scholarly journals Equality and Equity in Compensating Patient Engagement in Research: A Plea for Exceptionalism

2021 ◽  
pp. 174701612110599
Author(s):  
Jean-Christophe Bélisle-Pipon ◽  
Vincent Couture ◽  
Marie-Christine Roy
Keyword(s):  
Research Ethics ◽  
Patient Outcomes ◽  
Patient Engagement ◽  
Research Participation ◽  
Institutional Review Board ◽  
Research Approach ◽  
Institutional Review ◽  
Academic Policy ◽  
Patient Engagement In Research ◽  
The Right

Engaging citizens and patients in research has become a truism in many fields of health research. It is now seen as a laudable—if not compulsory—activity in research for yielding more impactful and meaningful citizen/patient outcomes and steering research in the right direction. Although this research approach is increasingly common and commendable, we recently encountered a major obstacle in obtaining an ethics certificate from an institutional review board (IRB) to conduct a study that places citizen/patient perspectives on equal footing with those of academic/policy experts. The obstacle was the interpretation of fairness in terms of compensation for research participation (i.e. honoraria). In terms of research ethics, this raised an important question: Should all types of participants be compensated equally, or should exceptions be made for citizen/patient participants? We argue that there are good reasons for exceptionalism and that clearer guidance on citizen/patient engagement in research should be embedded into research ethics doctrine.

scholarly journals 489 TWT-101: a phase 1 study of the novel HPK1 inhibitor CFI-402411 in patients with advanced cancer

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A519-A519
Author(s):  
Omid Hamid ◽  
Johanna Bendell ◽  
Siqing Fu ◽  
Kyriakos Papadopoulos ◽  
Judy Wang ◽  
...  
Keyword(s):  
T Cells ◽  
T Cell ◽  
Research Ethics ◽  
Potent Inhibitor ◽  
Phase 1 ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Research Ethics Board ◽  
Grade 3 ◽  
Advanced Tumors

BackgroundCFI-402411 is an orally available small molecule potent inhibitor of HPK1 (Hematopoietic progenitor kinase 1). T-cells are negatively-regulated at different junctures of cancer-immunity cycle by this regulatory kinase. HPK1, (also mitogen activated protein kinase kinase kinase kinase 1 (MAP4K1)) is a protein serine/threonine kinase predominantly expressed in hematopoietic cells. In T-cells, following T-cell receptor activation, HPK1 is recruited to the plasma membrane where it phosphorylates the adapter protein SH2 domain-containing leukocyte protein of 76 kDa (SLP-76), down-regulating signaling events required for T cell activation and proliferation. Selected for development based on its pharmacologic properties and preclinical activity in a variety of syngeneic cancer models and assays, with an IC50 = 4.0±1.3 nM, CFI-402411 is expected to relieve HPK1-mediated inhibition of T and B cells, facilitating an anti-tumor immune response.MethodsPhase 1, 3 + 3 design in patients. Patients have acceptable laboratory, other parameters for study entry. Single agent dose daily oral escalation cohort (A1) in advanced tumors, then dose expansion (A3) with biomarker backfill (A2) in select advanced tumors; combination with PD-1 Inhibitor (pembrolizumab) (B1, pembrolizumab eligible tumors with no prior grade >=3 related to CPI)) and expansion (B2, PD-1/PD-L1 naïve pembrolizumab eligible tumors). DLT defined as any grade >=3 toxicity in first cycle of therapy (21d cycles). Standard assessments for response per RECIST v1.1 or iRECIST. The starting dose level was 80mg.ResultsAt 10 June 2021 data is available for 12 patients from A1. Median age 61.5 years (range 33–73), 8 patients female, and 10 white. Diagnoses were pancreatic cancer, colorectal (3 pts), ovarian, basal cell, cholangiocarcinoma, sigmoid, salivary and breast cancer (1 pt). Six patients (50%) had 4 prior therapies, 1 patient (basal cell) had prior treatment with immune checkpoint inhibitor, pembrolizumab. Four doses studied: 80, 120, 180 and 270mg. TEAEs across all CTCAE grades, (in >2 patients) were diarrhea (6 patients), nausea (4 patients), dyspepsia (3 patients), fatigue (3 patients). No related grade 3–5 events, one immune related event (grade 1, weight loss). 3 grade 3 events all unrelated to study drug - pleural effusion, rash, thromboembolic event. Discontinuation due to disease progression was main reason (7 patients). PK and PD assessments will be updated at time of presentation.ConclusionsCFI-402411 is a potent inhibitor of HPK1 that is well tolerated with a manageable adverse event profile and dose escalations continue. Further safety and efficacy results will be presented at the meeting including additional cohorts if available.AcknowledgementsTreadwell Therapeutics thanks all sites, importantly their patients and their families.Trial RegistrationClinicalTrials.gov Identifier: NCT04521413Ethics ApprovalThis study obtained has obtained ethics approvals at multiple institutions globally including;USAWCG IRB - Western Institutional Review Board - MOD00002618 (Submission ID)IntegReview Institutional Review Board - N/AAdvarra Central IRB - SSU00130103IntegReview Institutional Review Board N/AAdvarra Central IRB - SSU00137751Advarra Central IRB - SSU00143275The University of Texas MD Anderson Cancer Center Institutional Review Board - 2020–0678 (IRB ID Number)Hong KongJoint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee - 2020.367 (Ref Number)CanadaOntario Cancer Research Ethics Board - 3320 (Project ID)Health Research Ethics Board of Alberta, HREBA Cancer Committee - HREBA.CC-20–0504 (Ethics ID Number)South KoreaimCORE - Seoul National University Hospital Institutional Review Board - H-2012-094-1182 (IRB Number)National Cancer Institute Review Board - 2020–0525–0001 (Receipt Number)All participants gave informed consent before taking part in this clinical trial.

Response

2000 ◽  
Vol 27 (1) ◽  
pp. 28-28
Author(s):  
David Wyatt Seal ◽  
Frederick R. Bloom ◽  
Anton M. Somlai
Keyword(s):  
Research Ethics ◽  
Applied Field ◽  
Ethical Dilemmas ◽  
Real Life ◽  
Field Research ◽  
Institutional Review Board ◽  
Board Governance ◽  
Practical Application ◽  
Multiple Strategies ◽  
Institutional Review

Lew Margolis’s commentary on our discussion of field dilemmas delineates the basic tenets of research ethics and presents the historical backdrop for Institutional Review Board governance of the conduct of scientific research. Margolis’s commentary also highlights two important points: (1) within broad boundaries, multiple strategies may exist for resolving ethical dilemmas, and (2) field judgments about the best strategy for resolving ethical dilemmas may sometimes appear less than optimal with hindsight. These emphases reinforce the critical need for continued dialogue about the practical application of research ethics in applied field settings. We further emphasize the importance of conducting this dialogue not only in community forums but in academic arenas. The professional expertise of field researchers often is derived from direct experience with or membership in the communities being studied. For academic discussion of research ethics to have real-life utility, it is essential that conceptual discussion be translated into discussion of these issues as they apply to real-life situations demanding real-life solutions. We invite others to continue this dialogue about the practical application of research ethics to dilemmas that have been encountered during the conduct of applied field research.

scholarly journals Negotiating the Ethical Conduct of Educational Research in an Institutional Review Board Space: Perspectives from a University in Ethiopia

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ashenafi Alemu
Keyword(s):  
Research Ethics ◽  
Educational Research ◽  
Ethical Issues ◽  
Behavioral Science ◽  
Institutional Review Board ◽  
Ethical Review ◽  
National Guidelines ◽  
African Countries ◽  
Institutional Review ◽  
Éthique De La Recherche

Some international researchers assume that there is a lack of ethical review of research in many countries of the Global South. However, numerous African countries have recently introduced local and national research ethics guidelines. This article unpacks how ethical reviews of research in education are negotiated in a higher education institution in Ethiopia. It employs a critical analytical lens to challenge some of the assumptions of Beaty’s (2010) Institutional Review Board (IRB) stakeholder model. The article begins with a discussion of the limitations inherent in the IRB model. Critical analyses of institutional documents and non-confidential, off-the-shelf IRB minutes are also conducted. The analysis shows that researchers within the medical and health sciences disciplines have well established organizational engagement when it comes to handling issues related to research ethics. However, the limited representation of the educational and social and behavioral science disciplines remains a challenge. Furthermore, ethical issues in conducting educational research are hardly addressed in the national guidelines for granting research ethics approval. This results in further marginalisation of the contributions of educational research to knowledge production. Certains chercheurs internationaux présument un manque de suivi éthique de la recherche dans plusieurs pays du Sud. Cependant, de nombreux pays d’Afrique ont récemment mis en place des recommandations au niveau local et national en ce qui concerne l’éthique de la recherche. Le présent article analyse comment le suivi éthique de la recherche en sciences de l’éducation est mené dans un établissement d’enseignement supérieur en Ethiopie. Adoptant un point de vue analytique critique, il remet en question certains présupposés du modèle de l’Institutional Review Board (IRB – comité d’éthique de la recherche) de Beaty (2010) basé sur la théorie des parties prenantes. L’article commence par considérer les limites du modèle de l’Institutional Review Board. Des analyses critiques sont également menées à partir de documents institutionnels et de comptes-rendus disponibles et non confidentiels de réunions de l’Institutional Review Board. Cette recherche démontre que les chercheurs en médecine et sciences de la santé ont des positions clairement établies et propres aux organismes auxquels ils appartiennent, qui leur permettent de faire face aux questions d’éthique de la recherche. Cependant, la sous-représentation des sciences de l’éducation, des sciences sociales et des sciences comportementales demeure problématique. De plus, les questions éthiques qui se posent dans la recherche en sciences de l’éducation sont à peine abordées dans les directives nationales qui permettent d’obtenir l’approbation du comité d’éthique de la recherche. Cela a pour conséquence d’éloigner un peu plus les contributions de la recherche en sciences de l’éducation de la production du savoir.

scholarly journals Modified Orbitozygomatic Craniotomy for Previously Coiled Giant Basilar Apex Aneurysm: 2-Dimensional Operative Video

2019 ◽  
Vol 17 (5) ◽  
pp. E199-E199
Author(s):  
Benjamin K Hendricks ◽  
Robert F Spetzler
Keyword(s):  
Video Recording ◽  
Institutional Review Board ◽  
Anterior Circulation ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Orbitozygomatic Approach ◽  
Clip Application ◽  
Complicating Factors ◽  
The Right ◽  
Significant Size

Abstract Basilar apex aneurysms are generally preferentially managed with endovascular intervention; however, these lesions can demonstrate refractory persistence despite this treatment and, in such cases, must be managed microsurgically. Successful navigation to and manipulation of the basilar apex through the orbitozygomatic approach requires an intricate understanding of the cerebrovascular microanatomy and arachnoid planes within interpeduncular fossa and comfort with use of the operating microscope for the long surgical trajectory to the basilar apex. This patient had a multiply recurrent basilar apex aneurysm; 3 previous coil embolization attempts had been made without successful aneurysm obliteration. This case presented multiple complicating factors, including the presence of a large coil mass and the significant size of the basilar apex lesion. An Allcock test was performed to determine the collateralization across the posterior communicating arteries, and no posterior communicating arteries were visualized, which suggested isolation of the posterior and anterior circulation. A fenestrated clip was utilized from the right side to occlude the base of the aneurysm. Single-clip application was not impeded by the coil mass. Postoperative angiography demonstrated complete occlusion of the aneurysm. The patient gave informed consent for surgery and video recording. Institutional review board approval was deemed unnecessary. Used with permission from Barrow Neurological Institute, Phoenix, Arizona.

Making the case for completion bonuses in clinical trials

2018 ◽  
Vol 16 (2) ◽  
pp. 176-182 ◽  
Author(s):  
Emily A Largent ◽  
Holly Fernandez Lynch
Keyword(s):  
Clinical Trials ◽  
Financial Incentives ◽  
Institutional Review Board ◽  
Study Endpoint ◽  
Ethical Problems ◽  
Research Participants ◽  
Institutional Review ◽  
The Right ◽  
Incentive Payments

Attrition is a serious problem in many clinical trials. The practice of offering completion bonuses—financial incentives offered to participants on the condition that they remain in a trial until they reach a prespecified study endpoint—is one means of addressing attrition. Despite their practical appeal, however, completion bonuses remain ethically controversial due to concern that they will coerce or unduly influence participants to not exercise their right to withdraw from a trial. Although this interaction with the right to withdraw does render completion bonuses conceptually distinct from other incentive payments offered to research participants, we argue here that completion bonuses are never coercive and, in the context of effective institutional review board oversight, are unlikely to be unduly influential. Nonetheless, because completion bonuses may in some cases still encourage unreasonable continued participation in a study, additional safeguards are appropriate. Rejecting completion bonuses entirely is, however, unnecessary and would problematically fail to address the significant ethical problems associated with participant attrition.

scholarly journals Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Guillaume Marquis-Gravel ◽  
Holly Robertson ◽  
W. Schuyler Jones ◽  
Danielle Riley ◽  
Daniel E. Ford ◽  
...  
Keyword(s):  
Informed Consent ◽  
Patient Engagement ◽  
Randomized Clinical Trials ◽  
Lessons Learned ◽  
Institutional Review Board ◽  
Ethical Review ◽  
Atherosclerotic Cardiovascular Disease ◽  
Institutional Review ◽  
Patient Centric

Abstract Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic “Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)” randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. Main text ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. Conclusion Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.

scholarly journals 545 A phase 2 study of retifanlimab in patients with advanced or metastatic merkel cell carcinoma (MCC) (POD1UM-201)

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A574-A575
Author(s):  
Giovanni Grignani ◽  
Piotr Rutkowski ◽  
Celeste Lebbe ◽  
Natalie Prinzi ◽  
Jean-jaques Grob ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Research Ethics ◽  
Health Research ◽  
Institutional Review Board ◽  
Phase 2 ◽  
Merkel Cell ◽  
Institutional Review ◽  
Phase 2 Study ◽  
Research Ethics Board ◽  
Grade 3

BackgroundRetifanlimab (INCMGA00012) is a humanized, hinge-stabilized immunoglobulin G4 kappa (IgG4κ), anti-programmed cell death protein (PD)-1 monoclonal antibody with safety and clinical pharmacology that are characteristic for the class. Evaluation of retifanlimab in solid tumors is under investigation in phase 2 and 3 studies. POD1UM-201 is an open-label, single-arm, multicenter, phase 2 study evaluating the efficacy and safety of retifanlimab in patients with chemotherapy-naïve or chemotherapy-refractory advanced/metastatic Merkel cell carcinoma (MCC). Updated results from the chemotherapy-naïve cohort are reported here.MethodsEligible patients were ≥18 years of age, had metastatic or recurrent unresectable loco-regional MCC, Eastern Cooperative Oncology Group performance status ≤1, measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and had not received prior systemic treatment for MCC. Retifanlimab 500 mg IV every 4 weeks (Q4W) was administered for up to 2 years. The primary endpoint was overall response rate (ORR) assessed by independent central review per RECIST v1.1. Secondary endpoints included duration of response, disease control rate (DCR; defined as proportion of patients with either an objective response or stable disease lasting at least 6 months), progression-free survival, overall survival, safety, and pharmacokinetics.ResultsAs of April 16, 2021, 87 patients with chemotherapy-naïve advanced/metastatic MCC had received retifanlimab. Per protocol, the primary efficacy analyses are based on the first 65 patients assessed. At the data cutoff, 34 of these 65 patients (52.3%) were on treatment; 4 (6.2%) had completed treatment; and 27 (41.5%) had discontinued treatment for reasons including disease progression (18 [27.7%]), adverse event (AE; 7 [10.8%]), death (1 [1.5%]), and physician decision (1 [1.5%]). The ORR in these patients was 46.2% (n=30: complete response, 8 [12.3%]; partial response, 22 [33.8%]). The DCR was 53.8% (n=35). Other secondary efficacy results are not yet mature. Among all treated patients (n=87), 66 (75.9%) had a treatment-emergent AE (TEAE), 25 (28.7%) had a grade ≥3 TEAE, and 12 (13.8%) had a grade ≥3 treatment-related AE. Twenty-three patients (26.4%) had an immune-related AE (irAE), and 8 (9.2%) had a grade ≥3 irAE. Four patients (4.6%) discontinued treatment due to irAEs (peripheral sensorimotor neuropathy, pancreatitis, eosinophilic fasciitis, and polyarthritis [each n=1]). One patient (1.1%) had a grade 3 infusion reaction.ConclusionsThese data from the POD1UM-201 trial show that retifanlimab monotherapy at 500 mg Q4W continues to demonstrate promising clinical activity and safety in patients with advanced/metastatic chemotherapy-naïve MCC. Updated results will be presented at the meeting.AcknowledgementsThe study is sponsored by Incyte Corporation (Wilmington, DE). Statistical support was provided by Xiaohan Xu of Incyte Corporation. Editorial assistance was provided by Matthew Bidgood of Envision Pharma Group (Philadelphia, PA, USA).Trial RegistrationClinicaltrials.gov NCT03599713; EudraCT 2018-001627-39Ethics ApprovalThe study was approved by institutional review boards or independent ethics committees in Canada (McGill University Health Center-Research Ethics Board [MP-37-2019-5103, MEO-37-2019-1616]; Ontario Cancer Research Ethics Board [1728]; Health Research Ethics Board of Alberta – Cancer Committee [HREBA.CC-19-0004, HREBA.CC-19-0020]); Czech Republic (Eticka komise Fakultni nemocnice Kralovske Vinohrady, Eticka komise IKEM a FTNsP, Eticka komise Nemocnice Na Bulovce, Statni ustav pro kontrolu leciv, Eticka komise FN a LF UP Olomouc [169/18MEK24, LEK/04/07/2018, (L-18-85) 8522/23.3.2021, 22.3.2021/9965/EK-Z]); France (Comité de Protection des Personnes Ile de France X [CNRIPH : 18.11.19.49212/Id. 2043]; Agence Nationale de Sécurité du Médicament et des Produits de Santé); Germany (Ethik-Kommission der Medizinischen Fakultaet der Universitaet Duisburg-Essen [18-8371-AF]; Bundesamt fuer Strahlenschutz; Paul-Ehrlich Institute); Hungary (Egeszsegugyi Tudomanyos Tanacs Klinikai Farmakologiai Etikai Bizottsaga [IV/2407-0/2021-EKL, OGYÉI/11697-2/2021]; Orszagos Gyogyszereszeti es Elelmezes-egeszsegugyi Intezet); Italy (Comitato Etico IRCCS Pascale Napoli [116/21 E - 87/18]; Comitato Etico IRCCS di Candiolo [232/2021]; Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari [736/CE]; Comitato Etico Locale per la Sperim. Clin. dei Medicinali dell’Az. Osp.ra Univ.ria Senese di Siena [14107]; Comitato Etico dell’IRCCS Istituto Nazionale per la Ricerca sul Cancro di Genova [389/2018 - 24/05/2021]; Comitato etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino [IEO 948 - RE3065/IB Edition 7 dated 10Nov2020 (SA7)]; Comitato Etico, Fondazione IRCCS Istituto Nazionale dei Tumori, .c. Medicina Oncologica 1 – Fondazio [INT 01/19]; Comitato Etico IRCCS Istituto Oncologico Veneto di Padova [EM 109/2021]; Comitato Etico dell’IRCCS Istituto Dermopatico dell’Immacolata Ospedale Generale S. Carlo di Roma [550/7]; AIFA – Agenzia Italiana del Farmaco [0040152-01/04/2021-AIFA-AIFA_USC-P]; Comitatao Etico Policlinico di Modena [1017/2018/FARM/AOUMO - EMENDAMENTO SOSTANZIALE IB EDIZIONE 7 DEL 10/11/20 (201800162739-010) (p. 9869/21)]); Poland (Komisja Bioetyczna przy Centrum Onkologii [no. 55/2019]; Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [UR/DBL/D/328/2019]); Spain (CEIC Hospital General Universitario Gregorio Marañon [280/18]; Agencia Española del Medicamento y Productos Sanitarios); Switzerland (Kantonale Ethikkommission Zürich (KEK-Zürich) [2019-00200]; Swissmedic [2019DR2035]); United Kingdom (North East – York Research Ethics Committee [248465]; Medicines and Healthcare products Regulatory Agency; Health Research Authority); United States (Copernicus Group IRB; Western Institutional Review Board [20181738, Work order number -– IQV1-18-309]; Roswell Park Cancer Institute IRB [STUDY00000802/P 75918]; Inova Institutional Review Board, Human Research Protection Program; Stanford IRB Research Compliance Office [48198]; Rush University Medical Center [18072304-IRB01]; University of Miami IRB; Mayo Clinic IRB – Rochester).

scholarly journals Research Ethics Step by Step

2020 ◽  
pp. 227-273
Author(s):  
Jaap Bos
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Institutional Review Board ◽  
Consent Form ◽  
List Type ◽  
General Knowledge ◽  
Know How ◽  
Institutional Review ◽  
Informed Consent Form ◽  
Research Designs

After Reading This Chapter, You Will: Have a general knowledge of Institutional Review Board (IRB) procedures Have the capacity to anticipate the basic ethical pitfalls in research designs Know how to counter common ethical objections Be able to design an informed consent form

Differing Understandings of Informed Consent Held by Research Institutions, People with Intellectual Disability, and Guardians

2019 ◽  
pp. 27-38
Author(s):  
Britteny M. Howell ◽  
Karrie A. Shogren
Keyword(s):  
Intellectual Disability ◽  
Informed Consent ◽  
Research Participation ◽  
Research Literature ◽  
Self Determination ◽  
Institutional Review Board ◽  
Research Institutions ◽  
Ethical Research ◽  
Institutional Review ◽  
Participation In Research

Increasing participation of people with intellectual disability (ID) is necessary for inclusive, ethical research that reduces persistent disparities in representation. However, many adults with ID have guardians, who must consent to research involvement. Researchers have found that guardians are less likely to provide consent than the person with ID, often resulting in lower participation. Institutional Review Board (IRB) members also have been found to hold very cautious views regarding research participation compared to the views of people with ID or their guardians. This chapter reviews issues that emerge because of differing views of research participation held by IRB members, guardians, and people with ID that may unnecessarily limit the participation of people with ID in research. The research literature on these barriers is summarized along with the authors’ own experiences with alternative participatory strategies that have the potential to increase both self-determination and participation in research for people with ID.

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