This week’s JAMA psychiatry summarises the changes in the federal US rules for consent. The US changes its rules slowly. In NZ we have an independent set of ethical review boards, who continually issue guidelines. One vexed issue is that in international collaborations there is a conflct between the local ethical concerns and international guidelines: as researchers you have to meet approval by oth sets of rules.
And at times they conflict.
The Common Rule enhances participant protections while limiting administrative burdens on research entities and investigators. It clarifies what qualifies as human subject research, exempting educational studies, behavioral assessments, public benefit program reviews, and secondary studies of stored biospecimens entailing minimal risks or conducted with “broad” consent. Researchers can examine confidential data or tissue banks for prospective participants without consent.
The Common Rule reduces IRB administrative responsibilities. Subject to exceptions, it (1) clarifies IRB procedures for research approval; (2) dispenses with onerous reviews of grant applications, contracts, and ongoing minimal-risk studies (eg, data analyses); (3) requires (in 3 years) single IRB approval and oversight of multi-institutional research (unless tribal or state laws mandate additional IRB review); and (4) facilitates online tools to help IRBs assess an expanded array of “exempt” or “expedited” research.
The rule simplifies the informed consent process to enable participants to better understand the scope, risks, and benefits of research. Prescribed elements of consent forms include a concise, up-front explanation of information a “reasonable” person would desire, such as purposes, risks, benefits, and alternative treatments. Investigators are empowered to seek broad consent to use identifiable data or biospecimens in unspecified future research instead of requiring additional consent, IRB waivers, or data deidentification.
The OHRP’s decision to not reform the Common Rule in certain areas was just as consequential. The rule still applies only to federally funded research. However, federal agencies can require enterprises receiving any federal research funds to apply Common Rule protections to all non–federally funded investigations. The rule also fails to mandate security measures such as encryption to safeguard personal data against hacking or unwarranted disclosure. In addition, it does not address compensation for research-related injuries.
The local conflicts will occur around stored specimens, and use of anonymised data. These are highly valued, offered as gifts to researchers by some Maori as they can see the general need for better health throughout the community, and are not to be commercially exploited, patented, or disengaged from the tribes and families who donated such. This issue is going to become more challenging.