The US Food and Drug Administration requires the use of a consent form as part of the protection of human subjects in clinical trials. To help increase the probability of consent form comprehension, the biopharmaceutical industry, FDA, National Cancer Institute, and National Institutes of Health often advise developing consent forms between a sixth and eighth grade reading level. Frior studies have examined consent comprehension at different reading levels. However, prior study results are often inconsistent, do not all utilize consents conforming to the code of Federal Regulations (CFR), and do not all report the validity or reliability of the comprehension measurement t d used or the studies' sample populations that are homogeneous and possess limiting characteristics. Thus the question remains whether lowering the reading level of a CFR-conforming consent fonn increases comprehension in a population devoid of predefined characteristics. Also unanswered is whether other variables, together or separate-Iy such as age, gender, income level, and prior exposure to consent forms affect comprehension of consent forms written at different reading levels.To establish baseline research regarding the comprehension-reading level relationship, a study was petformed utilizing a heterogeneous population of individuals waiting for jury ser-vice. The eflects on comprehension by age, income, gender, prior exposure to consent forms, and 6th versus loth grade reading level consents were examined. The consent forms' reading levels were determined using the Flesch-Kincaid Grade Level scale in Microsoft Word.Comprehension was measured using a validated Ls-question multiple-choice questionnaire that subjects completed after reading the consent forms. Statistical analysis of the effects by age and consent level on comprehension resulted in a significant main effect on comprehension by age, but no eflect by consent level. A comparison indicated that only the 30-44 and 60-75 age groups demonstrated significant differences in comprehension. An analysis of the eflects on comprehension by gender, income, and consenting to research in the past resulted in no significant main or interaction effects. Additional analysis confirmed that only age significantly affcted comprehension. The research concluded that gender, income, prior exposure to consent forms, and lowering consent reading level had no effect on comprehension, and comprehension was only afected by age after the age of 60. This study also confirmed that when used as a preliminary tod, scanning a consent form using the Flesch-Kincaid Index in Microsoft Word can prove effecve for developing consent forms-
The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. This educational activity is designated for a maximum of 1 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the atent oftheir participation in the activily. Disclosure It is Drug Information Association policy that all Jaculty participating in continuing education activities must disclose to the program audience ( I ) any real or apparent conflict(s) of interest related to the content oftheir presentation and (2) discussion ofunlabeled or unapproved uses of drugs or medical devices. Specific areas to be considered in this disclosure include the following: grants/research support. consultang relationships. speakers' bureau participation, significant equity (stock) positions, and sources of honoraria. Janet Cough has disclosed that she has no financial relationships to disclose. Michael Hamrell has disclosed that he has no financial relationships to disclose. Drug Iilfornmtion -J~m d .
This is the third of three articles on standard operating procedures or SOPS. It addresses how to write SOPs in clear, concise language so that processes and activities occur as they are supposed to. The first article addressed the need for SOPs and their value to the business unit. The second article addressed what SOPs an organization needs to think about and how to determine what SOPs to put in place. SOPs
The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.
The Food and Drug Administmtion (FDA) has for many years focused and identified its mission regarding medid products on tmditional dasses and uses for products. This legacy has contributed to a sometimes-confusing set of praiwct dassification precedents that are not alwajs s t r m g h q d or logid for the advanad ptwducts under development. complicating this jbrther is the fact that, although one FDA center may have histm'd responsibility or legal jurisMichael R. Hamrell, PhD, RAC Yorba Linda, California President, MORIAH Consultants.diction over a product, the medical and technical expertise necessary for the review of that product may reside elsewhere within the agency. This article provides an ovm'ew of the history of the regulation of m e d i d products by the FDA, particulady for products that are a combination of two different and active components. It also describes some ofthe current initiatives and regulations that try to darifi the issues and regulatory status of this graving class of medical products.
The structural features and lipid solubility of four different classes of antifolate compounds were compared for their inhibition of dihydrofolate reductase (DHFR) and growth in a normal and methotrexate (MTX)-resistant 3T6 mouse cell line. All of the compounds have been shown previously to have antifolate activity. The resistant cell line has a 7-fold increase in DHFR activity with normal transport, but an altered affinity for MTX. All the antifolates were equally effective in inhibiting DHFR and growth in the parent cell line. Inhibition of partially purified DHFR from the resistant cells increased with changes in lipid solubility and structure of the compounds, compared to the parent DHFR. These data demonstrate that the resistant cells may be more sensitive to the structurally dissimilar antifolates than to MTX and lend importance to further development of this type of antifolate. These results suggest that these compunds may be useful in circumventing antifolate resistance due to alterations in target enzyme concentration and drug-enzyme affinity, as well as drug transport.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.