ISTSS Letter in Response to the Proposed Revisions to the Common Rule

Letter communicating the ISTSS response to the proposed revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule)
 

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January 6, 2016

Jerry Menikoff, MD, JD
Office for Human Research Protections (OHRP) Department of Health and Human Services 1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Re: Comments on the advance notice of proposed rulemaking on human participants in research protections (HHS-OPHS-2015-0008)

Dear Dr. Menikoff:

 

The International Society for Traumatic Stress Studies (ISTSS) appreciates the opportunity to provide comments on the proposed revisions to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) outlined in the Notice of Proposed Rule Making (NPRM) published by the U.S. Department of Health and Human Services in the Federal Register on September 8, 2015. These revisions, which are intended “to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991” are critically important to ensuring better protection of human subjects involved in research while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

ISTSS is an international interdisciplinary professional organization that promotes advancement and exchange of knowledge about traumatic stress. This knowledge includes understanding the scope and consequences of traumatic exposure, preventing traumatic events and ameliorating their consequences, and advocating for the field of traumatic stress. Included among our over 2,200 members around the world are some of the most prolific researchers in the field of traumatic stress. The research of our members is broad and diverse and includes clinical trials (both psychosocial and medication interventions), genetic, observational, survey, and long-term follow-up studies with trauma survivors across the lifespan.

ISTSS believes that the aims of the proposed revisions to the Common Rule are consistent with practice for conducting trauma research and ISTSS practice parameters for working with those exposed to traumatic stress. It is important to regularly review the rules governing protection of human participants in research, as there have been many changes in science, clinical trials, genetics, and technology that have transformed research practice. The comments and concerns of ISTSS regarding these proposed revisions are primarily concerned with new exclusion criteria, and are shared below.

IRB Exclusion of Research that Does Not Entail Physical Risk

 

The NPRM proposes to exclude research from IRB review that does not entail physical risk. Much social, behavioral, and education research (SBER) will therefore be excluded, including manystudiesthatinquireabouttraumaanddonotcollectbiospecimens. Further,theNPRM suggests that any survey research “that would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation” would not require IRB review, as the U.S. population is familiar with survey research and does not require additional measures to protect themselves and their privacy from investigators.

• ISTSS believes that this exclusion should apply to surveys/interviews/etc. only in those instances in which participants are, in fact, informed of the research purpose, privacy safeguards, contact information, ability to opt out, and practices for retention and access of records. This is contrary to the current proposal that sharing the purpose, benefit, and voluntariness of the research will not be required. We believe that these should be required, when appropriate, even if not subject to IRB review. Further, we believe that as a premise of autonomy and respect, all potential research participants should receive this basic information. This practice should be routine, and if completed, human research participants will be more likely to be protected. Requiring the Principal Investigator (PI) to communicate this key information, but not requiring external review, would best meet the aims of efficiency and human subjects’ protections.
•  With respect to SBER studies of those exposed to trauma and stress (with or without the collection of biospecimens), the extant evidence suggests that psychological risk is minimal (Becker-Blease, & Freyd, 2006; Carlson et al., 2003; Kassam-Adams & Newman, 2005; Newman & Kaloupek, 2004, 2009; Newman et al., 2001; Pederson et al., 2014; Ruzek & Zatzick, 2000). In fact, ISTSS members have taken the lead in the trauma field in asking participants for their reactions to research participation with respect to risk, benefits, perceptions of justice and perceptions of autonomy, and many of these studies have been published in the ISTSS Journal of Traumatic Stress (Collogan et al., 2004; Dyregrov, Dyregrov, & Raundalen, 2000; Griffin et al., 2003; Johnson & Benight, 2003; Newman & Kaloupek, 2004, 2009; Resick, Iverson, & Artz, 2009; Rosenstein, 2004). Across a large range of trauma-exposed populations (e.g., children, refugees, survivors of sexual violence, injury, disaster), the evidence suggests that if participants are aware of the nature and purpose of the research, the cost-benefit ratio is favorable. In a few cases, some human subjects are more distressed than expected and experience regret, but this outcome occurs in a very small proportion of participants, and the distress is temporary. Further, studies that include a focus on trauma often make information available related to appropriate psychological referrals for participants who may experience distress. Thus, we believe that studies including such subjects are appropriate for exclusion. However as per above, we believe that PIs have a responsibility to explain the purpose, privacy safeguards, contact information, ability to optout,andpracticesforretentionandaccessofrecords. The final documentation should refer to more than the principles outlined in the Belmont Report but compel the PI to provide that basic information as part of the informed consent process.  
• ISTSS believes that it is important that IRB resources be prioritized for high risk studies. This proposed change to the Common Rule will likely add to efficiency of IRBs. It will be important for investigators to have access to a tool that will help in accurately determining what research is excluded under these new rules; however, without having seen the tool that is being proposed, it is difficult to assess whether this resource will be sufficient to add to the protection of human subjects.

• This proposed change in the review process places the responsibility of ethical scientific practice with the PI, instead of the IRB. We believe it is reasonable for investigators to make this determination; however, the documentation should be generated and given to the IRB to track. The tool should generate a report for the researcher and the IRB to keep on file. This change will require PIs to rely on best practice and may necessitate the development of additional training tools and mechanisms to address scientific misconduct. Further, without IRB review, many institutions may experience concerns about liability and difficulty remaining informed about PI research activities. It should be determined whether this new process would benefit from oversight at the federal or institutional level to conduct spot checks, etc. Further, professional organizations may play an important role in helping to determine best practice standards and dissemination of such standards to professionals, and institutions may wish to require appropriate education for their researchers on the criteria for exclusion.

Improving Consent Forms and Procedures

 

In an effort to improve the use of informed consent documentation, ISTSS strongly affirms the direction that the NPRM outlines. A clear understandable informed consent with appendices for more detailed information is critically important. Without the opportunity to review the Secretary’s template, it is difficult to offer specific suggestions at this time; however, we would like to reiterate that we believe that the intent of this proposed revision is critically important. It may be useful to define “essential information that a reasonable person would want to know in order to make an informed decision.” We would expect that research purpose, privacy safeguards, contact information, ability to opt out, and practices for retention and access of records would all be essential.

The NPRM suggests the public posting of consent forms for transparency on “a publicly available federal website that will be established as a repository for such consent forms” in “which it is anticipated that the website will be searchable.” It is not clear from the wording of this revision if this should only include clinical trials, federally funded practice, or all practice. This proposed revision requires further clarification. Given that the goal is transparency and that all other proposed changes do not distinguish between federal and non-federally funded entities, we believe that this should likely include all research; however, this is likely to be difficult to coordinate and track (note, for example, the difficulties with registering and tracking studies on clintrials.gov). Researchers have also expressed concern about the security of their intellectual property during the 60-day posting period that has been proposed. We are not sure that filing consent forms online will provide significant educational value; however, we do not oppose this practice. Much of the success of this process will be determined by how easy it is for investigators to post ICDs and the utility of the search tool.

Privacy

 

The proposed revisions in the NPRM aim to establish particular information security measures. Significant focus seems to be placed on issues related to biospecimens, while little attention is paid to other important issues including computer storage, hacking, etc. While this is an evolving process subject to rapid change, human subjects are likely to be better protected with wording focused on digital security minimum standards for identifiable information.

Central IRBs

 

In general, the choice to have one IRB for multi-site studies appears reasonable for efficiency although it may not enhance human research participants’ rights. There have been some expressed concerns that local cultural norms about incentives, recruitment, or follow-up procedures might be problematic; however, this can likely be addressed by PIs who can directly attend to differences in state laws and local customs regarding ethical principles and protections.

It is unclear as worded who would decide what IRB is to be used, and there is some concern that funding agencies or PIs might use the least stringent IRB. We believe that a clear and fair procedure must be established in order to ensure the protection of human research participants’ rights and that appropriate financial reimbursement would be established for the lead IRB.

Changes to Vulnerability

 

We believe that vulnerability to coercion or undue influence is the key vulnerability that must be considered in scientific research. This clarification will be beneficial to human subjects’ protections as long as this consideration includes intellectual capacities and environmental conditions. We encourage this to be indicated by evidence and not simply presumed.

The NPRM requested comments on changes to the term “handicapped.” It is advisable to change “handicapped” terminology but we are unclear if the term “physically disabled” meets the definition of vulnerability to coercion or undue influence. Unfortunately the sections on page 58 are unclear with respect to whether physical disability is now proposed to be a diversity criterion for justice, or vulnerability. These sections appear to be unclear.

• “IRBs considering the § ll.111(a)(3) approval criterion regarding equitable selection of subjects would need to focus on issues related to coercion or undue influence in research with vulnerable populations and not other considerations related to vulnerability.”
• “Physically disabled persons would be among the individuals that the IRB may consider in determining that the selection of subjects is equitable (§

• ll.111(a)(3)), and that the IRB may consider to be vulnerable to coercion or undue influence (§ ll.111(b)).”

Similarly the NPRM requested feedback regarding whether pregnant women and those with physical disabilities should be characterized as vulnerable to coercion or undue influence. Again, we would encourage the use of the evidence base to determine under what conditions this would be the case. In regard to trauma-related research on pregnant women, there is no evidence that pregnant women are unable to choose to participate (Schwerdtfeger & Nelson- Goff, 2008). We suspect that if this is the case in other fields, that they likely should not be characterized as vulnerable to coercion or undue influence.

The NPRM proposes many important revisions to the Common Rule. ISTSS believes that strong standards for scientific research with human subjects are important for ensuring the appropriate protection of research participants, while also facilitating valuable research. We appreciate the opportunity to share these comments on the proposed revisions to the Common Rule and believe that clear and transparent guidance during implementation will be essential.

If ISTSS can be helpful in answering any questions or providing any additional information, please contact me at [email protected].

Sincerely,

Rick Koepke
Executive Director
International Society for Traumatic Stress Studies

References

 

Becker-Blease, K. A., & Freyd, J. J. (2006). Research participants telling the truth about their lives: The ethics of asking and not asking about abuse. American Psychologist, 6, 218–226.

Carlson, E. B. Newman, E., Daniels, J. W., Armstrong, J., Roth, D. & Loewenstein, R. (2003). Distress in response to and perceived usefulness of trauma research interviews. Journal of Trauma and Dissociation, 4, 131-142. doi:10.1300/J229v04n02_08

Collogan, L. K., Tuma, F. K., Dolan-Sewell, R., Borja, S., & Fleischman, A. R. (2004). Ethical issues pertaining to research in the aftermath of disaster. Journal of Traumatic Stress, 17(5), 363-372.

Dyregrov, K., Dyregrov, A., & Raundalen, M. (2000). Refugee families' experience of research participation. Journal of Traumatic Stress, 13(3), 413-426.

Griffin, M. G., Resick, P. A., Waldrop, A. E., & Mechanic, M. B. (2003). Participation in trauma research: Is there evidence of harm? Journal of Traumatic Stress, 16(3), 221-227.

Johnson, L. E., & Benight, C. C. (2003). Effects of trauma-focused research on recent domestic violence survivors. Journal of Traumatic Stress, 16(6), 567-571.

Kassam-Adams, N., & Newman, E. (2005). Child and parent reactions to participation in clinical research. General Hospital Psychiatry, 27(1), 29-35. doi: http://dx.doi.org/10.1016/j.genhosppsych.2004.08.007

Newman, E., & Kaloupek, D. G. (2004). The risks and benefits of participating in trauma-focused research studies. Journal of Traumatic Stress, 17(5), 383-394.

Newman, E., & Kaloupek, D. G. (2009). Overview of research addressing ethical dimensions of participation in traumatic stress studies: Autonomy and beneficence. Journal of Traumatic Stress, 22(6), 595-602. doi:http://dx.doi.org/10.1002/jts.2046

Newman, E., Willard, T., Sinclair, R. & Kaloupek, D. (2001). The costs and benefits of research from the participants' view: The path to empirically informed research practice. Accountability in Research, 8, 27-47.

Pedersen, E. R., Kaysen, D. L., Lindgren, K. P., Blayney, J., & Simpson, T. L. (2014). Impact of daily assessments on distress and PTSD symptoms in trauma-exposed women. Journal of Interpersonal Violence, 29(5), 824-845.

Resick, P. A., Iverson, K. M., & Artz, C. E. (2009). Participant reactions to a pretreatment research assessment during a treatment outcome study for PTSD. Journal of Traumatic Stress, 22(4), 316-319.

Rosenstein, D. L. (2004). Decision-making capacity and disaster research. Journal of Traumatic Stress, 17(5), 373-381.

Ruzek, J. & Zatzick, D. (2000). Ethical considerations in research participation among acutely injured trauma survivors: An empirical investigation. General Hospital Psychiatry, 22, 27-36.

Schwerdtefger, K. L. & Nelson-Goff, B. S. (2008). The effects of trauma-focused research on pregnant female participants. Journal of Experimental Research on Human Research Ethics, 3, 59-67.