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:
a. The research question, research design and the used methodologies are scientifically valid.
b. The published literature favours the conduct of this research.
c. The researchers' experiences are appropriate for the research being applied for.
d. The research site is appropriately equipped to successfully conduct this research.
2- 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, which will be received by the research subjects, including monetary and other incentives, and make sure those are neither inappropriate nor exaggerated.
3- Fair selection of research participants: The REC should ensure that no particular group of people, or particular 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. Vulnerable populations include:
a. Children
b. Prisoners
c. Disadvantages persons…etc.
Researchers must present strong justifications when those vulnerable populations are specifically targeted.
4- Protection of the participants privacy and confidentiality: The REC must ensure that researchers have guaranteed the decency and privacy of research participants whilst those are engaged in the research.
Similarly, the REC must see strong measures that would maintain the confidentiality of the research participants' data during and after the conduct of the research.
• The Participant Information Sheet (PIS) is a document that contains all the information that research participants need to know about this study and their involvement. The PIS should be given to research participants and be kept with them.
• The Informed Consent (IC) form is 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.
You should include -at least- the following:
a. The research title that should clearly state the words "research", or "study".
b. Names and contact details of the researchers (put at least one phone number)
c. Purpose of the research
d. Research site and how will privacy be guaranteed
e. A statement on how will confidentiality of the collected data be safeguarded
f. Participants’ expected time commitment and the overall duration of the research project
g. The exact procedures which the participant will be involved in, preferably written in a bullet points
h. Photo and illustrations to simplify research steps and research tools (when applicable)
i. Risks and discomforts which participants will need to bear during the research
j. Benefits (if any) that the participant will get out of his/her participation. This could be financial, free consultations, free blood tests…etc
k. A statement about voluntary participation, and the right to withdraw at any time without any consequences to this decision.
l. Insurance to cover damages as a result of this research, and/or to compensate for injury, if applicable
m. Circumstances under which the research will be terminated, if applicable
n. Contact details of a third party to contact in case of concerns or complaints. In this part, please add the following statement:
“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”
You should include -at least- the following:
a. The research title that should clearly state the words "research", or "study".
b. Names and contact details of the researchers (put at least one phone number)
c. Purpose of the research
d. Research site and how will privacy be guaranteed
e. Risks and discomforts which participants will need to bear during the research
f. A space for the participant to write their names and insert their signature
Yes. As a general rule, the following should be observed in any PIS and IC documents.
a. Documents should be in the research participants' native language. The burden of accurately and formally translating the informed consent should be on the researchers.
documents should be written in simple, yet professional language (i.e. equivalent to 5th or 6th school grade level)
b. Documents should be free from any linguistic and structure errors
In case you are conducting a research on children or people with intellectual, cognitive or physical disability, you need to get a surrogate consent by the legally authorized representative. The legally authorized representative should be defined in your REC application form.
In the REC application form, you should also ensure that you write how will you obtain participants' Assent. An assent is when a participant expresses signs of agreement with their research involvement and not be showing any form of resistance or discontent.
In some studies, obtaining the consent is not possible or is impractical. In those cases, the REC may waive the informed consent as a requirement. The following are examples of such situations:
a. Emergency settings, in which consent or surrogate consent is not immediately possible
b. Retrospective studies, such as record review and analysis of leftover samples
c. Deception studies
d. Observational studies on a huge number of people
Waiving the consent must always be viewed as an exceptional situation. Researchers should, therefore, present a strong justification for requesting a waiver. A waiver must only be granted if the research being applied for is classified as a minimal risk.
In case of deception studies, and whenever possible, the consent must be sought from the participants after the completion of the study.
Yes. In some cases, signing the Informed Consent contradicts the principle of anonymity when research participation should be anonymous. This is commonly the case with questionnaire-based surveys. In those cases, participant’s submission of the questionnaire that they had filled is -in itself- an indication of consent. Hence there will be no need for signing an Informed Consent form. Nevertheless, the PIS containing the information stated above should be presented to research participants at the beginning of the survey.
a. Interventional research studies, which involve using or withholding medications or substances
b. Research studies in which vulnerable populations are recruited, such as children and cognitively-impaired or mentally-ill persons
c. Research studies in which persons with limited autonomy, such as students, prisoners and army personnel are recruited
d. Research studies involving topics of social or political sensitivity, such as sexuality, drug use, behavioral traits, suicidal ideation…etc.
e. Any research in which the informed consent is being waived, even when the risk is not more than minimal
f. Research studies involving genetic analysis
g. Research studies which might lead to identifying research participants, such as photographs or audio recording
At the beginning of their term, REC members sign a Non-Disclosure Agreement that includes a clause in which they must declare any conflict of interest related to the projects being reviewed, before the review starts. In case of a conflict of interest (such as being the researcher, or among the research team, or having any affiliation which would influence the decision…etc), the member leaves the meeting while the project is being reviewed and is formally notified with the review outcomes after the meeting.
• If you are a student at the bachelor’s, master’s, or PhD level, and your research project is part of the curriculum, you are eligible for an expedited review. Before you complete the REC form and upload your documents, we advise you to discuss the ethical elements of your research with the REC member in your College (this applies to Colleges of Medicine, Dental Medicine, Pharmacy and Health Sciences).
• Please note that if your research project involves risks that are greater than minimal, then the project will need to be subjected to full committee review.
• Please also note that, since you are a student, and Principal Investigator should be your supervisor.
Researchers from outside the University of Sharjah are required to submit their resume. This does not apply to researchers from the University of Sharjah.
The REC reports directly to the University of Sharjah Vice Chancellor for Research and Graduate Studies.
The REC meets regularly on the last Thursday of every month. There are times when the Committee does hold those monthly regular meetings. Those include examination weeks, public and university holiday. In special circumstances, the Committee holds off-scheduled meetings to order to expedite research projects of special nature, such as those that are time-sensitive.
Submission of research projects is available throughout the year. However, the Committee does not meet during the academic summer break.
The Committee puts efforts to complete the review within 30 days of submission. Reviews that take longer than 30 days are attributed to reasons such as: Academic holidays, high volume of applications, researchers not submitting essential documents, or submitting documents that are deficient or poorly written.
You do not need to notify the Research Ethics Committee if you decide to make changes to the list of investigators.
You need to submit a new application form if the modification alters the research-related risk. Examples include subjecting research participants to a new procedure or introducing a new test. If, however, the modification was minor and does not alter research-related risks, such as increasing the sample size, you will only need to notify the Research Ethics Committee by Email.
