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The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently approved guidelines on paying research participants, addressing a range of issues from “token” payments to frank coercion. After considerable discussion into the ethical implications of paying subjects too much or too little, SACHRP approved the guidelines, entitled “Addressing Ethical Concerns Regarding Offers of Payment to Research Participants.”
Post-approval monitoring (PAM) is one method that IRBs could employ when keeping tabs on minimal-risk studies or studies that no longer have to go through the continuing review process. It also can be a way for a small IRB to improve office efficiency and enhance relationships with investigators. IRBs that would like additional information from studies, after continuing review ends, could use PAM to obtain that information.
There are many ways IRBs could conduct post-approval monitoring programs. These can range from simple email questions and answers to full reviews at the research site. These programs often are designed to be educational, as well as adding a layer of accountability in the human research protection process.
Many informed consent forms fail to communicate simply and clearly. They might use language prospective research participants may not process easily. While the new Common Rule provides some suggestions for making informed consent documents more readable, there are additional steps IRBs and researchers could take to improve the forms, including incorporating plain language.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.
