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Unrecognized HIV infection among patients attending sexually transmitted disease clinics.

OBJECTIVES: This study examined voluntary HIV testing rates in sexually transmitted disease (STD) clinics. METHODS: Anonymous, unlinked surveys of HIV seroprevalence and medical chart abstractions were conducted in 28 STD clinics in 14 US cities in 1997. RESULTS: Among the 52 260 patients included in the anonymous HIV serosurveys, voluntary HIV testing rates by clinic ranged from 30% to 99% (median = 58%). Patients not tested were more likely to be HIV infected than were patients who were tested, even after those with documented HIV infection were excluded, regardless of demographic characteristics, risk group, or STD diagnosis. CONCLUSIONS: HIV infection is unrecognized in substantial numbers of patients with HIV infection visiting STD clinics. Efforts are needed to increase HIV testing and counseling of all patients visiting these clinics.

AIDS Serodiagnosis↗

Prevalence of HIV among pregnant women in Dundee 1988-1997: evidence to gauge the effectiveness of HIV prevention measures.

OBJECTIVES: During November 1988-July 1990, an HIV prevalence survey of pregnant women in Dundee, which used a combined voluntary diagnostic testing and voluntary unlinked anonymous approach, revealed a rate of 0.3%, the highest recorded prevalence among such a population in the U.K. at the time. To determine if, and why, any changes in HIV prevalence had occurred during the early to mid 1990s, further studies were conducted. METHODS: During January 1993-December 1997, antenatal patients of, and women undergoing therapeutic termination of pregnancy at, Ninewells Hospital, Dundee, were offered a diagnostic HIV antibody test. For those declining, residual sera from rubella specimens were tested for HIV antibodies using an unlinked anonymous approach which did not necessitate the securement of informed consent. Information about injecting drug use was obtained from all women and linked to their HIV test results. RESULTS: For all pregnant women, a significant decline in HIV prevalence (P<0.05) from 0.3% (19/6228) during 1988-1990 to 0.12% (22/17899) during 1993-1997 was observed. For those who injected drugs, prevalence decreased significantly (P<0.05) from 27.5% (11/40) to 7% (6/85), while among women who had never injected drugs prevalence decreased slightly, but not significantly (P>0.05), from 0.13% (8/6188) to 0.09% (16/17814).Prevalence in the non-injectors who reported no sexual intercourse with an injector was low at 0.04% (8/17682) during 1993-1997. No significant trends in HIV prevalence were seen over the 5 years up to 1997. CONCLUSION: The decline in HIV prevalence among pregnant women in Dundee during the early to mid-1990s can be explained predominantly by the control of HIV transmission among the city's injectors, and from them to the wider heterosexual population. It is likely that interventions designed to reduce needle/syringe sharing among injectors have been successful. It is imperative that the preventive effort is not allowed to be weakened.

Abortion, Induced↗

HIV testing in Denmark: a nominator-denominator study.

In order to describe prevalence and trends of HIV infection, demographic variables, risk factors, and reasons for seeking testing, and self-administered anonymous questionnaire was distributed to approximately 75% of all individuals tested for antibodies to HIV on a voluntary basis, in all parts of the Danish health-care system, in November 1987 and in April 1988. The number of questionnaires returned was 2143 (55%). Overall, HIV prevalence was 1.2% and was highest among homosexual and bisexual men: 6% in November and 9% in April, with no statistical difference. Sixteen per cent of the men reported homosexual behaviour, 7% reported intravenous drug use, and 60% more than one opposite-sex partner within the last 12 months. No substantial difference was observed between reported risk factors in November and April. Overall, 18% had been tested at least once before; this figure rose to approximately 50% among homosexual men and intravenous drug abusers, a substantial number of whom had engaged in risk behaviour since the latest test. Sixty percent of men and 75% of women were tested at general practitioners', and 22% and 13% at sexually transmitted disease clinics; only 6% of men and 3% of women had used alternative test sites. It is concluded that studies of anti-HIV-tested people can give detailed information about patterns of HIV testing and indications of trends in HIV infection rates, thereby supplementing other forms of HIV surveillance.

AIDS Serodiagnosis↗

Canadian experiences with AIDS and HIV infection.

Canada's first AIDS case was diagnosed in 1978, and a total of 2,003 cases had been recorded up to 19 September 1988. Nationwide, 82% of those afflicted have been homosexual or bisexual men, 5% have been immigrants from endemic regions, and 4.6% have been recipients of blood or blood products. Estimates of Canadians infected with HIV range from 10,000 to 50,000. A system of voluntary testing of individuals, combined with anonymous screening of populations for epidemiologic purposes, comprises the HIV testing program in Canada. Most major cities have volunteer AIDS support committees conducting education, advocacy, and support activities; Can$48 million has been allocated to educate the public about AIDS over the next five years. Research and international cooperation are also receiving increased priority and funding.

AIDS Serodiagnosis↗

Protecting patient privacy by quantifiable control of disclosures in disseminated databases.

One of the fundamental rights of patients is to have their privacy protected by health care organizations, so that information that can be used to identify a particular individual is not used to reveal sensitive patient data such as diagnoses, reasons for ordering tests, test results, etc. A common practice is to remove sensitive data from databases that are disseminated to the public, but this can make the disseminated database useless for important public health purposes. If the degree of anonymity of a disseminated data set could be measured, it would be possible to design algorithms that can assure that the desired level of confidentiality is achieved. Privacy protection in disseminated databases can be facilitated by the use of special ambiguation algorithms. Most of these algorithms are aimed at making one individual indistinguishable from one or more of his peers. However, even in databases considered "anonymous", it may still be possible to obtain sensitive information about some individuals or groups of individuals with the use of pattern recognition algorithms. In this article, we study the problem of determining the degree of ambiguation in disseminated databases and discuss its implications in the development and testing of "anonymization" algorithms.

Algorithms↗

Regional mapping panel for human chromosome 17: application to neurofibromatosis type 1.

A somatic cell hybrid mapping panel was constructed to localize cloned DNA sequences to any of 15 potentially different regions of human chromosome 17. Relatively high-resolution mapping is possible for 50% of the chromosome length in which 12 breakpoints are distributed over approximately 45 megabases, with an average spacing estimated at 1 breakpoint every 2-7 megabases. This high-resolution capability includes the pericentromeric region of 17 to which von Recklinghausen neurofibromatosis (NF1) has recently been mapped. Using 20 cloned genes and anonymous probes, we have tested the expected order and location of panel breakpoints and confirmed, refined, or corrected the regional assignment of several cloned genes and anonymous probes. Four markers with varying degrees of linkage to NF1 have been physically localized and ordered by the panel: the loosely linked markers myosin heavy chain 2 (25 cM) to p12----13.105 and nerve growth factor receptor (14 cM) to q21.1----q23; the more closely linked pABL10-41 (D17S71, 5 cM) to p11.2; and the tightly linked pHHH202 (D17S33) to q11.2-q12. Thus, physical mapping of linked markers confirms a pericentromeric location of NF1 and, along with other data, suggests the most likely localization is proximal 17q.

Animals↗

Guidelines for designing rapid assessment surveys of HIV seroprevalence among hospitalized patients. Centers for Disease Control and Prevention.

The Centers for Disease Control and Prevention has developed guidelines for determining HIV seroprevalence among patients seeking medical care at acute-care hospitals. The guidelines enable hospital staff members to perform a simple, rapid, and inexpensive survey to determine seroprevalence among the patient population, protecting the anonymity of those who are tested. The guidelines are based on national experience with large-scale anonymous, unlinked HIV serosurveys. The data from a rapid assessment survey are particularly useful for evaluating the need to provide routine, voluntary HIV counseling and testing and treatment for HIV infection. Beyond that, such data can be used in targeting education efforts, in reinforcing the use of appropriate universal precautions, in resource allocation, and in determining the need for further studies of HIV infection among the population in the hospital catchment area.

AIDS Serodiagnosis↗

Voluntary HIV counseling and testing: experience among the sexually active population in Bangui, Central African Republic.

OBJECTIVES: In July 1997, the National Reference Center for Sexually Transmitted Diseases of Bangui, Central African Republic (CAR), was expanded by the creation of an anonymous and voluntary counseling and testing (VCT) unit for HIV infection, the Anonymous Surveillance Unit (Unité de Dépistage Anonyme [UDA]). The goal of the UDA was to initiate and promote voluntary HIV testing in the general adult population of Bangui. We carried out an observational and comprehensive survey over a 4-year period to document and analyze the experience of VCT in the UDA, with special attention to risk factors associated with HIV infection. METHODS: All clients for VCT were given adequate pretest counseling by trained counselors focused on knowledge about HIV infection and sexually transmitted infections, individual risks of acquiring HIV, and anticipation of the client's attitude about test results. After consent was obtained, a blood sample was drawn and tested for HIV by two ELISAs in parallel. The client paid a standard cost of $1.20 at the initial visit. After a week, test results were given to the client during the posttest visit, at which time HIV-seropositive individuals received emotional support and were referred to specific social or medical structures. Seronegative clients received reinforcement of prevention messages and were asked to come back for serologic follow-up free of charge after 3 (M3) and 12 (M12) months. RESULTS: From July 1997 to March 2001, 5686 individuals aged 14 to 65 years (mean age, 27 years) had an initial visit for VCT (V1). Peaks of UDA visitation (250-450 clients) were observed on the annual AIDS Day in the CAR, at which time HIV serologic testing was offered free of charge. A total of 5060 (89%) clients came back for a second visit (V2) to receive test results. Among those, 18.3% were infected with HIV type 1. Multivariate analysis of risk factors demonstrated marked association of HIV seropositivity with age, female gender, widowed/divorced women, poor or low education level, occupations such as civil servants or merchants, presence of symptoms of sexually transmitted infections, and lack of systematic condom use. Single young women were at higher risk for HIV infection compared with men of the same age (OR = 7.7 for women aged 15-24 years, 95% CI: 4.0-14.0; OR = 2.8 for women aged 25-34 years, 95% CI: 1.7-4.5). Widowed women older than 44 years of age were more likely to be HIV-seropositive than men (OR = 10.0; 95% CI: 1.7-83.6). A total of 885 (21%) HIV-seronegative individuals returned for follow-up at 3 months (M3; 0.45% rate of seroconversion). Seventy-nine (9%) individuals returned at 12 months (M12), without any new cases of HIV infection. HIV-negative clients consulting at M3 and M12 showed a significant reduction in unprotected intercourse with occasional sexual partners. CONCLUSION: This experience demonstrates that VCT for HIV infection is feasible in Central Africa.

AIDS Serodiagnosis↗

The extent of undiagnosed HIV infection among emergency department patients: results of a blinded seroprevalence survey and a pilot HIV testing program.

This study was performed to determine the rate of previously undiagnosed HIV infection among patients presenting to an urban emergency department (ED) and to assess the feasibility of routinely offering voluntary HIV testing in this setting. HIV serostatus was determined anonymously among consecutive acute medicine and trauma ED patients (aged 18-55) who had blood drawn as part of their medical care. Excess serum was aliquoted and coded with an anonymous study code. Before performing HIV testing, the number of persons with previously reported HIV infection was determined by linkage with the state HIV/AIDS reporting registry. Concurrent with the blinded HIV serosurvey, ED patients were offered voluntary HIV testing in a pilot program. Overall, 76 of 2,155 (3.5%) adult ED patients in the blinded survey were HIV-seropositive, 15 of whom (0. 7% of those tested, 20% of those HIV-seropositive) had no infection previously reported to the state HIV/AIDS registry. In the pilot program, six of the 156 (3.8%) individuals who underwent voluntary HIV testing were HIV-seropositive, including three of 53 (5.6%) individuals without prior HIV testing. Of the six HIV-seropositive subjects, one was previously diagnosed, while five of the remaining 155 (3.2%) represented previously undiagnosed infections. Overall, 3. 5% of ED patients from whom blood was obtained for other reasons tested positive for HIV antibody, 20% of whom were previously undiagnosed. Implementation of the voluntary testing program uncovered newly diagnosed infection among 3.2% of those tested. An ED may be an important setting for routinely offering HIV testing, especially for patients who have not been previously tested for HIV.

Adolescent↗

Pharmacological content of tablets sold as "ecstasy": results from an online testing service.

PURPOSE: This study examined the pharmacological content of tablets sold as ecstasy, the variation of tablet content by geographic region, and change in tablet content between 1999 and 2005. METHODS: The sample was comprised of tablets anonymously submitted for laboratory testing between 1999 and 2005 (n=1214). Tablet height, width, geographic region, and year of submission were all used to predict the pharmacological content of the tablets. RESULTS: Overall, 39% of the tablets were comprised of MDMA only, 46% only contained substances other than MDMA and 15% were mixtures of MDMA and other substances. Tablet height and width were inversely related to tablet purity. Ecstasy tablets from California and Florida had decreased likelihoods of containing non-MDMA substances. The purity of tablets decreased over time, which was largely a result of an increasing number of tablets comprised of MDMA along with other substances. CONCLUSIONS: Ecstasy users may be putting themselves at increased risk of substance-induced anxiety, mood, and psychotic disorders by unknowingly ingesting substances other than MDMA. To decrease detrimental health effects, prevention programs should emphasize the impurity of ecstasy tablets and focus on the health impacts of these substances, particularly for populations at high-risk of substance-induced disorders.

Drug Contamination↗

Risk behaviour among blood donors who give blood in order to be tested for the human immunodeficiency virus.

BACKGROUND AND OBJECTIVES: There has been concern that some individuals may donate blood primarily motivated by the easy access to human immunodeficiency virus (HIV) testing, and that such donors may represent a risk to the transfusion service. In this article we focus on the risk behaviour of donors who reported that they gave blood in order to be HIV tested. MATERIALS AND METHODS: Anonymous questionnaires were given to 5859 blood donors. The response rate was 70%. RESULTS: Of the responders, 2.8% reported to have donated blood in order to be HIV tested. However, 87% of the donation-for-test group did not have any identified risk behaviour. CONCLUSIONS: The proportion who donated blood in order to be HIV tested was higher than expected, but the majority of the group did not have any identifiable HIV risk.

AIDS Serodiagnosis↗

Genotyping of Flavobacterium psychrophilum using PCR-RFLP analysis.

Genetic variability among 242 strains of Flavobacterium psychrophilum was characterized using polymerase chain reaction (PCR) followed by restriction fragment length polymorphism (RFLP) analysis. Universal Primers GYR-1 and GYR-1R, which were designed to amplify the gyrase subunit B gene (gyrB), yielded a 1178 bp PCR product encoding gyrB and a 290 bp PCR product of anonymous DNA from all F. psychrophilum strains tested. In the RFLP analysis of the anonymous 290 bp DNA marker, the restriction enzyme HinfI generated 2 cleavage patterns (Genotypes A and B). Genotype A was found only in isolates from ayu (n = 109), while Genotype B was found in isolates from coho salmon (n = 11), ayu (n = 35), rainbow trout (n = 43) and other fishes (n = 44). In the second experiment, Primers PSY-G1F and PSY-G1R specific for F. psychrophilum, were used to amplify gyrB. The specific primer pair amplified the expected size (1017 bp) PCR product from all F. psychrophilum strains. In the RFLP analysis of the gyrB, the restriction enzyme RsaI produced 2 genotypes, R and S. Genotype R was found in isolates from coho salmon (n = 6), ayu (n = 27), rainbow trout (n = 39) and other fishes (n = 4). Genotype S was found in isolates from coho salmon (n = 5), ayu (n = 117), rainbow trout (n = 4) and other fishes (n = 40).

Animals↗

A survey of pediatric critical care nurses' knowledge of pain management.

BACKGROUND: Although nurses are accountable for pain management, it cannot be assumed that they are well informed about pain. Nurses' knowledge base underlies their pain management; therefore, it is important to measure their knowledge. OBJECTIVE: To measure pediatric critical care nurses' knowledge of pain management. METHOD: A descriptive, exploratory study was done. After a pilot study, an investigator-developed Pain Management Knowledge Test was distributed to 50 pediatric ICU nurses. Test responses were collected anonymously and coded by number. Item analysis was done, and descriptive statistics were calculated. Modified content analysis was used on requests for pain-related information. RESULTS: The test return rate was 38%. The overall mean score was 63%. Mean scores within test subsections varied from 50% to 92%. Other mean scores were 85% on a nine-item scale of drug-action items and 92% on a two-item scale of intervention items. However, no nurse recognized that cognitive-behavioral techniques can inhibit transmission of pain impulses; only 32% indicated that meperidine converts to a toxic metabolite, only 47% recognized nalbuphine as a drug that may cause signs and symptoms of withdrawal if given to a patient who has been receiving an opioid; and only 63% indicated that when a child states that the child has pain, pain exists. Thirteen nurses requested pain-related information, and all requests focused on analgesic medications. CONCLUSIONS: Testing nurses' knowledge of pain indicated gaps that can be addressed through educational interventions. Research is needed in which the test developed for this study is used as both pretest and posttest in an intervention study with pediatric critical care nurses or is modified for use with nurses in other clinical areas.

Adolescent↗

[Childhood sexual abuses among 1307 adult students and analysis on results of Symptom Checklist-90 test].

OBJECTIVE: To survey the occurrence of childhood sexual abuses (CSA) among adult students and analyze the correlation between the sexual abuses and the results of Symptom Check-List-90 (SCL-90) test. METHODS: Questionnaire survey of 1307 adult students (701 female students, 606 male students) in a college about their personal experience on childhood sexual abuses. The surveys were conducted anonymously. And SCL-90 test was carried out at the same time. RESULTS: A total of 1307 students were surveyed. 18.67% of them (female students, 155, 22.11%; male students, 89, 14.69%) experienced non-physical contact sexual abuses and/or physical contact sexual abuses before the age of 18 years, among whom 124 students (female students, 81, 11.55%; male students, 44, 7.26%) experienced physical contact sexual abuses, including 35 (26 female; 9 male) who suffered attempted genital or anal sexual intercourse and 11 (8 female and 3 male) were forced for genital or anal sexual intercourse; 13.70% (female 15.66%; male 11.44%) said they experienced sexual abuses before the age of 16 years. Of the boys, experienced sexual abuse 54.7% from age 12 to age 16 years. And among the girls sexual abuses tended to increase with their growth (results of tendency test: chi(2) = 33.5, P < 0.001). The abusers were mostly males; only a small percentage of them used violence; for most female students who experienced non-physical contact sexual abuses, the abusers were strangers (78.7%), while 71.3% of physical contact abuses were from acquaintances, 12.5% of them were teachers, 17.5% were neighbors and 21.3% were relatives. Of the male victims, 89.9% said they knew the abusers before the abuses happened, 14.6% (13 out of 89) of them were teachers, and neighbors constituted another 21.3% (19 out of 89). Students who experienced childhood sexual abuses got higher scores than the students who didn't have such experience in the nine basic symptom factors of SCL-90 and higher than normal model of national young group notably. CONCLUSION: Childhood sexual abuse among students is not rare. The female students' incidence was obviously higher than that among the male students (chi(2) = 11.8, P = 0.001). About half of the abusers were the victims' close relatives, neighbors and teachers who live or study together with them. Personal experience of childhood sexual abuses may be one of the important factors influencing the victims' results of SCL-90 test.

Adolescent↗

An education model for otitis media care field-tested in Latin America.

The World Health Organization has designated the teaching of otitis media management skills a "priority" status. Effective treatment of ear disease requires that the physician be both informationally educated as well as physically trained to use otoscopy. Little is known about how well this education can be provided in a short time and in a foreign country. To more objectively assess teaching effect, results of an education session for rural Mexican pediatric primary-care providers who were given an intensive otitis media lecture and otoscopy skills workshop in 1990 were evaluated. To test immediate cognitive impact, an anonymous written examination was given both before and after the teaching session. Average test scores after the educational sessions improved 24% (p < 0.001) over baseline scores before the sessions. To evaluate long-term impact on clinical practice, a follow-up telephone survey 2 years later was conducted. The use of an otoscope to diagnose otitis media had increased from 40% to 93% of respondents. We conclude that pediatric primary-care providers in rural Mexico possess a baseline level of knowledge about otitis media that can be significantly enhanced with one educational session. Further, this teaching effort produces an impact on practice pattern that lasts at least 2 years.

Clinical Competence↗

Human immunodeficiency virus type 1 and hepatitis C virus co-infection and viral subtypes at an HIV testing center in Brazil.

Human immunodeficiency virus (HIV) testing sites have been recognized recently as potential settings for hepatitis C virus (HCV) screening since both viruses share common routes of transmission. HIV and HCV prevalence, predictors, co-infection rates, and viral subtypes were studied in 592 attendants at an anonymous HIV Counseling and Testing Center in central Brazil. Anti-HIV-1 and -HCV antibodies were screened by ELISA, and Western blots were used to confirm HIV infection. Among HIV-seropositive samples, reverse transcriptase-polymerase chain reaction (RT-PCR) and nested-PCR were used to subtype HIV-1 by the Heteroduplex Mobility Analysis (HMA) and HCV by the line probe assay (INNO-LiPA). HIV and HCV seroprevalence was 3.2% (95% CI 2.0-4.9) and 2.5% (95% CI 1.5-4.0), respectively. Intravenous drug use was the risk factor most strongly associated with both HIV and HCV infections, even in a population with few intravenous drug users (n = 6); incarceration was also associated with HCV. HIV/AIDS-positive sexual partner and homosexual/bisexual behaviors were associated independently with HIV-1. The prevalence of HCV infection among HIV-positive persons was 42% (95% CI 20-66), higher than in HIV-negative persons (1.2%; 95% CI 0.5-2.5). HIV-1 subtype B was identified in the env and gag regions of the genome. HCV subtype 3a predominated among co-infected persons and one HCV subtype 1a was detected. Overall, a similar prevalence of HIV and HCV infections and a higher prevalence of HCV among HIV-positive persons were observed. Integrated HIV and HCV screening at HIV testing sites may represent a unique opportunity to provide diagnosis and prevention strategies at a single visit.

Adolescent↗

HIV testing among injecting drug users in Glasgow.

The use of saliva rather than blood for epidemiological studies of HIV prevalence, especially among injecting drug users, has several practical advantages. In a cross-sectional, behavioural and prevalence study among drug users in Glasgow during 1990, salivary samples were therefore obtained by the use of salivettes. Such samples were requested for anonymous anti-HIV testing from 498 persons in locations varying from residential rehabilitation centres to the open streets. Of this number, 35 refused to give a sample, resulting in a compliance rate of 93%. Of the 463 salivettes received by the laboratory, eight were found to be dry. Of the remaining 455 specimens, eight were found to be positive for HIV-1 antibody by means of an IgG antibody capture ELISA, so giving a prevalence rate of 1.8%. The results of testing saliva and blood spot samples collected at the same time on filter paper from 98 persons for HIV-1 antibody were 100% concordant. The study confirms the experience of others that specimens of saliva are easy to collect under variable conditions by non-medical staff and demonstrates that the salivette can provide an HIV antibody test result the same as that obtained from a blood spot. The prevalence of HIV antibody determined in this study is similar to that of other studies taking place in the city during the same period of time.

Cross-Sectional Studies↗

Global gene mining and the pharmaceutical industry.

Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samples are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society of Human Genetics preparing background paper on 'Polymorphic sequence variants in medicine: Technical, social, legal and ethical issues. Pharmacogenetics as an example'. Within the European project Privacy in Research Ethics and Law (PRIVIREAL), recommendations for common European guidelines for membership in research ethical committees have been discussed, balancing the interests and assuring independence and legal competence. Good decision making, assuring legality of protocols and assessment of data protection is suggested to be part of any evaluation of protocols.

Drug Industry↗