Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda

Abstract

Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants’ understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted. Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.

Keywords

informed consent genomic research understanding research participants biobanking

Get full access to this article

View all access options for this article.

References

Afolabi

M. O.

Okebe

J. U.

Mcgrath

Larson

H. J.

Bojang

Chandramohan

(2014). Informed consent comprehension in African research settings. Tropical Medicine & International Health, 19(6), 625–642. https://doi.org/10.1111/tmi.12288

Albrecht

T. L.

Franks

M. M.

Ruckdeschel

J. C.

(2005). Communication and informed consent. Current Opinion in Oncology, 17(4), 336–339. https://doi.org/10.1097/01.cco.0000166654.23169.a2

Alkaraki

A. K.

Khabour

O. F.

Alzoubi

K. H.

Al-Ebbini

L. M.

Altaany

(2020). Informed consent form challenges for genetic research in Jordan. Journal of Multidisciplinary Healthcare, 13, 235–239. https://doi.org/10.2147/JMDH.S243669

Al-Riyami

Jaju

Silverman

H. J.

(2011). The adequacy of informed consent forms in genetic research in Oman: A pilot study. Developing World Bioethics, 11(2), 57–62. https://doi.org/10.1111/j.1471-8847.2010.00293.x

Bergenmar

Johansson

Wilking

(2011). Levels of knowledge and perceived understanding among participants in cancer clinical trials–factors related to the informed consent procedure. Clinical Trials (London, England), 8(1), 77–84. https://doi.org/10.1177/1740774510384516

Beskow

L. M.

Dombeck

C. B.

Thompson

C. P.

Watson-Ormond

J. K.

Weinfurt

K. P.

(2015). Informed consent for biobanking: Consensus-based guidelines for adequate comprehension. Genetics in Medicine, 17(3), 226. https://doi.org/10.1038/gim.2014.102

Beskow

L. M.

Friedman

Hardy

N. C.

Lin

Weinfurt

K. P.

(2010). Simplifying informed consent for biorepositories: Stakeholder perspectives. Genetics in Medicine, 12(9), 567–572. https://doi.org/10.1097/GIM.0b013e3181ead64d

Beskow

L. M.

Lin

Dombeck

C. B.

Gao

Weinfurt

K. P.

(2017). Improving biobank consent comprehension: A national randomized survey to assess the effect of a simplified form and review/retest intervention. Genetics in Medicine, 19(5), 505. https://doi.org/10.1038/gim.2016.157

Campbell

M. M.

Susser

Mall

Mqulwana

S. G.

Mndini

M. M.

Ntola

O. A.

Stein

D. J.

(2017). Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study. PLoS One, 12(11), e0188466. https://doi.org/10.1371/journal.pone.0188466

10.

Corneli

A. L.

Sorenson

J. R.

Bentley

M. E.

Henderson

G. E.

Bowling

J. M.

Nkhoma

Ahmed

(2012). Improving participant understanding of informed consent in an HIV-prevention clinical trial: A comparison of methods. AIDS and Behavior, 16(2), 412–421. https://doi.org/10.1007/s10461-011-9977-z

11.

de Vries

Abayomi

Littler

Madden

McCurdy

Oukem-Boyer

O. O. M.

Tindana

(2015). Addressing ethical issues in H3Africa research–the views of research ethics committee members. The HUGO Journal, 9(1), 1–4. https://doi.org/10.1186/s11568-015-0006-6

12.

Eisenhauer

E. R.

Tait

A. R.

Rieh

S. Y.

Arslanian-Engoren

C. M.

(2019). Participants’ understanding of informed consent for biobanking: A systematic review. Clinical Nursing Research, 28(1), 30–51. https://doi.org/10.1177/1054773817722690

13.

Emanuel

E. J.

Wendler

Grady

(2000). What makes clinical research ethical? Jama, 283(20), 2701–2711. https://doi.org/10.1001/jama.283.20.2701

14.

Falagas

M. E.

Korbila

I. P.

Giannopoulou

K. P.

Kondilis

B. K.

Peppas

(2009). Informed consent: How much and what do patients understand? The American Journal of Surgery, 198(3), 420–435. https://doi.org/10.1016/j.amjsurg.2009.02.010

15.

Garrett

S. B.

Murphy

Wiley

Dohan

(2017). Standard versus simplified consent materials for biobank participation: Differences in patient knowledge and trial accrual. Journal of Empirical Research on Human Research Ethics, 12(5), 326–334. https://doi.org/10.1177/1556264617731869

16.

H3Africa. (2014). Enabling the genomic revolution in Africa. Science. Retrieved from https://h3africa.org/.

17.

HHS.gov. (2018). Revised Common Rule 2018: General requirements for informed consent. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/annotated-2018-requirements/index.html-46.116.

18.

Hoover-Regan

Becker

Williams

M. J.

Shenker

(2013). Informed consent and research subject understanding of clinical trials. WMJ: Official Publication of the State Medical Society of Wisconsin, 112(1), 18–23. PMID: 23513309.

19.

Joffe

Cook

E. F.

Cleary

P. D.

Clark

J. W.

Weeks

J. C.

(2001). Quality of informed consent: A new measure of understanding among research subjects. Journal of the National Cancer Institute, 93(2), 139–147. https://doi.org/10.1093/jnci/93.2.139

20.

Kengne-Ouafo

J. A.

Millard

J. D.

Nji

T. M.

Tantoh

W. F.

Nyoh

D. N.

Tendongfor

Wanji

(2016). Understanding of research, genetics and genetic research in a rapid ethical assessment in north west Cameroon. International Health, 8(3), 197–203. https://doi.org/10.1093/inthealth/ihv034

21.

Kiguba

Kutyabami

Kiwuwa

Katabira

Sewankambo

N. K.

(2012). Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study. BMC Medical Ethics, 13(1), 21. https://doi.org/10.1186/1472-6939-13-21

22.

King

N. M.

(2019). Key information in the new common rule: Can it save research consent? Journal of Law, Medicine & Ethics, 47(2), 203–212. https://doi.org/10.1177/1073110519857276

23.

Klima

Fitzgerald-Butt

S. M.

Kelleher

K. J.

Chisolm

D. J.

Comstock

R. D.

Ferketich

A. K.

McBride

K. L.

(2014). Understanding of informed consent by parents of children enrolled in a genetic biobank. Genetics in Medicine, 16(2), 141–148. https://doi.org/10.1038/gim.2013.86

24.

MacQueen

K. M.

Chen

Ramirez

Nnko

S. E.

Earp

K. M.

(2014). Comparison of closed-ended, open-ended, and perceived informed consent comprehension measures for a mock HIV prevention trial among women in Tanzania. PLoS One, 9(8), e105720. https://doi.org/10.1371/journal.pone.0105720

25.

Mandava

Pace

Campbell

Emanuel

Grady

(2012). The quality of informed consent: Mapping the landscape. A review of empirical data from developing and developed countries. Journal of Medical Ethics, 38(6), 356–365. https://doi.org/10.1136/medethics-2011-100178

26.

Marshall

P. A.

Adebamowo

C. A.

Adeyemo

A. A.

Ogundiran

T. O.

Strenski

Zhou

Rotimi

C. N.

(2014). Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria. BMC Medical Ethics, 15(1), 38. https://doi.org/10.1186/1472-6939-15-38

27.

Mboowa

Mwesigwa

Katagirya

Retshabile

Mlotshwa

B. C.

Williams

Matshaba

(2018). The collaborative African genomics network (CAfGEN): Applying genomic technologies to probe host factors important to the progression of HIV and HIV-tuberculosis infection in sub-saharan Africa. AAS Open Res, 1, 3. https://doi.org/10.12688/aasopenres.12832.1

28.

McCarty

C. A.

Nair

Austin

D. M.

Giampietro

P. F.

(2007). Informed consent and subject motivation to participate in a large, population-based genomics study: The marshfield clinic personalized medicine research project. Public Health Genomics, 10(1), 2–9. https://doi.org/ 10.1159/000096274

29.

McCaughey

Chen

C. Y.

De Smit

Rees

Fenwick

Kearns

L. S.

Cook

A. L.

(2016). Participant understanding and recall of informed consent for induced pluripotent stem cell biobanking. Cell and Tissue Banking, 17(3), 449–456. https://doi.org/10.1007/s10561-016-9563-8

30.

Moodley

Singh

(2016). “It’s all about trust”: Reflections of researchers on the complexity and controversy surrounding biobanking in South Africa. BMC Medical Ethics, 17(1), 57. https://doi.org/10.1186/s12910-016-0140-2

31.

Mwaka

E. S.

Sebatta

D. E.

Ochieng

Munabi

I. G.

Bagenda

Ainembabazi

Kaawa-Mafigiri

(2021). Researchers’ perspectives on return of individual genetics results to research participants: A qualitative study. Global Bioethics, 32(1), 15–33. https://doi.org/10.1080/11287462.2021.1896453

32.

Mystakidou

Panagiotou

Katsaragakis

Tsilika

Parpa

(2009). Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries. SAHARA-J: Journal of Social Aspects of HIV/AIDS, 6(2), 46–57. https://doi.org/10.1080/17290376.2009.9724930

33.

Nabukenya

Ochieng

Mafigiri

D. K.

Munabi

Nakigudde

Nakwagala

F. N.

Mwaka

E. S.

(2022). Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: A qualitative study. Research Ethics, 1–17. https://doi.org/10.1177/17470161221076974.

34.

Naeim

Dry

Elashoff

Xie

Petruse

Magyar

Wenger

(2021). Electronic video consent to power precision health research: A pilot cohort study. JMIR Formative Research, 5(9), e29123. https://doi.org/10.2196/29123

35.

Ndebele

P. M.

Wassenaar

Munalula

Masiye

(2012). Improving understanding of clinical trial procedures among low literacy populations: An intervention within a microbicide trial in Malawi. BMC Medical Ethics, 13(1), 1–14. https://doi.org/10.1186/1472-6939-13-29

36.

Ngwenya

Luthuli

Gunda

Gumede

N. A.

Adeagbo

Nkosi

Wong

E. B.

(2020). Participant understanding of informed consent in a multidisease community-based health screening and biobank platform in rural South Africa. International Health, 12(6), 560–566. https://doi.org/10.1093/inthealth/ihaa072

37.

Nusbaum

Douglas

Damus

Paasche-Orlow

Estrella-Luna

(2017). Communicating risks and benefits in informed consent for research: A qualitative study. Global Qualitative Nursing Research, 4, 2333393617732017. https://doi.org/10.1177/2333393617732017

38.

Ogunrin

Taiwo

Frith

(2019). Genomic literacy and awareness of ethical guidance for genomic research in Sub-Saharan Africa: How prepared are biomedical researchers? Journal of Empirical Research on Human Research Ethics, 14(1), 78–87. https://doi.org/10.1177/1556264618805194

39.

Ormond

K. E.

Cirino

A. L.

Helenowski

I. B.

Chisholm

R. L.

Wolf

W. A.

(2009). Assessing the understanding of biobank participants. American Journal of Medical Genetics Part A, 149(2), 188–198. https://doi.org/10.1002/ajmg.a.32635

40.

Pace

Talisuna

Wendler

Maiso

Wabwire-Mangen

Bakyaita

Grady

(2005). Quality of parental consent in a Ugandan malaria study. American Journal of Public Health, 95(7), 1184–1189. https://doi.org/10.2105/AJPH.2004.053082

41.

Rahm

A. K.

Wrenn

Carroll

N. M.

Feigelson

H. S.

(2013). Biobanking for research: A survey of patient population attitudes and understanding. Journal of Community Genetics, 4(4), 445–450. https://doi.org/10.1007/s12687-013-0146-0

42.

Ramsay

De Vries

Soodyall

Norris

S. A.

Sankoh

(2014). Ethical issues in genomic research on the African continent: Experiences and challenges to ethics review committees: BioMed Central.

43.

Richter

Krawczak

Lieb

Wolff

Schreiber

Buyx

(2018). Broad consent for health care–embedded biobanking: Understanding and reasons to donate in a large patient sample. Genetics in Medicine, 20(1), 76. https://doi.org/10.1038/gim.2017.82

44.

Robinson

J. O.

Slashinski

M. J.

Wang

Hilsenbeck

S. G.

McGuire

A. L.

(2013). Participants’ recall and understanding of genomic research and large-scale data sharing. Journal of Empirical Research on Human Research Ethics, 8(4), 42–52. https://doi.org/10.1525/jer.2013.8.4.42

45.

Rutakumwa

de Vries

Parker

Tindana

Mweemba

Seeley

(2019). What constitutes good ethical practice in genomic research in Africa? Perspectives of participants in a genomic research study in Uganda. Global Bioethics, 31(1), 169–183. https://doi.org/10.1080/11287462.2019.1592867.

46.

Shelton

A. K.

Freeman

B. D.

Fish

A. F.

Bachman

J. A.

Richardson

L. I.

(2015). A computer-based education intervention to enhance surrogates’ informed consent for genomics research. American Journal of Critical Care, 24(2), 148–155. https://doi.org/10.4037/ajcc2015983

47.

Shiono

Y. N.

Zheng

Y.-F.

Kikuya

Kawai

Ishida

Kuriyama

Ohuchi

(2014). Participants’ understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START. Trials, 15(1), 375. https://doi.org/10.1186/1745-6215-15-375

48.

Ssali

Poland

Seeley

(2015). Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda. BMC Medical Ethics, 16(1), 86. https://doi.org/10.1186/s12910-015-0073-1

49.

Tabor

H. K.

Stock

Brazg

McMillin

M. J.

Dent

K. M.

J. H.

Bamshad

M. J.

(2012). Informed consent for whole genome sequencing: A qualitative analysis of participant expectations and perceptions of risks, benefits, and harms. American Journal of Medical Genetics Part A, 158(6), 1310–1319. https://doi.org/10.1002/ajmg.a.35328

50.

Taylor

H. A.

Washington

Wang

N.-Y.

Patel

H. D.

Ford

D. E.

Kass

N. E.

Ali

(2021). Randomized comparison of two interventions to enhance understanding during the informed consent process for research. Clinical Trials (London, England), 18(4), 466–476. https://doi.org/10.1177/17407745211009529

51.

Tindana

Bull

Amenga-Etego

de Vries

Aborigo

Koram

Parker

(2012). Seeking consent to genetic and genomic research in a rural Ghanaian setting: A qualitative study of the MalariaGEN experience. BMC Medical Ethics, 13(1), 15. https://doi.org/10.1186/1472-6939-13-15.

52.

Tindana

de Vries

Campbell

Littler

Seeley

Marshall

, & as members of the H3A Working Group on Ethics (2015). Community engagement strategies for genomic studies in Africa: A review of the literature. BMC Medical Ethics, 16, 24. https://doi.org/10.1186/s12910-015-0014-z.

53.

Traore

Bull

Niare

Konate

Thera

M. A.

Kwiatkowski

Doumbo

O. K.

(2015). Understandings of genomic research in developing countries: A qualitative study of the views of MalariaGEN participants in Mali. BMC Medical Ethics, 16(1), 1–10. https://doi.org/10.1186/s12910-015-0035-7

54.

UNCST (2014). Uganda National Council for Science and Technology: National Guidelines for Research Involving Humans as Research Partcipants. Kampala, Uganda.

55.

Upjohn

Wells

(2016). Challenges associated with informed consent in low-and low-middle-income countries. Frontiers in Veterinary Science, 3, 92. https://doi.org/10.3389/fvets.2016.00092

56.

Wejnert

Pham

Krishna

DiNenno

(2012). Estimating design effect and calculating sample size for respondent-driven sampling studies of injection drug users in the United States. AIDS and Behavior, 16(4), 797–806. https://doi.org/10.1007/s10461-012-0147-8

57.

Wendler

(2004). Can we ensure that all research subjects give valid consent? Archives of Internal Medicine, 164(20), 2201–2204. https://doi.org/10.1001/archinte.164.20.2201