RESEARCH TIPS

This column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research. 

This Month’s Subject—Full IRB Review: OHRP guidelines 45 CFR 46.111

Did you know?

IRB Full Board Reviewers consider these requirements:

1. In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

   • Risks to subjects are minimized.

   • Risks to subjects are reasonable in relation to anticipated benefits.

   • Selection of subjects is equitable.

   • Informed consent will be sought from each prospective subject or the subject's legally authorized representative.

   • Informed consent will be appropriately documented, in accordance with, and to the extent required by.

   • When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

   • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.




2. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

Additional Resources

1. Full text of 45 CFR 46

2. FDA guidelines 21 CFR 56.111
   Additional requirements include:

   • Adequate provision for monitoring the data

   • Safeguards for vulnerable populations

   • Part 50 Subpart D compliance for research with children

3. For additional information, contact the Human Research Protection Program at (413) 794-4356.