Appendix

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 professional and ethical conduct of research. This declaration must be signed by collaborator’s authorized signatory before 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) , representative of (full name of the collaborator group), 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: