After months of delay, revisions to the Common Rule – a regulation governing the use of human subjects in federal research – will take full effect on January 21. That means any institution receiving federal research funding must work quickly to implement the changes.
Last year, the Common Rule was revised for the first time since its publication in 1991 in order to strengthen protections for study participants and lighten administrative workloads for researchers.
High on the list of priorities is helping people make better decisions about whether to participate in a clinical trial. One key goal: ensuring the risks and benefits of participation are clear.
“Over the years, many have argued that consent forms have become these incredibly lengthy and complex documents that are designed to protect institutions from lawsuits, rather than providing potential research subjects with the information they need in order to make an informed choice about whether to participate in a research study,” explained Jerry Menikoff, MD, JD, director of the Department of Health and Human Services’ Office for Human Research Protections, in a press release announcing the revisions.
“We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants,” Menikoff said.
Below are five things you should know about the revised Common Rule.
1. Revised consent forms must quickly and clearly capture the research study.
People thinking about joining research studies face numerous decisions about whether to participate — including the potential risks and benefits of the research. Informed consent is meant to help ensure that participants or their legal representatives fully understand what it means to participate in the trial.
Thanks to one significant Common Rule revision, informed consent forms will have text at the top of the form that provides key information about the study. This means people will no longer have to wade through lengthy consent form language to find crucial information.
Another change provides additional information about a study’s results. The informed consent form must now include a statement about whether and when clinically relevant research results will be shared with subjects — such as a drop in the subject’s HIV viral load in response to a new therapy.
Tuesday, August 28, 2018
Here’s a brief history of the revised Common Rule and what lies ahead.
Ready: In January 2017, following a 5½ year rulemaking process, 16 federal agencies including the Department of Health and Human Services released significant updates to modernize the Common Rule.
Set: The revisions were supposed to take effect in January 2018. The AAMC and others urged postponement to give institutions and researchers more time to prepare, and the government agreed, extending the compliance date by one year.
Go: Starting January 21, 2019, every new federally funded study that involves human subjects must comply. Studies that started before then also must comply if researchers take advantage of certain revisions that make compliance easier, such as the elimination of yearly review for less-risky studies. They can opt to adopt those provisions any time during the six-month transition period that ends January 21. While some institutions may hope for additional delays or have slowed implementation efforts until government guidance clarifying key aspects of the revised Common Rule is released, federal officials say guidance is forthcoming and another extension is unlikely.
2. Less-risky studies will have less paperwork.
Currently, a study must undergo an annual review by an institutional review board (IRB) that is responsible for protecting the rights and welfare of research participants. Under the new rule, minimal-risk studies — such as those no riskier than a routine physical exam — won’t need this yearly check-in. That should help lighten the administrative burden for many researchers.
There’s a potential bump, though. Researchers will still need to keep the IRB updated about any problems or other noteworthy developments. So, they must be vigilant about documentation and communication to ensure research subjects are protected.
3. Rules for biospecimens don’t change — for now.
After much controversy and debate, the revised Common Rule doesn't cover unidentified biospecimens — things like blood and tissue not associated with private information that could be used to identify the donors.
But this may change. Federal officials will regularly work to determine whether emerging technologies like genome sequencing alter what it means for biospecimens to be “identifiable.” If at some point they decide that biospecimens are inherently identifiable, then studies that use them will have to comply with the rules as well.
4. Some things need to happen quickly.
“Institutions and researchers have been in limbo since 2017, when the final rule was first issued,” notes Heather H. Pierce, JD, MPH, AAMC senior director of science policy and regulatory counsel. “Now the required changes are coming fast, and compliance will be required whether or not federal officials have provided finalized guidance by January 21.”
Here are some items on institutions’ to-do lists:
- Revising consent forms to be more understandable
- Purchasing or updating computer software to document the informed consent process
- Preparing to post consent forms on a federal website so they’re publicly available
- Updating institutional policies and procedures
- Educating investigators and research staff about the changes
5. Some things can wait.
One new requirement is considered such a heavy lift that federal officials have allowed it to wait until January 2020. This change is the requirement to have a single IRB to oversee studies that are conducted at multiple sites. Institutions will need to decide which IRB will be the official reviewer of record and how they will coordinate among the various sites.