Standards and Guidelines for HIV Prevention Research: Considerations for Local Context in the Interpretation of Global Ethical Standards

Bridget G. Haire, Morenike Oluwatoyin Folayan, Brandon Brown

Abstract

While international standards are important for conducting clinical research, they may require interpretation in particular contexts. Standard of care in HIV prevention research is now complicated, given that there are now two new biomedical prevention interventions – ‘treatment-as-prevention’, and pre-exposure prophylaxis – in addition to barrier protection, counselling, male circumcision and treatment of sexually transmissible infections. Proper standards of care must be considered with regard to both normative guidance and the circumstances of the particular stakeholders – the community, trial population, researchers and sponsors. In addition, the special circumstances of the lives of participants need to be acknowledged in designing trial protocols and study procedures. When researchers are faced with the dilemma of interpretation of international ethics guidelines and the realities of the daily lives of persons and their practices, the decisions of the local ethics committee become crucial. The challenge then becomes how familiar ethics committee members in these local settings are with these guidelines, and how their interpretation and use in the local context ensures the respect for persons and communities.  It also includes justice and the fair selection of study participants without compromising data quality, and ensuring that the risks for study participants and their community do not outweigh the potential benefits. (Afr J Reprod Health 2014; 18[3]: 55-65)

 

Keyword: Standards of prevention, ancillary care, local context, ethical guidelines, research

 

Résumé 

Bien que les normes internationales soient importantes pour mener des recherches cliniques, elles peuvent exiger l’interprétation dans des contextes particuliers. La qualité des soins dans la recherche de la prévention du VIH est maintenant compliquée, étant donné qu'il y a maintenant deux nouvelles interventions de prévention biomédicale - «traitement comme prévention», et la prophylaxie de la pré-exposition - en plus de la protection de la barrière, l’orientation psychologique, la circoncision masculine et le traitement des infections sexuellement transmissibles. Des normes de soins doivent être prises en considération en ce qui concerne à la fois à des orientations normatives et les circonstances des parties prenantes particulières - la communauté, la population de l'étude, les chercheurs et les commanditaires. En outre, les circonstances particulières de la vie des participants doivent être reconnues dans la conception des protocoles d'essais et procédures de l'étude. Lorsque les chercheurs sont confrontés au dilemme de l'interprétation des lignes directrices internationales sur l'éthique et les réalités de la vie quotidienne des personnes et de leurs pratiques, les décisions du comité local d'éthique deviennent cruciales. Le défi devient alors de savoir à quel point les membres du comité éthique sont familiers membres du comité dans ces milieux  locaux avec ces lignes directrices, et comment leur interprétation et de l'utilisation dans le contexte local assure le respect des personnes et des communautés. Il comprend également la justice et la bonne sélection des participants à l'étude, sans compromettre la qualité des données, et de s'assurer que les risques pour les participants à l'étude et leur communauté ne l'emportent pas sur les avantages potentiels. (Afr J Reprod Health 2014; 18[3]: 55-65)

 

Mot-clé: Normes de prévention,  soins auxiliaires,  contexte local, des lignes directrices éthiques, recherche

Full Text:

PDF

References

Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, et al. Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial. PLoS Med.

; 2(11): e298. doi:10.1371/journal.pmed.0020298

Bailey R, Moses S, Parker C, Agot K, Maclean I, Krieger J, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007; 369:643-656.

Gray R, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda MHS, Noah Kiwanuka F, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet - 24 February

; 369: 657-666

Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. New Engl J Med. 2010; 363(27):2587-2599.

Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women. New Engl J Med. 2012; 367(5):399-410.

Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana. New Engl J Med. 2012; 367(5):423-434.

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 Infection with Early Antiretroviral Therapy. New Engl J Med. 2011; 365(6):493-505.

Rodger A, Bruun T, Cambiano V, Lundgren J, et al. HIV Transmission Risk Through Condomless Sex If HIV+ Partner On Suppressive ART: PARTNER Study. Conference on Retroviruses and Opportunistic Infections (CROI 2014). Boston, March 3-6. Abstract 153LB.

Abdool Karim Q, Abdool Karim S, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010; 333(6042):524. (6042).

Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al. Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand. N Engl J Med. 2009; 361(23):2209-2220.

Padian NS, McCoy SI, Abdool Karim SS, Hasen N, Kim J, Bartos M., et al. HIV prevention transformed: the new prevention research agenda, Lancet. 2011; 378: 269-278.

Jean K, et al "HIV incidence among women is associated with their partners' circumcision status in the township

Orange Farm (South Africa) where the male circumcision roll-out is ongoing (ANRS-12126)" IAC 2014;Abstract FRAE0105LB.

Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997; 337: 853-856.

Angell M. The ethics of clinical research in the third world. N Engl J Med 1997; 337: 847-849.

Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med. 1994; 331:1173-1180.

Varmus H and Satcher D. Ethical complexities of conducting research in developing countries. N Engl J

Med 1997;337:1000-1005

N.A. The Ethics of Placebo-Controlled Trials. N Engl J Med 2002; 346: 382-383. doi: doi:10. 1056 / NEJM200201313460522

Macklin, R. After Helsinki: Unresolved Issues in International Research Kennedy Institute of Ethics Journal 2001; 1: 117-36

Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Pre-exposure Prophylaxis for HIV Infection among African Women. N Engl J Med. 2012;367(5):411-422.

Marrazzo J, Ramjee G, Nair G, Palanee T, Mkhize B, Nakabiito C, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine, or vaginal tenofovir gel in the VOICE Study (MTN 003). 20th Conference on

Retroviruses and Opportunistic infections; 2013.

UNAIDS. Ethical considerations in biomedical HIV prevention trials [Additional guidance point added in 2012]. 2012. Available at: http://www.unaids.org/ en/media/unaids/contentassets/documents/unaidspubli cation/2012/jc1399_ethical_considerations_en.pdf Accessed 18 April 2014.

Rennie S, Sugarman J. Developing ethics guidance for HIV prevention research: the HIV Prevention Trials Network approach. Journal of Medical Ethics. 2010;36(12):810-815.

Medical Research Council. MRC Research Guide: Research involving human participants in developing societies. 2004. Available at: http://www.mrc. ac.uk/ Utilities/Documentrecord/index.htm?d=MRC002461 Accessed 18 April 2014.

UNICEF. The Nigeria situation. Available at: http:// www.unicef.org/nigeria/1971_2199.html Accessed 18 April 2014.

UNAIDS. 2013 Progress report on the global plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive Available at: http://www.unaids. org/en/media/ unaids/contentassets/documents/unaidspublication/20 13/20130625_progress_global_plan_en.pdf Accessed 18 April 2014.

National Population Commission [Nigeria] and ICF Macro. Nigeria Demographic and Health Survey 2008 Preliminary Report. Abuja, Nigeria and Calverton, Maryland: National Population Commission and ICF Macro, 2009.

New HIV Vaccine and Microbicide and Advocacy Society (NHVMAS). Nigeria- A Haven for Clinical trials. Sept 15, 2012. Available at: http://www. nhvmas-ng.org/news.php?news_id=66 Accessed 27 March 2014.

Yakubu A and Adebamowo CA. Implementing National System of Health Research Ethics Regulations: The Nigerian Experience. BEOnline. 2012; 1(1): 4-15.

Federal Ministry of Health. National code of research ethics. 2006. Available at: http://www. nhrec.net / nhrec/National_Code_for_Health_Research_Ethics_v 2.0.pdf Accessed 14 April 2014.

National Agency for Food and Drug Administration and Control. Available at: http:// health

marketinnovations.org/program/national-agency-foodand-drug-administration-and-control nafdac Accessed 14 April 2014.

National Agency for the Control of AIDS. National HIV/AIDS research policy. 2010

National Agency for the Control of AIDS. National research agenda on HIV and AIDS in Nigeria (2010-

. 2010

National Agency for the Control of AIDS. National HIV vaccine plan. 2013

Nigeria Health Journal. Lessons learnt from Trovan: equip whistle blowers to spot unethical clinical trials. January 28, 2011. Available at: http:// nigerianhealthjournal.com/?p=727. Accessed on 18th April, 2014.

Folayan MO, Oyedeji KS, Fatusi OA. Community Members’ Engagement with and Involvement in Genomic Research: lessons to learn from the field. Developing World Bioethics 2013; Apr 17. doi: 10.1111/dewb.12020.

Federal Ministry of Health: National HIV/AIDS and Reproductive Health Survey, 2005 (NARHS Plus). Federal Ministry of Health Abuja, Nigeria. 2006.

Federal Ministry of Health: National HIV/AIDS and Reproductive Health Survey, 2007 (NARHS Plus). Federal Ministry of Health Abuja, Nigeria. 2008.

Federal Ministry of Health: National HIV & AIDS and Reproductive Health Survey, 2012 (NARHS Plus). Federal Ministry of Health Abuja, Nigeria. 2013.

Federal Ministry of Health. Integrated Biological and Behavioural Sentinel Survey. Nigeria. 2007.

Federal Ministry of Health. Integrated Biological and Behavioural Surveillance Survey. Abuja: FMOH, HIV and AIDS Division. 2010

Federal Government of Nigeria. The Constitution of Federal Republic of Nigeria, 1999 42. UNFPA. Early marriage in Nigeria. http://nigeria.unfpa .org/nigeirachild.html Accessed 14 April 2014.

Federal Republic of Nigeria. Child's Rights Act No. 116,

Federal Republic of Nigeria Offical gazette (A451679. 2007Available at http://www. unicef. org/ wcaro/

WCARO_Nigeria_Factsheets_CRA.pdf.Accessed

th April, 2014

Federal Republic of Nigeria. Labor Act. Chapter 198.Law of the Federation of Nigeria 1990.Available at: http://www.nigeria-law.org/LabourAct.htm, Accessed 18th April, 2014

Okafor U. ‘The practice of child marriage in Nigeria’, April 4 2014. The Huffington post. Available at: http://www.huffingtonpost.com/udoka-okafor/thepractice-of-child-mar_b_5133881.html Accessed April 15, 2014.

Folayan MO, Haire BG, Harrison A, Brown B Odetoyingbo M, Festus OA. Ethical Issues in adolescents sexual and reproductive health research in

Nigeria. Dev World Bioeth 2014; doi:

1111/dewb.1206.

Schenk KD, Friedland BA, Chau M, Stoner M, Plagianos

MG, Skoler-Karpoff S, et al,. Enrollment of Adolescents Aged 16–17 Years Old in Microbicide Trials: An Evidence-Based Approach. Journal of Adolescent Health. 2014. Online 31 March 2014.

Folayan MO. Imosili A. Capacity for conduct of clinical research in Nigeria: opinion and perspectives of stakeholders. HIV Vaccine and Microbicide Advocacy Society Technical Report. August 2013.

Council for International Organizations of Medical (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subject Available at: http://www.recerca. uab.es/ceeah /docs / CIOMS.pdf accessed 20 April 2014.

Federal Government of Nigeria. Same sex Marriage (Prohibition) Act, 2013

Taylor, A. ‘Simple reason Nigeria just banned gay marriage and gay meetings’. Jan 15 2014. Business Insider (Australia). Available at: http://www. businessinsider.com.au/why-nigeria-banned-gaymarriage-and-gay-meetings-2014-1 Accessed August 12, 2014.

National Agency for the Control of AIDS. The National HIV/AIDS Strategic Framework and National

Strategic Plan 2010-15. 2010.

Federal Ministry of Health. The National Guidelines for HIV and AIDS Treatment and Care in Adolescent and Adults. 2010. Available at: http://www.who.int/ hiv/pub/guidelines/nigeria_art.pdf Accessed 18 April 2014.

Haire B, Jordens C. Standard of Prevention in the Real World: A qualitative Study of Principal Investigators in HIV Biomedical Prevention Trials. AJOB Primary Research. 2013;4(4):14-25.

Anderson JA. Clinical Research in Context: Reexamining the Distinction between Research and Practice. J Med Philos. 2010; 35(1):46-63.

Choopanya K, Martin M, Suntharasamai P, et al, for the Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users

Belsky L, Richardson HS. Medical researchers' ancillary clinical care responsibilities. BMJ. 2004; 328(7454):1494-1496.

Sagay AS. Current State of AIDS Epidemic in Nigeria: Role of ARVs on PMTCT. 2013 HIV Biomedical Prevention Forum. 18-19 November 2013. Available at: http://www.nhvmasng.org/forum/ slides/Current% 20State%20of%20AIDS%20Epidemic%20in%20Nige ria__%20Role%20of%20ARVs%20on%20PMTCT%

Solomon%20Sagaay.pdf. Accessed 18 April 2014.

Microbicides Trial Network (MTN). Study comparing injectable contraceptives DMPA and NET-EN finds HIV risk higher with DMPA Available at: http://www.mtnstopshiv.org/node/5487 Accessed 13 August 2014. http://www.mtnstopshiv. org/news/ studies/mtn003/qa

Oyediran KA, Feyisetan OI, Akpan T. Predictors of condom use amongst young never-married males in Nigeria. J Health Popul Nutr. 2011 June; 29(3): 273– 285.

Tobin-West CI, Maduka O, Onyekwere VN, Tella AO. Awareness, acceptability, and use of female condoms among university students in Nigeria: implications for STI/HIV prevention. International Journal of Adolescent Medicine and Health 2014;26(2):259-65. doi: 10.1515/ijamh-2013-0300.

Refbacks

  • There are currently no refbacks.