Text (Instruction Step Text)
From The Embassy of Good Science
Describe the actions the user should take to experience the material (including preparation and follow up if any). Write in an active way.
- ⧼SA Foundation Data Type⧽: Text
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At the end of the session take some time to explain what trainees are required to do in the [https://embassy.science/wiki/Instruction:A0d97625-d155-4f6f-abd0-2f84413888ad time in between the two face-to-face sessions].
At this point you:
1. Encourage your trainees to reflect on their respective training participants’ needs. It may be necessary for them to adapt their training to the level of expertise of their training participants, the local context, or the discipline(s).
2. Distribute the [https://www.dropbox.com/s/1fmppqv189jxlqj/Self%20reflection%20form.pdf?dl=0 self-reflection form] and explain to the trainees that this document is meant as a learning tool designed to help them reflect on their experience in facilitating the exercises. By answering the questions, your trainees may reflect on what went well in their facilitation and what they need to improve, learn or what needs further clarification.
3. Consider advising trainees to connect with a colleague, who is also participating in the training (if possible). This can support the learning experience and allow trainers in training to give feedback to each other and (if applicable) share the tasks required to organize the exercises. +
After having engaged with the material in sept 1 and 2, use the flashcards below to test your knowledge! +
Use the flashcards below to test your knowledge! +
Use the flashcards below to test your knowledge! +
Use the flashcards below to test your knowledge! +
Use the flashcards below to test your knowledge! +
Use the flashcards below to test your knowledge! +
''Target Audience: undergraduate and graduate students, early career researchers, prospective research integrity trainers.''
The [[Instruction:A0dd2e82-52e7-4030-a396-54525630e75c|Modified Dilemma Game]] developed by the [[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|VIRT2UE]] project presents a modified version of the [https://www.eur.nl/over-de-eur/beleid-en-reglementen/integriteit/wetenschappelijke-integriteit/dilemma-game#:~:text=Over%20de%20Dilemma%20Game%20app,professionalisme%20in%20onderzoek%20te%20stimuleren. Dilemma Game] developed by Erasmus University Rotterdam. This exercise supports participants in identifying research integrity principles, virtues and questionable research practices in a hypothetical case. It provides a framework to consider, choose and defend alternative courses of action regarding realistic research integrity dilemmas. +
'''''Target audience:''''' ''Bachelor and master students, doctoral students and early career researchers''
The [https://www.path2integrity.eu/ Path2Integrity] project introduces educators to innovative teaching methods that will take topics in Research Integrity and Ethics. The project provides introductory videos and information on the teaching methodology used, discussing research integrity and its significance. The easy to use and innovative materials can be found in the [https://www.path2integrity.eu/ri-materials Path2Integrity Training Programme] section. +
The goal of [https://h2020integrity.eu/ INTEGRITY] is to empower students and early career researchers. Rather than focusing on compliance, the project's approach is to develop the capacity of participants to identify, consider, and address integrity concerns in research procedures. +
The goal of [https://h2020integrity.eu/ INTEGRITY] is to empower students and early career researchers. Rather than focusing on compliance, the project's approach is to develop the capacity of participants to identify, consider, and address integrity concerns in research procedures. +
'''''Target audience:''''' ''Bachelor and master students, doctoral students and early career researchers''
The [https://www.path2integrity.eu/ Path2Integrity] project introduces educators to innovative teaching methods that will take topics in Research Integrity and Ethics. The project provides introductory videos and information on the teaching methodology used, discussing research integrity and its significance. The easy to use and innovative materials can be found in the [https://www.path2integrity.eu/ri-materials Path2Integrity Training Programme] section. +
'''''Target audience:''' Bachelor and master students, doctoral students and early career researchers.''
The [https://www.academicintegrity.eu/wp/bridge/ BRIDGE project] provides [https://www.academicintegrity.eu/wp/bridge-modules-2/ training modules] and [https://www.academicintegrity.eu/wp/vignettes_interactive/ vignettes] that can be inserted into research ethics and integrity courses. +
'''''Target Audience:''' undergraduate and graduate students, early career researchers, prospective research integrity trainers.''
The [[Instruction:A0dd2e82-52e7-4030-a396-54525630e75c|Modified Dilemma Game]] developed by the [[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|VIRT2UE]] project presents a modified version of the [https://www.eur.nl/over-de-eur/beleid-en-reglementen/integriteit/wetenschappelijke-integriteit/dilemma-game#:~:text=Over%20de%20Dilemma%20Game%20app,professionalisme%20in%20onderzoek%20te%20stimuleren. Dilemma Game] developed by Erasmus University Rotterdam. This exercise supports participants in identifying research integrity principles, virtues and questionable research practices in a hypothetical case. It provides a framework to consider, choose and defend alternative courses of action regarding realistic research integrity dilemmas. +
'''''Target Audience:''' undergraduate and graduate students, early career researchers, prospective research integrity trainers.''
The [[Instruction:A0dd2e82-52e7-4030-a396-54525630e75c|Modified Dilemma Game]] developed by the [[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|VIRT2UE]] project presents a modified version of the [https://www.eur.nl/over-de-eur/beleid-en-reglementen/integriteit/wetenschappelijke-integriteit/dilemma-game#:~:text=Over%20de%20Dilemma%20Game%20app,professionalisme%20in%20onderzoek%20te%20stimuleren. Dilemma Game] developed by Erasmus University Rotterdam. This exercise supports participants in identifying research integrity principles, virtues and questionable research practices in a hypothetical case. It provides a framework to consider, choose and defend alternative courses of action regarding realistic research integrity dilemmas. +
'''''Target audience:''' doctoral students and early career researches, senior researchers, and RE/RI experts''
The [[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|VIRT2UE]] project developed a training module introducing [[Instruction:D3ee617b-5d9b-4c47-a015-030b0354c9d2|supervision and mentorship practices]]. This module highlights the relevance of supervision, mentoring, and role-modelling in research environments and provides definitions of roles and their corresponding responsibilities. +
'''''Target audience:''' doctoral students and early career researches, senior researchers, and RE/RI experts''
The [[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|VIRT2UE]] project developed a training module introducing [[Instruction:D3ee617b-5d9b-4c47-a015-030b0354c9d2|supervision and mentorship practices]]. This module highlights the relevance of supervision, mentoring, and role-modelling in research environments and provides definitions of roles and their corresponding responsibilities. +
[[File:People discussing a contract.jpg|center|frameless|600x600px]]
Let’s find out more about the proposed study. While watching the next video, imagine that you are a member of an ethics review committee and your role is to make an assessment about whether or not to approve the study, to ask for changes to be made / further information, or to disallow the study. Make a note of any points or questions that arise for you.
[[File:Research_ethics_committee_members_discuss_the_proposal.mp4|600px|centre]]
====Video Transcript====
The research proposal
Over the past 7 years, a multinational group of scientists have been investigating the potential use of hematopoietic stem cell gene therapy as a treatment for Hunter syndrome. Hematopoietic stem cells (HSCs), also known as blood stem cells, are immature cells in the bone marrow that can develop into all types of blood cells. They have two key characteristics:
#Self-renewal. HSCs can divide and maintain themselves over long periods of time.
#Multipotency. HSCs can generate daughter cells that can differentiate into all blood cell types.
Pre-clinical studies undertaken in rodents have successfully demonstrated the potential of the HSC gene therapy to correct Hunter syndrome in the body and normalise brain pathology. Rodents with the syndrome, treated with the HSC gene therapy, showed dramatic improvements in their condition.
Now the same research group aims to test the approach in humans. This will be the first time it has been tested in humans. It is anticipated that the treatment via genetic manipulation of the patients’ own cells will result in the delivery of increased amounts of the IDS enzyme. As well as clinical efficacy, the study aims to evaluate the HSC gene therapy’s safety and tolerability, and pharmacodynamic effects.
The gene therapy involves collection of HSCs from the patients and inserting a working copy of the defective gene into their HSCs using a lentiviral gene therapy vector. The modified HSCs will then be infused back into the patient to engraft in the bone marrow. If engraftment of modified HSCs in the bone marrow is successful, these cells start to produce daughter blood cells. The daughter blood cells will contain a ''working copy of the IDS'' gene and the IDS enzyme will be distributed throughout the body, including the brain.
The study aims to recruit up to ten patients diagnosed with severe Hunter syndrome, aged between 3 months and 24 months at time of enrolment, and who have not yet shown developmental decline.
The treatment process will occur in 3 stages:
#Stem cell collection.
#Conditioning to prepare the bone marrow using chemotherapy.
#Infusion of gene-modified cells.
The study duration will be 24 months and the young patients will be checked at regular intervals during this period.
====The Discussion====
There may be opposing views on the research ethics committee about whether this study can be approved. It is certainly a proposal that demands careful ethical scrutiny. In the audio below you will hear from some REC members who discuss some of the issues that need to be considered. Check to see whether they address all of the points or queries that you noted.
[[File:Human gene editing REC discussion image.jpg|center|frameless|600x600px]]
====Discussion Transcript====
Research ethics committee discuss the proposal
REC member 1
The thing the concerns me most about this proposal is that it will involve very young and incredibly vulnerable children. They can’t consent to their participation, so that responsibility lies with their parents / legal guardians.
REC member 2
Don’t you think the parents or guardians are in the best position to decide what is in the best interests of their children?
REC member 1
I think the parents might feel pressure to consent to participation because they believe the study offers their child the best chance of recovery and that, by participating in this sort of study, their child will get better medical care and attention.
REC member 3
And the parents are liable to feelings of guilt either way, whether they consent or not. If they don’t consent, then their child will likely die during their teens. If they do consent, and things go wrong, they might feel responsible for making things worse.
REC member 4
I believe we have a moral duty to pursue research like this. There are more than 7,000 rare genetic diseases that we know of and about three-quarters of these affect children. If improvements are to be made in the care and treatment of these children, research is essential.
REC member 2
I can see the need for the research, but I wonder why the children have to be so young. Can’t the therapy be tried in adults or older children first?
REC member 1
I guess that’s because the study must be undertaken before any serious decline occurs, and with severe Hunter syndrome, that is only the case for the very young. Plus, the earlier the treatment occurs, the less damage that can be done. The ideal would be to stop the disease before any damage.
REC member 3
We must remember that gene editing is still highly experimental, so there might be a number of technical risks, and some of these risks might not even be known. This means that the children could suffer from serious consequences if the procedure fails or even if the procedure is successful. The parents will need to be fully informed about both the technology and the risks. There’s a chance that the treatment might make their child suffer even more than they would have done.
REC member 2
Yes, that’s true. What about the risks of off-target effects, or on-target effects, immunogenicity or genetic mosaicism? If we don’t know the precise risks, how can we decide whether the potential benefits outweigh the risk of harms to the children?
REC member 4
I think we can feel somewhat reassured by the fact that this is the same group that has undertaken the earlier testing in animals. They have developed and perfected the technique for this gene therapy, and they are confident that they are now in the position to move to testing in humans.
REC member 1
I agree. That does help to provide some reassurance, but there’s no way that all risks can be avoided. I would like to know what steps are being taken to minimise those risks.
REC member 4
We also need to consider the harm the potential for harm associated with the treatment process itself. Both stem cell collection and chemotherapy involve risks. Chemotherapy for bone marrow conditioning can lead to all of the well-known side effects like hair loss, nausea and vomiting, fatigue, and a compromised immune system. Participating in the trial will inevitably increase suffering in the short term.
'''Did the committee raise all of your concerns? In the next step we touch on some other points, but first, we ask you to think about balancing potential harms and benefits'''
Now that you have a blank Initiative for your project, it's time to add some information! In order to save your initiative page, you need to add at least 3 things: a '''Title''', an '''Image''', and a '''Link.'''
[[File:Initiative Prerequsities.png|center|frameless|600x600px]]
'''Title''' - This should be the title of your project. The title you enter will be used to link to resources across the Embassy platform, so it would be wise to use the shortest title possible!
'''Image''' - The image which will display next to your project name across the Embassy. If your project has a logo or icon, you should use this! Accepted filetypes include jpg/jpeg, png, svg and xml files with a maximum size of 120mb.
'''Link''' - Here you can include a link to your project website, or to a suitable alternative like the repository for your project outputs. This must take the form of a valid URL.
You can also add a description of your project to your initiative page in the "What is this about?" box, but keep it short - the word limit on this section is 75 words. +
The first type of resource that you can add to the Embassy are guidelines - systematic documents which provide advice or outline recommended practices to help individuals or organizations make informed decisions consistently and responsibly.
Guidelines which are relevant for adding to the Embassy should relate in some way to promoting integrity, transparency, and quality in research. They might offer best practices for handling data management, ethical approval processes, authorship issues, and other research integrity and ethics concerns.
To add a guideline, you need:
*A Title
*Some text in the "What is this about?" box
*Some selections in the "For whom is this important?" box
*A URL to the guideline in the "Link" box
For an example of a guideline, take a look at [[Resource:86081665-70a2-47b2-869e-d3ee84a92e9f|the TRUST code.]]
For further inspiration, look at the other [https://embassy.science/wiki/Special:BrowseData/Resource?_search_Resource_Type%5B0%5D=Guidelines Guidelines]. +
