Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons.

1992 ◽  
Vol 10 (11) ◽  
pp. 1810-1816 ◽  
Author(s):  
E Kodish ◽  
C Stocking ◽  
M J Ratain ◽  
A Kohrman ◽  
M Siegler
Keyword(s):  
Phase I ◽  
Ethical Issues ◽  
Institutional Review Board ◽  
Phase I Trials ◽  
Conducting Phase ◽  
Institutional Practice ◽  
Oncology Research ◽  
Institutional Review ◽  
Differences Of Opinion ◽  
Board Chairpersons

PURPOSE Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country. METHODS Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group. RESULTS The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials. CONCLUSION Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.

New requirements for phase I trials: a challenge for Italian clinical research

2018 ◽  
Vol 104 (1) ◽  
pp. 15-21 ◽  
Author(s):  
Emanuela Marchesi ◽  
Manuela Monti ◽  
Oriana Nanni ◽  
Lisette Bassi ◽  
Martina Piccinni-Leopardi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Phase I ◽  
Good Clinical Practice ◽  
Phase I Trials ◽  
Highly Qualified ◽  
Phase I Clinical Trials ◽  
Oncology Research ◽  
Standard Operating ◽  
Near Future

Background: In 2015, the Italian Medicines Agency (Agenzia Italiana del Farmaco; AIFA) issued the Determination 809/2015 with new requirements for phase I clinical trials. Before it came into force, we explored the extent to which several Italian oncology centers were working to implement it. Methods: A survey was conducted among 80 Italian centers involved in clinical trials. Investigators and research coordinators were surveyed. Results: Answers from 42 institutions were collected: among them 88.1% were involved in oncology research. In the last 5 years, 55% had conducted from 1 to 5 phase I trials, and only 16.7% more than 5. A third were involved in not-first-in-human research and none with healthy volunteers. The majority (57.1%) of the centers did not run any projects and trials are non-commercial, and about 35%, no more than 2. While 9.5% already met the standards for self-certification, 71.4% were working to achieve them. Standard operating procedures dedicated to research and the required good clinical practice training had been established by 57.1% and 76.2%, respectively. Fifty percent of laboratories were almost compliant with the Determination. After 10 months from its coming into force, 98 sites had applied for certification, of which 34 were oncology units. Conclusions: The new AIFA Determination imposes a certified organizational model on units and laboratories involved in phase I trials. Our results showed that great efforts were made to qualify for phase I research suggesting that other oncology units will apply for certification in the near future. Predictably, Italy will set the pace as a highly qualified country in which to conduct early-phase 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 Costs and Benefits of the National Cancer Institute Central Institutional Review Board

2010 ◽  
Vol 28 (4) ◽  
pp. 662-666 ◽  
Author(s):  
Todd H. Wagner ◽  
Christine Murray ◽  
Jacquelyn Goldberg ◽  
Jeanne M. Adler ◽  
Jeffrey Abrams
Keyword(s):  
Societal Perspective ◽  
National Cancer Institute ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Phase Iii ◽  
Research Staff ◽  
Oncology Research ◽  
Institutional Review ◽  
Definition Of ◽  
Central Institutional Review Board

Purpose In 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials. Methods We conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective. Results CIRB affiliation was associated with faster reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savings of $717 per initial review. The estimated cost of running the CIRB was $161,000 per month. The CIRB yielded a net cost of approximately $55,000 per month from a societal perspective. Whether the CIRB results in higher or lower quality reviews was not assessed because there is no standard definition of review quality. Conclusion The CIRB was associated with decreases in investigator and IRB staff effort and faster protocol reviews, although savings would be higher if institutions used the CIRB as intended.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2019 ◽  
pp. 545-548
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Conduct ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Essential Components ◽  
Financial Conflicts Of Interest

Describe the essential components of the ethical conduct of research, the role of the institutional review board, the process of informed consent, the potential areas of conflict of interest for clinicians participating in research, and other ethical issues related to research in HIV medicine.

Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?

2013 ◽  
Vol 41 (2) ◽  
pp. 397-410 ◽  
Author(s):  
Seema K. Shah
Keyword(s):  
Research Team ◽  
Antiretroviral Treatment ◽  
Hiv Transmission ◽  
Ethical Issues ◽  
Institutional Review Board ◽  
National Program ◽  
Common Rule ◽  
Institutional Review ◽  
The Common ◽  
Ethical Obligations

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment (ART) to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides antiretroviral treatment and care. Assuming the Institutional Review Board (IRB) raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address.

Undergraduate Research and the Institutional Review Board: A Mismatch or Happy Marriage?

1996 ◽  
Vol 23 (1) ◽  
pp. 20-25 ◽  
Author(s):  
Carl A. Kallgren ◽  
Robert T. Tauber
Keyword(s):  
Ethical Issues ◽  
Undergraduate Research ◽  
Human Subjects ◽  
Educational Experience ◽  
Psychological Research ◽  
Institutional Review Board ◽  
Research Projects ◽  
Institutional Review ◽  
Happy Marriage ◽  
Student Researchers

Many undergraduate research projects with human subjects are not reviewed by an Institutional Review Board (IRB). Undergraduate research should be reviewed to protect subjects' welfare, ethically and legally protect instructors, enhance the reputation of psychological research, and enrich the educational experience of student researchers. A survey of undergraduate researchers (N = 53), all of whom underwent the IRB process for their research, indicated that they thought they had learned more by going through the IRB process, produced a better product, viewed instructor feedback more positively, saw the instructor as more of an ally, treated their research more seriously, and were sensitized to ethical issues. We recommend the IRB process for all undergraduate research.

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