Home » Choose Beaumont » Research & Innovation » Policies & Procedures
Policies & Procedures
Research Administration Policies
100 - Inquires and Investigations of Alleges Research Misconduct
102 - Research Administration Oversight
103 - Competitive Grant Proposal Development and Submission
107 - Processing Confidentiality Disclosure Agreements
108 - Opting Out of Research, Communicating a Patients Request
110 - Biosafety Committee Operations
112 - Conflict of Interest for an Individual Involved in Research
113 - Clinical Research Quality and Process Improvement Program
114 - HIC Review of Non-Beaumont Research, Laboratory Send Out Specimens
116 - Complaints, Allegations of Non-Compliance and Confirmed Non-Compliance in Clinical Research
118 - Responsibilities of the Principal Investigator
123 - Transportation of Research Specimens
Human Investigation Committee Policies
200 - Reporting an Unanticipated Problem Involving Risk to Participants or Others
200A - Algorithm for Reporting Unanticipated Problems
201 - Correction of Documentation
202 - Amendment to the Protocol
205 - Continuing Review and Renewal of a Protocol
206 - Criteria for Determining Frequency of Review by the HIC
209 - Determination of Significant Risk Device
210 - Single Time Emergency Use of a Test Article
211 - Enrolling Non-English Speaking Study Participants
212 - Enrollment of Visually Impaired Participants
213 - Expedited Review of Research
214 - Recombinant DNA Research
215 - Guidelines for Blood Collection in Research
216 - HIC Initial Review of Research Protocols
219 - Humanitarian Device Exemption
220 - Compensation and Incentives Offered to Research Participants
221 - Informed Consent and Authorization in Research
223 - Investigational Device Studies
225 - Organization of the Human Investigation Committee
226 - PI Notification of Review Outcome and Response Requirements
227 - Planned Emergency Research
230 - Quality Assurance/Quality Improvement Projects
231 - Research Exempt from Full HIC Review
232 - Research Record Retention and Destruction
233 - Review by Another Institutional Review Board
234 - Clinical Research Study Promotion
237 - Study Completion, Closure or Expiration
238 - HIC Review of Research Involving Tissue/Specimen Banking
240 - Vulnerable Populations: Participants Who Become Prisoners
241 - Use of the National Cancer Institute Central IRB
242 - Vulnerable Populations: Children as Research Subjects
243 - Vulnerable Populations: Enrollment of Cognitively Impaired Participants
244 - Vulnerable Populations: Inclusion of Pregnant Women, Fetuses and Neonates in Research
245 - Inclusion of Women and Minorities in Clinical Research
246 - Coordinating Center and Lead Researcher Activities
248 - Using Databases, Repositories, Registries in Research
249 - Limited Data Release and Use Agreements
250 - Expanded Access and Use of Test Article for Compassionate Purposes
251 - Defining Human Subjects Research
252 - Recruiting Human Subjects for Clinical Research
253 - Investigational New Drug Research
254 - Administrative Hold Suspension and Terminations
255 - IRB Facilitated Review by Affiliate Site of Beaumont CCOP
256 - Vulnerable Populations: Enrollment of Employees, Students or Trainees
257 - Clinical Studies Conducted in Full Compliance with ICH-GCP Guidelines
257A - Clinical Studies Conducted in Full Compliance with ICH-GCP Guidelines Appendix
258 - Community Based Participatory Research
Research Finance Policies
300 - Professional Activity Fee
302 - Employees Working in Beaumont Research Outside Their Normal Employment Duties
303 - Research Time and Effort Reporting
304 - Establishing a Research Study Budget and Management of Research Funds
Research Education Policies
500 - Training and Education for Individuals Conducting Research
Clinical Research Standard Operating Procedures
600 - Assessing Protocol Feasibility
601 - External Regulatory Body Inspections or Audits
603 - Pre-Study Site Selection Visit
604 - Investigational and Study Agent Management
605 - Responsibilities of the Research Team
606 - Interactions with the Human Investigation Committee
607 - Investigational Device Accountability, Storage, Distribution and Return
608 - Regulatory Files and Study Subject Records
609 - Site-Sponsor/CRO Communications
610 - Sponsor/CRO Monitoring Visits


