Policies and 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

207 - Data Safety Monitoring

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

218 - HIPAA and Research

219 - Humanitarian Device Exemption

220 - Compensation and Incentives Offered to Research Participants

221 - Informed Consent and Authorization in Research

222 - Institutional Authority

223 - Investigational Device Studies

225 - Organization of the Human Investigation Committee

226 - PI Notification of Review Outcome and Response Requirements

227 - Planned Emergency Research

229 - Protocol Deviations

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

302A - Appendix A - Authorization and Acknowledgement of Arrangements for a Non-Division 08 Emp in Research Form

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

602 - Site Initiation

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

611 - Study Close-Out Visit

613 - Participant Recruitment and Screening

614 - Data Management

615 - Subjects Removed, Withdrawn or Lost to Follow-Up