Research Ethics FAQ

FAQ

NOTE: “Any research at UL, including human participants, human biological material, personal data, animals and/or potentially harmful changes to the environment, therefore, requires ethics approval by the Ethics Review Panel and/or the Animal Experimentation Ethics Committee.”  University of Luxembourg Research Ethics Guidelines, 2018-05-09, page 5.  See also the FAQ below: “How do I know if my project needs research ethics committee review/approval?”

Authorship and Publishing Questions

How do I determine who is an author and who receives an acknowledgment on my paper?  Watch this 2-min video and see this link: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

I helped out on a project.  Can I be a co-author on the project’s manuscript?  Helping on a project is very vague and needs more context. Also, if you did not write any of the manuscript, then co-authorship is not possible.  Supervision, providing funding or equipment, by themselves, also do not earn authorship. Project collaboration does not authomatically confer authorship.  For more details on the requirements of authorship, watch this 2-min video and see this link: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

I’m being pressured to give honorary authorship, what should I do? Honorary authorship is unethical. Watch this 2-min video. You can request an ethics consult from LARI to explore the situation and find a solution.

When does copy + paste = plagiarism? Direct quotes should be placed in double quotation marks (”   “) and cited with the reference source.  If not making a direct quote, then paraphrasing should be performed, followed by citation with the reference.  Our short video gives a lot of guidance: https://www.youtube.com/watch?v=N3hqARstzfc  Also, explore this online handbook:  https://writing.wisc.edu/Handbook/QuotingSources.html

Do images need to be cited? Images are often copyrighted and some may not be reproduced without permission from the author and fee payment, while some simply require citation/attribution.  Some images are not allowed to be modified. Check the copyright status before reproducing and modifying an image. https://creativecommons.org/licenses/

Is there a source for open-access images that can be used for presentations and publications? Yes!  Pixabay offers over 1.6million images, many of which are related to science and technology.

Do I need permission to use a survey/questionnaire in my research study? It is important to check the copyright status of surveys and questionnaires because some cannot be used without permission and fees from their owner (e.g., MMAS https://morisky.org/ )  Using these documents in your research without the needed permissions/fees is unethical and could lead to legal problems for you/your institution.

When does image enhancement (e.g., Western blot bands) cross the line and become data misconduct?  Explore this helpful guide about enhancement, cropping, contrast & brightness adjustment, color adjustment, cloning, and resizing.

Questions about Research with Human Participants

How do I know if my project needs research ethics committee review/approval? Check with the regulations that apply in the jurisdiction where you are collecting your research data. If you are collecting data in multiple countries, you need to verify the research ethics regulations for each country.  [Reminder, LARI is not a Research Ethics Committee; however, LARI can provide training and consultation about research ethics issues]. For Luxembourg laws pertaining to research ethics, visit the CNER website http://www.cner.lu/en-gb/statuteslegislation.aspx

“Any research at UL, including human participants, human biological material, personal data, animals and/or potentially harmful changes to the environment, therefore, requires ethics approval by the Ethics Review Panel and/or the Animal Experimentation Ethics Committee.”  University of Luxembourg Research Ethics Guidelines, 2018-05-09, page 5.

The journal in which you seek to publish your results might require research ethics committee approval. No research data should be collected prior to the required approval(s).  Data collected without the required approval(s) is generally not publishable.

Are there any special concerns when doing social media or Internet research? Yes, privacy and consent are some of the concerns, as well as Terms of Use restrictions. See this helpful guide: https://aoir.org/wp-content/uploads/2017/01/aoir_ethics_graphic_2016.pdf

What should I be most concerned about when writing the consent form? The biggest problem with research consent forms is that they often are written in scientific language that is too complex for the lay public to understand.  Include images and diagrams and aim for USA grade 8 reading level [12-13 yr olds], with short and simple paragraphs. Use simple terms, not medical or scientific terms — https://humansubjects.stanford.edu/new/docs/glossary_definitions/lay_language.pdf

What is the difference between assent, consent, and permission?  Children/minors assent (because they are not of legal age); adults with decisional capacity provide informed consent; parents provide permission for their children to participate. Below is general guidance*; however, always check the regulations in the country in which the data is being collected.

Age Group                            Guidance*

Under age 5yrs                   Use pictures/images in assent process; Get parental permission.

Under age 16yrs                 As above, plus include more descriptive, lay words.

Age 16-18yrs                       Parental permission not needed for “mature minors.”

How much can I pay research participants to enroll in my study? The answer partly depends on where the study is conducted.  For example, The Netherlands uses a standard wage formula for incentives.  Overall, the incentive is a small “thank you” and should not be excessive such that it lures people to participate and distracts them from reflecting on the risk:benefit profile of the study. The incentive should not bias the informed consent process.  The incentive should also be age-appropriate.

Can I pro-rate the research participant payments? Yes.  For example, if a study lasts 4 weeks and a participant drops out after 2 weeks, the consent form should be clear to state that participants will be paid for only 2 weeks.  Payments are for time, effort, and expenses (parking, meals, travel).

Is the research participant incentive/payment considered a study benefit?  No.  Never mention this as a study benefit in the consent form or elsewhere.

My participant enrollment is very slow and I think my target won’t be reached.  What should I do? This 3-min video is helpful.  Reflect on the target population and your recruitment method.  Are you using the best method to recruit? Increasing the recruitment incentive is not always the best solution. If you change your recruitment method you will need approval from your research ethics committee beforehand (this is usually a very simple process.) If you need advice about recruiting, ask for an ethics consult.

Can I change my protocol after I started data collection? Yes, these are called amendments, but you often need permission from the research ethics committee before you make the change.  Minor, administrative changes usually don’t need their pre-approval. Changes to protect the safety or welfare of research participants can generally be made without their pre-approval, but the research ethics committee will still need notification and eventual approval.  Changes to methods, including changes to cohort size, consent forms, and survey content, will need pre-approval from the research ethics committee (as per jurisdictional requirements).

Can researchers perform experiments on themselves? Self-experimentation is a matter for institutions and research ethics committees because a novel concept may outweigh the researcher’s concern for his/her own welfare. Self-experimentation (when permitted) is generally limited to studies with negligible risk and require the researcher-participant’s written informed consent. Negligible risk research has no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.

Can deception be used as a research method? Yes, under strict conditions. See pages 14, 17-18 https://ec.europa.eu/research/participants/data/ref/fp7/89867/social-sciences-humanities_en.pdf  and Section 8.07 of the Ethical Principles of Psychologists and Code of Conduct http://www.apa.org/ethics/code/index.aspx#807

Are there any special precautions when doing research in a participant’s home? Yes. Always inform a co-worker where you will be. Perform your research in a location of the home that is not a private space, such as a kitchen or living room (not a bedroom unless the person is bed-bound). Learn the floor-plan of the house so that you have an escape route in case you need to urgently leave for your safety. Carry your official university/institute ID with you that verifies you are a researcher.  Do not perform audio or video recording without express consent of the participant and take care to exclude others from the research area (non-study participants, children).

Are anonymous, anonymized, and coded data all the same thing?  No.  Anonymous data is data that is collected without any personal identifiers.  Anonymized data is data that was collected with personal identifiers that were then stripped away and thrown away permanently (not saved and not linked back to the data in any way).  Coded data is data that was collected with personal identifiers that were then stripped away and some or all saved with links/codes that connect the data to make it personally identifiable. Personal identifiers are sometimes defined by law. They can include things like name or initials, phone/fax number, email, IP address, tax file number, social security number, date of birth, fingerprint, iris scan, voice print, photo of face or other body part, hospital admission date, hospital discharge date, exact age if over 89 years, medical record number, insurance number, driver license number, etc.

Are there restrictions on doing data research on the deceased? Check your jurisdiction.  For example, USA health data is regulated by HIPAA and protects the deceased for 50 years after their death.  https://www.hhs.gov/hipaa/for-professionals/index.html   In the EU, the GDPR does not apply to the personal data of the deceased; however, each EU country is permitted to set their own regulations on this matter https://gdpr-info.eu/recitals/no-27/ .

What is the difference between an adverse event and an incidental finding? 

  • An adverse event (AE) is any untoward or unfavorable medical occurrence (physical or psychological) in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the person’s participation in the research, whether or not considered related to the participation in the research. Some AEs are reportable to research ethics committees and regulatory agencies.  Know their rules.
  • An incidental finding is an observation of potential clinical significance unexpectedly identified in a research participant that is unrelated to the purpose or variables of the research study. (doi: 10.1126/science.1115429)  Researchers should proactively contemplate the disclosure plan and discuss this in the informed consent form.  If the research involves whole genome sequencing, following these instructions: http://www.cner.lu/en-gb/procedures/incidentalfindings.aspx

Questions about Research with Live Animals

If I have concerns about animal distress, who should I contact? Clinical assistance can be obtained from the staff veterinarian associated with your laboratory or research approval.  If there is a laboratory manager, he/she should also be notified. Plans for reacting to animal distress should be proactively detailed in your research protocol.

How many animals do I need to perform my study?  Please consult with a statistician and also perform a literature search regarding your study method/design.  “The methods selected should use the minimum number of animals that would provide reliable results and require the use of species with the lowest capacity to experience pain, suffering, distress or lasting harm that are optimal for extrapolation into target species.” Page 34, item 13, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF

What is the most ethical way to euthanize an animal? Animal welfare codes/guidelines permit several methods. Please consider the species and refer to the guidelines in your region.  EU Annex IV http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF

How should I react if people in Luxembourg react negatively or fearfully to the concept of animal research and animal euthanasia? You can refer them to the animal welfare law (Chapter 8 Protection des animaux utilisés à des fins scientifiques https://deiereschutzgesetz.lu/la-loi/chapitre-8-protection-des-animaux-utilises-a-des-fins-scientifiques/#) and also note that euthanasia is also used with humans in Luxembourg as a humane method to end life http://luxembourg.public.lu/en/vivre/famille/fin-vie/euthanasie-soinspalliatifs/index.html).