Guidance for Human Subjects Protection in Research

The links on this page are meant to help you in preparing your application for research involving human subjects in accordance with the guidelines set forth by Brown University.

Consent Process and Consent Forms
Vulnerable Populations
Electronic Data Storage and Security
Biological Specimen and Tissue Storage
Data & Safety Monitoring
Certificates of Confidentiality
What Every Researcher Needs to Know

The Management of Human Research Studies Involving Drugs and Medication


Consent Process & Forms

Guidance on consent forms, recruitment, obtaining consent, and details on what must be included on these forms and how to avoid problems when creating them. 

Vulnerable Populations

Federal regulations 45 CFR 46 and 21 CFR 56 identify the following populations as potentially vulnerable and requiring certain protections:

Other considerations regarding the status of potential subjects that are reviewed in the specific context of the research include:

  • Economic disadvantage

  • Educational disadvantage

  • Language barriers or cultural values

  • Involvement in potentially emotional or otherwise sensitive current events or incidents

  • Health status and/or chemical use

  • Terminal illness

Research may also involve otherwise healthy, normal subjects but propose to address sensitive topics, including:

  • Sexual practices

  • Substance use/abuse

  • Illegal behavior

  • Religion

  • Immigration status

  • Race/Ethnicity

  • Physical emergency conditions in a community or geographic area

  • Economic status of the subject or subject’s family

  • Perceived sanctions for participation/non-participation

Electronic Data Storage and security

  • Brown’s CIS website contains important information about keeping your data safe and secure

Biological Specimen & Tissue Storage

  • Guidance on Coded Data⁄Human Specimens

  • IRB Recommendations for Storage

  • Suggestions for Informed Consent and Consent Forms

Data & Safety Monitoring

  • Data Safety Monitoring requirements of the IRB

  • Data Safety Monitoring Boards and Plans

Certificates of Confidentiality

  • Protect identifiable research information from forced disclosure

  • NIH Statement on Certificates of Confidentiality

  • NIH Guidelines on the use of Certificates of Confidentiality

What Every Researcher Needs to Know

  • PI Responsibilities/Qualifications

  • Minimizing Risk

  • Conflict of Interest

  • Informed Consent Process

  • Recruitment

  • Participant Compensation

  • Data and Safety Monitoring

  • Application Preparation

  • Post Approval Reviews

  • QA/QI

The Management of Human Research Studies Involving Drugs and Medication

  • The guidance is relevant to all human subjects research that includes the use of prescription medications in their study design

  • Compliance with RI Board of Pharmacy regulations as well as Brown University procedures for medication management in research studies are addressed in this guidance