Analyst clarifies use of the exempt category

It’s not exempt if it’s not human research

New IRBs and new IRB members, as well as those who have been working in the field of human research protection for years, often have questions regarding the use of the exempt category when research protocols are reviewed.

The first three things to consider is whether a protocol meets the definition of research, involves human subjects, and who will make the decision of whether it is exempt from IRB review.

While IRBs may find that they are never shown exempt research, the official position of the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is that someone other than the researcher should make this determination, says Glen Drew, MS, JD, a health policy analyst for Rockville, MD-based OHRP.

"This could be the IRB chair or an administrator," he says. "A number of institutions have a form to fill out if you are doing a project that you think is qualified for exemption, and this form could be reviewed by someone on the IRB or another group that is designated by the institution."

But the important thing is that the researcher does not make this decision on his or her own, Drew adds.

Another initial question is whether a particular protocol actually meets regulatory definitions for human subjects research, he notes.

"So when IRBs get a proposal, the first thing for them to look at is whether it does in fact involve the requirements for it being research," Drew says. "Is it organized activity intended to generate or produce or lead to generalizable knowledge, and if that is true then it is."

Once it’s determined that it is research, then the next question is whether it involves human subjects. For instance, research that involves only deceased people would not qualify as human subjects research, he notes.

Also, if a researcher is using a repository or source of data that has information about people, but this information is not identifiable and it’s information that is expected to be shared publicly, then it is not considered human subjects research, Drew says.

Once it has been determined that a protocol does involve human subjects research that may qualify for an exemption from IRB review must fall into one of six categories:

Category one. This is research conducted in an established or commonly accepted educational setting.

"It includes schools and universities and anywhere teaching activities are undertaken, including medical residencies and teaching hospitals, etc.," Drew says. "You don’t have to find that there is no or low risk for the exemption to apply, but exemptions are designed to cover things that are considered low risk."

He offers this example of what would qualify for a category one exemption: "If a teacher were teaching how to do research and describing the process, the research procedure would be the content of the education rather than research on education," Drew says.

For instance, a far-fetched example would be one in which a professor divided a class in half and had one half watch a movie based on a book and the other read the book, and then tested the students to see which technique was more effective, Drew says.

Category two. This category applies to research involving educational tests, survey procedures, interview procedures, or observation of public behavior.

"It’s probably the most confusing to work through," Drew says. "This exemption is available to use unless information is recorded in a way that the human subjects can be identified or if identifiers are linked with subjects."

So if an investigator recorded John Smith and gave a code number of A02 to John Smith, and all of the information related to A02 is available to the investigator who has access to a list that says who A02 is, then that research would not qualify for an exemption, he explains.

Alternatively, if a researcher is conducting a survey of passersby in a shopping mall and is not asking them for their names or recording them in an identifiable way, then this study would qualify for exemption, Drew says.

Category two research also requires that if a disclosure were made outside of the research study then it would not reasonably place subjects at risk of criminal or civil liability or be damaging to their employment, financial standing, or reputation, he adds.

"So if an investigator is asking subjects in a mall whether they use marijuana or other controlled substances, and if the investigator is just recording this information by male or female, then that could qualify for an exemption," Drew says. "But if the investigator is recording identifiable information, then the answer could be related to a particular individual and it would not qualify for an exemption."

The use of Internet surveys is a controversial area under category two exemptions, he reports. "If you’re obtaining identifiable information and it’s of a sensitive nature, then I think it would not be qualified for the exemption."

For example, an anonymous survey completed on-line and then sent to a designated e-mail address would be potentially identifiable because even with safeguards the person’s e-mail address could be traced back to that subject, and so that would not qualify for an exemption, Drew says.

Category three. Category three mirrors category two, except that it applies only to elected officials or candidates for political office, he notes.

"Federal statutes require that confidentiality of identifiable information will be maintained throughout the research or thereafter," Drew says. "So if someone is running for a political office, you can identify information about them and still qualify for exemption."

This definition of elected officials or candidates does not apply to the staff who work for the elected officials, he adds.

"It would be the mayor rather than the mayor’s secretary, or the head of the school board rather than a teacher," Drew explains.

An example of a study that might qualify for category three is one that involves asking elected officials or candidates whether they have ever smoked marijuana, he says.

Category four. This category applies to research involving the collection or study of existing data, pathological specimens, records, documents, or diagnostic specimens if the information is recorded in such a way that it cannot be identified or if it’s publicly available and de-identified, Drew says.

"The researcher can have access to it, but just can’t record the names or identifiers with information he or she records. The wrinkle here is the data or information has to be existing at the time the research is proposed," he explains. "You can’t just propose the research and have an ongoing collection of data and qualify for the exemption."

An example might be a study of X-rays or medical records to see if some diagnostic characteristic is related to a particular disease or conditions, such as if a review is made of X-rays of the head to look for an anomaly in people who have developed Alzheimer’s disease, Drew says.

Category five. This is a limited category that is available for the use by the Social Security Administration (SSA) and the Centers for Medicare & Medicaid Services.

"These are research and demonstration projects conducted by or subject to approval by department heads to study the benefit of service programs, people receiving benefits under programs, alternatives or changes to the programs, or possible changes to the methods of levels of benefits paid under those programs," Drew says.

For example, the SSA may wish to study whether it saves the government money and/or provides greater client satisfaction to make direct deposits to a client’s checking or savings account rather than sending the patient a check by mail.

Category six. Drew says he has never heard of this category being used, although it has a specific purpose. This category is for taste and food quality evaluation and consumer acceptance studies.

It has to meet one of two conditions: It has to involve wholesome food without additives being consumed or, if food is consumed with additives, it has to have levels of chemicals that are found to be safe by the Food and Drug Administration, the Environmental Protection Agency, and the Department of Agriculture, Drew explains.

"So if may be that someone in the supermarket asks whether you would prefer turkey sausage or pork sausage as part of a survey," he says.

Although these six categories are available for exempting research for IRB review, some institutions have separate policies that require all research to be reviewed by the IRB, and that also is acceptable by OHRP, Drew notes.