FAQs

Source: https://www.sharjah.ac.ae/en/Research/Departments/Research-Ethics/FAQs Parent: https://www.sharjah.ac.ae/en/Research/Departments/Research-Ethics

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FAQs

1. What are the elements that the REC reviews in a research project?

The elements that will be reviewed by the REC are:

1. Validity of the scientific design and methodology:\ Each research project must be scientifically valid. Conducting poor research means that research participants might be exposed to harm without any possible benefit to knowledge. The REC must ensure that the researchers have presented evidence of the following:

2. The research question, research design, and the methodologies used are scientifically valid.

3. The published literature favors the conduct of this research.
4. The researchers' experiences are appropriate for the research being applied for.
5. The research site is appropriately equipped to successfully conduct this research.
6. Favourable risk-benefit ratio:\ The REC should ensure that all risks (physical, psychological, social, financial, etc.) have been identified by the researchers and that every attempt was made to reduce those risks. The REC should also evaluate the actual and potential benefits to the research subjects.
7. Fair selection of research participants:\ The REC should ensure that no particular group of people or community is specially chosen to carry the burden of the research. The REC should ensure that both the benefits and the burden of research are distributed equally unless there is scientific reasoning to consider otherwise.
8. Protection of the participants' privacy and confidentiality:\ The REC must ensure that researchers have guaranteed the decency and privacy of research participants and have strong measures to maintain the confidentiality of their data.

2. What is the difference between the Participant Information Sheet and the Informed Consent form?

• Participant Information Sheet (PIS): A document that contains all the information that research participants need to know about the study and their involvement. The PIS should be given to research participants and kept with them.
• Informed Consent (IC) form: A document that contains a summary of the research steps, and which research participants sign and return to researchers. The IC form should be kept with the Principal Investigator for possible future audits.

3. What information should be included in the PIS?

The Participant Information Sheet (PIS) should include, at a minimum, the following:

• The research title that clearly states the words "research" or "study."
• Names and contact details of the researchers (at least one phone number).
• Purpose of the research.
• Research site and how privacy will be guaranteed.
• A statement about how the confidentiality of the collected data will be safeguarded.
• Participants’ expected time commitment and the overall duration of the research project.
• The exact procedures which the participant will be involved in.
• Photos and illustrations to simplify research steps and tools (when applicable).
• Risks and discomforts which participants will need to bear during the research.
• Benefits (if any) that the participant will get from their participation, such as financial incentives, free consultations, etc.
• A statement about voluntary participation, and the right to withdraw at any time without any consequences.
• Insurance to cover damages as a result of the research, and/or to compensate for injury (if applicable).
• Circumstances under which the research will be terminated (if applicable).
• Contact details of a third party to contact in case of concerns or complaints. For example:\ "In case of concerns or complaints regarding your participation in this research, you can contact the Research Ethics Committee at: 06-5057304 or by Email: REC@sharjah.ac.ae"

4. What information should be included in the IC form?

The Informed Consent (IC) form should include, at a minimum, the following:

• The research title that clearly states the words "research" or "study."
• Names and contact details of the researchers (at least one phone number).
• Purpose of the research.
• Research site and how privacy will be guaranteed.
• Risks and discomforts that participants will need to bear during the research.
• A space for the participant to write their names and insert their signature.

5. Are there other requirements related to the PIS and IC?

Yes. The following should be observed in any PIS and IC documents:

• Documents should be in the research participants' native language. The burden of accurately and formally translating informed consent documents should be on the researchers.
• Documents should be written in simple, yet professional language (i.e., equivalent to 5th or 6th school grade level).
• Documents should be free from any linguistic and structural errors.

6. How can we obtain consent from children and people with disabilities?

In case you are conducting research on children or people with intellectual, cognitive, or physical disabilities, you need to get a surrogate consent from the legally authorized representative. The legally authorized representative should be defined in your REC application form.

In the REC application form, you should also specify how you will obtain the participants' Assent. An assent is when a participant shows signs of agreement with their research involvement and is not showing any form of resistance or discontent.

7. Are there situations in which the Consent requirement is waived?

In some studies, obtaining consent is not possible or is impractical. The REC may waive the informed consent requirement in certain situations, such as:

• Emergency settings, where consent or surrogate consent is not immediately possible.
• Retrospective studies (e.g., record reviews, analysis of leftover samples).
• Deception studies.
• Observational studies involving a large number of people.

A waiver must always be justified and only granted if the research being applied for is classified as minimal risk. In case of deception studies, the consent must be sought from participants after the completion of the study, whenever possible.

8. Are there situations in which we must have PIS, but not the IC?

Yes. In some cases, signing the Informed Consent form contradicts the principle of anonymity when research participation should be anonymous (e.g., questionnaire-based surveys). In those cases, the submission of the filled questionnaire by the participant indicates consent, and no signature is required. However, the Participant Information Sheet (PIS) should still be presented to participants at the beginning of the survey.

9. What are the research projects in which an expedited review cannot be considered?

The following research projects cannot be considered for expedited review:

• Interventional research studies involving medications or substances.
• Research studies involving vulnerable populations (e.g., children, cognitively impaired individuals).
• Research studies involving persons with limited autonomy (e.g., students, prisoners).
• Research involving topics of social or political sensitivity (e.g., sexuality, drug use).
• Research where the informed consent is being waived, even if the risk is minimal.
• Research involving genetic analysis.
• Research that might lead to identifying participants, such as through photographs or audio recordings.

10. What if one of the members of the REC is the Principal Investigator or a Co-investigator of the project being reviewed?

At the beginning of their term, REC members sign a Non-Disclosure Agreement (NDA) and must declare any conflicts of interest related to the projects being reviewed before the review starts. If a conflict of interest exists (e.g., if the member is the researcher or part of the research team), the member must leave the meeting while the project is reviewed. They will be formally notified of the review outcome after the meeting.

11. I am a student. Is there a specific pathway to submit my research/graduation project?

If you are a student at the bachelor's, master's, or PhD level, and your research is part of the curriculum, you are eligible for an expedited review. Before completing the REC form and uploading your documents, it's recommended to discuss the ethical elements of your research with the REC member in your College (e.g., Colleges of Medicine, Dental Medicine, Pharmacy, and Health Sciences).

• If your research project involves risks greater than minimal, it will require full committee review.
• Your supervisor should be listed as the Principal Investigator for student research projects.

12. Do I need to submit my CV along with my research documents?

Researchers from outside the University of Sharjah are required to submit their CV. This requirement does not apply to researchers from the University of Sharjah.

13. Whom does the Research Ethics Committee report to?

The REC reports directly to the University of Sharjah Vice Chancellor for Research and Graduate Studies.

14. How frequently does the Research Ethics Committee meet?

The REC meets regularly on the last Thursday of every month. However, there are times when the Committee does not hold its monthly meetings (e.g., examination weeks, public holidays). In special circumstances, off-scheduled meetings may be held to expedite research projects of a time-sensitive nature.

15. Can we submit applications during the summer vacation?

Research project submissions are available throughout the year. However, the Committee does not meet during the academic summer break.

16. How long does it take to get my approval?

The Committee aims to complete the review within 30 days of submission. Delays beyond 30 days may be due to academic holidays, a high volume of applications, or incomplete documents.

17. I received ethical approval, but I want to make changes to the investigators. Do I need to notify the Research Ethics Committee?

You do not need to notify the REC if you make changes to the list of investigators.

18. What should I do if I need to make modifications to my research project after it has been approved?

If the modification alters the research-related risk (e.g., introducing a new procedure or test), you need to submit a new application. For minor modifications (e.g., increasing the sample size), you only need to notify the REC by email.