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Policies & Procedures
Research Administration Policies
100 - Research Misconduct, Inquiries and Investigations
102 - Research Administration Oversight
103 - Grant Development and Proposal 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
Human Investigation Committee Policies
200 - Adverse Events and Unanticipated Problems
200A - Algorithm for Reporting Unanticipated Problems
201 - Amendment or Correction Documentation
202 - Amendment to the Protocol
205 - Continuing Review and Renewal
209 - Significant Risk Device Determination
210 - Single Time Emergency Use
211 - Non-English Speaking Subject Enrollment
212 - Visually Impaired Subject Enrollment
213 - Expedited Review of Research
215 - Blood Collection in Research Guidelines
216 - Initial Review of Research
219 - Humanitarian Device Exemption
220 - Compensation to Research Participants
221 - Informed Consent and Authorization Process
223 - Investigational Device Studies
225 - Organization of the Human Investigation Committee
226 - Notification of Review Outcome and Response Requirements
227 - Planned Emergency Research
230 - Quality Assurance/Quality Improvement Projects
231 - Exempt from Full HIC Review
232 - Research Record Retention
233 - Review by Another Institutional Review Board
234 - Clinical Research Advertising
237 - Study Completion, Closure or Termination
240 - Vulnerable Populations: Participants Who Become Prisoners
241 - Use of the National Cancer Institute Central IRB
242 - Children as Research Subjects
243 - Cognitively Impaired Subjects
244 - Pregnant Women in Research
245 - Women and Minorities in Research
246 - Coordinating Center and Lead Researcher Activities
248 - Databases, Repositories, Registries and the HIPAA Privacy Rule
249 - Limited Data Use Agreements
250 - Compassionate Use and Expanded Access
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
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
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
604 - Investigational Drug Management
605 - Responsibilities of the Research Team
606 - Interactions with the Human Investigation Committee
607 - Test Article Accountability, Storage, Distribution and Return
608 - Regulatory Files and Study Subject Records
609 - Site-Sponsor/CRO Communications
