practices?
Throughout the world, different practices have been developed to protect the interest of children participating in clinical trials. In the United States, researchers have to ask permission from both minors and their parents or legal guardians. Permission from minors has to be definitive and the lack of objections cannot be defined as assent. When asking for assent, researchers should present all relevant information in a simple and understandable language, according to the child’s level of understanding (1). In the European Union, different practices exist, and some countries provide different legal and mandatory or recommended ages for assent (review of practices provided in tools section). In some situations, giving informed consent is not necessary. For example, when the only treatment for a disease is only available through clinical trials.[1]
The Embassy Editorial team, Iris Lechner, Rosie Hastings contributed to this theme. Latest contribution was Oct 20, 2020
Other information
Good Practices & Misconduct
- ↑ American Academy of Pediatrics Committee on Bioethics: Guidelines on foregoing life-sustaining medical treatment. Pediatrics. 1994;93(3):532-6.
