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ALNAS Research Policy

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Research committee members

ALNAS Hospital is committed to fostering high-quality research and maintaining ethical standards. This policy outlines the steps and requirements for initiating, conducting, and completing research activities within ALNAS hospital. It also provides guidelines for researchers at different stages of their research journey.

The process of Research Protocol Submission is:

Section 1: Starting Your Research Journey

Basic Training and Certification

○ Complete Good Clinical Practice (GCP) training, valid for 3 years.

OR obtain The Global health network certification, valid for 2 years.

Research certification is mandatory before initiating any research activity at ALNAS Hospital, for more information, kindly check page 6 “Scientific Research Ethics Policy

○ Attend CME sessions conducted by ALNAS Research Department Getting a Research Idea

○ Read scientific literature, especially the "Future Prospects" section in publications.

○ Brainstorm with colleagues and your department head to identify current challenges or areas requiring further investigation.

○ Join international registries related to specific diseases for collaborative research opportunities with other organizations.

○ If you are interested in participating in an active research project, contact ALNAS Research Department. The department can assist by enrolling you in one of the active projects within your department if possible.

1. First Steps

○ Read this policy thoroughly for detailed guidance. ○ Seek advice from ALNAS Research Department on the appropriate study design. ○ Write your protocol using the

ALNAS Protocol Template⁠

2. Informed Consent (If required)

○ Fill out this

LINK⁠

in simple Arabic to generate Informed consent. Include both the

Informed Consent⁠

and

Withdrawal Consent Form⁠

with the protocol submission. ○ Follow the Informed consent checklist to ensure compliance with ethical standards. ○ In case of case report, kindly use Case Report Informed Consent form

3. Approval Process

○ Submit your protocol to the Scientific Committee for review.

■ Possible Scientific Committee decisions: Approval, Conditional Approval, or Rejection (major modifications required). ○ After Scientific Committee approval, the final version will be presented in the upcoming Institutional Review Board (IRB) meeting for ethical approval. ■ Some protocols, like interventional studies, may require additional approvals from regulatory bodies such as the Higher Council for Research Ethics Review and/or the Egyptian Drug Authority (e.g. EDA Postgraduate research protocols additional requirements). ○ You are allowed to start your data collection after (1) receiving an IRB approval letter and (2) signing

confidentiality agreement form⁠

and (3) submitting the GCP certificate.

4. Enhancing Protocol Approval Chances

○ Obtain department head approval for conducting this research. ○ Get guidance from ALNAS Research Department and do the necessary modifications. ○ Submit your GCP certification or send it to ALNAS Research Department📨. ○ Make sure that your submitted research protocol fulfilling

Protocol review checklist⁠

○ Make sure that the submitted informed consent is fulfilling this checklist.

Section 2: Approvals to Conduct Research

● IRB committee Approval letter ○ The IRB approval letter is valid for 1 year. ○ For IRB renewal, Fill out IRB Renewal Request form. ■ If you are uncertain about whether your study requires an IRB approval extension, refer to the accompanying Supplemental Guidance on

IRB Renewal Request form⁠

(Page 3). ● Scientific committee Approval letter ○ In “case Report” or external IRB approval, you can begin using the data after 1️⃣receiving an approval on the Hospital data sharing permission Request and 2️⃣ signing the

confidentiality agreement form⁠

, and 3️⃣ submitting the GCP certificate. ● Data Collection ○ You are allowed to start your data collection only after 1️⃣ receiving an IRB approval letter and 2️⃣ signing the

confidentiality agreement form⁠

and 3️⃣ submitting the GCP certificate. ○ Ensure that informed consent forms are signed, fingerprinted by the patient or guardian (mandatory under Egyptian law), and witnessed by at least one hospital staff. ○ Document Archiving and confidentiality is the responsibility of the PI. ○ All soft copies of research-related documents will be saved in an online shared folder with restricted access to research members and ALNAS Research Department. ○ Backup hard copies will be securely stored in a well-secured file cabinet located at the Research department Office. ● Update the hospital with the current status of the project and Report any adverse event ○ Regularly update ALNAS Research Department by submitting progress reports every quarter (every 4 months) and Study Follow-Up Checklist. ○ Report adverse events using the

Adverse Reaction Reporting Form.⁠

Researchers are encouraged to follow these guidelines to ensure compliance with ethical and institutional standards.

Section 3: Managing Modifications and Renewals

1. Protocol Modifications ○ Fill out the

Deviation Report Form⁠

to the Scientific Committee for getting approval on the protocol changes. ○ Notify the hospital promptly of all modifications. 2. ALNAS IRB Renewal ○ In case of getting initial IRB approval from ALNAS IRB, fill out the IRB Renewal Request Form to extend your approval beyond the initial one-year period. 3. External IRB Approvals ○ If you have external IRB approval, obtain administrative approval from ALNAS Hospital by submitting

1️⃣ Hospital data sharing permission” Request to the Scientific Committee,

2️⃣ the external IRB approval document, and a

3️⃣ GCP certificate. 4. Researcher Transition ○ If resigning from the hospital, complete the Resignation transition form to ensure continuity of active research projects within ALnas Hospital.

Section 4: ALNAS Hospital Research Journey Support

1. ALNAS Research Department Support Researchers are encouraged to reach out to ALNAS Research Department for personalized guidance at any stage in their research to ensure their research meets high scientific and ethical standards

1️⃣ Idea Development: Assistance in refining research ideas and identifying study objectives. 2️⃣Study Design: Guidance on selecting the appropriate study design and methodology. 3️⃣ Protocol Writing: Help with completing the

ALNAS protocol template⁠

, and ensuring compliance with institutional and ethical standards. 4️⃣Ethical Approvals: Assistance in preparing documents for Scientific Committee and IRB approval, including

informed consent forms⁠

. 5️⃣Data Collection: Guidance on tools (such as

RedCap Registries⁠

), techniques, and data management strategies. 6️⃣Data Analysis: Support in selecting suitable statistical methods and interpreting results. 7️⃣Manuscript Preparation: Advice on writing, structuring, and formatting manuscripts for submission. 8️⃣Publication Process: Support in selecting journals, responding to reviewers, and completing publication requirements.

2. Requesting Research Kits or subscription ● For research projects requiring specific kits, software or materials, researchers must submit a formal request using the Research tool/kit Request Form. This ensures proper allocation and tracking of resources to support your study.

3. ALNAS Financial Publication support form ○ Researchers who have utilized ALNAS Hospital data, and are publishing in high-impact factor journals may apply for financial assistance to cover part of publication fees. To request support, researchers must complete the

Publication Financial Support Request Form⁠

and submit it, along with the required supporting documents, to ALNAS Research Department for scientific committee review and approval.

4. ALNAS Publication award ○ Projects utilizing ALNAS Hospital data and published in recognized journals are eligible for the publication award. Researchers can apply by completing the

Publication Award Application Form⁠

and submitting it to ALNAS Research Department along with the required supporting documents.

Section 5: Research Meetings and Communication

1. Scientific Committee Meetings

○ Held on the first Wednesday of every month📆. ○ Feedback on protocols will be shared via email or WhatsApp, including recommendations for modifications.

2. IRB Meetings

○ Conducted on a quarterly basis (every 3 months). ○ All IRB members have signed

IRB confidentiality agreement⁠

s to ensure research ideas are protected.

Section6: Ethical Guidelines

1. IRB Research Ethics Policy ○ Follow ALNAS Hospital’s ethical guidelines, available in

ALNAS IRB Policy⁠

, Scientific Research Ethics Policy , policy supplement .

2. IRB Decisions Possible outcomes: Acceptance, Conditioned Acceptance (modifications required), or Refusal (justified in a detailed report). 3. Scientific Committee Decisions ○ Possible outcomes: Acceptance, Conditioned Acceptance (modifications required), or Refusal (justified in a detailed report). ○ Conditioned acceptance: a list of additional required documents and/or protocol modification will be provided with a time frame of 15 days from the meeting.

For any inquiries, don’t hesitate to contact us 😊

☎️ Internal EXT: 3207

Official Email:
research.alnas@aljoud-ngo.com⁠
,

Gmail:
IRBalnas@gmail.com⁠

💬Whatsapp: Dr. Yasmin Elsobky 01224288425

⁠

👋 Learn more about IRB .

⁠

ALNAS IRB Policy All you need to know about ALNAS Institutional Review Board⁠

⁠

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