An ethics review is a process whereby your research is reviewed by a team of reviewers and/or researchers in your (or a related) discipline to make sure that it conforms to a set of ethical standards.
The ethics review is a process, which means that it takes time. Therefore, be patient and 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 (although the average three months).
The REC meets once every two months to conduct full reviews.
Usually yes. Regardless of your topic of study, everyone who applies for ethical approval should submit (upload) 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 within the application.
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.
The data needs to be stored securely for five 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. This was recently decided by the research committee to whom the REC reports.
Projects which have already received ethics approval from other recognised ethics committees (e.g. the HSE, Beaumont Hospital) can get an RCSI 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, upon receiving this the REC will issue a letter of acceptance of the given authorities approval.
Approval from ethics committees which are not recognised require chair approval only once all the relevant documentation such as the application and approval letter are uploaded onto our online application system.
The ethical review process can mean that your study may undergo changes as a result of the ethical review. The REC may make suggestions for changes, request more information, or just turn your application down. It is quite likely that you will have to resubmit your protocol with changes for it to receive approval. Be open to and prepared for the committees questions and suggestions.
When thinking about your research it is very easy to get caught up in your goals, but if you achieve some distance you will see that the well-being of your participants is more important than your research questions.
Do not be upset or surprised if you get a letter or email from the REC 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 points in a covering letter, and make the changes to your application, protocol and supporting documentation and appendices.
Make sure to underline, or highlight in some way all of the changes you have made, then you can then just resubmit your changes as an expedited review (i.e. your edited application will not need to receive full review at a REC meeting). If your changes are minor and short enough it may be possible to make your clarifications via email. You do not need to submit any non-relevant appendices or forms again.
If you want to change something after you’ve received approval, you’ll need to submit an ethics amendment. Don’t worry, this is not a big deal as 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 suddenly had a breakthrough and just reconceptualised the purpose or implications of your study, or if a brilliant new plan for data analysis just occurred to you. 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, regardless of whether you initially submitted a full or expedited review. If your changes are major, however, you may have to submit a full review. An example of a minor change would be adding one more questionnaire on a topic your study already passed review for investigating. Lots of minor changes do not a major change make, so do not worry if while you are adding that extra questionnaire you decide you also want to add a few more, extend your observation period, and start recruiting from another source. All the changes can go in one amendment. You should not start using amended procedures until they have received approval. Prior to submitting an amendment, please contact the REC at email@example.com and provide a word document outlining the changes you wish to make to the original application.
To submit an amendment use the ethics application – amendment form. Login as normal and use the 'amendment' option as opposed to 'edit'. Briefly describe your changes in the space provided. You will also need to resubmit your amended protocol (and appendices) with the changes underlined or highlighted, just like for a re-submission. Your supervisor will also need to sign a new declaration sheet to reflect the amended study.
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.
Any researcher who wishes for access to RCSI staff and/or students for research surveys, also need approval from the RCSI Evaluation Working Group and/or Students Union, which is now incorporated within the online application system.
For further information on surveys you can contact the Evaluation Working Group by email through the Quality Enhancement Office at firstname.lastname@example.org.