Institutional Review Board

Procedures as of January 1, 2013

 

All research involving collecting data from human participants must gain approval from the Institutional Review Board (IRB) before research can begin. Examples of data sets that require human participation include, but not limited to, questionnaires, interviews, systematic observation, focus groups, blood samples, human tissues, and video-recording. 

All research condcuted by AUC faculty, students, and staff requires IRB approval even if it will occur outside Egypt, and all research to be done at AUC or supported by AUC must receive IRB approval even if the principal investigator (PI) is not an AUCian.

Research done in the context of normal course assignments only, with no intention to publish the results or present them at a conference, does not need IRB approval.

For any IRB questions, you should contact the IRB chair, Atta Gebril

Effective January 1, 2013, all IRB proposals must be accompanied by proof of NIH training in the protection of human participants. Training is free and takes approximately three to four hours. Upon completion of the training, you will receive a certificate that should be attached to all future IRB applications. Check the training website here. The certificate number must appear in your application.

As a general rule, cases are sent for review to the IRB members only on Thursday afternoons at around 3 pm. However, it is a good idea to submit your proposals a few days ahead of time, so that you can be informed if anything is missing.

Please submit your application at https://irb.aucegypt.edu. (Please note that ONLY AUCians can apply through the system). To log into your account, you need to use your AUC ID and password. For new users, check the video tutorial here.

For any technical issues, please contact irb@aucegypt.edu

Approval by the IRB does not automatically mean approval by the Central Agency for Public Mobilization and Statistics (CAPMAS), the Egyptian government agency that approves survey and interview work done within Egypt.  To initiate a request for CAPMAS approval, please send a request to your school dean. The point of contact at AUC for CAPMAS issues is Amr Salama, the University counsellor. The IRB is not equipped to handle matters related to CAPMAS.

From now on, all students conducting graduate thesis work at AUC will need an IRB approval/waiver form at the time of registering for their 599 thesis research course, and another IRB approval/waiver form at the time of submitting the completed thesis to the Digital Archive and Research (DAR) Repository.

The Office of the Dean of Graduate Studies has these forms, which may also be posted to this website soon.

What needs to be included in an IRB proposal:

1.  An IRB online application form. This be accessed from the IRB website at irb.aucegypt.edu. All applicants must fill out the questionnaire completely, without deleting or skipping any questions, and all required attachments (such as the Informed Consent Form) must be attached to the online application form.
 
2. An Informed Consent Form. The IRB requires use of the official AUC Informed Consent Form Template. If the research will be done with Arabic-speaking participants, we will also need the Arabic translation of the Informed Consent Form.  If oral consent will be obtained, please upload a copy of the oral text that you will read to the participant.

3. If the research involves surveys or questionnaires, the IRB must review them. If the surveys and questionnaires will be administered in Arabic, we need to see your proposed Arabic translations of them as well.

4. If the research involves interviews, we need to know the following:
(a) Will the interviews be taped? If so, will it be on audiotape or only videotape?
(b) Where will the tapes be kept?
(c) How long will the tapes be kept?
(d) Who will have access to the tapes?

5. If you are an undergraduate student, you cannot make an IRB proposal yourself. One of your professors must agree to serve as the PI (principal investigator)

6. If you are a graduate student, you are currently permitted to be the PI (principal investigator) on an IRB proposal (though this may change in the future). However, you must list your department and the name of your adviser at the top of the proposal.

How quickly will I hear from the IRB?

IRB guidelines say that in most cases you should allow one month for processing of your case. In reality we are almost always much faster than that, often giving responses in less than one week. However, no one should leave their IRB application to the last minute under the assumption that our response/approval will be immediate. Many cases require multiple submissions before being approved. Furthermore, IRB personnel are sometimes given time off during holiday periods, due to the great demands the IRB places on their time.

Certain cases are so obviously harmless that the chair of the IRB is able to approve them as “exempt” without consulting the IRB as a whole. (See the IRB policy for a list of the criteria for exempt review).

In these cases, approval is often extremely fast. Cases not meeting the criteria for an exempt review will be sent to the IRB, which consists of six members other than the chair (one of whom is required to be a member from outside the AUC community).

What criteria does the IRB use in approving cases?

The IRB’s only criterion is whether or not the proposal provides adequate protection for the human participants in the research. We are not concerned with the scientific quality of the research and express no opinions about this point.

What are the possible responses from the IRB?

In some cases, the IRB expresses no objections to the proposal as submitted. In this case, the proposal is approved.

In a greater number of cases, the IRB asks for certain modifications to be made.

It is extremely rare that the IRB simply rejects a proposal. The only case in recent years in which this happened was with a highly-charged political proposal by an outside entity that seemed to IRB members to have no potential research value.

There are other rare cases in which an IRB proposal is sufficiently controversial that the IRB needs to meet with the applicant in person. When this occurs, the IRB may either choose to reject the proposal entirely, or to add restrictions to the nature of the research being proposed.

How do I resubmit a proposal if the IRB asks for changes?

Once the reviewers finish reviewing your case, they send their comments to the IRB chair. The IRB chair will send you the comments through the online system. Usually, you receive a notification by email when the feedback is ready. You will also receive comments from all of the IRB members who reviewed your proposal. When resubmitting, you should respond to all of these comments in the appropriate place on the online form. After that, you need to resubmit your application to the system one more time. Make sure that you receive a confirmation email after submission. If you do not receive an email, this means that your application has not been submitted yet.

What happens when IRB approval is received?

When approval is received, you will receive a signed approval letter via email from the chair of the IRB. If you are a graduate student, your thesis adviser will also be copied on the email.