Pub Date : 2022-07-01Epub Date: 2022-02-28DOI: 10.1177/15562646221081267
Erika Blacksher, Susan Brown Trinidad, R Brian Woodbury, Scarlett E Hopkins, Erica L Woodahl, Bert B Boyer, Wylie Burke, Vanessa Hiratsuka
Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alaska Native (AIAN) leaders about the potential value and ethical conduct of precision medicine research (PMR), an emerging approach to research that investigates the health effects of individual genetic variation in tandem with variation in health-relevant practices, social determinants, and environmental exposures. The event met key goals, such as relationship and rapport formation, cross-site learning, equality of opportunity to participate, and respect among participants in the context of disagreement.
{"title":"Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.","authors":"Erika Blacksher, Susan Brown Trinidad, R Brian Woodbury, Scarlett E Hopkins, Erica L Woodahl, Bert B Boyer, Wylie Burke, Vanessa Hiratsuka","doi":"10.1177/15562646221081267","DOIUrl":"10.1177/15562646221081267","url":null,"abstract":"<p><p>Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alaska Native (AIAN) leaders about the potential value and ethical conduct of precision medicine research (PMR), an emerging approach to research that investigates the health effects of individual genetic variation in tandem with variation in health-relevant practices, social determinants, and environmental exposures. The event met key goals, such as relationship and rapport formation, cross-site learning, equality of opportunity to participate, and respect among participants in the context of disagreement.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 3","pages":"304-316"},"PeriodicalIF":1.3,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9173705/pdf/nihms-1777095.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9463888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-01Epub Date: 2022-02-10DOI: 10.1177/15562646221076764
Astrid Berner-Rodoreda, Shannon McMahon, Nir Eyal, Puspita Hossain, Atonu Rabbani, Mrittika Barua, Malabika Sarker, Emmy Metta, Elia Mmbaga, Melkizedeck Leshabari, Daniel Wikler, Till Bärnighausen
Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for 'risky' HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field - particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally.
{"title":"Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions.","authors":"Astrid Berner-Rodoreda, Shannon McMahon, Nir Eyal, Puspita Hossain, Atonu Rabbani, Mrittika Barua, Malabika Sarker, Emmy Metta, Elia Mmbaga, Melkizedeck Leshabari, Daniel Wikler, Till Bärnighausen","doi":"10.1177/15562646221076764","DOIUrl":"10.1177/15562646221076764","url":null,"abstract":"<p><p>Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for 'risky' HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field - particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"346-361"},"PeriodicalIF":1.7,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9136368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47576527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-05-16DOI: 10.1177/15562646221096188
A. Matar, H. Silverman
Lately, there has been increased research performed in Egypt. In response, the Egyptian Parliament published its first clinical research law in December 2020. The official version of the law was translated to English from Arabic and back by an accredited translation service. We performed an ethical analysis of the law based on the seven ethical requirements for clinical research proposed by Emanuel et al. and compared it with other regulations in the Arab region. The law contains provisions that fulfill all requirements for ethical research to varying degree. Provisions necessitating the sharing of participants’ data and biospecimens by the Central Intelligence Agency requires further specifications to ensure privacy protection. Also, the law poses problematic liabilities that could hamper medical research. Egypt's law compares favorably with other laws in the region. Potential items that require further specification can be addressed in the executive regulations currently being drafted for the law.
{"title":"Ethical Analysis of Egypt's Law Regulating Clinical Research","authors":"A. Matar, H. Silverman","doi":"10.1177/15562646221096188","DOIUrl":"https://doi.org/10.1177/15562646221096188","url":null,"abstract":"Lately, there has been increased research performed in Egypt. In response, the Egyptian Parliament published its first clinical research law in December 2020. The official version of the law was translated to English from Arabic and back by an accredited translation service. We performed an ethical analysis of the law based on the seven ethical requirements for clinical research proposed by Emanuel et al. and compared it with other regulations in the Arab region. The law contains provisions that fulfill all requirements for ethical research to varying degree. Provisions necessitating the sharing of participants’ data and biospecimens by the Central Intelligence Agency requires further specifications to ensure privacy protection. Also, the law poses problematic liabilities that could hamper medical research. Egypt's law compares favorably with other laws in the region. Potential items that require further specification can be addressed in the executive regulations currently being drafted for the law.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"494 - 503"},"PeriodicalIF":1.3,"publicationDate":"2022-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43848660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-26DOI: 10.1177/15562646221094407
M. Tsan, Hannah Van Hook
The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance.
{"title":"Assessing the Quality and Performance of Institutional Review Boards: Impact of the Revised Common Rule","authors":"M. Tsan, Hannah Van Hook","doi":"10.1177/15562646221094407","DOIUrl":"https://doi.org/10.1177/15562646221094407","url":null,"abstract":"The Common Rule, revised extensively to enhance human subjects protections and to reduce burdens to investigators and institutional review boards (IRBs), was implemented on January 19, 2019. We analyzed IRB performance metric data from 2016 through 2021 to evaluate the potential impact of the revised Common Rule on the quality and performance of IRBs. From 2016 to 2021, exempt protocols increased by 159% and protocols requiring IRB continuing reviews decreased by 28%. As only 48% of all protocols in 2021 were subjected to the revised Common Rule requirements, numbers of exempt protocols and protocols requiring IRB continuing reviews will continue to increase and decrease, respectively, in the next few years. Among a total of 16 IRB performance metrics studied, 4 improved, 4 deteriorated, and 8 remained unchanged from 2016 through 2021. This study represents the first effort to evaluate the impact of revised Common rule on IRB quality and performance.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"525 - 532"},"PeriodicalIF":1.3,"publicationDate":"2022-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43044067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-19DOI: 10.1177/15562646221092663
Roma Dhamanaskar, W. Feldman, J. Merz
Impracticability is an ethical standard for waiver of informed consent in research. We examine how well the criterion of impracticability appears to have been fulfilled in a set of 36 completed randomized controlled trials (RCTs) that secured consent from some subjects or LARs and employed waivers to enroll others. These trials were identified among 155 RCTs using waivers of consent in a convenience sample drawn from 7 systematic reviews. Recruitment data were available for 19 of the 36 trials, revealing an average of 41.6% of subjects (range 0.2–98.7%, 95% CI: 24.8–58.4%) were enrolled without consent. Six trials enrolled less than 10% of subjects without consent and an overlapping set of 9 trials sought consent from all subjects or LARs at some sites while waiving consent at other sites. We question whether these trials were practicable without waivers and identify issues for consideration by investigators and ethics review boards.
{"title":"Practicalities of Impracticability: An Interim Review of Randomized Controlled Trials","authors":"Roma Dhamanaskar, W. Feldman, J. Merz","doi":"10.1177/15562646221092663","DOIUrl":"https://doi.org/10.1177/15562646221092663","url":null,"abstract":"Impracticability is an ethical standard for waiver of informed consent in research. We examine how well the criterion of impracticability appears to have been fulfilled in a set of 36 completed randomized controlled trials (RCTs) that secured consent from some subjects or LARs and employed waivers to enroll others. These trials were identified among 155 RCTs using waivers of consent in a convenience sample drawn from 7 systematic reviews. Recruitment data were available for 19 of the 36 trials, revealing an average of 41.6% of subjects (range 0.2–98.7%, 95% CI: 24.8–58.4%) were enrolled without consent. Six trials enrolled less than 10% of subjects without consent and an overlapping set of 9 trials sought consent from all subjects or LARs at some sites while waiving consent at other sites. We question whether these trials were practicable without waivers and identify issues for consideration by investigators and ethics review boards.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"329 - 345"},"PeriodicalIF":1.3,"publicationDate":"2022-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43775206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-14DOI: 10.1177/15562646221094922
I. Stevens, F. Gilbert
Deep brain stimulation (DBS) has progressed to become a promising treatment modality for neurologic and psychiatric disorders like epilepsy and major depressive disorder due to its growing personalization. Despite evidence pointing to the benefits of DBS if tested on these personalized qualitative metrics, rather than randomized-control trial quantitative standards, the evaluation of these novel devices appears to be based on the latter. This study surveyed the presence of this trend in the national regulatory guidelines of the prominent DBS researching countries. It was found that two governing bodies, in the European Union and Australia, acknowledged the option for qualitative measures. These findings support further development of national regulatory guidelines, so the neuroscientific community developing these neurotechnologies can better understand the impact their treatments have on patients.
{"title":"International Regulatory Standards for the Qualitative Measurement of Deep Brain Stimulation in Clinical Research","authors":"I. Stevens, F. Gilbert","doi":"10.1177/15562646221094922","DOIUrl":"https://doi.org/10.1177/15562646221094922","url":null,"abstract":"Deep brain stimulation (DBS) has progressed to become a promising treatment modality for neurologic and psychiatric disorders like epilepsy and major depressive disorder due to its growing personalization. Despite evidence pointing to the benefits of DBS if tested on these personalized qualitative metrics, rather than randomized-control trial quantitative standards, the evaluation of these novel devices appears to be based on the latter. This study surveyed the presence of this trend in the national regulatory guidelines of the prominent DBS researching countries. It was found that two governing bodies, in the European Union and Australia, acknowledged the option for qualitative measures. These findings support further development of national regulatory guidelines, so the neuroscientific community developing these neurotechnologies can better understand the impact their treatments have on patients.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"228 - 241"},"PeriodicalIF":1.3,"publicationDate":"2022-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49379549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-13DOI: 10.1177/15562646221093218
T. Haaser, V. Bouteloup, D. Berdaï, M. Saux
Debate is ongoing concerning the activities and functioning of Research Ethics Committees (REC), especially a possible science-or-ethics dichotomy in research ethics review. We retrospectively analyzed 145 letters issued by a French REC over 18 months. All queries were classified in three levels: qualification (definition of the problem), category (aggregation of broader topics) and finally fields (ethical, scientific, or administrative). Overall, 971 queries were identified, of which 407 (42%), 379 (39%), and 135 (14%) were deemed ethical, scientific, and administrative queries, respectively. The most frequent concern was about participants’ information. The main influencing factor was the profession of the reporting readers—scientific queries were more frequently raised by a methodologist, whereas ethical queries were more frequently raised by an ethicist. These results indicate that research ethics review is a multidimensional task that should be considered a collaborative effort.
{"title":"The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries","authors":"T. Haaser, V. Bouteloup, D. Berdaï, M. Saux","doi":"10.1177/15562646221093218","DOIUrl":"https://doi.org/10.1177/15562646221093218","url":null,"abstract":"Debate is ongoing concerning the activities and functioning of Research Ethics Committees (REC), especially a possible science-or-ethics dichotomy in research ethics review. We retrospectively analyzed 145 letters issued by a French REC over 18 months. All queries were classified in three levels: qualification (definition of the problem), category (aggregation of broader topics) and finally fields (ethical, scientific, or administrative). Overall, 971 queries were identified, of which 407 (42%), 379 (39%), and 135 (14%) were deemed ethical, scientific, and administrative queries, respectively. The most frequent concern was about participants’ information. The main influencing factor was the profession of the reporting readers—scientific queries were more frequently raised by a methodologist, whereas ethical queries were more frequently raised by an ethicist. These results indicate that research ethics review is a multidimensional task that should be considered a collaborative effort.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"242 - 253"},"PeriodicalIF":1.3,"publicationDate":"2022-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46155911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-18DOI: 10.1177/15562646221087530
S. Taplin, J. Chalmers, Judith Brown, Tim Moore, Anne Graham, M. McArthur
Hypothetical scenarios were used to assess the influence of the sensitivity of the study topic, payments, and study methods on research ethics committee (HREC) members’ approval of social research studies involving children. A total of 183 Australian HREC members completed an online survey. The higher the perceived sensitivity of the study topic, the less likely the study would be approved by an HREC member. HREC members were most likely to approve each of the hypothetical studies if no payment was offered. Payment was the most common reason for not approving the low risk studies, while risks were the most common reasons for not approving the more sensitive studies. Face-to-face interviews conducted at home with children elicited substantially higher rates of approval from HREC members with more sensitive study topics. Both HRECs and researchers may benefit from additional guidance on managing risks and payments for children and young people in research.
{"title":"How do Research Ethics Committee Members Respond to Hypothetical Studies with Children? Results from the MESSI Study","authors":"S. Taplin, J. Chalmers, Judith Brown, Tim Moore, Anne Graham, M. McArthur","doi":"10.1177/15562646221087530","DOIUrl":"https://doi.org/10.1177/15562646221087530","url":null,"abstract":"Hypothetical scenarios were used to assess the influence of the sensitivity of the study topic, payments, and study methods on research ethics committee (HREC) members’ approval of social research studies involving children. A total of 183 Australian HREC members completed an online survey. The higher the perceived sensitivity of the study topic, the less likely the study would be approved by an HREC member. HREC members were most likely to approve each of the hypothetical studies if no payment was offered. Payment was the most common reason for not approving the low risk studies, while risks were the most common reasons for not approving the more sensitive studies. Face-to-face interviews conducted at home with children elicited substantially higher rates of approval from HREC members with more sensitive study topics. Both HRECs and researchers may benefit from additional guidance on managing risks and payments for children and young people in research.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"254 - 266"},"PeriodicalIF":1.3,"publicationDate":"2022-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49643363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-28DOI: 10.1177/15562646221083384
Mitch Brown, R. McGrath, D. Sacco
Systemic efforts have been employed to improve the reproducibility of published findings in psychology. To date, little research has been conducted evaluating how well these efforts work. In an effort to bridge this gap, the current study looked at journal submission requirements intended to encourage authors to engage in best practices for facilitating reproducible science and offers preliminary evidence for their potential efficacy. We calculated reproducibility indices (p-curves) for three randomly selected empirical studies published in each of 23 psychology journals in 2019 and correlated quantitative results from those analyzes with the number of submission requirements for each journal that intended to ensure compliance with best reporting practices. Results indicated a greater number of submission requirements at a given outlet was associated with indices indicating greater likelihood of reproducibility of findings. We frame findings as impetus for future, more extensive, research to identify causal links between submission requirements and reproducibility.
{"title":"Preliminary Evidence for an Association between Journal Submission Requirements and Reproducibility of Published Findings: A Pilot Study","authors":"Mitch Brown, R. McGrath, D. Sacco","doi":"10.1177/15562646221083384","DOIUrl":"https://doi.org/10.1177/15562646221083384","url":null,"abstract":"Systemic efforts have been employed to improve the reproducibility of published findings in psychology. To date, little research has been conducted evaluating how well these efforts work. In an effort to bridge this gap, the current study looked at journal submission requirements intended to encourage authors to engage in best practices for facilitating reproducible science and offers preliminary evidence for their potential efficacy. We calculated reproducibility indices (p-curves) for three randomly selected empirical studies published in each of 23 psychology journals in 2019 and correlated quantitative results from those analyzes with the number of submission requirements for each journal that intended to ensure compliance with best reporting practices. Results indicated a greater number of submission requirements at a given outlet was associated with indices indicating greater likelihood of reproducibility of findings. We frame findings as impetus for future, more extensive, research to identify causal links between submission requirements and reproducibility.","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1","pages":"267 - 274"},"PeriodicalIF":1.3,"publicationDate":"2022-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47877317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Despite the importance and acceptance of research ethics consultation as an entity in many medical research areas, little is known about its status in nursing research. Focusing on inquiries from nurse researchers, we retrospectively analyzed records of integrated clinical research consultation, provided by members of the Clinical Research Center independently of the research ethics committee, at a Japanese university hospital during 2018-2019. Among various consultations in nursing studies (n = 101), 43 were related to research ethics. The main issues in research ethics consultation were compatibility with guidelines (n = 28; 65%) and application of ethics review (n = 12; 28%). Future studies should investigate international settings and address the relevance of research ethics consultation to promote proper nursing studies.
{"title":"Research Ethics Consultation in Nursing Studies.","authors":"Chikako Kane, Satoshi Sakaguchi, Masayuki Chuma, Kenta Yagi, Kenshi Takechi, Yuki Aoe, Tomoko Takagai, Hiroaki Yanagawa","doi":"10.1177/15562646211036577","DOIUrl":"https://doi.org/10.1177/15562646211036577","url":null,"abstract":"<p><p>Despite the importance and acceptance of research ethics consultation as an entity in many medical research areas, little is known about its status in nursing research. Focusing on inquiries from nurse researchers, we retrospectively analyzed records of integrated clinical research consultation, provided by members of the Clinical Research Center independently of the research ethics committee, at a Japanese university hospital during 2018-2019. Among various consultations in nursing studies (<i>n</i> = 101), 43 were related to research ethics. The main issues in research ethics consultation were compatibility with guidelines (<i>n</i> = 28; 65%) and application of ethics review (<i>n</i> = 12; 28%). Future studies should investigate international settings and address the relevance of research ethics consultation to promote proper nursing studies.</p>","PeriodicalId":50211,"journal":{"name":"Journal of Empirical Research on Human Research Ethics","volume":"17 1-2","pages":"63-69"},"PeriodicalIF":1.3,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39297431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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