Starting a Research Project at SKMCH&RC

What is Clinical Research?

For the purposes of these guidelines, clinical research is defined as a systematic activity that involves one or more of the following:

  • People (typically patients, their carers, staff or volunteers)
  • Their tissue
  • Their organs
  • Their personal information

And that meets all three of these criteria

  • Attempts to answer a clearly defined question
  • Employs systematic and rigorous methods
  • Leads to new knowledge that may be transferable / generalizable

The first two criteria will also be met by audit and service evaluation activities, but these differ from research in that audit seeks to measure existing practice against evidence based standards, and service evaluation addresses local service issues.

You need to register your project if it involves participants for whom SKMCH&RC has a duty of care, i.e. patients, their carers or staff including data or tissue deriving from the participants. You will also need to register your research if it occurs in SKMCH&RC premises even if it does not directly involve patients as would be the case of a medical physicist working on the development of instrumentation. You may begin your project only after you have received a formal letter of authorization from the Secretary of the RSG (Research Support Group). The independent scientific review process will be performed by colleagues, with quick turnaround.

Some examples:

  • If participants are recruited by virtue of their relationship with SKMCH&RC, but the study involves interviewing subjects in their own homes, the Hospital has a duty of care.
  • If the participants are recruited by virtue of their membership of a community group, and are interviewed on SKMCH&RC premises, SKMCH&RC has a duty of care.
  • If the participants are recruited by virtue of their membership of a community group, and are interviewed in their homes, SKMCH&RC does not have a duty of care. In this case, if the subjects were recruited or identified because of lists/data available at SKMCH&RC, the research still falls under the purview of SKMCH&RC.

Types of Research Projects

The following table will serve as a guide to various types of research projects and the various approvals required.

Type of work Purpose Data Access

Request

 Scientific Review IRB Approval
Informal review Typically <50 charts Exploring ideas If report generated
Clinical audits QA / audits Audit/service evaluation Yes No No
Non-interventional Descriptive(e.g. case report, case series) Descriptive article, intended for publication Yes Yes(copy of manuscript) Yes(copy of manuscript)
All studies involving any patient material (inc. slides, samples, x-rays, others) Research Yes Yes Yes
Analytic(e.g. cross sectional, case-control, cohort, others) Research Yes Yes Yes
Interventional Clinical trial(randomized and

non-randomized)

 Research Yes Yes Yes
Other experimental Research Yes Yes Yes

 

Conducting Research at SKMCH&RC

  1. Registration of research – done by submission of the research synopsis to the clinical research office. The recommended format is shown below. The CRO (Clinical Research Officer) will inform the MD (Medical Director) of the proposal.
  2. Scientific review. The MD will nominate a scientific review committee for the project. All SRC’s constituted will include MD, Sec SRC, Sec IRB, at least two members from the Consultant staff and at least one representative from the basic science research group. The committee will advise and facilitate the investigators and may support, oppose or suggest modifications to the proposal.
  3. IRB approval. Once scientific approval is obtained, the clinical research office will submit the study for IRB approval in coordination with the principal investigator. The primary objective of obtaining IRB approval is protection of the rights of study subjects and to address ethical issues. The IRB may approve, reject, modify or defer pending further information.
  4. Authorization by the MD
  5. Application for SKM funds
  6. Data Access Request. This will be sent to the department holding the clinical data, (Medical Records, Pathology, Radiology, others). Depending on the volume of the request and the nature of the project, adequate notice (preferably one week) must be provided. No other authorization is required, but a copy of all such requests must be sent to the Secretary of the Scientific Review committee, who will email this log to the MD on a monthly basis.
  7. Maintain site file
  8. Periodic progress reports
  9. Audit

Synopsis Requirements

The following general format should be used for submitting a synopsis

  1. Title
  2. Investigator(s) and institutional affiliations

III. Introduction

  1. Objectives
  2. Definitions
  3. Hypothesis

VII. Materials and Methods

  1. Study design
  2. Setting
  3. Duration
  4. Sample size and sampling techniques
  5. Inclusion and exclusion criteria
  6. Data analysis and statistical methods

VIII. Resource requirement

  1. Monetary
  2. Clerical, logistic and administrative
  3. Data entry by data section staff
  4. Statistical analysis
  5. Other

IX. References