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Institutional Review Board

Standard Operating Procedures


GENERAL ADMINISTRATION

GA 101

Policies and Procedures Maintenance

GA 102

Training and Education

GA 103

Management of IRB Personnel

GA 104- Investigator

Conflict of Interest: Resolution and Management of Investigator Conflicts of Interest

GA 104- IRB Members

Conflict of Interest: Disclosure of Conflicting Interests of IRB Members, Alternates, and Consultants

GA 105

Signatory Authority




IRB ORGANIZATION

OR 201

Composition of the IRB

OR 202

Management of the IRB

OR 203

Duties of IRB Members




FUNCTIONS AND OPERATIONS

FO 301

Research Submission Requirements

FO 302

Research Exempt from IRB Review

FO 303

IRB Meeting Administration

FO 304

Administrative Review and Distribution of Materials

FO 305

 

FO 306

Documentation and Document Management

 

External IRB Submission




REVIEW OF RdeH

RR 401

Expedited Review

RR 402

Initial Review: Criteria for IRB Approval

RR 403

Scientific Review and Departmental Review

RR 404

Continuing Review: Ongoing

RR 405

Continuing Review: Criteria for Renewal

RR 406

Investigating Reports of Noncompliance

RR 407

Study Completion

RR 408

Categories of Action

RR 409

IRB Processing Fee Policy






REVIEWS REQUIRING SPECIAL CONSIDERATION

SC 501

Vulnerable Populations

SC 502

Categories of Research




IRB COMMUNICATION AND NOTIFICATION

CO 601

Investigative Staff

CO 602

Other Entities




INFORMED CONSENT

IC 701

General Requirements and Documentation

IC 702

Informed Consent and Authorization Exemptions

IC 703

Assent

IC 704

Authorization for Use or Disclosure of Protected Health Information




QUALITY ASSURANCE

QA 801

QA/QC Program

QA 802

Audits by Regulatory Agencies

QA 803

Continuing Review Quality Assurance Process

QA 804

Database Quality assurance Process

   QA 805

Procedure for Review of Complaints, Concerns and Suggestions




PRIVACY PRACTICES

PP 901

PP 902

Privacy Practices

Honest Broker

Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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