1. Is my study a Human Subject Research?
Human Subject Research is defined as research about living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. In this regard, at MRC, studies which involve data collection from identifiable sources such as medical records, registries, previously collected bio specimen samples etc. are also categorized as Human Subject Research though there is no actual interaction or intervention happening with the individual.2. I am just doing a simple survey; do I need to submit my proposal to the IRB?
Prospective surveys can either be research or non-research. All research applications on ABHATH will go to IRB to determine if they need oversight or if they can be exempt from IRB oversight. Hence all research surveys need to be submitted as a research proposal on ABHATH. If you are unable to determine if your study is research or not kindly raise a help ticket briefing the study aim, procedures and expected outcome along with a copy of the survey questionnaire so that MRC can guide you to the right processes.3. I am not collecting any identifying information in my human participant research project. Do I need to submit my proposal to the IRB for review?
All human subject research needs to be submitted through ABHATH to MRC. All studies move to IRB review from where it is determined as Exempt from IRB Review or for IRB review. If you are unable to determine if your study is Research or not kindly raise a help ticket briefing the study aim, procedures and expected outcome along with a copy of the data collection sheets/survey questionnaire so that MRC can guide you to the right processes.
For further Information please refer to HMC HRP Policy on Ethics Review Of Research Involving Humans.4. I will be collaborating with another institution; do I need to submit to HMC IRB and also the other institution?
All research studies with an HMC PI need to be submitted to the MRC and processed via the IRB Office for level of review determination. IRB oversight and approval procedures needs to be done according to the study tasks being conducted in the study sites (HMC and collaborating institute). If activities carried out at any of the study sites are those that require IRB oversight e.g. medical procedures conducted on study participants, bio specimen collection, prospective collection of data from participants etc. then the study needs to be submitted to site IRB and reviewed for approval. If no such interventional procedures are being conducted at collaborative sites, the study need not obtain site IRB approval. Hence it is important to list clearly all tasks pertaining to a study within the research proposal application on ABHATH.5. When may I begin data collection for my study?
All research related activities including data collection may be conducted only after obtaining MRC approval.6. How long will it take for me to obtain approval to do my study?
The general timeline for an ideal complete study application to be processed through MRC from submission to approval would be six to eight weeks including the initial review, scientific review, hospital governance review, budget, legal and IRB review which occurs in parallel so as to save time. A more detailed time plan is available on the MRC Process Flow SOP.7. Who can I talk to if I have a question about my research project involving human participants?
For any queries related to research please open a help ticket on ABHATH providing a summary of your query. Alternatively you can also call on 4439-2440 or email AbhathSupport@hamad.qa
and fix appointments with the concerned person for further information and clarifications.8. What do the terms "consent" and "assent" mean? Aren't they the same thing? Do I always have to obtain the informed consent of the research participants?
All research studies that have been determined for expedited or full board review by the IRB office needs to have an Informed Consent Form. The Informed Consent Form is not just a form it is more of a process where information is presented to people so as to enable them to voluntarily decide whether or not to participate as research subjects. It ensures respect for people by providing the opportunity for thoughtful consent to ensure that participation is voluntary. All research studies that have been determined for expedited or full board review by the IRB office needs to have an Informed Consent Form if the research participants are adults (18 or above).
An assent form is a streamlined version of the consent which is used in a study if the research subjects include children (below 18).
Templates of ICF and assent are both available at the ‘Download Center’ within ABHATH.9. Do research participants always have to sign the consent document?
Consent forms should always be signed until and unless the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.10. Do I always have to obtain written permission from parents for children to participate?
Yes. In studies where children are the research subjects, besides the assent forms, ICF needs to be signed and obtained from their parents. This is to document that the parents are providing consent for their child to be included in the study. The ICF for parents in these studies should have the “Research with Children” signing page attached. 11. I am not collecting any identifying information. Do I still need an informed consent form?
Yes. Regardless of whether personal identifying information is being collected or not, studies that are have prospective collection of data through interaction or intervention with human subjects and determined to have expedited or full board IRB review should be having consenting documents. 12. What are the consent requirements for phone based research?
Studies in which participants are being contacted over telephone, a telephone script needs to be provided by the PI along with the study documents which needs to be reviewed by the IRB.13. Who is required to complete the human participants training?
All researchers involved in Human Subject Research at HMC need to complete the mandatory HIPs, Basic and GCP modules on the CITI program at: www.citiprogram.org14. When should a modification (amendment) to an approved research study be submitted?
The PI needs to submit and Amendment Request and related documents on ABHATH to MRC when any change is being made to an already approved research proposal. Amendments may be in title, design, methodology, sample size, sample type, documentation etc. few amendments would require Hospital Governance Approval in which case MRC will forward the same to the required hospitals for their review and approval before processing via IRB. 15. How do I obtain continued approval (renewal) for my research study? After my approved protocol has passed the one year expiration date what do I do?
HMC-IRB provides approvals for a year at a time. PIs are requested to provide a Progress Report and supporting documents 60 days prior to HMC-IRB ethical approval expiry date so that the Board can conduct continuing review and provide ethical approval for the next year. Once ethical approval (HMC-IRB Approval) has been expired for a study all research related tasks shall be halted until the continuing review approval is obtained from IRB and MRC.16. In the case of a potential unanticipated problem involving risks to participants or others, when is the principal investigator expected to report this occurrence to the IRB?
Any adverse events/ sentinel events need to be reported to the hospital/facility as well as IRB within 48 hours of occurrence. 17. Can the IRB temporarily or permanently discontinue a research project as result of an unanticipated problem involving risks to participants or others? Can the IRB request revisions to the approved research study and the informed consent form as a result of an unanticipated problem?
Yes, the HMC-IRB has authority to discontinue or halt a research project or request revisions to the approved research study as a result of an unanticipated problem or event.
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