Research Ethics Committee

Content:

1.    Introduction.......................................................................................................... 3 

2.    Scope of work.......................................................................................................3

3.    The research elements that will be reviewed by the REC......................... 4

4.    Levels of review.................................................................................................... 7

5.    Method of action..................................................................................................8

6.    Monitoring and interim reports.........................................................................8

7.    Termination of studies..........................................................................................9

8.    Special situations...................................................................................................9

9.    Membership and voting......................................................................................9

10.    Conflict of interest............................................................................................  10

11.    Meeting schedule.............................................................................................. 10

12.    Student research projects................................................................................ 11

13.    Annual report...................................................................................................   11

14.    Other issues.......................................................................................................  11

1.  Introduction

The University Research Ethics Committee (REC) was formed on the 29th Nov 2015 based on the Chancellor's Decision No. (86) for the academic year 2015/2016. This committee is a continuation of the previous committees, which performed the ethical reviews of research projects.

The duties stated in the Chancellor's decision can be outlined as follows

a. consist of a data collection that is systematic and pre-planned, and which adopts known research methodologies,

b. involve humans, human tissues, human samples, human data (including the archived data), and

c. would produce results in any form of scientific publication.

3. The research elements that will be reviewed by the REC

a. 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:

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

II. The published literature favours the conduct of this research.

III. The researchers' experiences are appropriate for the research being applied for.

IV. The research site is appropriately equipped to successfully conduct this research.

b. 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.

c. Fair selection of research participants
The REC should ensure that no particular group of people or a particular community is 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. 
Special attention should be put on reviewing research projects which target vulnerable populations, such as children, prisoners, disadvantages persons…etc. Researchers must present strong justifications when those vulnerable populations are specifically targeted.

d. Protection of the participants privacy and confidentiality
The REC must ensure that researchers have guaranteed the decency and privacy for the 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.
e. Informed consent

The REC must ensure that research participants are:

I. competent to understand the information presented to them regarding their research involvement, and

II.  completely free to make choices about their participation, without being coerced into it.

b. Be written in simple, yet professional language (i.e. equivalent to 5th or 6th school grade level). The form should be free from any linguistic and structure errors.

c. The title should clearly state the words "research", or "study" if in English, and the equivalent word if other languages are used.

d. The names, titles and contact details of the researchers.

e. The purpose of the research.

f.  The research site and how will privacy be guaranteed.

g. A statement on how will confidentiality of the collected data be safeguarded.

h. The participants' expected time commitment and the overall duration of the research project.

i. The exact procedures which the participant will be involved in. This should preferably be written in a bullet point format. The use of photos and diagrams which would simplify this engagement are strongly encouraged.

j. The risks and discomfort which the participant will need to bear during the research, and after its completion (if relevant).

k. Benefits (if any) that the participant will get out of his/her participation. This could be financial, free consultations, free blood tests…etc.

l. A statement about voluntary participation, and the right to withdraw at any time without any consequences to this decision.

m. Whether there will be an insurance to cover damages as a result of this research, and/or to compensate for injury.

n. Contact details of a third party to contact in case of concerns of complaints. Usually, this third party is the chair of the REC.

o. A statement about any unforeseeable risks.

p. The circumstances under which the research would be terminated.

I.   Persons below the legal age.

II.   Persons who are mentally or cognitively incompetent.

III.  Persons with deprived freedom (such as prisoners).

I. Emergency settings, in which consent or surrogate consent is not possible.

II. Retrospective studies, such as record review and analysis of leftover samples.

III. Deception studies

IV. Observational studies on a huge number of people.

The process of informed consent: 

There are three levels of review which is determined by the risk assessment of each application. Those are:

Exempted from review

When the research does not involve humans, human tissues, or human-related data. Examples of those studies include microbiological studies, cell culture studies…etc.

Expedited review

When the research is of no more the researchers minimal risk can be defined as any risk that is encountered by a person during his/her usual daily activities. Examples on this include questionnaire-based researches (if the questionnaires don't contain questions of sensitive nature).

Full review

When the research involves greater than minimal risk. The following are forms of research studies which would require an REC's full review:

I.   Interventional research studies, which involve using or withholding medications or substances.

II. Research studies in which vulnerable populations are recruited, such as children and cognitively-impaired or mentally-ill persons.

III. Research studies in which persons with limited autonomy, such as prisoners and army personnel are recruited.

IV. Research studies involving topics of social or political sensitivity, such as sexuality, drug use, behavioral traits, suicidal ideation…etc.

V.   Any research in which the informed consent is waived, even when the risk is not more than minimal.

VI.   Research studies involving genetic analysis.

VII.  Research studies which might lead to identifying research participants, such as photographs or audio recording.

After the application is received, the following steps will take place:

1. Compliance check

Compliance check will be performed by the committee's secretary. This step will include the following:

Checking that all the sections in the application form are filled.

Checking that all the necessary additional documents are attached, such as the informed consent, the research tools (if relevant), the recruitment  announcement (if relevant)…etc.

Checking that all the above documents are in their FINAL versions. For example, the informed consent is written in the participants' native language, and is in good professional style, free from language and structure errors.

2. Classification

When compliance is done, and the application is found to be in its final version, the application is then classified by the Chair or the Vice Chair of the committee into the three levels of review as discussed above (section 4).

The REC will have the right to monitor the progress of the research after approving it, and to make sure that all the steps approved by the committee are adhered to and have not been diverted from.

In certain studies in which the risk is above minimal, the REC might give an approval conditioned to providing the committee with a 6-month or 12-month interim report. The reports should include the progress of the study, recruitment and drop-out rates, and any unforeseeable risks which have been observed during the course of this study.

The REC has the right to terminate the study (after voting) if:

a. The researchers were found to have violated any of the conditions set forth in the REC's approval letter.

b. The researchers made modifications, whether minor or major, to their study protocol without informing the REC and obtaining the committee's approval.

c.  Risks were found to be greater than previously anticipated.

d. Severe incidents occurred, such as severe injury or death, and have been partly or fully attributed to the research.

e.   Any other reason which the REC finds sufficient to make the termination decision.

Meeting with the applicants

In certain situation, external consultants will be invited to the REC meetings to present their input on applications which are considered to be above minimal risk. Those consultants will be chosen by the committee, invited by the chair, and if the invitation is accepted, they will be presented with either a specific question or with part or all of the application to make comments upon. The involvement of external consultants should only take place after they sign a confidentiality statement.

The current committee consists of 8 members, the Chair, and the secretary. The composition of this committee is as follows:

• Three members from the College of Medicine.
• Two members from the college of Health Sciences.
• One member from the College of Pharmacy.
• One member from the College of Shariaa.
• One member from the College of Law.

• REC membership should consist of scientific members, statistician(s), and layperson(s).
• At least one layperson must always be present when final voting over an application is made.
• Meetings are official when more than half the members (including one layperson) are present.
• All 8 members have the right to vote. In case of equal number of votes, the committee's chair will cast his/her vote over the reviewed application.
• The committee's members, the chair and the secretary must sign a confidentiality statement before they begin reviewing applications.

In case the committee's chair, or one or more of the committee members, feel that there is a conflict of interest with a particular research application, he/she must leave the meeting room while the said application is being discussed. The chair/member must declare the conflict of interest once the application is put on the meeting agenda.

Conflict of interest includes: being the researcher, or among the research team, having any affiliation which would influence the decision, such as reviewing the application of one's own students or having financial or personal links to the sponsor of the study...etc.

The REC shall meet once every month during the academic year. A deadline for each monthly meeting will be set for submitting the applications for that particular meeting. Only COMPLETE applications (after compliance check) will be enlisted for the committee's meetings.

The REC will meet on the following tentative dates;

In order to facilitate and quicken the review process for research projects that are performed by students as part of their curriculum, the REC will review those projects by proxy through the designated committee member in each College (this applies to Colleges of Medicine, Dental Medicine, Pharmacy and Health Sciences).

The designated committee member will make the necessary recommendations to the students and review their amendments. When those amendments are satisfactorily addressed by students, the designated member will write a brief assessment report, which will be submitted to the Chair for issuing a formal approval letter.

If the designated committee member finds that the research protocol consists of risks that are greater than minimal, then the project will need to be subjected to full committee review.

A student research project is defined as any research project that is performed under academic supervision. This includes research projects at the undergraduate and postgraduate levels.

The REC chair, with the assistance of the secretary will prepare an annual report at the end of each academic year to the Vice Chancellor for Research. The report will include the number of applications received, their classifications, and the final decisions. The report will also include recommendations made by the committee members for the following year.

Researchers will be notified, in the decision letter, that if they were not satisfied with the decision of the REC, they can write to the Vice Chancellor fo

Prior reviews and approvals of research projects are to be taken into consideration, but must not substitute the review process of the REC of the University of Sharjah.