Human Research Protection Program (HRPP)

Van Andel Research Institute Human Research Protection Program

Alion_250x250Van Andel Research Institute (VARI) fosters a research environment that promotes respect for the rights and welfare of individuals recruited to participate in research conducted by or under the auspices of the Institute. The review and conduct of VARI’s research is guided by the principles of respect for persons, beneficence, and justice set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report). The actions of VARI adhere to all applicable federal, state, and local laws, regulations and guidelines, and VARI policies and procedures. As a result, VARI has established a Human Research Protection Program (HRPP). The VARI HRPP, in partnership with its research community and research participants, is responsible for ensuring ethical and equitable treatment and as well as ensuring that the rights and welfare of human subjects in research are protected.

Questions or Concerns
If you have a research related question or concern that we may be able to help resolve, please contact our office at 616.234.5830. You can also email ComplianceHelp@vai.org with your question or concern.

Policies and procedures
The policies and procedures document consists of 19 comprehensive sections that provide current guidelines for upholding VARI’s standards. The goal of this document is to provide guidance and to articulate the requirements of the HRPP in the conduct of human subjects research.

VARI HRPP Policies and Procedures Manual

 SECTION #
SECTION TITLE
1.Human Research Protection Program
2.Institutional Review Board
3.IRB Review Process
4.Quality Assurance
5.Study Suspension, Termination, and Investigator Hold
6.Documentation and Records
7.Obtaining Informed Consent from Research Subjects
8.Vulnerable Subjects in Research
9.FDA-Regulated Research
10.Unanticipated Problems Involving Risks to Subjects or Others
11.Protocol Exceptions or Deviations
12.Non-compliance
13.Complaints
14.Reporting to Regulatory Agencies and Institutional Officials
15.Investigator Responsibilities
16.Health Insurance Portability and Accountability Act (HIPAA)
17.Information Security
18.Repositories and Research Involving Biological Specimens or Coded Human Data
19.Special Topics