Abstract
Participants’ understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study’s aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study’s informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans’s informed, voluntary participation in clinical trials.
| Original language | English (US) |
|---|---|
| Journal | Journal of Empirical Research on Human Research Ethics |
| DOIs | |
| State | Accepted/In press - Apr 1 2018 |
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Keywords
- elements of informed consent
- ethics
- informed consent
- Mozambique
- recall
- understanding
ASJC Scopus subject areas
- Social Psychology
- Education
- Communication
Cite this
Assessment of Parents’/Guardians’ Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia. / Ossemane, Ezequiel B.; Moon, Troy D.; Sacarlal, Jahit; Sevene, Esperança; Kenga, Darlene; Gong, Wu; Heitman, Elizabeth.
In: Journal of Empirical Research on Human Research Ethics, 01.04.2018.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Assessment of Parents’/Guardians’ Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia
AU - Ossemane, Ezequiel B.
AU - Moon, Troy D.
AU - Sacarlal, Jahit
AU - Sevene, Esperança
AU - Kenga, Darlene
AU - Gong, Wu
AU - Heitman, Elizabeth
PY - 2018/4/1
Y1 - 2018/4/1
N2 - Participants’ understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study’s aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study’s informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans’s informed, voluntary participation in clinical trials.
AB - Participants’ understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study’s aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study’s informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans’s informed, voluntary participation in clinical trials.
KW - elements of informed consent
KW - ethics
KW - informed consent
KW - Mozambique
KW - recall
KW - understanding
UR - http://www.scopus.com/inward/record.url?scp=85045852106&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85045852106&partnerID=8YFLogxK
U2 - 10.1177/1556264618767780
DO - 10.1177/1556264618767780
M3 - Article
C2 - 29667543
AN - SCOPUS:85045852106
JO - Journal of Empirical Research on Human Research Ethics
JF - Journal of Empirical Research on Human Research Ethics
SN - 1556-2646
ER -