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Standard Operating Procedures (SOP)

The complete SOP Table of Contents is listed below, with direct links to each individual SOP. Section 600 specifically applies to Investigators.

Section 100 – Organizational Administration

 

HSPP 100-101

Delegation of Authority

HSPP 100-102

Standard Operating Procedures - Creation and Maintenance

HSPP 100-103

Composition of the IRB

HSPP 100-104

Appointment of IRB Members

Section 200 – Program Administration

 

HSPP 200-201

Administrative Review of Research

HSPP 200-202

Responsibilities of IRB Members

HSPP 200-203

Annual Resource Review

HSPP 200-204

Securing Legal Counsel

HSPP 200-205

Training, Education and Outreach

HSPP 200-206

Full Board Meeting – Agenda and Material Distribution

HSPP 200-207

Reports to IRB

HSPP 200-208

Confidentiality of the Review Process

HSPP 200-209

HSPP Executive Committee

Section 300 – Review of Research

 

HSPP 300-301

Definition of Human Subjects Research

HSPP 300-302

Review Process

HSPP 300-303

Use of Consultants

HSPP 300-304

Investigator Conflict of Interest

HSPP 300-305

IRB Member/Consultant Conflict of Interest

HSPP 300-306

Initial Review of Proposed Research

HSPP 300-307

Continuing Review

HSPP 300-308

Amendments

HSPP 300-309

Full Board Categories of Action

HSPP 300-310

Expedited Review

HSPP 300-311

Exempt Research

HSPP 300-312

Ethical Considerations and Exempt Research

HSPP 300-313

Identifying and Assessing Risk

HSPP 300-314

Suspension or Termination of Research

HSPP 300-315

Research Involving Children

HSPP 300-316

Research Involving Prisoners

HSPP 300-317

Research Involving Pregnant Women, Fetuses or Neonates

HSPP 300-318

Research Involving Other Vulnerable Populations

HSPP 300-319

Recruitment Procedures

HSPP 300-320

Privacy of Human Subjects

HSPP 300-321

Confidentiality of Identifiable Data

HSPP 300-322

Informed Consent Process and Documentation

HSPP 300-323

Waivers or Alterations to the Consent Process or Documentation Requirements

HSPP 300-324

Observation of the Consent Process

HSPP 300-325

Cooperative Research

HSPP 300-326

Deferral of Review to Other Institutions

HSPP 300-327

Sponsored Research

HSPP 300-328

Participant Concerns

HSPP 300-329

Investigator Concerns

HSPP 300-330

Unanticipated Problems and Serious Adverse Events

HSPP 300-331 Research Conducted Internationally

 

Section 400 – Documentation

 

HSPP 400-401

Protocol File

HSPP 400-402

Records Retention

HSPP 400-403

Meeting Minutes

Section 500 – Communications and Notifications

 

HSPP 500-501

Protocol Level Communications

HSPP 500-502

Automatically Generated Notifications

HSPP 500-503

Reports to Organizational Officials

Section 600 – Investigator Responsibilities

 

HSPP 600-601

Study Design and Oversight

HSPP 600-602

Risk Minimization

HSPP 600-603

Application for Initial Review

HSPP 600-604

Amendment Applications

HSPP 600-605

Consent Process

HSPP 600-606

Investigator and Study Personnel Training

HSPP 600-607

Unanticipated Problems and Serious Adverse Events

HSPP 600-608

Protocol Deviations and Non-Compliance

HSPP 600-609

Continuing Review

HSPP 600-610

Completion Report

HSPP 600-611 Conducting International Research