IRB FAQs and Procedures

Institutional Review Board (IRB)

 

Frequently Asked Questions

 

1. What does IRB mean?

IRB is the acronym for Institutional Review Board for human participants. The purpose of the IRB is to review all research that involves human participants in order to the protection of their safety and privacy. The Institutional Review Board at AUC complies with the guidelines of the United States Department of Health and Human Services. Please read AUC’s IRB policy for further information.

2. What is the purpose of the IRB?

The IRB reviews research proposals to ensure that researchers (investigators) plan to engage in ethical research methods. It is the responsibility of the IRB to assess if the proposed research will be conducted with respect for the participants, attempt to maximize the possible benefits and minimize the potential harms to the participants, and treat all individuals and groups of participants in a fair and equitable manner. 

3. How do I know if I need to obtain IRB approval?

 

IRB approval must be obtained by anyone doing research involving either live human participants or bodily tissue samples. Whether your research does or does not involve either human participants or bodily tissue samples, you need to complete these two forms.

Form 1: IRB Preliminary Approval or Waiver for Graduate Thesis (Before you start your research)

The IRB preliminary approval or waiver form should be signed once your thesis proposal/topic has been approved by the department. It is very important to submit this form before starting data collection for your research. This could take place prior to, or while, being enrolled in any of the following: 590, 591, 598 or 599 on the MA level or 691 or 699 on the PhD level.

This form should be submited to the department or program which will send it to the office of the dean of the school. 

Form 2: Proof of IRB Approval or Waiver for Completed Graduate Thesis (To be submitted with completed thesis and other forms requested below)

Each student’s thesis adviser is responsible for ensuring that this form is filled in accurately. Until this form is completed and approved, the thesis cannot be posted on DAR, and the student is not eligible to graduate. Please attach to the proof of IRB approval or waiver for completed thesis, a copy of the IRB approval letter, the abstract of the student’s thesis and thesis copyright and availability form. 

The above documents should accompany your completed thesis. This form must be signed by the student, the thesis adviser and the dean of the school and can be found here.
 

4. What exactly qualifies as a ‘human participant’?

Some students have questions as to whether their research involves human participants.  To evaluate whether or not your research involves human participants, you should use the following guidelines:

-Interaction with humans for the purpose of data collection: surveys, questionnaires, interviews, formal discussions

-Intervention with humans for the purpose of data collection: physical procedures, manipulation of environment to observe reactions

-Using private or identifiable information of humans: observations obtained from a setting in which the person would not expect this information to be used for research purposes, information given to the researcher by a person who would not expect this information to be used for research purposes, personal information provided by a person for a specific purpose other than a research project

5. What does the IRB proposal consist of?

The required parts of the IRB proposal are the NIH training completion certificate, the IRB application form, the informed consent forms in both English and Arabic (if your research participants are Arabic speakers), and copies of any surveys or questionnaires that you plan to use.

6. When can I begin data collection with human participants for my study?

Data collection with human participants can begin upon approval of your IRB proposal. Other forms of research may be conducted prior to IRB approval, however any form of research involving human participants should be avoided until you receive the official approval letter from the IRB.

7. When should I go through the application process?

For students planning to submit their theses at the end of spring semester, it is recommended that IRB approval is obtained as early in the fall semester as possible. As soon as a student has decided on their thesis project, they should go through the IRB process in order to ensure they have an adequate amount of time to conduct their thesis research. At the very latest a student hoping to complete their thesis in the spring semester should submit their proposal to the IRB by the third week of November. The IRB preliminary approval or waiver form should be signed once your thesis proposal/topic has been approved by the department. It is very important to submit this form before starting data collection for your research. This could take place prior to, or while, being enrolled in any of the following:  590, 591, 598 or 599 on the MA level or 691 or 699 on the PhD level.

8. How long should I expect the IRB approval process to take?

The IRB approval process varies from case to case. Some cases are approved almost immediately, while others will be sent back in need of revisions several times before being approved. You should always submit your application one month prior to when approval is needed.

9. Is there the possibility of receiving IRB approval for research I have already completed?

IRB approval CANNOT be obtained for research which has already been conducted. In order to submit your thesis, an IRB approval or waiver form must be submitted. If IRB approval is needed for your research project, you will not be able to submit a proposal upon completion of your project and failure to obtain IRB approval will result in the invalidation of your thesis.

 

10. What should I do if the IRB rejects my research proposal?

This is very rare, however, you will be able to alter you proposal to meet IRB requirements.

11. What should I do if I am not proficient in Arabic but I need my informed consent form or surveys in Arabic?

There is no official procedure for this. We recommend asking a native Arabic speaker for help or hiring a translator for assistance. It is very important that the English and Arabic forms include the exact same information; otherwise they will be sent back to you for revisions.

12. What is a PI?

PI stands for principal investigator. If you are a graduate student conducting research, you are the PI. For undergraduate students conducting research, you cannot be the PI and must find a professor to act as the PI and assist you with the IRB proposal.

13. What is the purpose of the informed consent form?

The informed consent form serves the purpose of informing the participants of what their participation involves. It is important for the participants to understand that their participation is completely voluntary and that they can decide to withdraw their participation at any point during the research. The form should provide information concerning what is being researched, what is being asked of the participants, and whether or not the information will be kept confidential.

14. Are there alternative ways of obtaining consent other than the informed consent form?

There are specific cases in which permission to obtain oral consent is given. The IRB is concerned with the protection of human participants, so you may request oral consent if you feel it will better protect the participants. Other cases in which oral consent is preferred would be when participants are illiterate or unable to understand the study through a written form. It is the researcher’s responsibility to ensure the participants fully understand what is being asked of them and the researcher should choose the most appropriate method of obtaining consent based on the nature of their research and the participants.

15. Are there any circumstances in which I can waive informed consent?

Informed consent is always recommended. However, in rare circumstances a waiver or alteration of some aspects of informed consent is allowed:
-The research involves no more than minimal risk to the subjects
-The waiver or alteration will not adversely affect the rights and welfare of the subjects
-The research could not practicably be carried out without the waiver or alteration
-The participants will be provided with additional pertinent information after participation

 

16. Does the IRB judge the intellectual quality of my research?

 

No. The IRB is not allowed to comment on the scientific quality of research. The sole task of the IRB is to protect human participants from possible harm.

17. Can the IRB help me attain approval from the Central Agency for Public Mobilization and Statistics (CAPMAS)?

 

No. Research needing approval from the Egyptian government agency CAPMAS must be sent to the Office of the University Counsellor after first obtaining IRB approval. Please note: Approval by the IRB in no way entails acceptance by CAPMAS. Researchers are responsible themselves for obtaining all necessary governmental approval.

 

Checklist for procedures to submit an IRB proposal
  

1. Complete the NIH training here.

2. Complete the online application form here.

3. Include informed consent forms (with your online application) in both English and Arabic if research involves Arabic speakers, and check to ensure these documents include exactly the same information. Please be advised that the IRB office does not collect these forms. They are kept with the thesis writer for future reference. They will not be included in the thesis.

4. Include any surveys or questionnaires you plan to use in your research in English, and Arabic when relevant, and check to ensure the questions have the same meaning in both languages. These documents will be included in your online application.