Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

E Denning; S Sharma; M Smolskis; G Touloumi; S Walker; A Babiker; M Clewett; E Emanuel; E Florence; A Papadopoulos; A Sánchez; J Tavel; C Grady; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group

doi:10.1111/hiv.12230

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

E Denning, S Sharma, M Smolskis, G Touloumi, S Walker, A Babiker, M Clewett, E Emanuel, E Florence, A Papadopoulos, A Sánchez, J Tavel, C Grady, International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group

Research output: Contribution to journal › A1: Web of Science-article › peer-review

Abstract

OBJECTIVES: Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants.

METHODS: Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants.

RESULTS: A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment.

CONCLUSIONS: These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.

Original language	English
Journal	HIV Medicine
Volume	16
Issue number	Suppl. 1
Pages (from-to)	24-29
Number of pages	6
ISSN	1464-2662
DOIs	https://doi.org/10.1111/hiv.12230
Publication status	Published - 2015

Keywords

Adult
Anti-Retroviral Agents
Antiretroviral Therapy, Highly Active
CD4 Lymphocyte Count
Cohort Studies
Female
HIV Infections
Humans
Informed Consent
Male
Time Factors
Treatment Outcome
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Access to Document

10.1111/hiv.12230

Cite this

Denning, E., Sharma, S., Smolskis, M., Touloumi, G., Walker, S., Babiker, A., Clewett, M., Emanuel, E., Florence, E., Papadopoulos, A., Sánchez, A., Tavel, J., Grady, C., & International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group (2015). Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Medicine, 16 (Suppl. 1), 24-29. https://doi.org/10.1111/hiv.12230

@article{27073e49161a443b9e40589b6bc1a4c5,

title = "Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial",

abstract = "OBJECTIVES: Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants.METHODS: Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants.RESULTS: A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment.CONCLUSIONS: These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.",

keywords = "Adult, Anti-Retroviral Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Cohort Studies, Female, HIV Infections, Humans, Informed Consent, Male, Time Factors, Treatment Outcome, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't",

author = "E Denning and S Sharma and M Smolskis and G Touloumi and S Walker and A Babiker and M Clewett and E Emanuel and E Florence and A Papadopoulos and A S{\'a}nchez and J Tavel and C Grady and {International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group}",

note = "{\textcopyright} 2015 British HIV Association.",

year = "2015",

doi = "10.1111/hiv.12230",

language = "English",

volume = "16 ",

pages = "24--29",

journal = "HIV Medicine",

issn = "1464-2662",

publisher = "John Wiley & Sons",

number = "Suppl. 1",

}

Denning, E, Sharma, S, Smolskis, M, Touloumi, G, Walker, S, Babiker, A, Clewett, M, Emanuel, E, Florence, E, Papadopoulos, A, Sánchez, A, Tavel, J, Grady, C & International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group 2015, 'Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial', HIV Medicine, vol. 16 , no. Suppl. 1, pp. 24-29. https://doi.org/10.1111/hiv.12230

TY - JOUR

T1 - Reported consent processes and demographics

T2 - a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

AU - Denning, E

AU - Sharma, S

AU - Smolskis, M

AU - Touloumi, G

AU - Walker, S

AU - Babiker, A

AU - Clewett, M

AU - Emanuel, E

AU - Florence, E

AU - Papadopoulos, A

AU - Sánchez, A

AU - Tavel, J

AU - Grady, C

AU - International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group

PY - 2015

Y1 - 2015

N2 - OBJECTIVES: Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants.METHODS: Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants.RESULTS: A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment.CONCLUSIONS: These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.

AB - OBJECTIVES: Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants.METHODS: Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants.RESULTS: A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment.CONCLUSIONS: These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.

KW - Adult

KW - Anti-Retroviral Agents

KW - Antiretroviral Therapy, Highly Active

KW - CD4 Lymphocyte Count

KW - Cohort Studies

KW - Female

KW - HIV Infections

KW - Humans

KW - Informed Consent

KW - Male

KW - Time Factors

KW - Treatment Outcome

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, N.I.H., Extramural

KW - Research Support, Non-U.S. Gov't

U2 - 10.1111/hiv.12230

DO - 10.1111/hiv.12230

M3 - A1: Web of Science-article

C2 - 25711320

SN - 1464-2662

VL - 16

SP - 24

EP - 29

JO - HIV Medicine

JF - HIV Medicine

IS - Suppl. 1

ER -

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

Abstract

Keywords

Access to Document

Fingerprint

Cite this