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PubMed2002

Informed consent and patient videotaping.

PURPOSE: To determine whether videotaping consent forms used in family medicine residencies meet the criteria for informed consent, adhere to published guidelines for videotaping patients, and are written at a suitable reading level. METHOD: Three reviewers independently evaluated videotaping consent forms obtained from 20 family practice residencies to determine whether they included the elements of informed consent and conformed to published guidelines for ethical videotaping. The reading level of each consent form was also determined using a standardized assessment. RESULTS: Depending on the reviewer, only one to three of the 20 consent forms were judged adequate in providing a patient with enough information to make an informed choice. Specific aspects of voluntariness were absent from most of the forms. In addition, the reading level was, on average, well above recommended levels for patient comprehension. CONCLUSION: Most of the videotaping consent forms analyzed in this study did not provide adequate information to assist patients in making a voluntary, informed choice to be videotaped. The absence of this information raises the potential for violations of patient privacy and confidentiality.

Confidentiality↗
PubMedDate not supplied

[Informed consent for gastrointestinal endoscopy. A patient-opinion survey].

AIM: Written consent is not advised in France because it is thought it may alter the patient's trust in his/her doctor. Our aim was to elaborate a consent form for gastrointestinal endoscopy and to assess the patient's opinion concerning the written consent process. METHODS: Seven health professionals and seven patients or users elaborated a consent form and a list of 24 questions about the written consent process. The consent form, accompanied with an information form, was given to the patients before endoscopy. For a period of 9 consecutive days, all patients undergoing gastrointestinal endoscopy were asked to fill out the questionnaire at the end of the procedure. RESULTS: One hundred and forty-three patients participated in the survey. Twenty-eight were unable to read the form. One hundred patients filled out the form. Sixty-six percent of the patients were satisfied with the written consent process. Only 10% considered that the written consent process altered their trust in their doctor. Ninety-eight percent of the patients were satisfied with the consent form and 97% felt it was clear and comprehensible. Eighty percent of the patient felt it was reassuring. CONCLUSIONS: Written consent does not alter the patient's trust in his/her doctor. The majority of the patients understood the written consent process and agreed with it. Almost all patients were satisfied with the consent form we elaborated, suggesting that its use could be generalized.

Disclosure↗
PubMed2003

The effects of local review on informed consent documents from a multicenter clinical trials consortium.

There is increasing controversy about the appropriate role of the local institutional review board in the review of multicenter clinical studies. We evaluated the effects of the local review process at 25 study sites on the consent forms from two studies of the Tuberculosis Trials Consortium, a multicenter trials group. Two independent reviewers classified all changes made in the centrally approved consent forms; a third reviewer evaluated those changes if the two initial reviewers disagreed. The median time to initial local approval was 104.5 days (range 31-346). There were no changes in the study protocols as a result of local review. Consent forms became longer and less readable after local review, with a mean increase in grade level of 0.9 (+/-0.9) reading grade levels (p<0.001). A median of 46.5 changes (range 3-160) were made in the centrally approved forms. Most changes (85.2%) involved altering wording without affecting meaning. Errors were commonly introduced (11.2% of changes), and 33 of 50 (66%) locally approved consent forms contained at least one error in protocol presentation or a required consent form element. Local approval of two multicenter clinical trials was time-consuming and resulted in many changes in centrally approved consent forms. These changes frequently decreased readability and introduced errors.

Canada↗
PubMed2006

Experiences from the front-line routine consenting of surplus surgically removed tissue: without investment by the National Health Service fully informed consent for all is not available.

The study investigated the routine introduction of a new surgical consent form containing a tissue consent section to investigate patient attitudes to the use of surplus tissue for research (after the Alder Hey inquiry) and also the differing approaches by consent takers. All surgical consent forms received in histopathology for the same 2-month period in 2 consecutive years were analysed, recording available information about the specimen, the tissue consent section and, for the second year, the consent taker. The findings showed that <5% of patients whose views were recorded disagreed with the use of their tissue for research. They also showed that the number of completed forms sent to histopathology had increased but the pattern of completion had changed very little. A wide variation between departments and also between clinicians was apparent in the levels of completion of the tissue consent section, suggesting wide variability in the quality of the consenting process. When asked, patients rarely object (<5%) but if the highest standards of consent for surgical tissue are to be achieved and the wishes of patients to donate tissue are to be effectively recorded then new resources or approaches will be needed for this process.

Attitude to Health↗
PubMed2002

[Patterns of information and informed consent procedures. Study of the Ethical Commission of the ANMCO].

A survey on patterns of information and informed consent procedures during daily clinical practice has been performed by the Ethical Commission of ANMCO. A structured questionnaire (38 questions) was sent to the 653 cardiological units of the National Health Service in Italy. Four hundred and eighty (73.5%) were received. The following variables were considered to evaluate differences in the answers from the various cardiological units: geographical site, presence or absence of an in-patient department, a cath-lab, and of cardiac surgery facilities. Independent predictors of returning questionnaires were: geographical site (Northern Italy vs Central and Southern) and the presence of a cath-lab. Informed consent forms were provided in 53% of instances, while in 40% a free comment about the topic of informed consent was sent. Statistically significant differences in the answers were found about physicians' and nurses' role, ways of information, qualitative and quantitative risk estimates, other persons' role, models of consent forms and procedures of obtaining consent. Free comments and informed consent forms did not allow a statistical analysis. However, they still provided sufficient material to identify specific patterns of how cardiologists deal with the informed consent process. The distinction between the two phases of information and consent was rarely clear. Information or educational material was often mixed with consent forms. While some still showed a paternalistic approach, or else considered informed consent as a formal act, others demonstrated a deep understanding of the significance of the concept of informed consent. A widespread need of guidelines and standard patterns resulted.

Ethics↗
PubMed2005

Informed consent for vascular intervention.

AIM: To audit documentation of the process of informed consent in patients undergoing vascular surgical and radiological procedures. METHOD: A retrospective audit of randomly selected elective vascular radiological and surgical admissions was undertaken at Christchurch Hospital (Christchurch, New Zealand) to assess documented evidence of the consent process. Clinic letters, handwritten entries in patient notes, and consent forms were scrutinised and data collated on which medical practitioners took consent, what details of the consent process were documented, and what additional information was made available to patients. RESULTS: 100 sets of notes were reviewed (surgical n=51, radiological n=49). For patients undergoing vascular surgery, the consent form was signed by a consultant in 2 (4%) sets of notes compared to 46 (94%) for patients undergoing vascular radiological intervention (p<0.001). All radiology consent forms were signed on the day of the procedure whereas 43 (84%) of surgical consent forms were signed before the day of surgery (p<0.01). Documentation that risks had been discussed with the patient was present in 44 (86%) sets of surgical notes compared to 20 (41%) radiology notes (p<0.001). Additional information (e.g. College of Surgeons' information leaflets) was supplied to 6 (12%) surgical patients and none of the patients undergoing radiological intervention (p<0.05). CONCLUSIONS: In our centre, documentation of the process of informed consent compares favourably with the published literature. This study demonstrates significant differences in documentation between surgery and radiology.

Adult↗
PubMed2006

New challenges facing interinstitutional social science and educational program evaluation research at academic health centers: a case study from the ELAM program.

Since the mid-1990s, the protection of human subjects through institutional review boards (IRBs) has progressively broadened in scope. In this case study, the authors describe their challenges in effectively handling IRB processes to conduct educational and social sciences research within academic health centers, particularly (1) complications in conducting longitudinal interinstitutional research that involves multiple IRBs, each with different procedures that changed over ten years; and (2) factors affecting consent form and survey response rates when applying the biomedical IRB process to obtain the consent of human subjects for participation in social and educational research. The authors had a unique opportunity to follow the effect of changes in consent forms (from no form to a one-page form to a three-page form requiring signature of a witness), ways of administration (in person or by mail), and time of administration (at the time of the program or years later) on consent form and survey response rates among medical and dental school faculty members. The authors explore the extended timelines required for data collection and increased costs in dealing with these issues, as well as the effects on response rates of consent form language and administration procedures. The authors recommend strategies to lessen adverse effects of dealing with multiple IRBs at different institutions for social science and educational research, and discuss policy implications for funders, institutions and investigators.

Academic Medical Centers↗
PubMed1996

Informed consent for medical research: common discrepancies and readability.

OBJECTIVE: To identify common discrepancies and average reading grade levels for informed consent forms (ICFs) as submitted to institutional review boards (IRBs) by medical researchers. METHODS: A retrospective evaluation of ICFs as submitted to IRBs of 3 university-affiliated hospitals during a 1-year period. ICF content was evaluated using a checklist of 23 requirements specified in the federal regulations governing human research. Documents then were computer-analyzed to determine the readability scores using 2 common indexes of comprehension. A discrepancy was defined as any instance in which an ICF did not address an applicable requirement in the Code of Federal Regulations. RESULTS: Eighty-two ICFs representing 16 medical specialties were evaluated; 8 (10%) were from emergency medicine. Eighteen ICFs (22%) were conspicuously incomplete, lacking > or = 9 federal requirements. The mean number of discrepancies was 4.7 (95% CI, 3.9-5.5) Common omissions included: a statement about who is doing the research, number of subjects in the study, circumstances when a subject's participation may be terminated, disclosure of alternative procedures, and notice to subjects regarding new findings. The mean Flesch grade level required to read all ICFs was 13.8 (95% CI, 13.5-14.2), implying that the majority of the U.S. adult population would be unable to comprehend these forms. CONCLUSION: Designing a consent form to meet all of the federal requirements while maintaining a level of reading comprehension suitable for the general population is a difficult task for investigators.

Adult↗
PubMed2003

Problematic variation in local institutional review of a multicenter genetic epidemiology study.

CONTEXT: Sequencing of the human genome provides an immense resource for studies correlating DNA variation and epidemiology. However, appropriately powered genetic epidemiology studies often require recruitment from multiple sites. OBJECTIVES: To document the burden imposed by review of multicenter studies and to determine the variability among local institutional review boards (IRBs) in the approval of a multicenter genetic epidemiology study. DESIGN: A PubMed search was performed to determine the frequency of citations of multicenter studies by 5-year intervals from 1974 through 2002. A 7-question survey was sent to all participating study centers to obtain information on frequency of IRB meetings, dates for submission and approval, use/nonuse of a specific consent form, type of review performed, types of consent forms required, preparation time, and number of changes requested by the IRB at each center. Centers also provided a copy of all consent forms they generated and IRB correspondence regarding the study. SETTING AND PARTICIPANTS: Thirty-one of 42 cystic fibrosis care centers in this single US multicenter genetic epidemiology study of cystic fibrosis replied, yielding a 74% response rate. MAIN OUTCOME MEASURES: Frequency of published research studies and consistency among IRBs. RESULTS: The number of all published single-center studies has increased 1.3-fold since 1985, while the number of published epidemiology and genetic epidemiology multicenter studies increased by 8- and 9-fold, respectively, during this same period. Evaluation of the risk of the same genetic epidemiology study by 31 IRBs ranged from minimal to high, resulting in 7 expedited reviews (23%) and 24 full reviews (77%). The number of consents required by the IRBs ranged from 1 to 4; 15 IRBs (48%) required 2 or more consents, while 10 (32%) did not require assent for children. The most common concern (52%) of IRBs pertained to the genetic aspects of the study. CONCLUSIONS: Review of a protocol for a multicenter genetic epidemiology study by local IRBs was highly variable. Lack of uniformity in the review process creates uneven human subjects protection and incurs considerable inefficiency. The need for reform, such as the proposed centralized review, is underscored by the ever increasing rate of genetic discoveries facilitated by the Human Genome Project and the unprecedented opportunity to assess the relevance of genetic variation to public health.

Cystic Fibrosis↗
PubMed2004

Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.

OBJECTIVE: To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols. METHOD: A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol. RESULTS: Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most (n=23) recalled speaking with someone before enrolling in the protocol, and most (n=26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person (n=27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most (n=23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., "something wrong") was discovered during the protocol. CONCLUSION: The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.

Adult↗
PubMed2004

Factors influencing middle and high schools' active parental consent return rates.

The authors examined factors influencing the return rates for attempting to collect active parental consent forms from 21,123 students in the 7th through 10th grades in 41 middle and high schools. Overall return rates from middle schools were higher than from high schools. Schools that offered high levels of staff support for collecting consent forms had higher return rates. Procedures where the consent form was attached to a school form that parents had to complete and return to the school yielded the highest return rate. Implications for how researchers can obtain a high parent consent form return rate are discussed.

Adolescent↗
PubMed2005

Informed consent in renal transplantation.

PURPOSE: This study was performed to assess how well completed the new consent forms are for patients undergoing renal transplantation. METHODOLOGY: 100 patients were randomly selected from the 160 who had a renal transplantation, at a single centre in the UK, over an 18 month period. The notes were located and the consent forms scrutinised. FINDINGS: Seven sets of notes could not be traced and 10 did not contain a relevant consent form. Forty eight per cent of completed forms mentioned the source of organ while 8% mentioned on which side the operation was to be performed. Twelve risks and complications were identified as being relevant to this procedure but no single form mentioned all 12. In most cases a senior member of the surgical team obtained consent. IMPLICATIONS: The demonstrated variability in the amount of detail on consent forms lends weight to the call for the use of procedure specific forms. While such variability does not necessarily equate with not gaining valid, informed consent, this form, at present, serves as the only record of what has been discussed with the patient. These findings should encourage all surgeons to complete the forms themselves, be as detailed as possible, and ensure that the form is filed in the patients' notes.

Consent Forms↗
PubMed2004

Uncertain benefit: investigators' views and communications in early phase gene transfer trials.

We report on a study of potential sources of therapeutic misconception in early phase gene transfer research, examining how investigators and their consent forms represent the prospect for direct benefit. Our analysis demonstrates that even though half of PIs said they expected direct medical benefit for their subjects, they did not necessarily convey this to their subjects. What they reported telling subjects resembled what was written in their consent form, which suggests that, far from being irrelevant, the consent form is an influential component of the consent process. We also demonstrate that the language used to describe direct benefit in consent forms and PIs' discussions was mostly vague, ambiguous, and indeterminate about benefit, rather than clearly negative. This was especially true for cancer and vascular disease trials. Our respondents found the problem of balancing hopes and expectations, for themselves and for their subjects, extraordinarily challenging. In the current era, investigators face such challenges without consistent normative guidance or agreed-upon standards for how to talk about scientific promise and uncertainty in early phase trials. This dilemma cannot be effectively addressed by individual investigators alone, but must be acknowledged and openly discussed by the scientific community at large.

Cardiovascular Diseases↗
PubMed2001

[Evaluation of thoroughness and legibility of informed consent documents in pediatric surgery].

BACKGROUND: The written information that is provided to the patient must gather a series of characteristics, quantitative and qualitative, so that fulfill the ethical criteria that govern the theory of the Informed Consent. AIMS: To evaluated the degree of exhaustivity and readability of a series of Informed Consents forms in Pediatric Surgery units. MATERIAL AND METHODS: 1. Forms: We evaluated 118 consent forms submitted by 17 pediatric surgery units. 2. Exhaustivity: The studied variables have been: name of the hospital, name of the patient, name of the physician, date, description of the procedure, objectives, risks mention, personalized risks, possibility of recovery, benefits of the procedure, alternatives, possibility from withdrawing the assent, arrangement to widen the information, comprehension of the document, express assent and signatures. All the variables are dichotomics, being collected your presence or absence. 3. Readability: Each document has been introduced in the program "Corel Word Perfect". It was applied to the usefulness "Grammatik" and were collected: number of words, number of phrases, Flesch/Kincaid index, Orational Complexity index and LEGIN index. RESULTS: 1. Exhaustivity: The paragraphs presence in the different forms by order of frequency were: physician signature (100%), express assent (100%), signatures (100%), date (98%), name of the patient (97%), comprehension of the forms (97%), name of the physician (94%), risks mention (92%), name of the hospital (85%), description of the procedure (78%), possibility from withdrawing the assent (70%), personalized risks (67%), arrangement to widen information (43%), to explain alternatives (41%), objectives of the procedure (36%), benefits (36%), and possibility of the recovery (16%). 2. Readability: 11.1% of the forms fulfills the Flesch index, 27.9% the Orational Complexity index, and 22.1% LEGIN index. CONCLUSIONS: Most of the documents offer sufficient quantity of information with respect to the formal aspect and the risks an less with respect to the benefits. This seems to indicate your defensive character. Equally, they are difficult to reading and by difficult to understanding.

Child↗
PubMed2001

Predicting Performance on the National Athletic Trainers' Association Board of Certification Examination From Grade Point Average and Number of Clinical Hours.

OBJECTIVE: To determine whether grade point average, hours of clinical education, or both are significant predictors of performance on the National Athletic Trainers' Association Board of Certification examination and whether curriculum and internship candidates' scores on the certification examination can be differentially predicted. DESIGN AND SETTING: Data collection forms and consent forms were mailed to the subjects to collect data for predictor variables. Subject scores on the certification examination were obtained from Columbia Assessment Services. SUBJECTS: A total of 270 first-time candidates for the April and June 1998 certification examinations. MEASUREMENTS: Grade point average, number of clinical hours completed, sex, route to certification eligibility (curriculum or internship), scores on each section of the certification examination, and pass/fail criteria for each section. RESULTS: We found no significant difference between the scores of men and women on any section of the examination. Scores for curriculum and internship candidates differed significantly on the written and practical sections of the examination but not on the simulation section. Grade point average was a significant predictor of scores on each section of the examination and the examination as a whole. Clinical hours completed did not add a significant increment for any section but did add a significant increment for the examination overall. Although no significant difference was noted between curriculum and internship candidates in predicting scores on sections of the examination, a significant difference by route was found in predicting whether candidates would pass the examination as a whole (P =.047). Proportion of variance accounted for was less than R(2) = 0.0723 for any section of the examination and R(2) = 0.057 for the examination as a whole. CONCLUSIONS: Potential predictors of performance on the certification examination can be useful to athletic training educators in assisting students. These findings must be used cautiously because of the low proportion of explained variance. Low R(2) values suggest that the largest contributors to performance on the examination were not identified in this study. Although the results of this study support the decision to discontinue the internship route to certification, continued research focusing on identification and investigation of the constructs that contribute to examination success is needed.

Journal Article↗
PubMed2002

Keeping pace with HIPAA's changes: straight talk from the trenches.

Over the past several months, the Department of Health and Human Services (DHHS) has issued new final and proposed rules pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The privacy rule was finalized on August 14, 2002. Changes made to the original rule were in general beneficial to providers. Consent forms will no longer be required for treatment, although providers may choose to continue to use them. Physicians will still be required to use and disclose only the "minimum necessary" protected health information (PHI) to accomplish the purpose for which the information is being used or disclosed, but the new final rule excludes some situations in which the minimum necessary requirement will apply. A model business associates contract is provided in the final rule, making it easier for providers to comply with the rule's requirement that they have written business associate contracts with vendors who need access to the provider's PHI to perform tasks on behalf of providers. Researchers now only need to provide one form for consent and authorization, instead of two. There are also proposed changes in the transaction rule. Certain data elements that were required by the final rule are now situational in the proposed rule. Unnecessary data elements have been removed. Certain items, like special program indicator codes, will now be able to be reported via external code sets rather than as data elements in a transaction. The proposed rule also adopts requests from the industry by adding data elements, codes, or loops to enable covered entities to perform certain business functions in the standardized transactions, such as cross-referencing two subscriber IDs (e.g., surviving spouse and dependents). A final rule was published in May 2002 that created a standard employer identifier. The Employer Identifier Number (EIN) that is already in use by the IRS will be the standardized unique employer identifier number. A proposed rule to cease using the National Drug Codes in transactions for nonretail pharmacy transactions was published in May 2002. DHHS developed the proposal in response to widespread industry concern over the tremendous cost of implementing the National Drug Codes (NDC). The NDC will either not be replaced at all, or will be replaced by the HCPCS. This article is not, and should not be construed as, legal advice or an opinion on specific situations.

Journal Article↗
PubMed2000

Postal consent for upper gastrointestinal endoscopy.

BACKGROUND: Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that "appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought". AIMS: To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy. METHODS: Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire. RESULTS: 275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92. 2%) reported the information given in the booklet to be "very useful", and all reported it to be "clear and understandable". CONCLUSION: A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.

Appointments and Schedules↗