Population-based research is enhanced by biological

measures, but biological sampling raises complex ethical

issues. The third British National Survey of Sexual

Attitudes and Lifestyles (Natsal-3) will estimate the

population prevalence of five sexually transmitted

infections (STIs) (Chlamydia trachomatis, Neisseria

gonorrhoeae, human papillomavirus (HPV), HIV and

Mycoplasma genitalium) in a probability sample aged

16e44 years. The present work describes the

development of an ethical approach to urine testing for

STIs, including the process of reaching consensus on

whether to return results. The following issues were

considered: (1) testing for some STIs that are treatable

and for which appropriate settings to obtain free testing

and advice are widely available (Natsal-3 provides all

respondents with STI and healthcare access

information), (2) limits on test accuracy and timeliness

imposed by survey conditions and sample type, (3)

testing for some STIs with unknown clinical and public

health implications, (4) how a uniform approach is easier

to explain and understand, (5) practical difficulties in

returning results and cost efficiency, such as enabling

wider STI testing by not returning results. The agreed

approach, to perform voluntary anonymous testing with

specific consent for five STIs without returning results,

was approved by stakeholders and a research ethics

committee. Overall, this was acceptable to respondents

in developmental piloting; 61% (68 of 111) of

respondents agreed to provide a sample. The

experiences reported here may inform the ethical

decision making of researchers, research ethics

committees and funders considering population-based

biological sampling

Beddows, S

Field, N

Ison, C

Johnson, AM

Mercer, CH

Nicholson, S

Soldan, K

Sonnenberg, P

Tanton, C

Journal of Medical Ethics

PubMed

Population-based research is enhanced by biological measures, but biological sampling raises complex ethical issues. The third British National Survey of Sexual Attitudes and Lifestyles (Natsal-3) will estimate the population prevalence of five sexually transmitted infections (STIs) (Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus (HPV), HIV and Mycoplasma genitalium) in a probability sample aged 16–44 years. The present work describes the development of an ethical approach to urine testing for STIs, including the process of reaching consensus on whether to return results. The following issues were considered: (1) testing for some STIs that are treatable and for which appropriate settings to obtain free testing and advice are widely available (Natsal-3 provides all respondents with STI and healthcare access information), (2) limits on test accuracy and timeliness imposed by survey conditions and sample type, (3) testing for some STIs with unknown clinical and public health implications, (4) how a uniform approach is easier to explain and understand, (5) practical difficulties in returning results and cost efficiency, such as enabling wider STI testing by not returning results. The agreed approach, to perform voluntary anonymous testing with specific consent for five STIs without returning results, was approved by stakeholders and a research ethics committee. Overall, this was acceptable to respondents in developmental piloting; 61% (68 of 111) of respondents agreed to provide a sample. The experiences reported here may inform the ethical decision making of researchers, research ethics committees and funders considering population-based biological sampling

Field, Nigel

Tanton, Clare

Mercer, Catherine H.

Nicholson, Soazig

Soldan, Kate

Beddows, Simon

Ison, Catherine

Johnson, Anne M.

Sonnenberg, Pam

Sexual Reproductive Health and Rights Repository (Aga Khan University)

Testing for sexually transmitted infections ina population-based sexual health survey:development of an acceptable ethical approachNigel Field,1 Clare Tanton,1 Catherine H Mercer,1 Soazig Nicholson,2 Kate Soldan,3Simon Beddows,3 Catherine Ison,3 Anne M Johnson,1 Pam Sonnenberg1ABSTRACTPopulation-based research is enhanced by biologicalmeasures, but biological sampling raises complex ethicalissues. The third British National Survey of SexualAttitudes and Lifestyles (Natsal-3) will estimate thepopulation prevalence of five sexually transmittedinfections (STIs) (Chlamydia trachomatis, Neisseriagonorrhoeae, human papillomavirus (HPV), HIV andMycoplasma genitalium) in a probability sample aged16e44 years. The present work describes thedevelopment of an ethical approach to urine testing forSTIs, including the process of reaching consensus onwhether to return results. The following issues wereconsidered: (1) testing for some STIs that are treatableand for which appropriate settings to obtain free testingand advice are widely available (Natsal-3 provides allrespondents with STI and healthcare accessinformation), (2) limits on test accuracy and timelinessimposed by survey conditions and sample type, (3)testing for some STIs with unknown clinical and publichealth implications, (4) how a uniform approach is easierto explain and understand, (5) practical difficulties inreturning results and cost efficiency, such as enablingwider STI testing by not returning results. The agreedapproach, to perform voluntary anonymous testing withspecific consent for five STIs without returning results,was approved by stakeholders and a research ethicscommittee. Overall, this was acceptable to respondentsin developmental piloting; 61% (68 of 111) ofrespondents agreed to provide a sample. Theexperiences reported here may inform the ethicaldecision making of researchers, research ethicscommittees and funders considering population-basedbiological sampling.INTRODUCTIONTesting of biological samples in epidemiologicalresearch raises important ethical questions.1 Theissues are particularly complex when applied tosexually transmitted infections (STIs) because of thestigma associated with diagnosis and the impor-tance of confidentiality.2 Researchers are also facedwith the decision of whether and when to discloseresults to research participants.3 This paperdescribes the development of an ethical approach tourine-based STI testing in the third British NationalSurvey of Sexual Attitudes and Lifestyles (Natsal-3).Natsal-3 is a probability sample of 15 000 adultsaged 16e74 years in Britain for which surveyfieldwork started in 2010. It follows previousNatsal surveys in 1990 and 2000.4 5 The surveycollects behavioural data, including sexual activity,partnership patterns, sexual function and healthoutcomes. In addition, Natsal-3 employs urine-based testing to estimate prevalence of Chlamydiatrachomatis, Neisseria gonorrhoeae, human papillo-mavirus (HPV), HIV and Mycoplasma genitalium ina subgroup of 5000 respondents aged 16e44 years.Benefits of biological testing in population-basedresearchLinking biological information to behavioural anddemographic data can strengthen population-basedresearch. For example, in 2000, Natsal-2 measuredurinary C trachomatis prevalence, which informedthe decision to extend national screening to men.6Among many others, national surveys such as theUK Biobank, Health Survey for England (HSE), theEnglish Longitudinal Study of Ageing (ELSA),the USA Health and Retirement Study (HRS) andthe National Health and Nutrition and ExaminationSurvey (NHANES) collect biological samples forbiomarkers of disease. Biomarkers are not subject toreporting bias and lend considerable weight to thescientific reliability and precision of data, and maybe used to validate self-reporting.7 These studiesinform a wide range of health-related activities.An ethical framework for biological testing inpopulation-based researchBiological testing in population-based research alsoraises important ethical considerations, for whichthe bioethical principles (autonomy, beneficence,non-maleficence and justice), set out by Beauchampand Childress, provide a framework.8 Beauchampand Walters also identified four secondary princi-ples: ‘fidelity ’, ‘confidentiality ’, ‘utility ’ and‘veracity ’.9 The WHO and Joint United NationsProgramme on HIV/AIDS (UNAIDS) applied thesestandards to guide the design of population-basedsurveys measuring HIV prevalence.10 First, respon-dents should ‘be protected from any harm’, whichincludes safeguarding respondent confidentiality.Second, respondents should ‘participate in thebenefits of the research’. This is more complexbecause there may be no direct benefits forrespondents in population-based surveys, butrather indirect societal benefits.11 12 Direct clinicalbenefits may occur where results are returned torespondents with advice and/or treatment.WHO/UNAIDS guidelines therefore suggestreferral to free testing where results are notreturned.10 Third, respondents should ‘be informed1Centre for Sexual Health & HIVResearch, Research Departmentof Infection & Population Health,University College London,London, UK2National Centre for SocialResearch, London, UK3Health Protection Agency,London, UKCorrespondence toDr Nigel Field, Centre for SexualHealth & HIV Research,Research Department ofInfection & Population Health,University College London,Mortimer Market Centre, offCapper Street, London WC1E6JB, UK; nigel.field@nhs.netReceived 28 June 2011Revised 17 November 2011Accepted 9 December 2011Published Online First17 January 2012This paper is freely availableonline under the BMJ Journalsunlocked scheme, see http://jme.bmj.com/site/about/unlocked.xhtml380 J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068Brief reportof the procedures and risks’. And fourth, respondents should‘freely choose whether or not to participate in the study’.International guidelines for HIV testing have distinguishedbetween unlinked anonymous testing (UA), where results areirreversibly unlinked from the person tested, and linked testing,where results may or may not be returned.13 A programme ofUA HIV surveillance testing has been successfully in place in theUK since 1990.14 However, the UA surveys differ from Natsal-3in two key respects; (1) the UA research programme is not theprimary reason for obtaining the sample tested, which isa routine sample and would otherwise have been discarded, and(2) individual consent for HIV testing on the leftover bloodsamples is not usually required.10Whether to return STI results in Natsal-3Focus group studies suggest significant public interest in indi-vidual results from genetic research studies,15 but no studieshave directly investigated preferences for obtaining results in thecontext of population-based STI research.In designing Natsal-3, the decision to return STI results ornot was an ethical concern because harm to respondents andtheir sexual partners might be avoided by returning results fortreatable infections. Full disclosure is also consistent withupholding respect for respondents, and includes those wishingto participate only where results are returned.16 We consideredthe risks associated with not returning STI results against thealternative risks if named testing was conducted and resultswere returned.METHODSWe undertook an extensive development phase to agree and testthe acceptability and feasibility of STI testing in Natsal-3. Theethical principles described above informed our initial approachduring the study funding process, and this was endorsed viaindependent peer review. An informed consensus was thensought through consultation with stakeholders including theHealth Protection Agency (HPA), clinicians and the study ’sAdvisory Group (which includes representatives from theTerrence Higgins Trust, Family Planning Association and UKDepartment of Health). The approach was submitted to a NHSresearch ethics committee (REC) before piloting of the wholesurvey was undertaken in 23 postcode sectors across GreatBritain. Within each sector, 25 addresses were randomly selectedto yield a total sample of 575 addresses, of which 434 wereresidential with English-speaking and eligible occupants (aged16e74 years). Interviews took place between March and May2010. The response rate was 50.2%: 111 respondents aged16e44 years reporting at least one sexual partner were invited toprovide a urine sample.RESULTSThe availability of free STI tests in BritainFor some STIs, there are specific recommended treatments withdirect clinical benefits (table 1). However, it was argued thatspecific written details describing access to and availability ofSTI/HIV testing, as well as general sexual health informationcould be provided to respondents, and that these services providea more appropriate setting for free diagnostic testing than ispossible for Natsal-3. For C trachomatis, there is now widespreadtesting in the community, and for young people since 2003,a national screening programme, such that an estimated 22.1%of 15e24 year olds were screened in 2010.18 Sexual healthscreening was less accessible in 2000, when Natsal-2 did returnC trachomatis results.19Accuracy and timeliness of survey testsAs in other surveys, the tests used in Natsal-3 may not reach therequired level of clinical diagnostic accuracy, while still beingsufficiently accurate for population prevalence estimates (table1). Under study conditions some loss in sensitivity is expected,due to limitations on the specimen type and the need totransport, freeze and batch test samples, which may result inclinically unacceptable delays. The standard of diagnostic accu-racy is a concern for all respondents. For example, a null ornegative result feedback might result in undue reassurance andbe without the health education messages that can be deliveredwhen this occurs in a clinical setting. Providing STI test results,where the prevalence and therefore positive predictive valuesmay be low raises the possibility of false positives, which wouldalso cause harm through undue concern (table 1).Results with unknown clinical and public health implicationsFor HPV and M genitalium, the clinical and public health impli-cations currently remain uncertain, such that a positive resultmay not require specific management, treatment or partnernotification and may cause unnecessary and unethical distress(table 1).A consistent approach supports effective communicationProviding results for some STIs, but not others, may be misin-terpreted in that respondents may wrongly assume the resultsto apply to all STIs. A thorough understanding of the studydesign is a prerequisite for obtaining informed consent fromrespondents, and we argued that a uniform approach to testTable 1 Whether or not to return STI results for the third British National Survey of Sexual Attitudes andLifestyles (Natsal-3): infection-specific issues (as of 2009)Free NHStesting availableClinical standard fortreatment availablePrevalence ofundiagnosed infectionsSample type andtesting is of clinicaldiagnostic standardChlamydia trachomatis Yes Yes High No*Neisseria gonorrhoeae Yes Yes Low No*HIV Yes Yes Lowy NoHPV Noz No High NAxMycoplasma genitalium Noz No Unknown NAxBold type shows factors that favour named testing.*Due to delay and batch testing.yThe Health Protection Agency estimates that 24% of HIV-infected people are unaware of their infection in the UK.17zNot usually performed.xA clinical standard for testing is not currently available.HPV, human papillomavirus; NA, not applicable; STI, sexually transmitted infection.J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068 381Brief reportresults is easier to communicate, both for interviewers to explainand for respondents to understand.Practical considerations and cost efficiencyIn Natsal-2, where C trachomatis prevalence was approximately2%, a research nurse was employed to actively follow-upcases.6 19 Even with considerable effort, it proved impossible tocontact 11% of cases with their results, and clinical outcomeswere only available in half of contacted cases. Other authorshave acknowledged the human and financial cost associated withappropriate return of results.15 For Natsal-3, non-return wasargued to enable testing of a wider range of infections to identifycoinfection and associated risk factors. We reasoned that maxi-mising the scientific output from biological testing is desirable,provided ethical principles are not compromised, and is consis-tent with an obligation to spend public research funds wisely.AcceptabilityIn piloting, 61% (68 of 111) of respondents agreed to providea urine sample without receiving results. In Natsal-2, in 2000,when C trachomatis results were given, 71% of participants agreed.6Few respondents raised concerns that results would not bereturned. Some respondents were reassured after discussing theirconcerns with the interviewer. Data from the developmental phasewere used to inform the study design and the patient informationliterature, and to support subsequent REC applications.DISCUSSIONThis paper describes the development of, and basis for, an ethi-cally sound approach to STI testing within a large, population-based survey. Our approach was guided by ethical, practical andscientific principles and considerations. The testing of STIs andthe decision not to return results was accepted by a REC, withinthe context that respondents were informed about andconsented to this methodology. Although there are not directbenefits to participation, voluntary anonymised testing, withspecific consent for this, including the knowledge that resultswill not be returned, was acceptable to respondents whenpiloted in Natsal-3.Acknowledgements We thank the Natsal-3 team members, the studystakeholders and Advisory Group members who contributed to the content of thiswork. The authors thank Kevin Fenton in particular for helpful discussions on theissues raised in this paper.Funding The authors thank the Medical Research Council and Wellcome Trust forfunding the Natsal-3 study. The views expressed in this paper are those of the authorsand not necessarily those of the funders. MRC: G0701757, Wellcome: 084840.Competing interests None.Patient consent Study subjects were members of the public rather than patients,and a specific consent form, approved by the research ethics committee, wasdeveloped for the study.Ethics approval Oxford A MREC.Contributors AMJ, as Principal Investigator for Natsal-3, and PS, Natsal-3Co-Applicant, are joint senior authors with overall responsibility for this work. NFdrafted this paper in discussion with all authors. All authors participated in itsstructure, content and preparation.Provenance and peer review Not commissioned; externally peer reviewed.Data sharing statement The data presented in this study are pilot data, which areonly accessible by the Natsal-3 study team. However, Natsal-3 survey data will bemade publicly available after the end of the study through the UK data archive hostedby Essex University (http://www.data-archive.ac.uk).REFERENCES1. Bauer S. Societal and ethical issues in human biomonitoringea view from sciencestudies. Environ Health 2008;7(Suppl 1):S10.2. Hood JE, Friedman AL. Unveiling the hidden epidemic: a review of stigmaassociated with sexually transmissible infections. Sex Health 2011;8:159e70.3. Wolf LE, Bouley TA, McCulloch CE. Genetic research with stored biologicalmaterials: ethics and practice. IRB 2010;32:7e18.4. Johnson AM, Wadsworth J, Field J, et al. Sexual Attitudes and Lifestyles. Oxford:Blackwell Scientific Publications, 1994.5. Johnson AM, Mercer CH, Erens B, et al. Sexual behaviour in Britain: partnerships,practices, and HIV risk behaviours. Lancet 2001;358:1835e42.6. Fenton KA, Korovessis C, Johnson AM, et al. Sexual behaviour in Britain: reportedsexually transmitted infections and prevalent genital Chlamydia trachomatis infection.Lancet 2001;358:1851e4.7. Banks J, Marmot M, Oldfield Z, et al. Disease and disadvantage in the United Statesand in England. JAMA 2006;295:2037e45.8. Beauchamp C. Principles of Biomedical Ethics. 5th edn. New York: Oxford UniversityPress, 2001.9. Beauchamp T, Walters L, eds. Contemporary Issues in Bioethics. Belmont,California: Wadsworth Publishing Company, 1994.10. WHO. UNAIDS: Guidelines for Measuring National HIV Prevalence in Population-Based Surveys. Geneva: UNAIDS/WHO, 2006.11. de Melo-Martin I. A duty to participate in research: does social context matter? AmJ Bioeth 2008;8:28e36.12. Schaefer GO, Emanuel EJ, Wertheimer A. The obligation to participate in biomedicalresearch. JAMA 2009;302:67e72.13. WHO. UNAIDS: Guidelines for Using HIV Testing Technologies in Surveillance:Selection, Evaluation and Implementation 2009 Update. Geneva: UNAIDS/WHO, 2009.14. Gill ON, Adler MW, Day NE. Monitoring the prevalence of HIV: foundations fora programme of unlinked anonymous testing in England and Wales. BMJ1989;299:1295e8.15. Murphy J, Scott J, Kaufman D, et al. Public expectations for return of results fromlarge-cohort genetic research. Am J Bioeth 2008;8:36e43.16. Shalowitz DI, Miller FG. Disclosing individual results of clinical research: implicationsof respect for participants. JAMA 2005;294:737e40.17. Health Protection Agency. HIV in the United Kingdom: 2011 Report. London,Colindale: Health Protection Services, 2011.18. National Chlamydia Screening ProgrammedNCSP Home. http://www.chlamydiascreening.nhs.uk/19. McCadden A, Fenton KA, McManus S, et al. Chlamydia trachomatis testing in thesecond British national survey of sexual attitudes and lifestyles: respondent uptakeand treatment outcomes. Sex Transm Dis 2005;32:387e94.PAGE fraction trail=2.75382 J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068Brief report

Testing for sexually transmitted infections in a population-based sexual health survey: development of an acceptable ethical approach

Nigel Field

Clare Tanton

Catherine H Mercer

Soazig Nicholson

Kate Soldan

Simon Beddows

Catherine Ison

Anne M Johnson

Pam Sonnenberg

Crossref

Testing for sexually transmitted infections in a population-based sexual health survey: development of an acceptable ethical approach: Table 1

Population-based research is enhanced by biological measures, but biological sampling raises complex ethical issues. The third British National Survey of Sexual Attitudes and Lifestyles (Natsal-3) will estimate the population prevalence of five sexually transmitted infections (STIs) (Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus (HPV), HIV and Mycoplasma genitalium) in a probability sample aged 16-44 years. The present work describes the development of an ethical approach to urine testing for STIs, including the process of reaching consensus on whether to return results. The following issues were considered: (1) testing for some STIs that are treatable and for which appropriate settings to obtain free testing and advice are widely available (Natsal-3 provides all respondents with STI and healthcare access information), (2) limits on test accuracy and timeliness imposed by survey conditions and sample type, (3) testing for some STIs with unknown clinical and public health implications, (4) how a uniform approach is easier to explain and understand, (5) practical difficulties in returning results and cost efficiency, such as enabling wider STI testing by not returning results. The agreed approach, to perform voluntary anonymous testing with specific consent for five STIs without returning results, was approved by stakeholders and a research ethics committee. Overall, this was acceptable to respondents in developmental piloting; 61% (68 of 111) of respondents agreed to provide a sample. The experiences reported here may inform the ethical decision making of researchers, research ethics committees and funders considering population-based biological sampling

Mercer, Catherine H

Johnson, Anne M

LSHTM Research Online

LSHTM Research OnlineField, N; Tanton, C; Mercer, CH; Nicholson, S; Soldan, K; Beddows, S; Ison, C; Johnson, AM;Sonnenberg, P; (2012) Testing for sexually transmitted infections in a population-based sexual healthsurvey: development of an acceptable ethical approach. Journal of medical ethics, 38 (6). pp. 380-2.ISSN 0306-6800 DOI: https://doi.org/10.1136/medethics-2011-100068Downloaded from: http://researchonline.lshtm.ac.uk/4649172/DOI: https://doi.org/10.1136/medethics-2011-100068Usage Guidelines:Please refer to usage guidelines at https://researchonline.lshtm.ac.uk/policies.html or alternativelycontact researchonline@lshtm.ac.uk.Available under license: Creative Commons Attribution Non-commercialhttp://creativecommons.org/licenses/by-nc/3.0/https://researchonline.lshtm.ac.ukTesting for sexually transmitted infections ina population-based sexual health survey:development of an acceptable ethical approachNigel Field,1 Clare Tanton,1 Catherine H Mercer,1 Soazig Nicholson,2 Kate Soldan,3Simon Beddows,3 Catherine Ison,3 Anne M Johnson,1 Pam Sonnenberg1ABSTRACTPopulation-based research is enhanced by biologicalmeasures, but biological sampling raises complex ethicalissues. The third British National Survey of SexualAttitudes and Lifestyles (Natsal-3) will estimate thepopulation prevalence of five sexually transmittedinfections (STIs) (Chlamydia trachomatis, Neisseriagonorrhoeae, human papillomavirus (HPV), HIV andMycoplasma genitalium) in a probability sample aged16e44 years. The present work describes thedevelopment of an ethical approach to urine testing forSTIs, including the process of reaching consensus onwhether to return results. The following issues wereconsidered: (1) testing for some STIs that are treatableand for which appropriate settings to obtain free testingand advice are widely available (Natsal-3 provides allrespondents with STI and healthcare accessinformation), (2) limits on test accuracy and timelinessimposed by survey conditions and sample type, (3)testing for some STIs with unknown clinical and publichealth implications, (4) how a uniform approach is easierto explain and understand, (5) practical difficulties inreturning results and cost efficiency, such as enablingwider STI testing by not returning results. The agreedapproach, to perform voluntary anonymous testing withspecific consent for five STIs without returning results,was approved by stakeholders and a research ethicscommittee. Overall, this was acceptable to respondentsin developmental piloting; 61% (68 of 111) ofrespondents agreed to provide a sample. Theexperiences reported here may inform the ethicaldecision making of researchers, research ethicscommittees and funders considering population-basedbiological sampling.INTRODUCTIONTesting of biological samples in epidemiologicalresearch raises important ethical questions.1 Theissues are particularly complex when applied tosexually transmitted infections (STIs) because of thestigma associated with diagnosis and the impor-tance of conﬁdentiality.2 Researchers are also facedwith the decision of whether and when to discloseresults to research participants.3 This paperdescribes the development of an ethical approach tourine-based STI testing in the third British NationalSurvey of Sexual Attitudes and Lifestyles (Natsal-3).Natsal-3 is a probability sample of 15 000 adultsaged 16e74 years in Britain for which surveyﬁeldwork started in 2010. It follows previousNatsal surveys in 1990 and 2000.4 5 The surveycollects behavioural data, including sexual activity,partnership patterns, sexual function and healthoutcomes. In addition, Natsal-3 employs urine-based testing to estimate prevalence of Chlamydiatrachomatis, Neisseria gonorrhoeae, human papillo-mavirus (HPV), HIV and Mycoplasma genitalium ina subgroup of 5000 respondents aged 16e44 years.Benefits of biological testing in population-basedresearchLinking biological information to behavioural anddemographic data can strengthen population-basedresearch. For example, in 2000, Natsal-2 measuredurinary C trachomatis prevalence, which informedthe decision to extend national screening to men.6Among many others, national surveys such as theUK Biobank, Health Survey for England (HSE), theEnglish Longitudinal Study of Ageing (ELSA),the USA Health and Retirement Study (HRS) andthe National Health and Nutrition and ExaminationSurvey (NHANES) collect biological samples forbiomarkers of disease. Biomarkers are not subject toreporting bias and lend considerable weight to thescientiﬁc reliability and precision of data, and maybe used to validate self-reporting.7 These studiesinform a wide range of health-related activities.An ethical framework for biological testing inpopulation-based researchBiological testing in population-based research alsoraises important ethical considerations, for whichthe bioethical principles (autonomy, beneﬁcence,non-maleﬁcence and justice), set out by Beauchampand Childress, provide a framework.8 Beauchampand Walters also identiﬁed four secondary princi-ples: ‘ﬁdelity ’, ‘conﬁdentiality ’, ‘utility ’ and‘veracity ’.9 The WHO and Joint United NationsProgramme on HIV/AIDS (UNAIDS) applied thesestandards to guide the design of population-basedsurveys measuring HIV prevalence.10 First, respon-dents should ‘be protected from any harm’, whichincludes safeguarding respondent conﬁdentiality.Second, respondents should ‘participate in thebeneﬁts of the research’. This is more complexbecause there may be no direct beneﬁts forrespondents in population-based surveys, butrather indirect societal beneﬁts.11 12 Direct clinicalbeneﬁts may occur where results are returned torespondents with advice and/or treatment.WHO/UNAIDS guidelines therefore suggestreferral to free testing where results are notreturned.10 Third, respondents should ‘be informed1Centre for Sexual Health & HIVResearch, Research Departmentof Infection & Population Health,University College London,London, UK2National Centre for SocialResearch, London, UK3Health Protection Agency,London, UKCorrespondence toDr Nigel Field, Centre for SexualHealth & HIV Research,Research Department ofInfection & Population Health,University College London,Mortimer Market Centre, offCapper Street, London WC1E6JB, UK; nigel.field@nhs.netReceived 28 June 2011Revised 17 November 2011Accepted 9 December 2011Published Online First17 January 2012This paper is freely availableonline under the BMJ Journalsunlocked scheme, see http://jme.bmj.com/site/about/unlocked.xhtml380 J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068Brief reportof the procedures and risks’. And fourth, respondents should‘freely choose whether or not to participate in the study’.International guidelines for HIV testing have distinguishedbetween unlinked anonymous testing (UA), where results areirreversibly unlinked from the person tested, and linked testing,where results may or may not be returned.13 A programme ofUA HIV surveillance testing has been successfully in place in theUK since 1990.14 However, the UA surveys differ from Natsal-3in two key respects; (1) the UA research programme is not theprimary reason for obtaining the sample tested, which isa routine sample and would otherwise have been discarded, and(2) individual consent for HIV testing on the leftover bloodsamples is not usually required.10Whether to return STI results in Natsal-3Focus group studies suggest signiﬁcant public interest in indi-vidual results from genetic research studies,15 but no studieshave directly investigated preferences for obtaining results in thecontext of population-based STI research.In designing Natsal-3, the decision to return STI results ornot was an ethical concern because harm to respondents andtheir sexual partners might be avoided by returning results fortreatable infections. Full disclosure is also consistent withupholding respect for respondents, and includes those wishingto participate only where results are returned.16 We consideredthe risks associated with not returning STI results against thealternative risks if named testing was conducted and resultswere returned.METHODSWe undertook an extensive development phase to agree and testthe acceptability and feasibility of STI testing in Natsal-3. Theethical principles described above informed our initial approachduring the study funding process, and this was endorsed viaindependent peer review. An informed consensus was thensought through consultation with stakeholders including theHealth Protection Agency (HPA), clinicians and the study ’sAdvisory Group (which includes representatives from theTerrence Higgins Trust, Family Planning Association and UKDepartment of Health). The approach was submitted to a NHSresearch ethics committee (REC) before piloting of the wholesurvey was undertaken in 23 postcode sectors across GreatBritain. Within each sector, 25 addresses were randomly selectedto yield a total sample of 575 addresses, of which 434 wereresidential with English-speaking and eligible occupants (aged16e74 years). Interviews took place between March and May2010. The response rate was 50.2%: 111 respondents aged16e44 years reporting at least one sexual partner were invited toprovide a urine sample.RESULTSThe availability of free STI tests in BritainFor some STIs, there are speciﬁc recommended treatments withdirect clinical beneﬁts (table 1). However, it was argued thatspeciﬁc written details describing access to and availability ofSTI/HIV testing, as well as general sexual health informationcould be provided to respondents, and that these services providea more appropriate setting for free diagnostic testing than ispossible for Natsal-3. For C trachomatis, there is now widespreadtesting in the community, and for young people since 2003,a national screening programme, such that an estimated 22.1%of 15e24 year olds were screened in 2010.18 Sexual healthscreening was less accessible in 2000, when Natsal-2 did returnC trachomatis results.19Accuracy and timeliness of survey testsAs in other surveys, the tests used in Natsal-3 may not reach therequired level of clinical diagnostic accuracy, while still beingsufﬁciently accurate for population prevalence estimates (table1). Under study conditions some loss in sensitivity is expected,due to limitations on the specimen type and the need totransport, freeze and batch test samples, which may result inclinically unacceptable delays. The standard of diagnostic accu-racy is a concern for all respondents. For example, a null ornegative result feedback might result in undue reassurance andbe without the health education messages that can be deliveredwhen this occurs in a clinical setting. Providing STI test results,where the prevalence and therefore positive predictive valuesmay be low raises the possibility of false positives, which wouldalso cause harm through undue concern (table 1).Results with unknown clinical and public health implicationsFor HPV and M genitalium, the clinical and public health impli-cations currently remain uncertain, such that a positive resultmay not require speciﬁc management, treatment or partnernotiﬁcation and may cause unnecessary and unethical distress(table 1).A consistent approach supports effective communicationProviding results for some STIs, but not others, may be misin-terpreted in that respondents may wrongly assume the resultsto apply to all STIs. A thorough understanding of the studydesign is a prerequisite for obtaining informed consent fromrespondents, and we argued that a uniform approach to testTable 1 Whether or not to return STI results for the third British National Survey of Sexual Attitudes andLifestyles (Natsal-3): infection-specific issues (as of 2009)Free NHStesting availableClinical standard fortreatment availablePrevalence ofundiagnosed infectionsSample type andtesting is of clinicaldiagnostic standardChlamydia trachomatis Yes Yes High No*Neisseria gonorrhoeae Yes Yes Low No*HIV Yes Yes Lowy NoHPV Noz No High NAxMycoplasma genitalium Noz No Unknown NAxBold type shows factors that favour named testing.*Due to delay and batch testing.yThe Health Protection Agency estimates that 24% of HIV-infected people are unaware of their infection in the UK.17zNot usually performed.xA clinical standard for testing is not currently available.HPV, human papillomavirus; NA, not applicable; STI, sexually transmitted infection.J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068 381Brief reportresults is easier to communicate, both for interviewers to explainand for respondents to understand.Practical considerations and cost efficiencyIn Natsal-2, where C trachomatis prevalence was approximately2%, a research nurse was employed to actively follow-upcases.6 19 Even with considerable effort, it proved impossible tocontact 11% of cases with their results, and clinical outcomeswere only available in half of contacted cases. Other authorshave acknowledged the human and ﬁnancial cost associated withappropriate return of results.15 For Natsal-3, non-return wasargued to enable testing of a wider range of infections to identifycoinfection and associated risk factors. We reasoned that maxi-mising the scientiﬁc output from biological testing is desirable,provided ethical principles are not compromised, and is consis-tent with an obligation to spend public research funds wisely.AcceptabilityIn piloting, 61% (68 of 111) of respondents agreed to providea urine sample without receiving results. In Natsal-2, in 2000,when C trachomatis results were given, 71% of participants agreed.6Few respondents raised concerns that results would not bereturned. Some respondents were reassured after discussing theirconcerns with the interviewer. Data from the developmental phasewere used to inform the study design and the patient informationliterature, and to support subsequent REC applications.DISCUSSIONThis paper describes the development of, and basis for, an ethi-cally sound approach to STI testing within a large, population-based survey. Our approach was guided by ethical, practical andscientiﬁc principles and considerations. The testing of STIs andthe decision not to return results was accepted by a REC, withinthe context that respondents were informed about andconsented to this methodology. Although there are not directbeneﬁts to participation, voluntary anonymised testing, withspeciﬁc consent for this, including the knowledge that resultswill not be returned, was acceptable to respondents whenpiloted in Natsal-3.Acknowledgements We thank the Natsal-3 team members, the studystakeholders and Advisory Group members who contributed to the content of thiswork. The authors thank Kevin Fenton in particular for helpful discussions on theissues raised in this paper.Funding The authors thank the Medical Research Council and Wellcome Trust forfunding the Natsal-3 study. The views expressed in this paper are those of the authorsand not necessarily those of the funders. MRC: G0701757, Wellcome: 084840.Competing interests None.Patient consent Study subjects were members of the public rather than patients,and a specific consent form, approved by the research ethics committee, wasdeveloped for the study.Ethics approval Oxford A MREC.Contributors AMJ, as Principal Investigator for Natsal-3, and PS, Natsal-3Co-Applicant, are joint senior authors with overall responsibility for this work. NFdrafted this paper in discussion with all authors. All authors participated in itsstructure, content and preparation.Provenance and peer review Not commissioned; externally peer reviewed.Data sharing statement The data presented in this study are pilot data, which areonly accessible by the Natsal-3 study team. However, Natsal-3 survey data will bemade publicly available after the end of the study through the UK data archive hostedby Essex University (http://www.data-archive.ac.uk).REFERENCES1. Bauer S. Societal and ethical issues in human biomonitoringea view from sciencestudies. Environ Health 2008;7(Suppl 1):S10.2. Hood JE, Friedman AL. Unveiling the hidden epidemic: a review of stigmaassociated with sexually transmissible infections. Sex Health 2011;8:159e70.3. Wolf LE, Bouley TA, McCulloch CE. Genetic research with stored biologicalmaterials: ethics and practice. IRB 2010;32:7e18.4. Johnson AM, Wadsworth J, Field J, et al. Sexual Attitudes and Lifestyles. Oxford:Blackwell Scientific Publications, 1994.5. Johnson AM, Mercer CH, Erens B, et al. Sexual behaviour in Britain: partnerships,practices, and HIV risk behaviours. Lancet 2001;358:1835e42.6. Fenton KA, Korovessis C, Johnson AM, et al. Sexual behaviour in Britain: reportedsexually transmitted infections and prevalent genital Chlamydia trachomatis infection.Lancet 2001;358:1851e4.7. Banks J, Marmot M, Oldfield Z, et al. Disease and disadvantage in the United Statesand in England. JAMA 2006;295:2037e45.8. Beauchamp C. Principles of Biomedical Ethics. 5th edn. New York: Oxford UniversityPress, 2001.9. Beauchamp T, Walters L, eds. Contemporary Issues in Bioethics. Belmont,California: Wadsworth Publishing Company, 1994.10. WHO. UNAIDS: Guidelines for Measuring National HIV Prevalence in Population-Based Surveys. Geneva: UNAIDS/WHO, 2006.11. de Melo-Martin I. A duty to participate in research: does social context matter? AmJ Bioeth 2008;8:28e36.12. Schaefer GO, Emanuel EJ, Wertheimer A. The obligation to participate in biomedicalresearch. JAMA 2009;302:67e72.13. WHO. UNAIDS: Guidelines for Using HIV Testing Technologies in Surveillance:Selection, Evaluation and Implementation 2009 Update. Geneva: UNAIDS/WHO, 2009.14. Gill ON, Adler MW, Day NE. Monitoring the prevalence of HIV: foundations fora programme of unlinked anonymous testing in England and Wales. BMJ1989;299:1295e8.15. Murphy J, Scott J, Kaufman D, et al. Public expectations for return of results fromlarge-cohort genetic research. Am J Bioeth 2008;8:36e43.16. Shalowitz DI, Miller FG. Disclosing individual results of clinical research: implicationsof respect for participants. JAMA 2005;294:737e40.17. Health Protection Agency. HIV in the United Kingdom: 2011 Report. London,Colindale: Health Protection Services, 2011.18. National Chlamydia Screening ProgrammedNCSP Home. http://www.chlamydiascreening.nhs.uk/19. McCadden A, Fenton KA, McManus S, et al. Chlamydia trachomatis testing in thesecond British national survey of sexual attitudes and lifestyles: respondent uptakeand treatment outcomes. Sex Transm Dis 2005;32:387e94.PAGE fraction trail=2.75382 J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068Brief report

Testing for sexually transmitted infections in a population-based sexual health survey: development of an acceptable ethical approach.

UCL Discovery

Testing for sexually transmitted infections ina population-based sexual health survey:development of an acceptable ethical approachNigel Field,1 Clare Tanton,1 Catherine H Mercer,1 Soazig Nicholson,2 Kate Soldan,3Simon Beddows,3 Catherine Ison,3 Anne M Johnson,1 Pam Sonnenberg1ABSTRACTPopulation-based research is enhanced by biologicalmeasures, but biological sampling raises complex ethicalissues. The third British National Survey of SexualAttitudes and Lifestyles (Natsal-3) will estimate thepopulation prevalence of five sexually transmittedinfections (STIs) (Chlamydia trachomatis, Neisseriagonorrhoeae, human papillomavirus (HPV), HIV andMycoplasma genitalium) in a probability sample aged16e44 years. The present work describes thedevelopment of an ethical approach to urine testing forSTIs, including the process of reaching consensus onwhether to return results. The following issues wereconsidered: (1) testing for some STIs that are treatableand for which appropriate settings to obtain free testingand advice are widely available (Natsal-3 provides allrespondents with STI and healthcare accessinformation), (2) limits on test accuracy and timelinessimposed by survey conditions and sample type, (3)testing for some STIs with unknown clinical and publichealth implications, (4) how a uniform approach is easierto explain and understand, (5) practical difficulties inreturning results and cost efficiency, such as enablingwider STI testing by not returning results. The agreedapproach, to perform voluntary anonymous testing withspecific consent for five STIs without returning results,was approved by stakeholders and a research ethicscommittee. Overall, this was acceptable to respondentsin developmental piloting; 61% (68 of 111) ofrespondents agreed to provide a sample. Theexperiences reported here may inform the ethicaldecision making of researchers, research ethicscommittees and funders considering population-basedbiological sampling.INTRODUCTIONTesting of biological samples in epidemiologicalresearch raises important ethical questions.1 Theissues are particularly complex when applied tosexually transmitted infections (STIs) because of thestigma associated with diagnosis and the impor-tance of conﬁdentiality.2 Researchers are also facedwith the decision of whether and when to discloseresults to research participants.3 This paperdescribes the development of an ethical approach tourine-based STI testing in the third British NationalSurvey of Sexual Attitudes and Lifestyles (Natsal-3).Natsal-3 is a probability sample of 15 000 adultsaged 16e74 years in Britain for which surveyﬁeldwork started in 2010. It follows previousNatsal surveys in 1990 and 2000.4 5 The surveycollects behavioural data, including sexual activity,partnership patterns, sexual function and healthoutcomes. In addition, Natsal-3 employs urine-based testing to estimate prevalence of Chlamydiatrachomatis, Neisseria gonorrhoeae, human papillo-mavirus (HPV), HIV and Mycoplasma genitalium ina subgroup of 5000 respondents aged 16e44 years.Benefits of biological testing in population-basedresearchLinking biological information to behavioural anddemographic data can strengthen population-basedresearch. For example, in 2000, Natsal-2 measuredurinary C trachomatis prevalence, which informedthe decision to extend national screening to men.6Among many others, national surveys such as theUK Biobank, Health Survey for England (HSE), theEnglish Longitudinal Study of Ageing (ELSA),the USA Health and Retirement Study (HRS) andthe National Health and Nutrition and ExaminationSurvey (NHANES) collect biological samples forbiomarkers of disease. Biomarkers are not subject toreporting bias and lend considerable weight to thescientiﬁc reliability and precision of data, and maybe used to validate self-reporting.7 These studiesinform a wide range of health-related activities.An ethical framework for biological testing inpopulation-based researchBiological testing in population-based research alsoraises important ethical considerations, for whichthe bioethical principles (autonomy, beneﬁcence,non-maleﬁcence and justice), set out by Beauchampand Childress, provide a framework.8 Beauchampand Walters also identiﬁed four secondary princi-ples: ‘ﬁdelity ’, ‘conﬁdentiality ’, ‘utility ’ and‘veracity ’.9 The WHO and Joint United NationsProgramme on HIV/AIDS (UNAIDS) applied thesestandards to guide the design of population-basedsurveys measuring HIV prevalence.10 First, respon-dents should ‘be protected from any harm’, whichincludes safeguarding respondent conﬁdentiality.Second, respondents should ‘participate in thebeneﬁts of the research’. This is more complexbecause there may be no direct beneﬁts forrespondents in population-based surveys, butrather indirect societal beneﬁts.11 12 Direct clinicalbeneﬁts may occur where results are returned torespondents with advice and/or treatment.WHO/UNAIDS guidelines therefore suggestreferral to free testing where results are notreturned.10 Third, respondents should ‘be informed1Centre for Sexual Health & HIVResearch, Research Departmentof Infection & Population Health,University College London,London, UK2National Centre for SocialResearch, London, UK3Health Protection Agency,London, UKCorrespondence toDr Nigel Field, Centre for SexualHealth & HIV Research,Research Department ofInfection & Population Health,University College London,Mortimer Market Centre, offCapper Street, London WC1E6JB, UK; nigel.field@nhs.netReceived 28 June 2011Revised 17 November 2011Accepted 9 December 2011Published Online First17 January 2012This paper is freely availableonline under the BMJ Journalsunlocked scheme, see http://jme.bmj.com/site/about/unlocked.xhtml380 J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068Brief reportof the procedures and risks’. And fourth, respondents should‘freely choose whether or not to participate in the study’.International guidelines for HIV testing have distinguishedbetween unlinked anonymous testing (UA), where results areirreversibly unlinked from the person tested, and linked testing,where results may or may not be returned.13 A programme ofUA HIV surveillance testing has been successfully in place in theUK since 1990.14 However, the UA surveys differ from Natsal-3in two key respects; (1) the UA research programme is not theprimary reason for obtaining the sample tested, which isa routine sample and would otherwise have been discarded, and(2) individual consent for HIV testing on the leftover bloodsamples is not usually required.10Whether to return STI results in Natsal-3Focus group studies suggest signiﬁcant public interest in indi-vidual results from genetic research studies,15 but no studieshave directly investigated preferences for obtaining results in thecontext of population-based STI research.In designing Natsal-3, the decision to return STI results ornot was an ethical concern because harm to respondents andtheir sexual partners might be avoided by returning results fortreatable infections. Full disclosure is also consistent withupholding respect for respondents, and includes those wishingto participate only where results are returned.16 We consideredthe risks associated with not returning STI results against thealternative risks if named testing was conducted and resultswere returned.METHODSWe undertook an extensive development phase to agree and testthe acceptability and feasibility of STI testing in Natsal-3. Theethical principles described above informed our initial approachduring the study funding process, and this was endorsed viaindependent peer review. An informed consensus was thensought through consultation with stakeholders including theHealth Protection Agency (HPA), clinicians and the study ’sAdvisory Group (which includes representatives from theTerrence Higgins Trust, Family Planning Association and UKDepartment of Health). The approach was submitted to a NHSresearch ethics committee (REC) before piloting of the wholesurvey was undertaken in 23 postcode sectors across GreatBritain. Within each sector, 25 addresses were randomly selectedto yield a total sample of 575 addresses, of which 434 wereresidential with English-speaking and eligible occupants (aged16e74 years). Interviews took place between March and May2010. The response rate was 50.2%: 111 respondents aged16e44 years reporting at least one sexual partner were invited toprovide a urine sample.RESULTSThe availability of free STI tests in BritainFor some STIs, there are speciﬁc recommended treatments withdirect clinical beneﬁts (table 1). However, it was argued thatspeciﬁc written details describing access to and availability ofSTI/HIV testing, as well as general sexual health informationcould be provided to respondents, and that these services providea more appropriate setting for free diagnostic testing than ispossible for Natsal-3. For C trachomatis, there is now widespreadtesting in the community, and for young people since 2003,a national screening programme, such that an estimated 22.1%of 15e24 year olds were screened in 2010.18 Sexual healthscreening was less accessible in 2000, when Natsal-2 did returnC trachomatis results.19Accuracy and timeliness of survey testsAs in other surveys, the tests used in Natsal-3 may not reach therequired level of clinical diagnostic accuracy, while still beingsufﬁciently accurate for population prevalence estimates (table1). Under study conditions some loss in sensitivity is expected,due to limitations on the specimen type and the need totransport, freeze and batch test samples, which may result inclinically unacceptable delays. The standard of diagnostic accu-racy is a concern for all respondents. For example, a null ornegative result feedback might result in undue reassurance andbe without the health education messages that can be deliveredwhen this occurs in a clinical setting. Providing STI test results,where the prevalence and therefore positive predictive valuesmay be low raises the possibility of false positives, which wouldalso cause harm through undue concern (table 1).Results with unknown clinical and public health implicationsFor HPV and M genitalium, the clinical and public health impli-cations currently remain uncertain, such that a positive resultmay not require speciﬁc management, treatment or partnernotiﬁcation and may cause unnecessary and unethical distress(table 1).A consistent approach supports effective communicationProviding results for some STIs, but not others, may be misin-terpreted in that respondents may wrongly assume the resultsto apply to all STIs. A thorough understanding of the studydesign is a prerequisite for obtaining informed consent fromrespondents, and we argued that a uniform approach to testTable 1 Whether or not to return STI results for the third British National Survey of Sexual Attitudes andLifestyles (Natsal-3): infection-specific issues (as of 2009)Free NHStesting availableClinical standard fortreatment availablePrevalence ofundiagnosed infectionsSample type andtesting is of clinicaldiagnostic standardChlamydia trachomatis Yes Yes High No*Neisseria gonorrhoeae Yes Yes Low No*HIV Yes Yes Lowy NoHPV Noz No High NAxMycoplasma genitalium Noz No Unknown NAxBold type shows factors that favour named testing.*Due to delay and batch testing.yThe Health Protection Agency estimates that 24% of HIV-infected people are unaware of their infection in the UK.17zNot usually performed.xA clinical standard for testing is not currently available.HPV, human papillomavirus; NA, not applicable; STI, sexually transmitted infection.J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068 381Brief reportresults is easier to communicate, both for interviewers to explainand for respondents to understand.Practical considerations and cost efficiencyIn Natsal-2, where C trachomatis prevalence was approximately2%, a research nurse was employed to actively follow-upcases.6 19 Even with considerable effort, it proved impossible tocontact 11% of cases with their results, and clinical outcomeswere only available in half of contacted cases. Other authorshave acknowledged the human and ﬁnancial cost associated withappropriate return of results.15 For Natsal-3, non-return wasargued to enable testing of a wider range of infections to identifycoinfection and associated risk factors. We reasoned that maxi-mising the scientiﬁc output from biological testing is desirable,provided ethical principles are not compromised, and is consis-tent with an obligation to spend public research funds wisely.AcceptabilityIn piloting, 61% (68 of 111) of respondents agreed to providea urine sample without receiving results. In Natsal-2, in 2000,when C trachomatis results were given, 71% of participants agreed.6Few respondents raised concerns that results would not bereturned. Some respondents were reassured after discussing theirconcerns with the interviewer. Data from the developmental phasewere used to inform the study design and the patient informationliterature, and to support subsequent REC applications.DISCUSSIONThis paper describes the development of, and basis for, an ethi-cally sound approach to STI testing within a large, population-based survey. Our approach was guided by ethical, practical andscientiﬁc principles and considerations. The testing of STIs andthe decision not to return results was accepted by a REC, withinthe context that respondents were informed about andconsented to this methodology. Although there are not directbeneﬁts to participation, voluntary anonymised testing, withspeciﬁc consent for this, including the knowledge that resultswill not be returned, was acceptable to respondents whenpiloted in Natsal-3.Acknowledgements We thank the Natsal-3 team members, the studystakeholders and Advisory Group members who contributed to the content of thiswork. The authors thank Kevin Fenton in particular for helpful discussions on theissues raised in this paper.Funding The authors thank the Medical Research Council and Wellcome Trust forfunding the Natsal-3 study. The views expressed in this paper are those of the authorsand not necessarily those of the funders. MRC: G0701757, Wellcome: 084840.Competing interests None.Patient consent Study subjects were members of the public rather than patients,and a specific consent form, approved by the research ethics committee, wasdeveloped for the study.Ethics approval Oxford A MREC.Contributors AMJ, as Principal Investigator for Natsal-3, and PS, Natsal-3Co-Applicant, are joint senior authors with overall responsibility for this work. NFdrafted this paper in discussion with all authors. All authors participated in itsstructure, content and preparation.Provenance and peer review Not commissioned; externally peer reviewed.Data sharing statement The data presented in this study are pilot data, which areonly accessible by the Natsal-3 study team. However, Natsal-3 survey data will bemade publicly available after the end of the study through the UK data archive hostedby Essex University (http://www.data-archive.ac.uk).REFERENCES1. Bauer S. Societal and ethical issues in human biomonitoringea view from sciencestudies. Environ Health 2008;7(Suppl 1):S10.2. Hood JE, Friedman AL. Unveiling the hidden epidemic: a review of stigmaassociated with sexually transmissible infections. Sex Health 2011;8:159e70.3. Wolf LE, Bouley TA, McCulloch CE. Genetic research with stored biologicalmaterials: ethics and practice. IRB 2010;32:7e18.4. Johnson AM, Wadsworth J, Field J, et al. Sexual Attitudes and Lifestyles. Oxford:Blackwell Scientific Publications, 1994.5. Johnson AM, Mercer CH, Erens B, et al. Sexual behaviour in Britain: partnerships,practices, and HIV risk behaviours. Lancet 2001;358:1835e42.6. Fenton KA, Korovessis C, Johnson AM, et al. Sexual behaviour in Britain: reportedsexually transmitted infections and prevalent genital Chlamydia trachomatis infection.Lancet 2001;358:1851e4.7. Banks J, Marmot M, Oldfield Z, et al. Disease and disadvantage in the United Statesand in England. JAMA 2006;295:2037e45.8. Beauchamp C. Principles of Biomedical Ethics. 5th edn. New York: Oxford UniversityPress, 2001.9. Beauchamp T, Walters L, eds. Contemporary Issues in Bioethics. Belmont,California: Wadsworth Publishing Company, 1994.10. WHO. UNAIDS: Guidelines for Measuring National HIV Prevalence in Population-Based Surveys. Geneva: UNAIDS/WHO, 2006.11. de Melo-Martin I. A duty to participate in research: does social context matter? AmJ Bioeth 2008;8:28e36.12. Schaefer GO, Emanuel EJ, Wertheimer A. The obligation to participate in biomedicalresearch. JAMA 2009;302:67e72.13. WHO. UNAIDS: Guidelines for Using HIV Testing Technologies in Surveillance:Selection, Evaluation and Implementation 2009 Update. Geneva: UNAIDS/WHO, 2009.14. Gill ON, Adler MW, Day NE. Monitoring the prevalence of HIV: foundations fora programme of unlinked anonymous testing in England and Wales. BMJ1989;299:1295e8.15. Murphy J, Scott J, Kaufman D, et al. Public expectations for return of results fromlarge-cohort genetic research. Am J Bioeth 2008;8:36e43.16. Shalowitz DI, Miller FG. Disclosing individual results of clinical research: implicationsof respect for participants. JAMA 2005;294:737e40.17. Health Protection Agency. HIV in the United Kingdom: 2011 Report. London,Colindale: Health Protection Services, 2011.18. National Chlamydia Screening ProgrammedNCSP Home. http://www.chlamydiascreening.nhs.uk/19. McCadden A, Fenton KA, McManus S, et al. Chlamydia trachomatis testing in thesecond British national survey of sexual attitudes and lifestyles: respondent uptakeand treatment outcomes. Sex Transm Dis 2005;32:387e94.PAGE fraction trail=2.75382 J Med Ethics 2012;38:380e382. doi:10.1136/medethics-2011-100068Brief report

A duty to participate in research: does social context matter?

Chlamydia trachomatis testing in the second British national survey of sexual attitudes and lifestyles: respondent uptake and treatment outcomes.

Contemporary Issues in Bioethics.

Disclosing individual results of clinical research: implications of respect for participants.

Genetic research with stored biological materials: ethics and practice.

Guidelines for Measuring National HIV Prevalence in PopulationBased Surveys.

Guidelines for Using HIV Testing Technologies in Surveillance: Selection, Evaluation and Implementation

Health Protection Agency. HIV in the United Kingdom:

Monitoring the prevalence of HIV: foundations for a programme of unlinked anonymous testing in England and Wales.

National Chlamydia Screening ProgrammedNCSP Home.

Principles of Biomedical Ethics. 5th edn.

Public expectations for return of results from large-cohort genetic research.

Sexual Attitudes and Lifestyles.

Sexual behaviour in Britain: partnerships, practices, and HIV risk behaviours. Lancet

Sexual behaviour in Britain: reported sexually transmitted infections and prevalent genital Chlamydia trachomatis infection. Lancet

Societal and ethical issues in human biomonitoringea view from science studies. Environ Health 2008;7(Suppl 1):S10.

The obligation to participate in biomedical research.

Unveiling the hidden epidemic: a review of stigma associated with sexually transmissible infections. Sex Health 2011;8:159e70.

http://discovery.ucl.ac.uk/1336342/1/Field_Testing%20for%20sexually%20transmitted%20infections%20in%20a%20population-based%20sexual%20health%20survey%253A%20development%20of%20an%20acceptable%20ethical%20approach.pdf

Testing for sexually transmitted infections in a population-based sexual health survey: development of an acceptable ethical approach

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