Openness to protect human subjects in research

The Department of Health and Human Services recently published a proposal to update the federal regulations that govern research on human subjects. It’s a very interesting proposal with a lot of potential changes on the table, and has received more than 1,000 comments (rare for this sort of thing). Yesterday, I submitted comments on the proposal. Unfortunately, I had to deal with a personal matter just as the comments were due, so they’re less detailed and less polished than I would have liked. The comments are below: (Update: my comments are now available on Regulations.gov as well.)

I welcome the opportunity to comment on the Department of Health and Human Services’ (HHS) advance notice of proposed rulemaking (ANPRM) on human subjects research protections. Modernizing federal regulations to better protect human subjects could advance science and bolster public trust in the research system, strengthening the economy and improving health while upholding human rights.

I submit these comments in my personal capacity, representing solely my own opinion. However, my background may inform the reading of these comments. I have participated in research as a human subject, including survey research as well as greater-than-minimal risk research. Professionally, I research government transparency, including topics such as scientific integrity, focusing on the role of information in improving lives and increasing democratic accountability. Previously, my work focused on public access to scientific information. In addition, I am a graduate student in the School of Library and Information Studies at Florida State University, studying information seeking and use.

In my opinion, several of the information management reforms proposed in the ANPRM could enhance the protection of human subjects and increase public trust in the research system. These changes could benefit the research system by aiding in the recruitment of human subjects. In addition, HHS should consider other reforms not specifically proposed in the ANPRM.

I recommend that HHS consider amending the federal rules on human subjects protection to:

  1. Respect and enhance scientific openness;
  2. Empower research participants and their communities;
  3. Minimize and mitigate information risks; and
  4. Collect the data necessary for system oversight.

1. Human subjects research protections should respect and enhance scientific openness

Openness is a fundamental characteristic of science, and human subjects research protections should respect and enhance scientific openness. I applaud HHS’ consideration of increasing the reuse of existing data and biospecimens (see Question 23). HHS should seek ways to expand appropriate sharing of data and biospecimens, while mitigating information risks to such sharing (see #3).

Openness can strengthen human subjects protections in other ways as well. Articles 20 and 21 of the Helsinki Declaration prohibits the repetition of a study where the outcome is already known, to avoid exposing human subjects to unnecessary risk. As a result, prompt and widespread communication of results is necessary to ensure human subjects are protected, along with sharing and reuse of data and biospecimens. To avoid unnecessarily exposing human subjects to the risks of research, HHS should ensure that the results of human subjects research are rapidly and effectively disseminated to the research community, such as under the National Institutes of Health (NIH) Public Access Policy.

2. Human subjects research protections should empower research participants and their communities

Although human subjects protection is the responsibility of the research and oversight community rather than of the subject, federal regulations should empower subjects to protect themselves to the greatest extent possible. HHS’ consideration of mechanisms to improve informed consent is particularly important in this regard (see Questions 35-53). HHS may also wish to consider readability and comprehension testing to improve consent forms. HHS should also ensure that subjects and potential subjects are informed of potential risks through public access to the proposed database of adverse events reporting (see Question 69).

With regard to the extension of federal regulations to some non-Federally funded research (Question 71), without prejudice to the resolution of the overall question, it is important that subjects and potential subjects be informed of the protections applicable to the context. HHS should require studies to inform subjects whether or not the federal human subjects research protections apply to the study, with a brief description of said protections and a reference to an easy-to-understand website with additional information.

Because the goal of human subjects research is ultimately to improve health, it is important that human subjects research protections leverage opportunities to do so, both for the subjects specifically and for their communities. Access to information is a key method for doing so. For instance, results should be returned to research participants whenever possible, including publications describing overall results of the study (see Question 18). Public access to research results (see #1) and to trial information (see #4) also would advance this aim.

3. Human subjects research protections should minimize and mitigate information risks

The adequate protection of research participants’ privacy is critical to the functioning of the research system and an important factor in the successful recruitment of human subjects. To prevent the damage that data breaches could wreak on the research system, human subjects research protections should ensure proper data security, such as by establishing mandatory standards for data security as proposed in the ANPRM. In addition, promptly notifying individuals of data breaches, as proposed in the ANPRM, is important to mitigate the impact of any security failures.

However, while it may be necessary to reexamine the role of institutional review boards (IRBs) in ensuring data security, HHS should be hesitant to eliminate such a role altogether. Through their approval and oversight, IRBs are the institutional guarantors of human subjects protection, and HHS should be cautious to remove vital aspects of that protection from the boards’ purview. HHS should carefully consider the most effective role of IRBs in ensuring data security: for instance, whether inspector certification of compliance and retrospective IRB audits would ensure protection.

4. Human subjects research protections should collect the data necessary for system oversight

The ANPRM correctly identifies the need for effective data collection and information management in conducting oversight of human subjects research protections. However, HHS should consider expanding required reporting where necessary, in addition to streamlining existing reporting requirements.

For instance, with regard to Question 70 re: ClinicalTrials.gov, the recent report of International Research Panel of the Presidential Commission for the Study of Bioethical Issues identifies needed improvements to trial registration and reporting, including increased reporting and public access to information.

In another example where increased reporting and transparency could strengthen oversight, Menikoff in 2010 proposed that investigators should disclose their consent forms. Such disclosure, the author argued, would ultimately improve the quality of consent forms, in addition to allowing potential subjects to more easily locate appropriate trials.

Sincerely,

Gavin Baker

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