The Ethics Blog

A blog from the Centre for Research Ethics & Bioethics (CRB)

Tag: informed consent

Research nurses on ethical challenges in recruiting participants for clinical research

Nurse talking to patient, Photo by RDNE Stock project on pexels
16 January, 2024 / / 1 Comment

In clinical research with participating patients, research nurses play a central role. On a daily basis, they balance the values of care and the needs of research. For these nurses, it is clear that patients’ informed consent for research participation is more than just a one-time event completed by signing the form. The written consent is the beginning of a long relationship with the patients. The process requires effective communication throughout the course of the study, from obtaining consent to subsequent interactions with patients related to their consent. The research nurses must continuously ensure that participating patients are well informed about how the study is progressing, that they understand any changes to the set-up or to the risks and benefits. If conditions change too much, a new consent may need to be obtained.

Despite research nurses being so deeply involved in the entire consent process, there is a lack of research on this professional group’s experiences of and views on informed consent. What problems and opportunities do they experience? In an interview study, Tove Godskesen, Joar Björk and Niklas Juth studied the issue. They interviewed 14 Swedish research nurses about ethical challenges related to the consent process and how the challenges were handled.

The challenges were mainly about factors that could threaten voluntariness. Informed consent must be given voluntarily, but several factors can threaten this ethically important requirement. The nurses mentioned a number of factors, such as rushed decision-making in stressful situations, excessively detailed information to patients, doctors’ influence over patients, and disagreement within the family. An elusive threat to voluntariness is patients’ own sometimes unrealistic hopes for therapeutic benefit from research participation. Why is this elusive? Because the hopes can make the patients themselves motivated to participate. However, if the hopes are unrealistic, voluntariness can be said to be undermined even if the patients want to participate.

How do the research nurses deal with the challenges? An important measure is to give patients time in a calm environment to thoughtfully consider their participation and discuss it. This also reduces the risk of participants dropping out of the study, reasoned the nurses. Time with the patients also helps the research nurses to understand the patients’ situation, so that the recruitment does not take place hastily and perhaps on the basis of unrealistic expectations, they emphasized. The interviewees also said that they have an important role as advocates for the patients. In this role, the nurses may need time to understand and more closely examine the patients’ perspectives and reasons for potentially withdrawing from the study, and to find suitable solutions. It can also happen that patients say no to participation even though they really want to, perhaps because they are overwhelmed by all the information that made participation sound complicated. Again, the research nurses may need to give themselves and the patients time for in-depth conversations, so that patients who want to participate have the opportunity to do so. Maybe it is not as complicated as it seemed?

Read the important interview study here: Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences.

The study also highlights another possible problem that the research nurses raised, namely the questionable exclusion of certain groups from research participation (such as people who have difficulty understanding Swedish or have reduced cognitive ability). Such exclusion can mean that patients who want to participate in research are not allowed to do so, that certain groups have less access to new treatments, and that the scientific quality of the studies is hampered.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Godskesen, T., Björk, J. & Juth, N. Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences. Trials 24, 801 (2023). https://doi.org/10.1186/s13063-023-07844-6

This post in Swedish

Ethics needs empirical input

How clearly are ethical approval and informed consent reported in published articles?

Looking through a looking glass
3 October, 2023 / / 1 Comment

In a scientific article, it is of course essential that the authors describe the aim, methods and results of the study. But all researchers also have a research ethical responsibility to reflect on ethical aspects of the work and to plan and carry out their studies in accordance with relevant laws and guidelines. The ethical approach in the study should also be described in the article. This description is not as extensive as the method description, but certain information about ethical approval and informed consent should be given with sufficient detail. If the study also entailed specific ethical challenges, perhaps because it involved vulnerable participants such as seriously ill or dying patients, then the article should report how the challenges were handled regarding, for example, obtaining informed consent.

Although scientific journals have the standard that information on ethical approval and informed consent must be declared, it is unclear how well this requirement is complied with in practice, by both authors and journal editors. A group of ethics researchers, including Tove Godskesen, William Bülow and Stefan Eriksson linked to CRB, recently investigated this question within a relevant field, namely research on palliative and end-of-life care. Patients who participate in such research can be considered vulnerable and research in this area involves particular ethical challenges. How well do scientific publications in the field meet the requirements for reporting ethical approval and informed consent?

The ethicists’ survey was conducted on 169 empirical studies in 101 journals, published after January 1, 2019. It was limited to studies conducted in Norway and Sweden, as the author group was well acquainted with the regulations and practices of ethical review in these countries and could therefore assess whether the articles contained information about relevant laws and authorities. To rate how well the articles reported ethical approval and consent, a scoring scale was created from 0 to 3. Articles with no reporting at all received a score of 0 and articles with minimal reporting (e.g., “Ethical approval was granted”) received a score of 1. If the article contained clear and concise statements about ethical approval and informed consent, and in addition included one piece of detailed information (such as the name of the committee or authority that gave the approval), then the article received a score of 2.

An original feature of the examination is the detailed requirements for obtaining the highest score. The requirements for scoring 3 are intended to also serve as a suggestion for best practice. They are proposed as a possible basis for clearer guidelines in the future for authors, journal editors and peer reviewers. What details must be reported to get the score 3? No irrelevant details, but perfectly reasonable information if you think about it. For example, the identity of the review board should be disclosed as well as the identification number of their decision. Why? To be able to contact the board for verification or questions, for readers to be able to see that the research complies with relevant laws and ethical guidelines, and for the public to be able to access the information. One should also mention the Act under to which the decision on ethical approval was made. Why? It shows that the researchers are ethically proficient and it helps editors and reviewers to compare the statements with legal requirements in doubtful cases. Regarding informed consent, one should state, among other things, what type of consent was obtained and from whom the consent was obtained. Why? So that one can assess whether the procedures meet ethical requirements in the current case. In palliative care research, for example, both the patients and their families can be involved in the consent process. Also for the informed consent, relevant legislation should be indicated to demonstrate awareness of legal requirements and to enable critical review.

The requirements are therefore about completely reasonable information that should be easy to provide. But what were the results of the survey? I content myself with reproducing the percentage of articles that received the lowest and the highest scores. A non-negligible proportion of the articles contained no reported information at all and got 0 points: 5% for ethical approval and 13% for informed consent. A larger but still small proportion of the articles reported sufficiently detailed information to receive the highest score: 27% for ethical approval and 19% for informed consent.

Considering that the requirements for the highest score can be considered reasonable and not particularly onerous, the results are disappointing. The substandard reporting creates uncertainty about the ethical rigor of studies, the authors write in their conclusion, which is particularly troubling for studies with vulnerable participants, such as patients in palliative and end-of-life care, who require special ethical considerations.

What can we do about the problem? A common measure is training in research ethics, which is of course important. But the authors suggest that a more effective way to quickly bring about change is for scientific journals to start making clearer demands on how ethical approval and informed consent must be reported in articles to be considered for publication. So why not use the requirements to get the highest score on this survey as a template? They are proposed as a reasonable description of best practice. Read the survey here: How do journals publishing palliative and end-of-life care research report ethical approval and informed consent?

In a box in the article, the authors cite an exemplary description of ethical approval and informed consent that includes the details for score level 3. It strikes me how clarifying it is to see a good example, so look for the box in the article.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Godskesen, T., Vie, K.J., Bülow, W., Holmberg, B., Helgesson, G. and Eriksson, S. (2023), How do journals publishing palliative and end-of-life care research report ethical approval and informed consent? Learned Publishing. https://doi.org/10.1002/leap.1580

This post in Swedish

Thinking about authorship

The importance of ethical review in research with severely ill children

5 September, 2023 / / 1 Comment

Research ethics committees play an important role in safeguarding human beings in research. Respect for human dignity in research has not always been self-evident. The emergence of research ethics has taken place in the wake of ethical scandals and abuses in which society’s most vulnerable have been used and exploited in the name of science. I am thinking, for example, of the Nazis’ cruel medical experiments on children and other vulnerable people.

At a time when the role of ethical review is being vigorously debated in the media and the research community, it is important to do research on the significance of ethical review. In particular, we should explore the question how ethical review serves to protect those most vulnerable from being exploited in research.

In a recent study conducted by myself together with Anna T. Höglund, Sara Frygner-Holm and Tove Godskesen, we focus on ethical issues in research with ill children, who are often considered a particularly vulnerable group in research. We have interviewed members of the Swedish Ethical Review Authority about their perceptions of ethical issues in research applications involving ill children, for example children with cancer.

One thing that members really emphasized was how crucial it is that the researcher provides good, age-appropriate information to children when they invite them to research. Without good information, children are excluded from being involved in a meaningful way in decisions about research participation. Many of the members we interviewed were concerned that good information for children was often missing from research applications. This suggests that we as researchers may need to increase our efforts to really take children’s legal right to information and participation seriously and not leave the decisions about research participation to the parents alone. There might be a need for more practical guidance on how we can inform and ask children about research in an ethically sound and sustainable way.

Children’s active participation in decisions about research participation is ethically important, but so is of course also children’s right to be protected from various risks associated to research. Some populations of severely ill children are “heavily researched,” among them children with cancer. This is of course very good because it enables groundbreaking medical advances in childhood cancer care and treatment. But at the same time, we know that children and their parents can be particularly vulnerable when recruited to research, due to their challenging life situation. They are also very dependent on the healthcare system. For such reasons, the committee members in the study considered it essential that the children’s physical as well as mental health and integrity are sufficiently protected. This means that as a researcher, you should not only focus on medical risks, but also consider how the whole child is affected, both short and long term, by being part of your research project.

The members we interviewed felt they had an ethical responsibility to protect children from “bad research” – when severely ill children give of their precious time and energy, it is especially important that the research is of high scientific quality and answers research questions that are truly important, new and urgent. It has been controversial whether or not research ethics committees should assess the design and quality of research. However, as shortcomings in design and quality can significantly reduce the potential benefits of a project, such aspects should be assessed as part of the ethical review, so that ill children can be spared participation in research that is not likely to lead to new knowledge or medical advances.

Ethical review is governed by laws and regulations. Some members were concerned that the ethical review system risks becoming too one-sidedly focused on legal compliance and formalities, giving ethical reflection to little space. Ethical review of research involving severely ill children undoubtedly places high demands not only on legal competence, but also on clinical and ethical competence, good teamwork and personal qualities such as accuracy and responsibility. Moreover, the emergence of new advanced technologies in research and healthcare constantly presents research ethics committees with new complex ethical issues to ponder and address. Thankfully, philosophy and its ethical principles offer invaluable tools!

So, what is the role and significance of ethical review in research with ill children? As our study suggests, ethical review and research ethics committees have, among other things, a crucial role in monitoring and promoting children’s right to information, participation and protection from harm and risks in research. These are urgent tasks, both from a children’s rights perspective and a research ethics perspective. If you want to know more about our results and read our discussion of the findings, you can find the study here: Research ethics committee members’ perspectives on paediatric research: a qualitative interview study.

Children’s perspectives have not been represented in research ethics to any great extent and more knowledge is therefore needed regarding children’s own experiences of research participation. Therefore, in an upcoming study, we will now interview children with cancer and their parents about how they experienced being asked to participate in research. 

Kajsa Norberg Wieslander

Written by…

Kajsa Norberg Wieslander, PhD student at the Centre for Research Ethics & Bioethics, is exploring ethical and clinical aspects of recruiting children with cancer to research studies.

Norberg Wieslander, K., Höglund, A. T., Frygner-Holm, S., & Godskesen, T. (2023). Research ethics committee members’ perspectives on paediatric research: a qualitative interview study. Research Ethics, 0(0). https://doi.org/10.1177/17470161231179663

This post in Swedish

Ethics needs empirical input