scholarly journals Informing research participants of research results: analysis of Canadian university based research ethics board policies

2006 ◽  
Vol 32 (1) ◽  
pp. 49-54 ◽  
Author(s):  
S D MacNeil
Keyword(s):  
Research Ethics ◽  
Research Results ◽  
Research Participants ◽  
Research Ethics Board

scholarly journals Improving dissemination of study results: perspectives of individuals with cystic fibrosis

2019 ◽  
Vol 15 (3-4) ◽  
pp. 1-14
Author(s):  
Emily Christofides ◽  
Karla Stroud ◽  
Diana Elizabeth Tullis ◽  
Kieran C. O’Doherty
Keyword(s):  
Cystic Fibrosis ◽  
Research Ethics ◽  
Research Results ◽  
Research Participants ◽  
Study Results ◽  
Research Findings ◽  
The Impact ◽  
To Receive ◽  
Accessible Format

The practice of communicating research findings to participants has been identified as important in the research ethics literature, but little research has examined empirically how this occurs and what research participants’ views are in this regard. We interviewed 21 adults with cystic fibrosis who had previously participated in research and 2 research coordinators at a cystic fibrosis clinic. We aimed to better understand research participants’ views on receiving research results, types of findings they are interested in, how they would like to receive this information, and the impact this might have on future participation. Participants reported that they do not generally recall receiving study findings, though many reported that they would like to receive them. While some participants were not interested in receiving results, all participants felt that these results should be provided when desired by participants and believed that receiving study findings would support future participation. Participants felt that an accessible format, such as a lay summary, would be most helpful. This study supports calls to make study findings available to participants, though the format in which they are provided requires consideration. Participants rarely recalled receiving findings despite the clinic in which this study was conducted returning them regularly. Therefore, questions pertaining to the provision of study findings must focus less on whether to share the findings and more on how to share them with participants most effectively. The logistics of providing study findings may be challenging in some cases, but participant support for the practice highlights its importance.

A Survey of Researchers[rquo] Practice in Returning Research Results To Research Participants. Oral Abstracts Presented at ASH Annual Meeting 2003.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3130-3130
Author(s):  
Heather B. Rigby ◽  
Conrad V. Fernandez
Keyword(s):  
Research Ethics ◽  
Annual Meeting ◽  
International Research ◽  
The United States ◽  
Research Community ◽  
Return Of Results ◽  
Research Results ◽  
Research Participants ◽  
Return Of Research Results ◽  
Study Participants

Abstract Background: Offering research results to study participants is increasingly considered an ethical obligation founded on the principle of respect for persons. This practice acknowledges the importance of the participant’s contribution in the study and, in some instances, enables the participant to benefit directly from the health information derived from the research. Recent studies have established that there is growing support for this practice among investigators and study participants in highly selected populations. The frequency and means of this practice is unknown in the broader national and international research community. Methods: We pilot-tested a questionnaire, which we designed for this study. It had a high content validity. The questionnaire was designed to document the frequency with which researchers offer return of results to research participants, the means by which researchers offer results, the role of Research Ethics Boards (REBs) in the return of research results, and the demographics of the study participants. We classified all 887 abstracts presented at the American Society of Hematology Annual Meeting in December 2003 according to study type. Only those abstracts involving human subjects were included. Of the 478 eligible abstracts, email addresses for 472 (98.7%) first or senior authors were found using public web sites. The investigators were sent the 4–5 minute survey by email. Two reminders were sent to non-respondents. Responses were downloaded to a secure server and analyzed by descriptive and Chi squared techniques. Results: Interim results were obtained 11 days after initiating the survey. Complete responses were received from 84 of the 471 (18%) investigators. Most responders were physicians (n=68; 81%) and almost half (n=40; 47%) received Research Ethics Board (REB) approval for their study in the United States. Only 23 (27%) investigators had a formal plan for the return of results to study participants. No clear preference for any one means of returning research results was indicated. The majority (n=18; 78%) indicated that they would provide the participant with a choice of whether or not to receive research results and most (n=14; 61%) indicated that they would provide an overall summary of results rather than an overall summary plus individual level results. Reasons for not returning research results included: did not consider it (n=25), contact difficulties (n=22), and participant difficulty in understanding results (n=19). Cost and concern for the patient regarding adverse effects of receiving results were infrequently cited. Only 2 (2%) of investigators reported that their REB mandated the offer of return of research results to all participants. 55 researchers (66%) supported or strongly supported the return of results to participants, 27 (32%) were neutral, and only 2 (2%) opposed or strongly opposed this practice. Updated data and further analyses will be reported at the annual meeting. Conclusion: Investigators in the international research community infrequently offer to return results to research participants, and REBs rarely mandate this practice. Our study reaffirms the findings of other studies that indicate a high level of support for this practice among researchers. Further work is needed to assess participant needs and concerns, and how to bridge the gap between the expressed attitudes of researchers and actual practice.

scholarly journals Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

2015 ◽  
Vol 43 (4) ◽  
pp. 827-842
Author(s):  
Anya E.R. Prince ◽  
John M. Conley ◽  
Arlene M. Davis ◽  
Gabriel Lázaro-Muñoz ◽  
R. Jean Cadigan
Keyword(s):  
Medical Record ◽  
Medical Records ◽  
Genomic Research ◽  
Research Results ◽  
Research Participants ◽  
Difficult Question ◽  
Automatic Placement ◽  
Study Participants ◽  
Research Studies

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored.

Ethics and the Ruling Relations of Research Production

2003 ◽  
Vol 8 (1) ◽  
pp. 70-80 ◽  
Author(s):  
Carole Truman
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Process ◽  
Research Governance ◽  
Community Mental Health Service ◽  
Moral Obligations ◽  
Research Participants ◽  
Research Production ◽  
Health And Social Care ◽  
Ethical Approval

The role of research ethics committees has expanded across the UK and North America and the process of ethical review has become re-institutionalised under proposals for research governance proposed by government. Ethics committees have gained a powerful role as gatekeepers within the research process. Underpinning the re-constitution of ethical guidelines and research governance, are a range of measures which protect institutional interests, without necessarily providing an effective means to address the moral obligations and responsibilities of researchers in relation to the production of social research. Discussion of research ethics from the standpoint of research participants who in this paper, are service users within health and social care, provides a useful dimension to current debate. In this paper I draw upon experiences of gaining ethical approval for a research study which focused on user participation within a community mental health service. I discuss the strategies used to gain ethical approval and the ‘formal concerns’ raised by the ethics committee. I then describe and discuss ethical issues which emerged from a participants’ perspective during the actual research as it was carried out. These experiences are analysed using aspects of institutional ethnography which provides a framework to explore how the experiences of research participants are mediated by texts which govern the processes of research production. The paper highlights incongruities between the formal ethical regulation of research, and the experiences of research participants in relation to ethical concerns within a research process.

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.

scholarly journals Research and Publication Ethics

2021 ◽  
Vol 7 (3) ◽  
pp. 198-207
Author(s):  
PO Olatunji
Keyword(s):  
Research Ethics ◽  
Early Research ◽  
Publication Ethics ◽  
Research Participants ◽  
Research Findings ◽  
Research Period

Research is an effort to seek the truth and communicate it. In the process, participants or subjects of research must be recognised and respected, and the principles of research ethics must protect the vulnerable from exploitation. The researcher must do the reporting of research findings with honesty and professionalism. Non-adherence to the above principles in the early research period resulted in gross abuse of personality and autonomy. Research is now subjected to rigorous scrutiny to stem the tide of abuse and ascertain and guarantee the sanctity of the research participants, process and product. These are the fundamentals of the practice of ethics in both research and publication. In effect, this paper aims to address ethics and its application to research and publications.

scholarly journals Could providing financial incentives to research participants be ultimately self-defeating?

2016 ◽  
Vol 12 (3) ◽  
pp. 137-148 ◽  
Author(s):  
TL Zutlevics
Keyword(s):  
Intrinsic Motivation ◽  
Research Ethics ◽  
Financial Incentives ◽  
Financial Incentive ◽  
Ethics Committees ◽  
Ethical Guidelines ◽  
Research Participants ◽  
Human Research Ethics ◽  
Institutional Review ◽  
The Individual

Controversy over providing financial incentives to research participants has a long history and remains an issue of contention in both current discussions about research ethics and for institutional review bodies/human research ethics committees which are charged with the responsibility of deciding whether such incentives fall within ethical guidelines. The arguments both for and against financial incentives have been well aired in the literature. A point of agreement for many is that inducement in the form of financial incentive is permissible when the risk of harm to the individual is negligible in terms of degree and probability of occurrence. In the absence of harm to the individual, encouraging more people to participate in research would appear to be a good thing in so far as it will lead to statistically more robust research outcomes, which can then be translated into better healthcare and other practice. Whilst, on the face of it, this position seems highly defensible, I will explore the possibility that it is counterproductive – that is, providing individuals with financial incentives to become research participants may have the unintended outcome of reducing participation rates in some areas of research. In exploring this idea I will draw on empirical findings from the literature on crowding-out – the hypothesis that providing monetary incentives to people can backfire by overall reducing intrinsic motivation, in this instance intrinsic motivation to behave altruistically or undertake civic duties.

Sign in / Sign up

Export Citation Format

Share Document