Research Proposal Submission Guidelines

REQUIRED PROPOSAL FORMAT

1. COVER PAGE
Include the study title and specify the expected duration of the study from the time
of approval until the time of submission of final report.

Choose type of research project. Enter the name of potential sponsor(s)/

collaborator(s) if funded project. If you are requesting for fund, fill and attach the
research fund form.

If study involves pharmaceutical product or drug, fill and submit pharmacy form. If
study has approval from another (IRB), specify name of the other IRB. If study
involves sending biological samples outside the Kingdom, specify to which country.

2. ADD RESEARCH CO-INVESTIGATORS

As a principle investigator, you can add Co-Investigator(s) in your research
application. You will need their full name, email, job title, job ID, department and
organization.

3. ADD CONTACT PERSON

Indicate the primary contact person. You need to add his/her full name, email, and
mobile number.

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 4. ABSTRACT
Summarize the proposal that includes a brief background, a statement of
significance, study specific aims, brief methods to be used to achieve study aims, a
description of how the results may fill an important gap in the research area.
Recommended length is less than 300 words.

5. INTRODUCTION
Review the relevant literature to the proposed study and include the following:

 What has already been accomplished in the field?

 What is the rationale behind the study? Why is it worth doing?
 What gaps would the study fill in the area of investigation?
 What relevant work has been done by the Investigators (or others) to indicate
the expected productivity of the proposal?
 Provide preliminary data, if any.
 What are the expected benefits and adverse effects to patients, if applicable?

6. AIM(S) OF THE STUDY

A clear and concise statement(s) of aim(s).

7. METHODS
Describe clearly (provide references where applicable):

 The study design, e.g. experimental design open, controlled, placebo-

controlled, crossover; and phase, e.g., phase I, II, or III or IV.
 The study setting.
 On-site established methods and new methods, if any.
 The procedure for data collection and analysis.
 Potential difficulties and limitations of the methods to be used, and ways by
which these difficulties can be resolved.
 If the proposal is examining a CLINICAL question , e.g., interventional trials of
drugs, devices, or procedures, the following information should be included:
 A clearly defined method for patient recruitment including advertisement,
if any, and clear patients inclusion and exclusion criteria.
 A clear specification of the test and control interventions; if the study is a
drug trial, give clinical trial dosage, duration of therapy, and adjunctive
therapy, if any.

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  Defined primary and secondary outcome measures to be used for
treatment comparisons.
 Guidelines for random treatment allocation, if applicable.
 Required length of patient follow-up.
 Monitoring and properly documenting therapeutic progress and adverse
effects.
 Documentation of therapeutic progress (i.e., evaluation parameters) and
adverse effects of the proposed activity.
 Guidelines for early stopping the study, if required.

 Describe what will actually be done to the subjects during their participation
in the study. Make certain that the following is included, if applicable:

 A description of what is being done for research purposes and what is being
done as part of standard clinical care.

 A list of tests and procedures that will be performed for research purposes
(e.g., blood tests, urine tests, cultures, interviews, questionnaires, surgical
procedures, cardiac catheterization, pulmonary function tests, X-rays, scans,
etc.).

 A brief description of the analyses that will be performed on the biologic or

non-biologic (i.e. questionnaires) samples collected.

 A list of investigational drugs that will be administered.

 A list of investigational devices that will be used.

 A statement that defines who will be financially responsible for the costs
associated with participation in the study (e.g., travel, examinations,
procedures, drugs, devices, etc.), and a statement that defines what will be
provided without cost to the subjects

6. STATISTICAL CONSIDERATIONS

 Describe methods of statistical analysis and include plans for interim analysis.
State the reason for choosing such methods. If analysis is computer aided, state
the name and source of the software used. Also, include plan for analysis of
dropouts, crossover, and poor compliance, if applicable.

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  Determine appropriate sample size or number of study participants based on
clearly defined expected outcomes.

7. ETHICAL CONSIDERATIONS

 Specify the number of subjects to be enrolled at KSMC and the total number
to be enrolled in the study (if multi-center study).

 List main characteristics of the study population (gender, age range, racial and
ethnic groups) and justify any exclusion of specific gender, age, and racial or
ethnic groups.

 Specify the inclusion and exclusion criteria and whether vulnerable subjects
will be involved (i.e., subjects with diminished mental capacity, children,
pregnant women, fetuses, economically or socially deprived subjects,
prisoners) and if so, what are the special precautions that will be taken to
ensure that the consent is freely given and that the rights and welfare of the
subjects are protected (e.g., assent from children).

 Specify where and how research data will be stored to ensure confidentiality,
and who will have access to information about the subjects that is identifiable.

 Describe how subjects will be identified and recruited for participation in the
study, when and where consent will be obtained, and how the PI (or the
delegated staff) will determine whether the subjects (or their surrogates)
understand the information that is provided in the consent document.

 Indicate whether the study will include medical record review (hard copy or via
computer) and if so, list those individuals (e.g., co-investigators, fellows,
research nurses, research coordinators, pharmaceutical company protocol
monitors, etc.) who require access to the record.

8. WORK PLAN

Include a work plan that mainly describes the following:

 Timetable of events in chronological order.

 The role and responsibilities of the persons involved in the study.

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 9. REFERENCES

Number references consecutively, in the order in which they are first mentioned in
the text. A numbered list of complete references, in order of appearance, should
be included here.

10 INFORMED CONSENT / CONSENT WAIVER REQUEST:

The general rule is that research involving human subjects requires a documented
(written) informed consent (in Arabic and English). The consent document must
include “basic elements” and when applicable “additional elements” (refer to
guidelines for consent documents).

The IRB may approve a waiver of signed informed consent or a waiver of informed
consent. A copy of the consent form should be given to the research subject (or
surrogate), another copy should be kept in the medical record of the patients
involved in the research, and the original document should be kept with the
principal investigator.

The KSMC Institutional Review Board (IRB) may grant a waiver of informed
consent if the following four criteria are met. (Answer No to all questions)

1. Does the research present more than minimal risk*of harm to the subject?
2. Will the waiver adversely affect the rights and welfare of the subjects?
3. Can the research be practically conducted without the waiver?
4. Will the subjects be provided with additional pertinent information after
participation, whenever appropriate?

In addition, you have to indicate why you are requesting a consent waiver.
(Justifications for your request). If your research doesn’t match with the waiver
criteria or you have answered YES to any of the above question, you will need to
upload the consent form.

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 11 INVESTIGATORS ASSURANCE

This form indicates that Investigator(s) have/has a substantial contribution to this

proposal and will adhere to it and to the required later follow up and steps.

Print the form from the submission system, sign it and upload it in the documents
upload section.

12 CONFLICT OF INTEREST DECLARATION

KSMC Research Centre requires that all investigators make written declarations of
their relevant interests, including those of their immediate family, spouses, and
children.

Conflict of interest declarations should include but not be limited to:

 Any full- or part time employment or service as an officer or board member.

 Consultant or advisory arrangements (paid or unpaid).
 Stock ownership or options (unless in a diversified fund not controlled by the
individual).
 Any other direct or indirect financial interest.
 Honoraria – payments for specific speeches, seminar presentations or
appearances.
 Research funding, expert testimony or any other remuneration (trips, gifts, etc.).

First, you have to select investigators names who don’t have conflict of interest in
the first section.

Second, you have to select investigators names who have conflict of interest to be
declared in the second section.

Third, print the form directly from the submission system, sign it from all
investigator(s), and upload it along with declaration letter for investigators who
have conflict of interest.

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 13 POTENTIAL HAZARD AND TOXICITY

If the proposed research project involve any toxic chemicals or hazardous micro-
organisms, you have to specify the following:

 List the chemicals/organisms and describe the nature of hazards involved.

 Describe the safety measures and procedures to be used in disposal of such
toxic agents and to protect the personnel and the environment.

14 PRINCIPLE AND CO-INVESTIGATORS CV’S

Fill Principle investigator and co-investigator(s) information. That should include the
following:
 Educational Details.
 Employment History.
 Research and Scholarly Work.

15 DOCUMENTS UPLOAD

Upload the following documents where applicable:

 CITI/NIH Certificate for all investigators in one merged PDF file.

 Investigators Assurance Form (signed).
 Conflict of Interest Declaration Form signed) in addition to deceleration letter
if any.
 Data collection form.

For more information and assistance, please contact

Research Center on rc@ksmc.med.sa

T: 011 4355555 ext. 2345

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