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Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

Koonrungsesomboon N, Laothavorn J, Karbwang J - Trop Med Health (2015)

Bottom Line: The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF.However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively.Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan ; Graduate School of Biomedical Science, Nagasaki University, Nagasaki, Japan.

ABSTRACT
The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

No MeSH data available.


The frequency of incorrect answers for each question. Of the 139 incorrect answers from 107 participants, the two most common incorrect answers were on the ethical issues of (1) authority of persons who can access the data and (2) the need for prorated payment, which accounted for 35% (49/139) and 28% (38/139) of all the incorrect answers, respectively. The participants made a relatively small number of mistakes on the remaining six ethical issues: compensation in case of any injury during participation (13/139), right of the subjects to withdraw (10/139), confidentiality of the data (10/139), right of the subjects to refuse (8/139), contact person for more information during the study (7/139), and experimental nature of the study (4/139).
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Figure 2: The frequency of incorrect answers for each question. Of the 139 incorrect answers from 107 participants, the two most common incorrect answers were on the ethical issues of (1) authority of persons who can access the data and (2) the need for prorated payment, which accounted for 35% (49/139) and 28% (38/139) of all the incorrect answers, respectively. The participants made a relatively small number of mistakes on the remaining six ethical issues: compensation in case of any injury during participation (13/139), right of the subjects to withdraw (10/139), confidentiality of the data (10/139), right of the subjects to refuse (8/139), contact person for more information during the study (7/139), and experimental nature of the study (4/139).

Mentions: There were a total of 139 incorrect answers from the 107 participants; the frequency of incorrect answers for each question is presented in Figure 2. The most common incorrect answer was in case study 5, which describes the authority of research-related persons to access the data. This question accounted for 35% of all the incorrect answers (49/139). The second most common mistake was in case study 6, describing the need for prorated payment, which accounted for 28% of all the incorrect answers (38/139). Most of the participants who made mistakes on case study 6 chose the answer that suggests that payment should be made at the end of the study.


Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

Koonrungsesomboon N, Laothavorn J, Karbwang J - Trop Med Health (2015)

The frequency of incorrect answers for each question. Of the 139 incorrect answers from 107 participants, the two most common incorrect answers were on the ethical issues of (1) authority of persons who can access the data and (2) the need for prorated payment, which accounted for 35% (49/139) and 28% (38/139) of all the incorrect answers, respectively. The participants made a relatively small number of mistakes on the remaining six ethical issues: compensation in case of any injury during participation (13/139), right of the subjects to withdraw (10/139), confidentiality of the data (10/139), right of the subjects to refuse (8/139), contact person for more information during the study (7/139), and experimental nature of the study (4/139).
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4491494&req=5

Figure 2: The frequency of incorrect answers for each question. Of the 139 incorrect answers from 107 participants, the two most common incorrect answers were on the ethical issues of (1) authority of persons who can access the data and (2) the need for prorated payment, which accounted for 35% (49/139) and 28% (38/139) of all the incorrect answers, respectively. The participants made a relatively small number of mistakes on the remaining six ethical issues: compensation in case of any injury during participation (13/139), right of the subjects to withdraw (10/139), confidentiality of the data (10/139), right of the subjects to refuse (8/139), contact person for more information during the study (7/139), and experimental nature of the study (4/139).
Mentions: There were a total of 139 incorrect answers from the 107 participants; the frequency of incorrect answers for each question is presented in Figure 2. The most common incorrect answer was in case study 5, which describes the authority of research-related persons to access the data. This question accounted for 35% of all the incorrect answers (49/139). The second most common mistake was in case study 6, describing the need for prorated payment, which accounted for 28% of all the incorrect answers (38/139). Most of the participants who made mistakes on case study 6 chose the answer that suggests that payment should be made at the end of the study.

Bottom Line: The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF.However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively.Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan ; Graduate School of Biomedical Science, Nagasaki University, Nagasaki, Japan.

ABSTRACT
The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

No MeSH data available.