Factors influencing parental consent for participation in clinical research involving their children in Egypt

Nasef, Nehad; Shabaan, AbdElaziz; Mohammed, Sawsan F.; S, Kandel; Settin, Ahmad; Zedan, Mohamed M; Fouda, Ashraf

doi:10.26719/2014.20.3.162

Cited by 6 publications

(16 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In our survey, vaccine trials appeared more appealing for participant enrollment than treatment-related trials (17.5% vs. 15%). The mentioned percentage is lower than the percentage reported from previous surveys conducted to assess people's agreement to participate in any clinical trial in the MENA region ( Al-Rawashdeh et al, 2019 , Altaf et al, 2019 , Gharaibeh et al, 2020 ; Lawati et al.,2018; Nasef et al.,2014 ). A public survey conducted in Saudi Arabia demonstrated that 26.9% of the participants were willing to participate in clinical trials ( Al-Rawashdeh et al,2019 ).…”

Section: Discussioncontrasting

confidence: 54%

“…To our knowledge, there is a scarcity of data pertaining to knowledge, attitude, and perception towards participation in clinical trials among the public from this region. A lot of published literature report data from the healthcare settings in the region ( Al-Dakhil et al, 2016 , Altaf et al, 2019 , Gharaibeh et al, 2020 ; Lawati et al,2018; Nasef et al.,2014 ). This study highlighted that only 15 to 17.5% of the surveyed people were willing to participate in COVID-19 clinical trials.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Knowledge, attitude, and perception of public about participation in COVID-19 clinical trials: A study from Egypt and Saudi Arabia

Elshammaa

Hamza²,

Elkholy

et al. 2022

Saudi Pharmaceutical Journal

View full text Add to dashboard Cite

Background Pharmaceutical firms are striving to find potential treatments to prevent and treat COVID-19. One of the gold standards to evaluate treatment is a clinical trial; however, the difficulty in patient recruitment could act as a determinant. It is evident from the registry data that very few studies have been conducted involving the population of the Middle East and North Africa (MENA) region. Aim To document knowledge, perception, and attitude of the public from Two large countries in the MENA region (Egypt and Saudi Arabia) towards participation in clinical trials focused on evaluating potential COVID-19 treatments. Method A cross-sectional study was conducted that used a snowball sampling strategy for recruitment. General population 18 years old or older, who lived in Saudi Arabia or Egypt were invited. The survey was adopted from literature and was approved by an ethics committee. Results Out of 800 participants in the survey, 407 participants were from Egypt, and 393 were from Saudi Arabia. Most participants (48%) had moderate knowledge, i.e., > 60% < 80%. The results revealed poor attitude (88.5%) and poor perceptions (45.8%) regarding participation in COVID-19 clinical trials. Education and residence were identified as determinants of participants’ knowledge, attitude, and perceptions. Participants' knowledge and understanding of COVID-19 trials did not impact their willingness to participate. This coupled with a poor attitude and perception among the masses drastically affects any potential for participation in future clinical trials. Conclusion: A relatively small proportion of participants were interested in enrolling in COVID-19 studies. Increased collective engagement through social media and healthcare professionals can help improve attitudes and perceptions toward trial participation.

show abstract

Section: Discussioncontrasting

confidence: 54%

Section: Discussionmentioning

confidence: 99%

Knowledge, attitude, and perception of public about participation in COVID-19 clinical trials: A study from Egypt and Saudi Arabia

Elshammaa

Hamza²,

Elkholy

et al. 2022

Saudi Pharmaceutical Journal

View full text Add to dashboard Cite

show abstract

“…However, only 48% of the participants indicated that it is acceptable to test new drugs on paediatric participants. Objection to the use of new drugs or vaccines was one of the factors underlying the opposition to paediatric CTs 26. Although the study did not explore the reasons underpinning the objections to participating in CTs, we believe that the fear of adverse events, as well as safety concerns, may have been responsible 25 27…”

Section: Discussionmentioning

confidence: 97%

Knowledge of and attitudes toward clinical trials in Saudi Arabia: a cross-sectional study

et al. 2019

View full text Add to dashboard Cite

ObjectivesClinical trials (CTs) are considered an important method for developing new treatments and providing access to potentially effective drugs that are still under investigation. Measuring the public’s knowledge of and attitudes toward CTs is important for assessing their readiness for and acceptance of human drug testing, which has previously not been assessed in the Kingdom of Saudi Arabia (KSA). The objective of this study is to explore the Saudi public’s knowledge of and attitudes toward CTs as well as participation in trials to test new or approved drugs.DesignCross-sectional.SettingThe 2016 Al Jenadriyah cultural/heritage festival in Riyadh, KSA.ParticipantsParticipating booths and exhibition halls, as well as festival visitors, were approached to participate in the study.Primary and secondary outcome measuresKnowledge of and attitudes toward CTs.ResultsThe final number of participants was 938. The responses were converted to a percentage mean score (out of 100) for each knowledge-related response and attitude. The total mean knowledge score was 56.8±24.8 and the attitude-related score was 61.5±28.0. Although most of the participants supported testing approved or off-label and new drugs on adult and paediatric patients, only a third (30.5%) agreed that new drugs could be tested on healthy volunteers. The results indicated that gender, educational level, income, medical background, age and health insurance were independently associated with the level of knowledge of CTs. In terms of attitudes toward CTs, the factors that were independently associated were gender, educational level and medical background.ConclusionsThe Saudi public has a low level of knowledge and a moderately positive attitude toward CTs. There is a moderate positive correlation between the two factors such that as knowledge of CTs increases, the Saudi public will hold more positive attitudes toward CTs.

show abstract

“…Nevertheless, they stated that a complex informed consent form and misunderstanding of the term 'randomization' hindered parental approval of participation. In a study that was conducted in Egypt [11], found several factors that influence parental consent for participation in clinical research involving children in Egypt. The study found that factors favoring consent were: research of benefit to child, and enough explanation about the benefits that can be gained from the research.…”

Section: Discussionmentioning

confidence: 99%

Perceptions of Saudi parents on the participation of their infants in clinical research

Al‐Alaiyan¹,

AlSanad²,

Al-Ali³

et al. 2016

Clin Obstet Gynecol Reprod Med

View full text Add to dashboard Cite

Objectives: To examine attitudes of Saudi parents about doing research on their infants.Subjects and methods: Fifty eight parents of newborn infants in the neonatal intensive care unit (NICU), and 42 parents of the normal newborn nursery (NNN) returned completed questionnaires. The survey included questions with graded responses and five research scenarios with different levels of risks and benefits. Statistical analysis included Chi square analysis and Fisher's exact test were used to determine a difference between the two groups in responses to scale items. Results:We found that parents showed generally favorable attitudes toward research with infants. Comparisons between the two parent groups revealed a significant difference (p<0.05) on just one item which showed that the NNN group had a good understanding of the way research was conducted. There were no statistical differences in the five scenarios except in scenario that parents in NICU were significantly more likely to enroll their infants in research. There was an agreement; with few exceptions, parents wanted to be asked for consent and would like to make decisions by themselves. Conclusion:Parents included in this study understand the importance of doing research even they are in agreement in enrolling their own infants in studies that are risky but they want to be consented before commencing any research.

show abstract

Factors influencing parental consent for participation in clinical research involving their children in Egypt

Cited by 6 publications

References 23 publications

Knowledge, attitude, and perception of public about participation in COVID-19 clinical trials: A study from Egypt and Saudi Arabia

Knowledge, attitude, and perception of public about participation in COVID-19 clinical trials: A study from Egypt and Saudi Arabia

Knowledge of and attitudes toward clinical trials in Saudi Arabia: a cross-sectional study

Perceptions of Saudi parents on the participation of their infants in clinical research

Contact Info

Product

Resources

About