Committee On Research with Human Subjects

RESEARCH PROJECTS INVOLVING HUMAN SUBJECTS/PARTICIPANTS

Pursuant to action taken by the Council of Trustees, all members of the Shippensburg University faculty, staff, and student body (whether full or part-time) who are conducting research, development, or related activities with human beings as subjects[1], must comply with procedures published by the Office of Research Integrity, Office of the Secretary of Health and Human Services. The completion and filing of the form, Application to Use Human Subjects in Research is required. This form must be completed for each project before any research is conducted (e.g., data is collected) and before support for this research is solicited from any source.

For projects running longer than twelve months, continuing review is required on or before the anniversary date of the initial request. The form indicated above should be used for this continuing review and request for approval.

The person filing an application must be the principal investigator. All applications will be referred to the chairperson of the Committee on Research on Human Subjects. This committee is appointed by the president of the university and meets the criteria for membership established at 45 CFR Part 46.107. If the application satisfies the criteria for expedited review as established at 45 CFR Part 46.110, the chairperson or his/her representative Board member will conduct the review. The full committee will consider those applications that do not meet the criteria for expedited review. The criteria to be used by the full committee for review of applications are established at 45 CFR Part 46.111. These criteria are:

1. Risks are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits to subjects and the importance of the knowledge that may reasonably be expected to result.
3. The selection of subjects is equitable.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
5. Informed consent will be appropriately documented.
6. Provision is made for monitoring the data collected to insure the safety of the subjects.
7. Adequate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data.
8. Where subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards are included to protect the rights and welfare of these subjects.