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
International Compilation of Human Research Standards - 2018 Edition

The Management of Human Research Studies Involving Drugs and Medication

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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

Certificates of Confidentiality (CoC) help researchers protect the privacy and confidentiality of human subjects enrolled in sensitive, health-related research by allowing them to refuse to disclose names or other identifying characteristics of research subjects in response to legal demands.  Traditionally, investigators conducting sensitive research with human subjects were required to apply to their funding agency for a CoC, and the process was often confusing and lengthy.  As part of the 21st Century Cures Act, NIH has released a revised policy related to Certificates of Confidentiality that went into effect on October 1, 2017.

Under the new policy, all biomedical, behavioral, clinical, or other research that was commenced or ongoing on or after December 13, 2016, funded wholly or in part by the NIH, that collects or uses identifiable, sensitive information is deemed to be issued a CoC and is therefore required to protect the privacy of individuals who are subjects of such research.  Going forward, CoCs will be granted automatically to all applicable studies as a part of the regular terms and conditions of award.

All studies that have a CoC are required to include specific language in all consent documents to inform participants of the protections provided by the CoC as well as the limits of those protections.

Additional information about the new policy can be found on the NIH website

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

International Compilation of Human Research Standards - 2018 Edition

Investigators conducting human subjects research are responsible for understanding and complying with the laws and research regulations of the country where they will be doing research.

The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines (collectively referred to as standards) that govern human subjects research in 130 countries, as well as standards from a number of international and regional organizations. This Compilation was developed for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research around the world.
Content experts from around the world, listed at the back of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered in this Edition. Four new countries are featured in the 2018 Edition: Algeria, Madagascar, Mali, and Saint Lucia. For the first time, this year’s Compilation includes a section on Social-Behavioral Research. 

Compiled By:
Office for Human Research Protections
U.S. Department of Health and Human Services

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