title: Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study.
abstract: BACKGROUND
  The consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.
  
  
  METHODS
  We adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.
  
  
  RESULTS
  We found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.
  
  
  CONCLUSIONS
  The study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration.
authors.affiliation: School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia. fasiltekola@yahoo.com
authors.forename: Fasil
authors.initials: F
authors.lastname: Tekola
authors.forename: Susan
authors.initials: S
authors.lastname: Bull
authors.forename: Bobbie
authors.initials: B
authors.lastname: Farsides
authors.forename: Melanie J
authors.initials: MJ
authors.lastname: Newport
authors.forename: Adebowale
authors.initials: A
authors.lastname: Adeyemo
authors.forename: Charles N
authors.initials: CN
authors.lastname: Rotimi
authors.forename: Gail
authors.initials: G
authors.lastname: Davey
mesh_terms: D000328:Adult; D000368:Aged; D000538:Aluminum Silicates; D000077215:Clay; D003153:Community Health Services / Q000941:ethics; D003219:Confidentiality / Q000941:ethics; D004604:Elephantiasis / Q000191:economics / Q000209:etiology / Q000235:genetics* / Q000517:prevention & control / Q000523:psychology* / Q000628:therapy; D005002:Ethiopia; D005260:Female; D017144:Focus Groups; D020022:Genetic Predisposition to Disease; D036281:Genetic Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D008875:Middle Aged; D033262:Narration; D018579:Patient Selection; D036301:Qualitative Research; D035842:Research Subjects / Q000523:psychology*; D012307:Risk Factors; D012987:Soil; D013240:Stereotyping; D011795:Surveys and Questionnaires; D035502:Trust
chemical_list: D000538:Aluminum Silicates; D012987:Soil; D000077215:Clay
references.citation: Trop Doct. 2003 Oct;33(4):217-20
references.pmid: 14620426
references.citation: Soc Sci Med. 2007 Nov;65(10):2105-15
references.pmid: 17689846
references.citation: Bull Med Ethics. 2002 Oct;(182):17-23
references.pmid: 14983848
references.citation: Genome Res. 1998 Aug;8(8):755-7
references.pmid: 9724320
references.citation: Soc Sci Med. 2008 Sep;67(5):721-33
references.pmid: 18375028
references.citation: Am J Hum Genet. 1998 Sep;63(3):696-702
references.pmid: 9718343
references.citation: PLoS Negl Trop Dis. 2009 Jul 21;3(7):e482
references.pmid: 19621067
references.citation: JAMA. 2001 Jan 10;285(2):207-11
references.pmid: 11176815
references.citation: BMJ. 1998 Mar 28;316(7136):1002-3
references.pmid: 11645039
references.citation: Soc Sci Med. 2005 Oct;61(7):1463-73
references.pmid: 16005781
references.citation: BMJ. 2004 May 15;328(7449):1203
references.pmid: 15142946
references.citation: Trans R Soc Trop Med Hyg. 2007 Jan;101(1):91-6
references.pmid: 16884751
references.citation: Trop Med Int Health. 2008 Oct;13(10):1277-83
references.pmid: 18721188
references.citation: Trop Med Int Health. 2006 Jul;11(7):1136-44
references.pmid: 16827714
references.citation: Hastings Cent Rep. 1996 Sep-Oct;26(5):25-9
references.pmid: 8891706
references.citation: Soc Sci Med. 2005 Jul;61(2):443-54
references.pmid: 15893058
references.citation: Trans R Soc Trop Med Hyg. 2008 May;102(5):439-44
references.pmid: 18339411
references.citation: Soc Sci Med. 2004 Dec;59(12):2547-59
references.pmid: 15474208
references.citation: IRB. 2006 May-Jun;28(3):1-6
references.pmid: 17036437
references.citation: Soc Sci Med. 2005 Sep;61(6):1211-22
references.pmid: 15970232
references.citation: Soc Sci Med. 1999 Jan;48(2):139-48
references.pmid: 10048773
references.citation: Soc Sci Med. 2008 Sep;67(5):708-20
references.pmid: 18362046
references.citation: Ann Epidemiol. 2005 Oct;15(9):712-9
references.pmid: 16157258
references.citation: Soc Sci Med. 2007 Dec;65(11):2284-95
references.pmid: 17884264
references.citation: BMJ. 1998 Mar 28;316(7136):1001-2
references.pmid: 11645038
references.citation: Br J Dermatol. 2008 Sep;159(4):903-6
references.pmid: 18671781
references.citation: Soc Sci Med. 2008 Mar;66(6):1379-92
references.pmid: 18237833