In order to approve a research
activity, CORIHS must determine that all of the following requirements are satisfied:
- Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate,
by using procedures already being performed on the subjects for diagnostic
or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable, in relation to the purposes of the research and the setting
in which the research will be conducted.
- Informed consent is obtained in compliance with CORIHS policy as outlined in these guidelines.
- Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. When the research requires testing the subject
for illegal drug use, CORIHS may recommend that the investigator or sponsor
obtain a certificate of confidentiality from NIH (for more information on
certificates of confidentiality, go to http://grants1.nih.gov/grants/policy/coc/faqs.htm
- Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who
are economically or educationally disadvantaged, appropriate additional safeguards
have been included in the study to protect the rights and welfare of these
subjects.
- All personnel associated with the research who either deal directly with the human subject or with human tissue and/or data, have successfully completed SBU's training program on
the protection of human subjects in research. Details concerning SBU's
training program are provided in Section 17.
|