Guidelines For Research Collaborations & Grant Applications

Following are important considerations to be followed while undertaking research collaborations between SKMCH&RC and collaborating academic groups, organizations and sponsors of research:

6.1 Compliance to research guidelines

Research guidelines define the scientific standard and code of ethical conduct of research involving human subjects, which should be followed by all researchers of the hospital, as well as collaborating institutes and individuals.

6.2 Feasibility assessment

This is a process to assess if proposed collaboration is feasible in SKMCH&RC before the expression of interest can be communicated. It is usually done with the help of related specialists who can take the lead and play a key role in the conduct of the proposed research. Medical director as head of research is kept posted for information and approvals. At this step, we are interested to see if we are in agreement with the scientific content of the proposed research and have sufficient resources to perform it (investigators, availability of target population and recruitment potential, other facilities, time requirements and funds). At this point, any major ethical concerns raised by the subject area experts are also discussed with the proposed collaborator. For collaborative research projects, a designated person from SKMCH&RC must be part of the proposed project.

Mandatory approvals and legal agreements

Research studies to be done in collaboration with other organizations would require additional steps which may involve IRB review at collaborating institute, collaboration agreement or data/material transfer agreement and funding agreement, or others as per relevant national and international laws and regulations.

6.3 Grant applications

After initial feasibility assessment completion, the collaborating partners may proceed with a grant application with an undertaking that the proposed project will be initiated upon successful receipt of the grant funds as per SKMCH&RC requirements for the ethical conduct of research and applicable local and international regulations. Clinical research office facilitates prospective collaborators in this process

For further details please contact the following

Clinical Research Administrator

Shaukat Khanum Memorial Cancer Hospital & Research Centre

7 – A, Block R – 3, Muhammad Ali Johar Town, Lahore

Tel: +92 (0)42 35905000 Ext.4280/4286

Fax: +92 (0)42 35945209

E-mail: crc3@skm.org.pk

6.4 Guidelines for Collaborating groups, Organizations and Sponsors and for use of Contract Research Organization (CROs) by Sponsors

In line with its commitment to perform research of highest scientific and ethical standard, Hospital leadership ensures that collaborating groups, organizations and sponsors ensure their compliance to the ethical values and processes promising protection of human research participants from research risk.

It is a pre-requisite that all collaborators declare their commitment to the professional and ethical conduct of research. This declaration must be signed by collaborator’s authorized signatory before the start of any collaborative study in SKMCH&RC.

(A template declaration is provided below)
Declaration Template

Subject: Declaration confirming commitment to ethical conduct of research

Reference of collaboration (provide complete name of collaborative group and title of study):

I, the undersigned (name and position), and representative of (full name of the collaborator group), and proposing collaboration (title), confirm that:

I will comply with the hospital’s policies and processes for monitoring and evaluating the quality, safety, and ethics of the research
I will use research teams that are appropriately trained and qualified to conduct the research
I will protect the privacy and confidentiality of subject data
I will not permit patient or researcher incentives that would compromise the integrity of the research
I will ensure that the research data are reliable and valid, and the results and reporting are statistically accurate, ethical, and unbiased.
Furthermore, when sponsors plan to use a contract research organization they will ensure the following
I will share information and documentation related to the activities and responsibilities assigned to a contract research organization.
I will ensure that duties and functions transferred to the contract research organization are contained in a written contract, which should specify that the contract research organization or sponsor is responsible for monitoring and evaluating the quality, safety, and ethics of the research.
I will be responsible for monitoring the above contract.

Signed:_____________________

Name:______________________

Designation:_________________

Affiliation:___________________

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Guidelines For Research Collaborations & Grant Applications

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