Readability of informed consent documents and its impact on consent refusal rate
Introduction: Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same. Methods: We accessed 300 ICDs from studies submitted to institutio...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2025-01-01
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| Series: | Perspectives in Clinical Research |
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| Online Access: | https://journals.lww.com/10.4103/picr.picr_322_23 |
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| author | Yash V. Kamath Yashashri C. Shetty Ishita C. Lanjewar Ankita Kulkarni |
| author_facet | Yash V. Kamath Yashashri C. Shetty Ishita C. Lanjewar Ankita Kulkarni |
| author_sort | Yash V. Kamath |
| collection | DOAJ |
| description | Introduction:
Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same.
Methods:
We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch–Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant.
Results:
Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal–Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = −0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014).
Conclusion:
Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance. |
| format | Article |
| id | doaj-art-2a73133dfd3b4a6fb38c0e926fbce363 |
| institution | Kabale University |
| issn | 2229-3485 2229-5488 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj-art-2a73133dfd3b4a6fb38c0e926fbce3632025-01-14T08:49:58ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852229-54882025-01-01161384310.4103/picr.picr_322_23Readability of informed consent documents and its impact on consent refusal rateYash V. KamathYashashri C. ShettyIshita C. LanjewarAnkita KulkarniIntroduction: Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same. Methods: We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch–Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant. Results: Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal–Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = −0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014). Conclusion: Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance.https://journals.lww.com/10.4103/picr.picr_322_23ethics - researchethics committeesinformed consent |
| spellingShingle | Yash V. Kamath Yashashri C. Shetty Ishita C. Lanjewar Ankita Kulkarni Readability of informed consent documents and its impact on consent refusal rate Perspectives in Clinical Research ethics - research ethics committees informed consent |
| title | Readability of informed consent documents and its impact on consent refusal rate |
| title_full | Readability of informed consent documents and its impact on consent refusal rate |
| title_fullStr | Readability of informed consent documents and its impact on consent refusal rate |
| title_full_unstemmed | Readability of informed consent documents and its impact on consent refusal rate |
| title_short | Readability of informed consent documents and its impact on consent refusal rate |
| title_sort | readability of informed consent documents and its impact on consent refusal rate |
| topic | ethics - research ethics committees informed consent |
| url | https://journals.lww.com/10.4103/picr.picr_322_23 |
| work_keys_str_mv | AT yashvkamath readabilityofinformedconsentdocumentsanditsimpactonconsentrefusalrate AT yashashricshetty readabilityofinformedconsentdocumentsanditsimpactonconsentrefusalrate AT ishitaclanjewar readabilityofinformedconsentdocumentsanditsimpactonconsentrefusalrate AT ankitakulkarni readabilityofinformedconsentdocumentsanditsimpactonconsentrefusalrate |