IRBs sometimes go overboard in requiring risk details in consent

Define reasonable protection

When IRBs review protocols involving social-behavioral research, it's a good idea to define what IRB members believe are reasonable protections.

Once the definition is made, then the IRB may need to adjust policies accordingly. For instance, the IRB should examine whether it is necessary to require detailed explanations for standard informed consent items, according to an expert.

"IRBs need to be balanced between what is a reasonable protection versus an unreasonable protection," says Elana Newman, PhD, an associate professor in the department of psychology at the University of Tulsa in Tulsa, OK.

"Sometimes I think we're so concerned by presumed fragility or the resilience [of research participants], that we may shape the research enterprise in a way that's not a win-win situation for everyone," Newman says.

"For example, we may choose not to study something we need to understand to help survivors of trauma," Newman says. "Or we may say, 'You can't do this kind of thing because they're too weak.'"

It's important for IRB members to improve the process through respect and reasonable protections, based on facts, not fears, she adds.

Newman's work involves people who have been victims of trauma. Unless there was a head injury, these potential research participants are healthy and able to provide informed consent, Newman says.

However, during the aftermath of a traumatic event, people will need greater care during the informed consent process, she suggests.

"There was a small study done that asked women 72 hours after a sexual assault if they could be contacted later for research," Newman says. "Ten to 29 months later they were located, and very few of the 15 women remembered signing an informed consent form."

Only one of the women objected to the research, but the study suggests that the informed consent process could be refined for this population, Newman says.

Newman's research has found that a majority of subjects in trauma research do not regret their research participation, even when they experience strong emotional reactions.1

It's possible then that when these subjects experience emotional distress it could be an indicator of emotional engagement with the research project rather than an indicator of harm.1

Another item for debate in research involving trauma victims has to do with recruitment.

"Say you've decided that for whatever study you're doing, it's important to find people who are trauma-exposed, such as hurricane survivors or rape survivors or whatever," Newman says. "There's some debate about whether you should tell potential participants that a portion of the sample has been selected based on rape or the trauma."

This disclosure could run counter to participants' interest when it's weighed against confidentiality or suspicion of harm, Newman says.

"We don't know the answer," she says.

Early in Newman's career she wanted to locate adults who as children were sexually abused, she recalls.

"I wanted to send them notes saying, 'You were once seen as a patient in this hospital. Could we contact you?'" Newman says. "The IRB asked me to write a note, saying, 'You were sexually abused. May we see you?'"

Newman disagreed with the IRB, arguing that their version of the note was not ethical because there was the potential that someone besides the survivor would open the mail and see the letter.

So what is the most ethical way of recruiting survivors of trauma without being deceptive?

The answer will vary with the situation, Newman says.

"If you're recruiting people from a domestic violence shelter or a Red Cross shelter, then there's no harm in saying, 'Well, you're here, but if you contact them in other ways you have to think about that,'" Newman says.

Another ethical dilemma arises in relation to mandatory reporting laws and whether to disclose these in the informed consent.

"When someone discloses abusive parenting, there are a lot of different principles that clash," Newman explains. "There's the ethical responsibility to protect children or confidentiality or subject autonomy — all of these can conflict."

Investigators handle this issue in a variety of ways.

For example, one research team evaluated 12 year olds, using a computer, Newman says.

"It prevented interviewers from directly hearing information that would fall under mandatory reporting," Newman says. "Although this strategy was legally defensible, was it ethically defensible?"

Also, IRBs would need to ask themselves whether this strategy would reduce the risk to families.

"We need to understand the costs and benefits of using these methodologies and how they should go about complying with the law that requires them to protect children," Newman says.

IRBs should also think about how much detail they wish to require in studies involving trauma victims.

For example, a review of survey methods to study child abuse showed that there were lower prevalent rates of physical abuse, but not sexual abuse, when the parents got information about the potential for mandated reporting, Newman says.

"We noticed that parents were less apt to report physical abuse when they were told about mandatory reporting," she adds.

IRBs need scientific evidence regarding the different reporting methods, Newman says.

"The same investigator could have two consent forms," Newman explains. "In one they really explain in detail what mandated reporting is and, in the other, they could do it in a more cursory fashion."

She suggests the two versions could read like this:

  • In the event that you disclose that you're harming yourself or someone else, we may need to break confidentiality and report this as required by state law.
  • This study is private and confidential, and all information will be kept private except that which is required by law. That is, if any respondent reports child maltreatment that was not previously disclosed to the authorities, the interviewers are required by law to report this information to the proper authorities. The team will only report the minimal information necessary. Similarly, if the child or guardian says they are in immediate danger of hurting themselves or others, confidentiality will be broken to establish a plan to keep the person safe, and the child will know this ahead of time, as well.

Newman finds that speaking frankly with potential research participants helps.

For instance, she might tell them that some questions will make them feel nervous, upset, or bored, and that they can skip these questions at any point they desire, Newman says.

"A small group of people find the surveys, the research experience, more upsetting than they anticipated," Newman says. "They aren't dysfunctionally distressed, but more distressed than they anticipated, and that seems like something that would be important to tell someone in advance."

While researchers and IRBs sometimes have a 'don't ask, don't tell' policy, Newman says her experience with trauma survivors has led her to a different strategy.

"My argument is that in the trauma field, we've been very careful about this, and I think these kinds of questions need to be asked in certain protocols without making it too impossible for the researcher to do his or her work."

Also, it's important to put this type of research into context: Even researchers who work with college student populations will unintentionally include in their studies young people who are dealing with severe psychological problems, Newman notes.

"There are silent trauma exposures in every sample," Newman adds.

"We simply have to be aware of these issues, gather data on them, and then make rational choices," she says. "But to me the biggest issue is that we don't stifle research."

Reference:

  1. Newman E, Kaloupek DG. The Risks and Benefits of Participating in Trauma-Focused Research Studies. J Trauma Stress. 2004;17:383-394.