The following policies guide all IRB activities and procedures outlined in this document.
- CSS acknowledges and accepts its responsibility for protecting the rights and welfare of human subjects participating in our research.
- CSS acknowledges that it and especially its investigators bear full responsibility for ethically performing all research covered by these policies and procedures and complying with federal, state, and local laws as they apply to such research. CSS assures that it and its investigators will satisfy the following requirements before involving human subjects:
- Risks to participants are minimized by using procedures that are consistent with sound research design and do not unnecessarily expose participants to risks or duplicate procedures that are already being performed on participants for prevention, diagnostic, or treatment purposes.
- Risks to participants are reasonable compared to the knowledge that might reasonably be expected to result.
- Participant selection is equitable.
- The principal investigator will acquire informed consent appropriate to the project from each prospective participant or the participant’s legally authorized representative, unless otherwise exempted by state or federal law.
- The principal investigator will appropriately document informed consent and will retain it in a secure manner such as a locked file cabinet or protected computer server.
- The research plan ensures participant safety.
- Each research project will have adequate provisions to protect individual participant’s privacy and maintain data confidentiality.
- CSS recognizes that for those who are likely to be especially vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, individuals with impaired decision-making capabilities, or economically or educationally disadvantaged persons, the research plan needs appropriate additional safeguards.
- CSS encourages and promotes constructive communication among its administrators, research supervisors, research investigators, and all other relevant parties to maintain a high level of awareness for safeguarding research subjects’ rights and welfare.
- CSS oversees higher-risk projects by reviewing each open project at least annually to assure that investigators are effectively applying its practices and procedures designed for the protection of the rights and welfare of human subjects.
- CSS posts this statement of ethical principles and policy on its Web page as a separate document.
- CSS requires that principal investigators and other key project staff be trained in the rights and protection of human subjects (CITI Training).