Procedures

The Human Subjects Research Subcommittee must approve ANY research conducted at Lander University that utilizes human subjects.

GUIDELINES FOR SUBMITTING A RESEARCH APPLICATION
Lander University’s Human Subjects Research Committee (HSRC) policies and procedures are currently being revised in order to comply with the Federal Regulations for the Protection of Human Subjects ( 45 CFR 46) as established by the US Department of Health and Human Services . The following information is designed to guide you through key steps in the application and review process. Please feel free to contact any member of the HSRC for further guidance and assistance.

Categories of Review
Research reviewed by the HSRC will fall into one of four categories:

1. Exempt: The research is exempt from expedited and full committee review. The HSRC Chair reviews the applicant’s submission and either approves, requests modification, or disapproves the research for this category of review. This category frequently applies to scholarship related to teaching techniques or effectiveness.
2. Exempt Class Projects:“Class Projects” refers to any course-based work that involves human participants (eg. student projects conducted as an assignment for a research methods course). The research is exempt from expedited and full committee review. See Guidelines for Class Projects Exemption for specific requirements to qualify for this category. The HSRC Chair reviews the applicant’s submission and either approves, requests modification, or disapproves the research for this category of review.
3. Expedited: The research is exempt from full committee review. The chair and two other members of the HSRC review the applicant’s submission and either approve, request modification, or disapprove the research. Investigators may request full committee review for applications that are disapproved after an expedited review. Individuals anticipating conducting research during the summer months should submit research protocols by May 1.
4. Full Committee Review:   All other applications will be reviewed by the HSRC at one of its convened meetings. Meetings of the full committee will be held six times an academic year and scheduled for the months of September, October, November, February, March, April. Additional meeting times may be arranged at the discretion of the Chair. Research proposals that require full committee review are reviewed by a quorum of HSRC members, including at least one member whose primary concerns are in the nonscientific areas. If your research requires full committee review, please submit your application at least 10 working days prior to an upcoming meeting. Individuals anticipating conducting research during the summer months should submit research protocols in order to be reviewed during the April meeting. 

Below is a link to the Office of Human Research Protection’s (OHRP) Decision Charts. These will help you determine whether your research qualifies as exempt, expedited, or requires a full review of the HSRC.

Submitting a Research Application for Review
Once you determine the review category for which your research qualifies (exempt, exempt class projects, expedited, or full committee review), follow the steps below:

1. Complete the appropriate HSRC application for your review category.
2. Submit the completed application to your department or unit research review committee and chair/director for review and approval. This step does not apply to Exempt Class Projects unless designated otherwise by your department/unit.
3. Once approved within your department/unit, make the appropriate number of copies of your completed application according to your review category:
   • Exempt: 1 copy
   • Exempt Class Projects: 1 copy
   • Expedited: 3 copies
   • Full Committee Review: 7 copies
4. Submit all copies to Donna Atkins, Office of Academic Affairs, LC 106.