Research Ethics Committee

You do not need RCSI REC approval for audit.

However you are likely to need approval from the hospital, health centre or other institution where your audit is performed.

If you are not sure whether your project is research or audit this simple guide may help.

If you are still not certain then the Health Research Authority in the UK also have a helpful web based decision tool: http://www.hra-decisiontools.org.uk/research/index.html

The submission must be on the REC application form.

There are detailed guidelines on completing the REC form on the VLE.

The REC usually meets on the first Wednesday of each month. The committee does not meet during July and August. The deadline for all necessary documentation is normally 2 weeks prior to the next REC meeting.

If you are a student joining an overseas research project you may only need to complete a shorter form. This is normally applicable if all three conditions below are met:

1. Where RCSI students join overseas projects which already have (or are in the process of obtaining) their local REC / IRB approval.
2. Where RCSI has a MOU with the overseas institution or some existing relationship with the institution (if this is in doubt the RCSI Institutional Officer will adjudicate).
3. Where no human participant data will be brought back to, or processed in, RCSI or any EU country.

The submission must be on the REC student overseas project application form available on the VLE.

The application form and associated paperwork will be sent for review to two or three members of the REC who will examine them and provide a formal report to the full Committee.

It is then the responsibility of the REC to approve or reject the application. Many applications will be sent back to applicants with suggestions for revision to address any concerns expressed by the REC.

Significant revisions will be reviewed again and reported during the next REC meeting. Minor revisions, however, may be approved directly by the Chairman.

How long will the ethical review process take?

The average is 2 - 3 months. Your research will be reviewed by a team of reviewers and/or researchers to make sure that it conforms to a set of ethical standards. The ethics review is a process which takes time. Therefore leave yourself time (typically 2-3 months) from the time you submit for your study application to completion of the process; some ethically complex or sensitive studies have taken six months or more to get approval. The Research Ethics Committee normally meets every month to conduct full reviews. Further information on the typical process can be found under Review Process.

Do I need to submit a protocol?

Usually Yes - regardless of your topic of study, everyone who applies for ethical approval should submit a study protocol along with their application. Be very careful to ensure that the information contained in your protocol is consistent with the information provided with in the application.

Do I need a gatekeeper?

Usually yes, as it is inappropriate for researchers to initially directly contact potential participants in their study. A gatekeeper should be named and used to send out initial contact information etc. A gatekeeper can also be used to anonymise the data if appropriate.

What are the current best practice guidelines for data protection?

The data needs to be stored securely for 5 years and then destroyed. Both the applicant and their supervisor are responsible for the data security and the project. Please include a full address and contact number for both the applicant and the supervisor within the REC application. It is insufficient for a masters/undergraduate student to be solely responsible for the data by themselves.

Do I need REC approval when I am conducting the study on another site with their own ethics committee?

RCSI Bahrain staff and students are normally advised to seek RCSI Bahrain REC approval for research projects first. However for projects which have already received ethics approval from other recognised ethics committees (e.g. the NHRA, KHUH, BDF or Salmaniya Hospitals) can apply for an RCSI Bahrain REC approval letter once the applicant has sent the REC a copy of the finalised version of the application that received approval and a copy of a signed approval letter from the given authority that includes the title of the study as stated in the application and the names of the applicants.

What kind of outcome can I expect?

 There are three possible outcomes:

• The REC may accept your application as it is. NB: this is the outcome less than 50% of the time.
• The REC may request that you resubmit the application having addressed specified ethical, methodological or scientific issues. The REC may ask for further information. This is the commonest outcome.
• The REC may reject your application. This is uncommon.
• The ethical review process can mean that your study may undergo changes as a result of the ethical review. Be open to and prepared for the committee's questions and suggestions. When thinking about your research it is very easy to get caught up in your goals, but the Declaration of Helsinki makes it clear that the well-being of your participants must take precedence over your research questions.

Why is the REC interested in issues of scientific validity or methodology?

The Declaration of Helsinki (Sections 21 and 22) makes it clear that poor quality research is by definition unethical. This is because subjects are put through procedures and exposed to possible risk and resources are expended for no reliable gain in knowledge, or even the risk of erroneous "knowledge".

Resubmissions:

Do not be upset or surprised if you get a letter or email from the Research Ethics Committee saying that they need a number of points to be addressed before they can approve your research study. Most applicants have to make changes and resubmit. Address all of the REC committee's points in a covering letter, and make the changes to your application, protocol and supporting documentation and appendices using track changes (or a different coloured font). You can then just resubmit your changes as an expedited review - your edited application may not need to receive full review at a REC meeting. You do not need to submit any non-relevant appendices or forms again.

What if I want to change something in my study after I've already received ethical approval?

You will need to submit an ethics amendment. It is not unusual to find out that the procedures you initially envisioned aren't working out in the real world, but it's vitally important that you do not use your revised procedures until you have notified the REC and received approval for them. 

If you make any changes to the procedures of your study you need to submit an Ethics Amendment. You don't need to submit an amendment if you have  the purpose or implications of your study, or if you modify your plan for data analysis. You only need to submit an amendment if something in your study is changing from the perspective of your research methods or study participants. So, increasing your sample size, adding measures, changing recruitment procedures, broadening inclusion criteria, etc. are the types of activities that require an amendment. Most amendments are considered "minor changes to an already approved protocol" and so qualify for expedited review. If make a number of minor changes they can be considered in one amendment. You should not start using amended procedures until they have received approval.

If you wish to submit an amendment, please contact Research Ethics Committee Administrator, and provide a word document outlining the changes you wish to make to the original application. You will also need to resubmit your amended protocol (and appendices) with the changes noted on track changes (or similar), just like a re-submission. Your supervisor will need to sign a new declaration sheet to reflect the amended study.

I have received ethical approval. Now what?

After you have received ethical approval you can go ahead and start recruiting participants or collecting your data. Be sure to keep a copy of the official letter of approval in a safe place. If there is ever a question about whether you received ethical approval, this letter will be very important. The letter also contains your application Reference Number which you will need to quote within all further correspondence and on all future amendments. What if I still need more information? Talk to your study supervisor who will be familiar with the process.