Starting a Research Project at SKMCH&RC

1.1  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 cares 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, following research review and approval applicable to your research project

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.

1.2  Types of Research Projects Undertaken at SKMCH&RC:

The research division at SKMCH&RC is divided into three sections

  • Clinical Research Office
  • Basis Science Research Lab
  • Cancer Registry and Clinical Data Management

In addition, individual departments are also involved in research activities specific to their respective specialties. Pharmacy, nursing, radiology, pathology, ancillary teams and other relevant services also provide support for various research studies where required.

The following table gives an overview of the various types of research projects undertaken at the hospital and their approval requirements;

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* Scientific review in case of multicenter investigational new drug /device/biologics trials is done during the internal feasibility assessment process facilitated by the Clinical Research Office. Proposed investigators, who are subject area experts, are part of this assessment and studies are reviewed for both scientific content and their logistic feasibility at the hospital. (See section 2.7.1 for details)

1.3  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.
  1. Scientific review – The MD will nominate a scientific review committee for the project. All SRC’s constituted will include MD, Secretary SRC, Secretary IRB, at least two members from the Consultant staff and at least one representative from the basic science research group and the cancer registry and clinical data management (CRCDM) section . The committee will advise and facilitate the investigators and may support, oppose or suggest modifications to the proposal.
  2. 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.Research projects which fall in the following categories also need to be submitted to the National Bioethics Committee (NBC), Pakistan for review and approval
  • All projects that cover the whole of Pakistan or that are to be conducted in two or more provinces / regions of Pakistan (“national-level research projects”)
  • All projects that have a collaborator from outside Pakistan, irrespective of whether or not they are funded by a donor from outside Pakistan.

Click here to download NBC application form, exemption request form and guidance sheet (used with thanks and permission of National Bioethics Committee, Paksitan)

http://nbcpakistan.org.pk/downloads.html

  1. Applicationfor SKM funds (if applicable)
  2. Maintenance of a site file and research records:This includes essential documentation related to the study such as protocol, signed consent forms, case report forms/source data , ethics review approval record, regulatory approval (where applicable), medication management records (in case of studies involving investigational new drug/device/biologic interventions), hazardous material management (if applicable). Investigators should retain a record of study team qualification and delegation of study related duties as per their qualification and experience. For interventional drug/device /biologic studies, reporting of adverse events as per hospital adverse event reporting (ADR) system should be ensured along with sponsor and IRB reporting requirements. In addition, all incidents and near misses related to study intervention and procedures should be reported as per hospital incident reporting system.
  3. Preperation of periodic progress reports

 

1.4  SUBMISSION REQUIREMENTS:

 The following general format should be used as guidance for submitting a synopsis and related documents (such as Informed consent forms etc.) for review and approval;

I. Study Title

II. Investigator(s) With Institutional Affiliations

III. Introduction         

IV. Objectives

V. Definitions

VI. Hypothesis

VII. Materials And Methods

Study Design: Describe in detail the design and methodology of the study. Identify and distinguish between those procedures that are standard of care and those that are experimental. Provide a detailed description of the planned data collection, specific outcomes, and criteria for evaluation and endpoint definition.

Setting

Duration: Include the frequency and duration of each activity and the total length of subject participation.

Sample Size and Sampling Techniques: If applicable; include information on stratification or randomization plans, the maximum number of subjects you plan to recruit for this study. If this is a multi-site study, indicate the projected total subject accrual.

Inclusion and Exclusion Criteria

Study Procedures:  Include details on medical procedures

Data analysis and statistical methods: Describe the statistical considerations for the study, how the sample size was determined, and how the results will be analyzed, if applicable.

For Interviews/Focus groups:  Attach copies of any scripts and/or questions that will be used to guide the interviews/groups. Indicate the member(s) of the study team who will conduct the interviews/focus groups and any necessary qualifications such as special training, supervision etc.

For Studies involving Surveys/Questionnaires:   List all of the measures/instruments that will be used for this study and attach copies for these. Indicate the member(s) of the study team who will use these measures/instruments and any necessary qualifications such as special training or licenses.

For studies involving use of existing data/specimen: When using existing data/specimen and Applying for Exemption, Describe the following: the source of data/specimen and the process used to unlink the data or specimen/make it anonymized/ (the process by which identified data is recorded in a way that individuals cannot be identified)

VIII. HUMAN RESEARCH SUBJECT PROTECTION

Risks, Discomforts and Potential Harms: Describe the risks associated with each research intervention (physical, psychological, social, and other factors) with estimated probability that a given harm may occur and the potential reversibility. Describe the safety precautions that will be taken to minimize risks/harms. When appropriate include a study monitoring plan for safety of participants and for the validity and integrity of data.

Potential Benefits and Alternatives:

Describe any potential for direct benefits to participants in the study. There may be no direct benefits.  Also include information on the importance of the knowledge that may reasonably be expected to result.  Also describe the alternatives available to patients in cases of non-participation in research.

Informed consent: Indicate the types of consent that will be involved in this study and attach copies of the informed consent/assent document that will be used for this study. If waiver of Informed consent is considered justified, describe with reasoning.

Data Privacy and Confidentiality: How will the data for this study be collected and recorded? Describe the provisions to protect the privacy of the individual.  Where will the research data be stored & how it will be secured? Who will have access to the study records or data? Specify their name, role and affiliation.

IX. RESOURCE REQUIREMENT

Monetary, logistic and administrative or other

X. REFERENCES