Human Research Protection Program

Guidelines, Policies and Regulations

The Brandeis University Human Research Protection Program has compiled a manual that describes the most common issues it has come across when reviewing human subjects research protocols and the most common questions asked, as well as the basic administrative processes involved.

In addition to this manual, below you will find a link to the HRPP policies and standard operating procedures, as well as a link to the federal regulations. 

Human Subject Research

• Human Subjects Research Investigator Manual (pdf)

 HRPP Standard Operating Procedures (SOP)

• SOP 101: Initial Review of Research

• SOP 102: Continuing Review of Research

• SOP 103: Reporting of Institutional Review Board Findings and Actions

• SOP 104: Determining Which Projects Require Review More Often Than Annually

• SOP 105: Determination of the Need for Verification That No Material Changes Have Occurred

• SOP 106: Prompt Reporting of Proposed Changes in a Research Activity

• SOP 107: Prompt Reporting of Any Unanticipated Problems and Noncompliance

• SOP 201: Jurisdiction of the Institutional Review Board

• SOP 202: Institutional Review Board and Institutional Official Authority and Responsibilities

• SOP 203: Human Research Protections Program Staff Responsibilities

• SOP 204: Principal Investigator Requirements and Responsibilities

• SOP 205: Student and Postdoctoral Scholar Researcher Requirements

• SOP 206: Human Subjects Research Training Requirements

• SOP 207: Research Involving Outside Collaborators

• SOP 208: Institutional Review Board Member Conflicts of Interest

• SOP 209: Investigator Disclosure of Conflicts of Interest

• SOP 403: Data Management and Protection

HRPP Policies

• HRPP Policy 101: Data Retention

• HRPP Policy 102: Title IX Reporting Exception for Research

Code of Ethics, By Discipline

• American Academy of Religion

• American Anthropological Association (pdf)

• American Educational Research Association (pdf)

• American Political Science Association (pdf)

• American Psychological Association

• American Sociological Association

• Association of Clinical Research Professionals

Federal Regulations

• Code of Federal Regulations on the Protection of Human Subjects

• The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules

• Family Educational Rights and Privacy Act (FERPA)