Chester Medical School

MD7100 Research Proposal Form

• All projects should be carefully considered in discussion with your supervisor. You
should complete this form in full (including your signature) and send to your
supervisor for initial review by the date agreed by your supervisor

• Once your supervisor has reviewed the form, they will return a signed copy as a PDF
for you to submit to the submission link called ‘Research Proposal Form’ on MD7100
Moodle site by 2pm on Monday 21st March 2022

You must not proceed with your project until you receive an acknowledgement
from your supervisor that you can begin undertaking the research.

Section A:
Student Name Rizwana Fatima
Student Number 2124859
MSc Programme Oncology
Supervisor Name Dr. Svetlana Mysina

Section B: Project Type

Select (double click in the box and checked) the project type thatbest describes
the proposed research:

• Systematic review
• Systematic review with data analysis or analysis of data published in peer reviewed
journals✔️
• Analysis of existing unpublished data or data published in online repositories
• Laboratory based research project
• Work based research project
• Collection of new data from participants (questionnaire or interview)
Section C: Project Aims and Objectives
Aims
What is your research question?
Patients with metastatic malignant melanoma (MM) benefited only slightly from
traditional cytotoxic chemotherapy. Despite the fact that immune checkpoint
inhibitors (ICIs) have been the primary treatment for patients with advanced or
metastatic melanoma, there is currently a lack of scientific proof for their
application in MM. The purpose of this systematic review and meta analysis is to
summarise the efficacy and safety of ICIs in patients with advanced or metastatic
MM.

Objectives
How are you going to investigate the proposed research question? You should use
bullet points to provide this information (up to 6 bullet points should be
suffice).Provide sufficient information to ensure your reviewer can understand how
you propose to undertake the research.

• systematic search in electronic databases (PubMed, Cochrane library, Web

of science)
• A retrospective systematic review and meta-analysis of peer-reviewed
primary research articles related to the metastatic malignant melanoma will
be considered.
• primary outcomes included the overall response rate (ORR), progression-
free survival (PFS), median overall survival (OS), one-year PFS rate, and
one-year OS rate.
• risk of bias will be conducted to check the quality and bias of the included
studies.
• meta-analysis will be conducted after statistical analysis of the data
extracted from the included studies.
Section D: Permission and Other Considerations
Please answer ‘YES’ or ‘NO’ the following questions and for any to which the
answer is ‘YES’, complete the action needed

Will your research project… YES/NO If YES – action needed

Involve any external organisation for Discuss further with your
which separate research ethics NO supervisor and a
clearance is required dissertation co-ordinator.
Complete Section E:
Human Ethical
Considerations
Involve working at a study site that is not Discuss further with your
owned by the University NO supervisor and a
dissertation co-ordinator.
Complete Section G: Data
storage.
Involve direct and/or indirect contact with NO Complete Section E:
human participants? Human Ethical
Considerations
Did you answer NO to all questions? YES Complete Section G: Data
storage
Section E: Human Ethical Considerations

Please answer ‘YES’ or ‘NO’ the following questions.

Will your research project… YES/NO

Involve direct and/or indirect contact with NO
human participants?
Cause (or could cause) pain, physical or NO
psychological harm or other negative
consequences
to human participants?
With respect to human participants or NO
stakeholders involve any deliberate
deception, covert data collection or data
collection without informed consent?
Involve interventions with children and young NO
people under 16 years of age?
Potentially reveal incidental findings related to NO
human participant health status?
Present a risk of compromising the anonymity NO
or confidentiality of personal, sensitive or
 confidential information provided by human
participants and/or organisations?
Involve colleagues, students, employees, NO
business contacts or other individuals whose
response may be influenced by your power or
relationship with them?
Require the co-operation of a gatekeeper for NO
initial access to the human participants
(e.g. zoo’s, pupils/students, self-help groups,
nursing home residents, businesses,
charities, museums, government
departments, international agency)?
Offer financial or other incentives to human NO
participants?
Administer drugs, placebos or other NO
substances (e.g. food substances, vitamins)
to human participants?
Raise any other human ethical concerns not NO
covered in this checklist?

If you have answered ‘YES’ to any of the questions, you should complete
Section F but you must also complete an application and submit to the
Faculty Research Ethics Committee (FREC) so a committee can consider
your research proposal. Further information is available in Section 6 of the
dissertation handbook. You should seek advice from your supervisor regarding
procedures for ethical review – no application should be submitted for ethical
review without the approval of your supervisor.

If separate research ethics clearance is required from an external organisation,

this should be discussed with your supervisor.

Section F: Further Information

Potential Issue Mitigation to be employed

List any potential issues raised in Section E and state how you intend to mitigate
these issues.

SECTION G: Data storage – Compliance with GDPR and data protection

Please describe which of the following will be involved in your arrangements for
storing data: (please note that any data stored on computer must have password
protection as a minimum requirement):

Data storage
Arrangements to be employed
YES/NO
arrangements
for data security

Manual Files (e.g.

NO NOT REQUIRED
paper documents)
Home or another
NO NOT REQUIRED
personal computer
University computer YES STUDENT LOGIN
Private company or
NO NOT REQUIRED
work-based computer
 Personal laptop
YES PASSWORD PROTECTED
computer
Personal Other
(please define e.g. YES PASSWORD PROTECTED
tablets)
Shared laptop
NO NOT REQUIRED
computer
Shared Other (please
NO NOT REQUIRED
define e.g. tablets)

Section H: Student Declaration

This section is to be completed by the student.

I confirm that:
• The information in this application is, to the best of my knowledge, accurate
and I take full responsibility for it;
• I undertake to abide by the ethical principles embodied in the good practice
guidelines identified in this application and in the Research Governance
Handbook;
• I am aware of my responsibility to be up-to-date and compliant with the
requirements of the law and relevant guidelines relating to data security;

Signature: Rizwana Fatima

Date: 21/03/2022
If all relevant sections are completed, you should now email this completed form to
your supervisor for review.

Section I: Supervisor Review

This section is to be completed by the supervisor.

This proposed research project requires FREC ethical review

This project does not require full ethical review at FREC

I confirm that any data that has been provided to the student (where relevant) has
been collected with appropriate ethical and legal considerations and include any
relevant ethical approval references here.

By signing this proposal, I confirm that the applicant has discussed their research
proposal with me, and that I have read and agree to support this application.

Signature:

Date: 10.06.2022

Once this section has been completed, it should be returned to the student as a
PDF.