Institutional Review Board


Institutional Review Board (IRB)

2020, 2nd half

Submission, Reviews and IRB meetings Dates

 

PI submission deadline for a study to be reviewed on IRB meeting 

 

Thursdays 

12 noon

Reviewer comments submission deadline

 

Thursdays 

12 noon

 

IRB Meetings dates

 

 

Tuesdays 

1-3 pm

9th July

16th July

July 21st

13th August

20th August

August 25th

10th September

17th September

September 22nd

8th October

15th October

October 20th

12th November

19th November

November 24th

10th December

17th December

December 22nd

           

The IRB is a committee of scientists, non-scientists, community representatives and health care professionals. It reviews research studies in an effort to protect the rights, safety and well-being of research participants and ensure the integrity and confidentiality of their information. In addition to documenting information needed by patients or healthy volunteers to enable them to make informed decisions on whether to participate in a research or not.

The Institutional Review Board at King Fahd Specialist Hospital in Dammam is registered locally by the Saudi National Commission for Bioethics (NCBE) with the number H-05-D-002 and dated 04/06/1432 AH. It operates according to NCBE regulations, Good Clinical Practice Guideline (GCP) and the Association for accreditation of Human Research Protection Programs (AAHRPPInc®.) standards, which has granted the hospital accreditation in 2014 and renewed it in 2017.

Researchers

We are pleased to serve you, please note:

  1. Prior approval of human research study protocols by the IRB is mandatory. You need to get a formal approval letter from the IRB before you can begin your research, including any data collection, or research participants' recruitment. Submit your request using the initial submission package Forms in the link
  2. Changes in approved research may not be initiated without IRB review and approval except when they are necessary to eliminate apparent immediate hazards to participating subjects. Amendments need to be submitted Forms in the link
  3. You should report any unexpected serious harm to participants or unanticipated problems involving risks to participants or others using the Forms in the link
  4. If you plan to extend your pre-approved research period, you should renew your IRB approval using the Forms in the link, the same form is used to close out your study.
  5. All researchers are required to complete the following training courses according to the type of study:
  • All documents should be sent by e-mail to: IRB@kfsh.med.sa
  • Make sure to submit all required documents, at least one month before the anticipated start day of research.
  • Make sure to submit complete applications. Incomplete requests will not be processed and will be returned to investigators for completion.
  • Upon receiving a complete application, it will be evaluated to determine whether it meets the definition of Human Research (link to definition) and if it does, it will be evaluated to determine the appropriate level of IRB review in accordance with regulations.
  • This evaluation classifies research into one of three categories:
    1. eligible for exemption from periodic review;
    2. qualified for expedited review; or
    3. subject to the most comprehensive IRB evaluation at one of the committee’s monthly meetings.
  • You will be notified of the specific review level, the approximate time required to complete your application review, and the final IRB decision.

Research Participants

Welcome! Are you thinking of becoming a volunteer for research? Are you a current or past volunteer? If so, we highly appreciate and value your involvement and we are grateful for it. We are here for any comments or queries.

  • Prior IRB approval of human research protocols is mandatory. The IRB evaluates the research projects to ensure your safety, protect your rights and welfare before and during your research study. The IRB only decides whether it is right to ask people to participate in a particular research study or not, based on an assessment of the desired benefits and potential risks in the research plans.
  • The IRB ensures that necessary information needed by potential participants whether patients or healthy volunteers is documented in the best way possible to enable them to make an informed decision on whether to participate in the research or not. The IRB does not take the decision to participate on your behalf, but it ensures that you are provided with simplified correct information about the research to enable you to make the decision that is best for you.
  • In addition, the IRB reviews and monitors research studies while they are being conducted in order to ensure the protection of the rights of volunteers and their safety.

Community Representatives

The IRB at KFSH-D is proud of its’ members, who serve as representatives of the community and their contributions.

The IRB greatly depends on their insights and evaluation of the research documents, especially informed consent forms that detail research participants on their research rights and duties.

If you wish or wish to join us, contact the IRB Administration.

IRB Administration
Email:IRB@kfsh.med.sa
Tel: 8442222, Ext: 2978, 7093
Research Executive Administration - King Khalid Medical City (REA-KKMC)
King Fahad Specialist Hospital-Dammam, Saudi Arabia
Bldg. 100, First Floor,Office 31, 28