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The legal implications of lingual nerve injuries.

Hopefully this analysis is useful. In summary let us make three simple points: Be conscious of your position in the "personal injury" market, but do not be afraid to use your judgment. If you are an expert, do not set a standard of perfection when working out what is reasonable care. Your communication skills are the most important skill you have in order to avoid claims. And on a final note, a draft "consent form" that will provide complete protection is often requested. There is no such thing. The issue is communication with your patient so that they will accept what has happened to them if their lingual nerve is damaged. Ideally this involves a clear explanation, provision of a written outline and a written acknowledgement from the patient that they have received this explanation. The latter requirement is because we are all human--and humans forget things when they are in pain, or distress. The author is currently working with the Australian Dental Association Victorian Branch Inc. and other professional associations in relation to written material to be distributed to make warnings more effective. No doubt, you will receive more information about this initiative in due course.

Clinical Protocols↗

Written information for transurethral resection of the prostate--a national audit.

OBJECTIVES: To assess the use and content of written information relating to transurethral resection of the prostate (TURP). MATERIALS AND METHODS: All 328 full members of the British Association of Urological Surgeons (BAUS) were requested to submit any information sheets or specialized consent forms given to patients about to undergo TURP. They were asked to record when the information was given and whether this was recorded in the notes. The sheets were analysed with reference to a nominally comprehensive list of topics suitable for inclusion in such sheets. RESULTS: One-hundred and eleven replies were received (34%) which represents 44% of urological departments. Of those replying, only 56 used information sheets for TURP. The overall comprehensiveness of the information was surprisingly poor, with 12% omitting to mention retrograde ejaculation and 19% failing to discuss the need for a catheter. CONCLUSION: The written information given to patients about to undergo TURP appears inadequate. There is a need for a nationally accepted information sheet that can be edited locally.

Communication↗

How informed is signed consent?

The assurance that patients fully understand the information given to them before they sign the consent form for operation has never been validated in this country. One hundred patients were interviewed by an independent medical observer in one surgical unit in a teaching hospital between two and five days after their operation. Although all the patients interviewed were fully aware that they had had an operation, 27 did not know which organ was operated on and 44 were unaware of the exact nature of the surgical procedure. A significantly higher age group was observed in the group of patients who were unaware of the basic facts relating to their operation, and the problem was encountered most commonly in patients over the age of 60. Because of the medical and legal importance the findings of this pilot study warrant further large scale investigations.

Age Factors↗

Ultrasound and the IRB.

The purpose of this paper is to assist researchers in writing their research protocols and subject consent forms so that both the Institutional Review Board (IRB) and subjects are assured of the minimal risk associated with diagnostic B-scan ultrasound as it is used in speech research. There have been numerous epidemiological studies on fetal ultrasound and laboratory studies on the effects of ultrasound on various types of tissue, and the American Institute of Ultrasound in Medicine and the World Federation for Ultrasound in Medicine and Biology have concluded that B-scan diagnostic ultrasound procedures are safe if conducted in a prudent manner. To this end, this paper will present a list of potential risks associated with diagnostic ultrasound so that researchers can explain to the IRB and subjects why diagnostic ultrasound, and B-scan in particular, is minimal risk.

Biomedical Research↗

Researching children: issues arising from a phenomenological study with children who have diabetes mellitus.

In Britain the incidence of diabetes mellitus in children is increasing. These children are health care consumers and will continue to be throughout their lives. It is important that their views are sought regarding their health care condition. A phenomenological study was undertaken with six children aged 7-12 years regarding their experience of living with diabetes. This research highlighted several issues regarding the conduct of research with children. Access to children required negotiation with the ethics committee and the parents. It was also important to seek the consent of the children via the signing of a consent form, as well as an on-going process throughout the conduct of the research. In addition, appropriate communication methods had to be utilized, acknowledging the age and abilities of individual children. The use of both verbal and non-verbal communication skills were important, but the use of non-verbal skills appeared to be the most significant. Researchers should not be bound by the supposed abilities of children and should take care not to underestimate the awareness and maturity that some children possess when addressing issues of concern to themselves. When given the opportunity, children were keen to express their views and were very articulate in doing so. There is much scope for future research studies seeking children's perceptions about their health care condition.

Behavioral Research↗

Informed consent in clinical research with drugs in Spain: perspective of clinical trials committee members.

A survey among members of 16 Clinical Trials Committees and the Clinical Trials Evaluation Team of the Spanish Ministry of Health was carried out to discover their opinions about the procedure used to obtain informed consent in clinical research with drugs. The responses of the 111 persons surveyed indicate that 97% consider that informed consent should be obtained before the patient is included in the trial, that it must "always" be in writing (68%), and that the consent form must previously have been approved by the Clinical Trials Committee (87%). The minimum information to be provided to the patient must be read by and later supplied to the subject (76%), and for at least 90% of the members surveyed it must "always" include: an invitation to participate in the clinical trial, information about the purpose, predictable benefits and risks of the trial, the statement that participation is voluntary and that refusal to participate would not imply loss of usual medical care, and that the trial was approved by the Clinical Trials Committee. Only 33% of those surveyed considered that the study design should "always" be described to the patient. In order to find out what the general outlook on this issue is in Spain, it is necessary to perform studies among medical investigators and patients.

Clinical Trials as Topic↗

Take-home informed consent for intravenous contrast media: do patients learn more?

RATIONALE AND OBJECTIVES: In 1978, Morrow et al published the results of a simple technique for raising radiation oncology patients' levels of awareness about medical options. They reported that providing written information at least 24 hours in advance was an effective tool for increasing the baseline knowledge in this patient group. However, Morrow's cohort consisted exclusively of cancer patients receiving radiation therapy. The authors of this article are concerned with whether the encouraging results reported by Morrow are reproducible when applied to patients awaiting invasive radiologic procedures. METHODS: One hundred sixty consecutive outpatients awaiting contrast were block randomized into one of eight groups based on age, sex, and previous contrast exposure. For each group, half were given their consent form at least 24 hours prior, and the other half at the time of their procedure. All patients were tested at the time of their procedure to evaluate knowledge retention. RESULTS: Comparison between the two study groups showed no overall statistically significant differences either in knowledge (experimental group 4.7 +/- 1.32 versus 4.38 +/- 1.30 control group) or level of satisfaction. Additionally, individuals experienced with contrast failed to outperform those who had never previously been given contrast. There is no significant difference in the performance between the two sexes regardless of group. CONCLUSIONS: The providing of information 24 to 72 hours in advance of an invasive procedure does not have a beneficial effect over just providing the same information at the time of the study.

Age Factors↗

[Protection of study participants through standardised information--proposal of a unified criterion catalogue for the activities of ethics committees--results of an expert survey].

CONTEXT: The main task of the ethics committees is the protection of study participants against unethical research. The international consensus on ethical aspects, however, is only partially considered in legal regulations. In Germany, the regulations for approval procedures of clinical studies have been increasingly standardised, but this does not apply to information for study participants. The aim of this study was to propose a list of criteria for information for study participants based on comparisons of existing resources and international standards. METHODS: The available criteria for the development of information for study participants and consent forms of the ethics committees of the German State Medical Chambers (n = 16) were analysed and compared. The criteria identified were complemented with indications provided in international guidelines and compiled in a catalogue. This first version of a list of criteria (58 items) was submitted to an expert panel of members of the ethics committees (n = 16) and patient and consumer representatives (n = 18), and subjected to corresponding revision. RESULTS: In Germany, the guidelines for the development of information for study participants are not standardised. The list of criteria resulting from international guidelines and the available criteria of the State Medical Chambers consisted of 58 items. The expert panel agreed on most of the items, and a revised version of the catalogue is now available. CONCLUSION: The list of criteria may contribute to standardisation of information for study participants in clinical studies for the activities of the ethics committees.

Attitude to Health↗

Cross-cultural perspectives on research participation and informed consent.

This study examined Portuguese Canadian and Caribbean Canadian immigrants' perceptions of health research and informed consent procedures. Six focus groups (three in each cultural group) involving 42 participants and two individual interviews were conducted. The focus groups began with a general question about health research. This was followed by three short role-plays between the moderator and the assistant. The role-plays involved a fictional health research study in which a patient is approached for recruitment, is read a consent form, and is asked to sign. The role-plays stopped at key moments at which time focus group participants were asked questions about their understanding and their perceptions. Focus group transcripts were coded in QSR NUDIST software using open coding and then compared across cultural groups. Six overriding themes emerged: two were common in both the Portuguese and Caribbean transcripts, one emphasized the importance of trust and mistrust, and the other highlighted the need and desire for more information about health research. However, these themes were expressed somewhat differently in the two groups. In addition, there were four overriding themes that were specific to only one cultural group. In the Portuguese groups, there was an overwhelming positive regard for the research process and an emphasis on verbal as opposed to written information. The Caribbean participants qualified their participation in research studies and repeatedly raised images of invasive research.

Adult↗

[Difficulties with conducting clinical trials in France].

France ranks third among European countries as regards the level of investment in clinical R&D and, overall, accounts for a contributive effort proportional to the size of its population and pharmaceutical market respectively. However, there is a trend for phase II and III studies to become proportionally fewer than in the past, while the number of phase IV studies is increasing. In a growing proportion of the mega-trials, which are instrumental for establishing evidence-based practice, French experts, investigators and, even more seriously, French patients, are insufficiently represented. Though studies in France are initiated relatively fast due to a clear regulatory framework and perform equally well as far as quantitative and qualitative factors are concerned, compared with most European countries involved in clinical research the costs incurred per completed patient are higher than those recorded in the other countries. Academic research shares most of these constraints and suffers from a lack of financial and human resources, while it faces additional delays in implementing studies because of longer administrative processes. Given the stakes in play, specific solutions should be implemented to maintain and further develop French competitiveness in clinical R&D. At the patient level, positive perception and awareness of the usefulness and safety of participating in clinical trials need to be emphasized. Education at the school level and using the lay media should be developed. Intervention of institutional and government officials is much needed. Direct patient recruitment should be developed through advertisement and the Internet, as well as within doctors' offices and through collaboration with patients' organizations. Patient information and consent forms should be made much simpler than those imposed within the framework of global studies because of FDA requirements. The French health system discourages the recruitment of patients by investigators who are not the family doctor or the usual care provider. Thus, motivation and education of general practitioners and hospital doctors may be increased by involving them during the trial design phase and in the publication process. Specific administrative solutions, within private or public institutions, need to be developed for investigators who do not personally wish to receive investigation fees. Because of lack of availability, investigators need to be assisted with study nurse services and site management organizations, particularly within hospitals and clinics, using the model of the Clinical Investigation Centres. Networks of clinical investigation centres and of individual investigators need to be created. Implementing these solutions should lead to better implications for and reputation of French clinical research.

Clinical Trials as Topic↗

Psychotherapeutic counseling and pregnancy rates in in vitro fertilization.

PURPOSE: Since the Austrian propagation bill of July 1, 1992, was passed into law, Austrian physicians are committed to offer psychological counseling to women before performing assisted reproductive techniques, unless refused by the patient. The acceptance of psychotherapeutic counseling (PSITCO) and its influence on pregnancy rate were carefully reviewed. METHODS: The study comprised 1156 consecutive patients (mean age, 33.3 years) and 1736 in vitro fertilization (IVF) cycles. In a consent form for follicle puncture, the patients were interviewed about PSITCO as follows. Several methods of psychological support during IVF-embryo transfer treatment were offered to patients especially psychotherapy, hypnotherapy, and relaxation and physical perception exercises. RESULTS: Forty-two and three-tenths percent of patients rejected PSITCO, 17.8% had already received PSITCO, and 10.4% were willing to undergo PSITCO. The acceptance of PSITCO had no relevance on pregnancy rate. The cumulative calculation of pregnancy rates showed that up to 56.4% of women who had undergone PSITCO conceived. In patients who were planning to undergo PSITCO, the pregnancy rate was 41.9%. Concerning the cumulative pregnancy rate, this study showed that patients who accepted or underwent PSITCO had a higher pregnancy rate than those who did not avail themselves of this possibility. CONCLUSIONS: These results should encourage sterility specialists to consider psychological therapy as an essential aspect of IVF. Solely a written declaration of the patient stating his/her awareness of the possibility to undergo PSITCO is, in our opinion, insufficient.

Adult↗

Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients.

BACKGROUND: The process by which patients are informed and their consent is obtained in phase I trials has thus far been only marginally studied. Since 1986 we have followed an oral procedure, consisting of three consecutive conversations in which the investigator responsible for phase I studies, the research nurse and the patients' relatives and/or friends also participate, followed by the patients signing of a written consent form. It is required that six items of information considered essential by our staff be conveyed to patients by the responsible investigator. Meerwein's model, which defines three main dimensions of the informing process (the information itself, the emotional and interactive aspects), has been studied to ascertain whether it can be applied to evaluate the quality of the information proffered. METHODS: Thirty-two conversations were taped, transcribed and evaluated by one psychiatrist and one psychologist. A quantitative analysis of information was performed by calculating the number of patients to whom the essential items of information had been conveyed. The qualitative analysis was performed by rating on a five-point scoring system, from 1 (very bad) to 5 (excellent), the three dimensions of the informing process for each patient and by calculating for each dimension the mean score of the constituent items. RESULTS: Complete information about the characteristics of the phase I drug and the modalities of the treatment and follow up was given to almost 80% of the patients. All but one of the items of the information dimension scored 3.5 or higher, with the one related to the assessment by the doctor of the patient's understanding at the end of the consultation scoring less than 3 in 53% of the patients. All items of the emotional dimension scored higher than 3.5. Greater difficulty was encountered by the physician with the interactive dimension, the lowest mean scores being reported on the items related to the doctor's awareness of the indirectly expressed anxieties of the patients. In 71% of the consultations the three dimensions of information scored more than 3 and balanced one another, indicating a successful consultation by the Meerwein model. CONCLUSIONS: The informed consent procedure applied was satisfactory from a quantitative point of view, and the main items of information were acceptable to the patients. Meerweins's model proved to be applicable and useful for identifying pitfalls in communication. Greater attention should be paid to the indirect messages and implied criticisms of the patients to improve their participation in decision making. Physicians should become more skillful in providing adequate information and improve their methods of communication.

Adolescent↗

Some implications of the Human Rights Act 1998 for the medical treatment of children.

Although the Gillick decision was hailed as an important step in the furtherance of respect for children's autonomy, subsequent judgments seemed to undermine this important principle. While it would be difficult to criticise the outcomes of some of the key cases, the reasoning by which these were achieved is rather more contentious. There have been some interesting discussions suggesting more constructive approaches but there is still a great deal of anecdotal evidence indicating that conservative assessments of children's ability to be involved in decisions about their medical treatment remain the norm. The new Department of Health consent forms should help to create a climate where assessment of a child's competence will become more sophisticated. This paper will argue that the Human Rights Act 1998 offers another opportunity to reassess more traditional approaches to children's capacity; indeed, this could be violation, inter alia, of the right not to be subject to inhuman and degrading treatment under Article 3 in extreme circumstances and the right to private and family life enshrined in Article 8. Clearly, it is not always practicable to carry out assessments rigorously and some health professionals may feel they do not have the expertise to do this, but some basic criteria could assist here; courts are not likely to expect more than a demonstration that best endeavors have been employed in reasoned decision-making. Additionally, other privacy rights may have implications for the medical decision-making process as it affects children and their carers particularly where conflict arises. Disputes may also ensue from the right to manifest religion and other beliefs",' under the Act. This paper will explore how such challenges to those responsible for the medical treatment of children may fare.

Child↗

The Continuity Trap in Data Science Health Research.

Secondary use is now the ordinary condition of data science health research rather than an exception to it. Electronic health records collected for clinical care become prediction tools and inputs for generative AI; imaging archives become foundation-model corpora; genomic datasets become resources for polygenic risk scores; and legacy biospecimens become renewable, indefinitely distributable cell lines. Governance has responded by emphasizing verifiable instruments such as provenance logs, repository approvals, broad-consent forms, data-use agreements, model cards, records of processing, and locality-preserving architectures. These instruments are necessary, and they answer real questions about lineage, privacy, institutional responsibility, and accountability, but they are not sufficient to establish that a present use remains ethically justified. We define ethical continuity as the persistence of normatively relevant relationships between the original conditions of data generation or material collection and subsequent downstream uses, such that current uses remain justifiable in light of the expectations, permissions, meanings, and relational obligations present at entrustment. We then define the Continuity Trap as a review-stage governance error in which a salient signal of continuity in one domain is treated as sufficient evidence of ethical continuity overall, causing inquiry into the remaining domains to close prematurely. The trap is not ordinary noncompliance, ethics creep, or a demand for universal rereview; it is a cross-domain inference error that can arise even in careful, good-faith review. We distinguish it from proxy closure, of which it is a continuity-specific subtype, and from Goodhart's and Campbell's laws, which describe how measures degrade once they become targets. We operationalize ethical continuity across 4 domains: provenance, semantics, authorization, and relational standing, developed in our Representational Veracity framework, and we show that these domains can diverge as data are linked, transformed, modeled, and redeployed. We identify the institutional mechanisms-provenance privilege, descriptor sedimentation, authorization fossilization, and community effacement-that cause auditable signals to be overread, and we examine how the US Health Insurance Portability and Accountability Act (HIPAA) of 1996, the General Data Protection Regulation, the European Health Data Space, US Food and Drug Administration guidance, the US National Institute of Standards and Technology (NIST) AI Risk Management Framework, and federated-learning governance can reduce risk while still inducing continuity traps. We apply the framework to consent and nonconsent settings, including public health, immunization, syndromic, and wastewater surveillance, polygenic risk scores, induced pluripotent stem cells, federated learning, and health-related large language models. The policy implication is trigger-based continuity review: rather than rereviewing every reuse, investigators and reviewers should identify the weakest continuity domain at the present data stage and impose a domain-matched safeguard, recorded in a short continuity statement. This reframing is intended for the committees, repositories, funders, and governance bodies that decide whether reuse may proceed, and it matters most in cross-border and low-resource settings. Provenance should begin ethical review; it should not end it.

Data Science↗

American Society of Clinical Oncology policy statement: oversight of clinical research.

UNLABELLED: Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public understanding of clinical research oversight. 6. Enhance the efficiency and cost-effectiveness of the clinical research oversight system. This policy statement makes recommendations in several areas that serve as principles to support an improved system of oversight for clinical research. ASCO will work with all parties involved in the clinical research system to develop the steps necessary to implement these recommendations. Centralized Trial Review: A large percentage of oncology clinical trials are coordinated through the National Cancer Institute's (NCI) system of cooperative groups, which already incorporates centralized scientific review. As such, there is a tremendous opportunity to employ a centralized mechanism to provide ethical review by highly trained IRB members, allowing local IRBs to take advantage of the financial and time efficiencies that central review provides. Centralized review boards (CRBs) would also contribute consistency and efficiency to the process. Once successfully completed, the review would represent an approval to open the protocol at all of the institutions that have subscribed to the centralized review system. Local IRBs would be able to devote time usually spent on initial review to ongoing monitoring of the trial taking place at their institution. Considering the enormous size and complexity of the clinical research enterprise, ASCO envisions multiple CRBs, which could be distributed as regional review boards. Central review will use a single protocol and consent form, and monitor and evaluate adverse events (AEs) on a global basis, eliminating many of the time-consuming steps for the local IRB. Global monitoring and assessment of AEs has real potential to enhance trial participants' safety by giving local institutions more information on the overall trial and enabling them to devote more time to ongoing review of the trial onsite. Use of a CRB also has real potential to reduce the costs of clinical trial oversight by allowing local IRBs to eliminate the costs of initial review. These efficiencies will likely lead to institutions redirecting funds toward monitoring ongoing trials. Although a CRB has potential to improve the efficiency of the process, a CRB could also have tremendous ability to delay valuable trials. Checks and balances must be included in the newly devised system to ensure timely review and appeals of CRB actions. ASCO proposes the advent of a new pilot program for centralizing review of clinical trials. It requires clear engagement of all stakeholders in planning the experiment, clear articulation of the goals, and assurance of federal regulatory protection for institutions choosing to participate. If successful, this CRB pilot project could be expanded to include multi-institutional industry-sponsored research. Education and Training:Education and training are critical to the ultimate success of an improved oversight system. All members of the research team should receive comprehensive education on conducting scientifically and ethically valid clinical research. The curriculum should also include information on the prevailing local and federal regulations that pertain to the clinical trials process. IRB members should also receive ongoing education and training in the review of clinical research protocols. IRB training should pay particular attention to nonscientific members to give them the tools necessary to speak on behalf of research participants. ASCO should develop a curriculum that focuses on the proper conduct of human research and emphasize ethically sound clinical research in the context of its Annual Meeting. Informed Consent: Investigators and review boards have specific roles to play in ensuring the education of trial participants through the informed consent process, both when they are considering trial enrollment and as they participate in the trial. Review boards and investigators should focus primarily on the informed consent process, rather than the informed consent documents. Federal Oversight: The federal government has an important role to play in the oversight of clinical research. This role should be expanded to cover all research, not just that which is funded by the federal government or conducted with the oversight of the Food and Drug Administration (FDA). The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the FDA should provide clear regulatory support and guidance for local institutions that choose to employ a CRB. In the case of the pilot CRB discussed in this policy statement, it should serve as the preferred option for the cancer cooperative group clinical trials. Ideally, the federal government should unify and streamline its regulations for the oversight of clinical research. Resources Supporting Clinical Research Infrastructure:An effective oversight process demands the highest quality scientific and ethical review and onsite monitoring of the safety of trial participants. This can only be accomplished by the involvement of an experienced IRB that receives funding, resources, and institutional support enabling it to fulfill its mandate. CONFLICT OF INTEREST: Critical to the integrity of research is the absence of bias in the process. ASCO strongly recommends the adoption of standards for the identification, management, and, where appropriate, elimination of conflicts of interests, whether they are actual, potential, or apparent.

Biomedical Research↗

Communicating probabilistic information to cancer patients: is there 'noise' on the line?

The objective was to examine the way that cancer patients translate verbal descriptors of probability into numerical estimates. A list of words commonly used on consent forms to describe the likelihood for benefits or risks of therapies was provided to 100 cancer patients. Two formats, paper/pencil or computer, were used to provide the list of words. Two methods, magnitude estimation and linear analogue scaling, were used to obtain probability estimates for each word. In addition, two scenarios were developed to study 'context effects' on numerical interpretations of verbal descriptions of probability. All patients provided numerical values for the words on two occasions, separated by one week, and two interviewers collected the data. Regardless of method or format, each word elicited widely variable numerical interpretations. An ANOVA model, including patient, word, interviewer, time, method and format, indicated that patient and interviewer produced major effects on probability estimates. Agreement between methods and across time was good. Paper/pencil and computer formats yielded similar results. Context effects did not appear to influence the numerical probabilities elicited by the 2 scenarios. It was concluded that, within this group of patients, there was no consensus about numerical meaning of a given word, and that interviewers can systematically influence numerical interpretations. There appears to be a great deal of 'noise' in this particular line of communication between patients and health professionals.

Aged↗

Root resorption related to orthodontics and other factors: a review of the literature.

Each patient (and parents or guardian) should be clearly informed that there is a real possibility of one or more teeth undergoing root resorption during orthodontic procedures. They should sign an Information and Consent Form arranged by the dentist that they understand these risks before treatment is begun. Open bite cases possess significantly great degrees of resorption. Since trauma is closely associated with root resorption, the patient (and parents or guardian) should be questioned concerning previous traumatic occurrences that involved blows or accidents involving the teeth. Periapical radiographs are an important part of orthodontic records. They are useful to compare pretreatment and posttreatment root resorption. Maxillary incisors are affected more frequently and to a greater degree than the rest of the teeth during active treatment. Also, root resorption of the upper incisors during the initial 6-9 months of treatment with fixed appliances gives a high risk for continued resorption during the subsequent treatment. Therefore, it would be prudent to take periapical radiographs periodically during treatment. When root resorption is detected during active treatment, a decision must be made as to whether to continue, modify or discontinue the treatment. Extremely heavy forces should be avoided, since they have been shown to produce greater resorption activity. The ectopic eruption of canines causes a significant number of resorptions in lateral incisors. Habits adversely affect root resorption and should be eliminated if possible. Pathological lesions increase the risk of resorption. Periodontal disease increases the risk of resorption. The practitioner contemplating doing orthodontics should be cognizant of the above factors in evaluating the risk of root resorption. Patients (and parents or guardians) should be made clearly aware that any type of orthodontic treatment carries with it the risk of root tip blunting or resorption during orthodontic therapy.

Child↗

Informed consent.

Information to make patients fully aware of all the details of treatments is an important part of the medical practice before obtaining patient's signature in the consent form. Explanation may be detailed enough to make patients understand the process of treatment. However, sometime it may not be inclusive enough to cover all major statements that give pros and cons of the treatment. Perhaps detailed explanation may reveal too much information that may discourage patients to receive treatments and cause fear, anxiety, and hopelessness. If health care personnels do not mention all the risks involved in medical treatments, they may be subjected to an accusation of concealing the truth that should be made known to patients. This is one of many ways of looking at the problems. There is no easy answer to the problem of what 'appropriate' explanation should be. Most of our patients are from all walks of life which are not medical profession, and they do not have knowledge to understand technical terms. How should we approach patients in order to be safe from an accusation of that we are not over supporting, not giving the patients false hope? Therefore, we would like to present a guideline for informing and explaining to the patients under the following headings (15): 1. Diseases or major symptoms which are diagnosed. 2. The necessity to receive treatments for the benefits of patients or fetus. 3. If possible, determine the duration of treatments. 4. Methods of treatment, evaluation, and schedule for next appointment. 5. Inform about necessary investigations. 6. Inform about complications of risks, and cost of investigations 7. Usefulness and results of investigations. 8. If options of treatments are available, they should be explained in details, the pros and cons, the risks, and the costs, etc. 9. Maintaining medical confidentiality and the use of patient chart by medical personnel and other related health care providers, for instance, hospital staffs from all levels, medical students, technical medical students, and social workers, etc.

Humans↗