Social work researchers and the Institutional Review Board: Benefits, Challenges, and Ideas for Support

Social work researchers and the Institutional Review Board: Benefits, Challenges, and Ideas for Support

Nancy Shore, University of New England

Peggy West, University of Washington
Abstract

Social work researchers are required to submit a human subjects application to the Institutional Review Board (IRB) when their projects meet the definition of research specified by the human subjects regulations. The IRB review aims to strengthen the ethical conduct of research. This study was designed to understand social work researchers' experiences with the IRB. Twenty social workers were interviewed and a content analysis was done on the feedback they received from the IRB. Findings from the study resulted in a set of recommendations, which require attention from the University, IRB, School of Social Work, and the social work researcher.

Key words: Ethics; Social work research; Institutional Review Board.
1. Introduction

University-based social work researchers must submit a human subjects application to the Institutional Review Board (IRB) when their projects meet the definition of research as specified by the federal regulations. The IRB process aims to strengthen the research ethics and to assure that study participants are not exploited. The federal human subjects regulations, also known as the Common Rule, define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (Department of Health and Human Services, et al., 2001, §46.102).

The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) articulated the guiding ethical principles that inform the Common Rule. These ethical principles are Respect for Persons, Beneficence, and Justice. These three principles were written in the abstract to provide a conceptual framework for ethical analysis and to allow for local interpretation of the principles (Jonsen, 2001). While the Belmont Report’s primary intent was to create an analytical framework, the Common Rule’s intent was to articulate what are the rules, key definitions used within these rules, and the functioning and composition of the IRB review committee.

The Common Rule specifies criteria for three different levels of ethical review: exemption, minimal risk and full review. An exempt project must meet one of six criteria listed within the regulations, e.g., Educational Research Conducted in Educational Settings. Studies eligible for minimal review are those in which risk is assessed to be no greater than what can be expected in daily life. Full review is required for a study where risks include potential damage to the physical or psychological health, reputation, or economic welfare of a subject. As an example, this research study required full review. Risks to reputation and economic welfare were considered the primary concerns, as the study potentially could reveal a lack of compliance with the human subjects regulations.

The IRB committee must include at least five reviewers. Committee composition is further outlined in the Common Rule. As an example, the Common Rule states, “each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution” (Department of Health and Human Services, et al., 2001, §46.107). The overall intent is to create a diverse and knowledgeable review committee.

The authority of the IRB includes approval, approval with contingencies, deferral, or no-approval of research proposals; continuing review; observing, monitoring, and auditing of research projects; and suspension or termination of approval. The charge of the IRB is to assess research proposals across the Belmont Report’s three ethical principles. This includes a careful examination of the informed consent process, a risk/benefit analysis, and determination as to whether there is a fair distribution of burdens and benefits.

As the review process differs across universities, researchers should familiarize themselves with local IRB practices and the Common Rule. To more fully understand the regulations, it is also strongly recommended that researchers gain an understanding of the historical context and critiques of the regulations. Numerous articles and texts within the bioethics literature, for example, provide a historical overview of the regulations and describe the challenges with a regulatory system that has largely developed in response to ethical violations (e.g., Advisory Committee on Human Radiation Experiments, 1996; Kahn, J., Mastroianni, A., & Sugarman, J., 1998; Moreno, J., Caplan, A., & Wolpe, P., 1998).
2. Relevance to Social Work Field

The IRB review process has not been explored systematically in the social work literature. Murray, Donovan, Kail and Medvene (1980) reviewed the social work literature and found no references to how the ethical guidelines affected social workers. These authors also reported that the 1980 version of the NASW Code of Ethics failed to make “specific reference to formal procedures either for obtaining informed consent or for institutional review” (Murray et al., p. 26). Of note, the revised 1996 NASW code continues to assume a less stringent position implying that the IRB “should be” consulted, rather than stating consultation as a requirement. Additionally Murray et al. interviewed twelve social work researchers and found that, in general, there was a desire to strengthen the professional code of ethics rather than increase “governmental intrusion.”

Grigsby and Roof (1993) also found inadequate attention to ethics within social work research texts published after 1975. They reviewed nine texts and found that only a third of the texts explicitly mentioned participant rights. Implications include the potential for “impediments to the generation of high-quality social work research that involves human subjects, in that researchers may be less attuned to the pitfalls for research that is not sensitive to ethical issues” (p. 459). Current research texts indicate a shift toward greater attention to ethics through an inclusion of a historical overview of the human subjects regulations, a discussion of the IRB purpose and function, and information regarding informed consent requirements (e.g., Rubin and Babbie, 2001; Grinnell, 2001).

Several social work journal articles provide more specific calls for action within the social work community. Blaskett (1998), for example, advocates for social workers to have a stronger voice in the promotion of ethical research, seeing the benefit of applying social work skills to the ethical review process. Similarly, Massat and Lundy (1997) recommend infusing the current ethical principles, as specified by the human subjects regulations, with empowerment principles.

There is a need for increased attention within social work to the human subjects review process. There is no recent empirical data on how social work researchers perceive the benefits and challenges with the IRB, nor is there discussion on how researchers can be supported through the review process. A need for this information was further reinforced through the authors’ experiences offering support to social work researchers in the completion of IRB applications. The authors noted that applicants frequently voiced confusion and/or frustration with the IRB process. The current study was designed to explore social work researchers’ perceptions of and experiences with the IRB. The compilation of experiences and challenges encountered in the review process will help to create a preliminary set of recommendations for Schools of Social Work and IRBs aimed at enhancing the human subjects review process.
3. Methods

The study sample included twenty social work researchers who submitted a research proposal that required a minimal risk or full review. Exemption applications were excluded, because anecdotal evidence suggested that the minimal risk and full review process present greater challenges than the more streamlined exemption process.

The participants included 7 graduate students, 6 staff, and 7 faculty researchers. Researchers used a wide range of designs, including ethnographies, clinical trials, epidemiological studies, and participatory action research. The researchers’ data sources included interviews and survey results, as well as secondary data sets. The estimated number of submissions per researcher ranged from 1 to 15, with an average of 4. The majority of applications (89%) required full review. Student researchers overall submitted the smallest number of applications. Of note, the results do not specify whether researchers are student, staff, or faculty. Contrary to what we expected, the researcher’s position did not result in significant differences.

Participants chose whether to be interviewed or to complete a written survey. Ninety-five percent of the participants completed the interview. The written survey contained the same questions as the interview guide. The questions included 1) what are your perceptions of the review process; and 2) how can the School of Social Work and/or IRB offer increased support to applicants? The interviews lasted approximately 45 minutes and were audiotaped with the participants’ permission. The audiotapes were transcribed verbatim. The authors coded the transcripts independently and compared and discussed their tentative coding schemes. Themes were identified using the constant comparative method (Lincoln and Guba, 1985).

Participants also provided their correspondence between themselves and the IRB regarding the status of their application. When participants had submitted more than one application to the IRB, they selected which application to include in the study. A content analysis of the written correspondences was completed across the following two areas: 1) the types of changes required or questions posed by the IRB and 2) how the researcher responded to the IRB’s feedback.

As this study is exploratory and included researchers affiliated with one university, the findings and recommendations represent an important first step in understanding potential challenges and recommendations to facilitate the IRB process. Social work researchers are encouraged to critically reflect upon which recommendations are most appropriate, given the specifics of their social work program and university culture. This paper concludes with recommendations for future studies, including the suggestion to broaden the study sample to include social work researchers affiliated with various institutions.
4. Results

Study results were categorized into three broad areas: 1) perceptions of the review process, 2) areas of IRB feedback, and 3) assessment of practical support and recommendations. For the remainder of this paper, the term “researcher” will be used instead of “study participant.”
4.1 Perceptions of the review process
Perceived purpose of the IRB

Researchers described the IRB’s primary purpose as the protection of study participants from harm and the assurance of ethical research. Protection includes researchers safeguarding confidentiality and presenting participants with an informed consent that relays key information, including the voluntary nature of the study.

Several of the researchers also considered the IRB purpose to extend beyond study participant protection, to include consideration of the general public and the legal protection of the investigative team and the University. For several of the researchers, protection of the University made sense yet they were wary it potentially took precedence. As one researcher shared, “I would like to think the purpose of the IRB was to actually look at the research that we are doing [but] in practice I really have felt like they are more in the business of protecting the university.”

While most of the researchers agreed that the purpose included the protection of study participants, questions were raised with how “research” was defined by the regulations. A researcher voiced frustration with the operating assumptions underlying the regulations, stating that research funded by federal grants is considered the norm. As a result, two problems were identified. First, the underlying assumptions of the definition create a “gray zone” for program evaluation, which may not meet the regulation’s definition of research. Without an approval, the dissemination of evaluation findings may be restricted. Secondly, unethical practices that are not labeled as “research” might occur without the benefit of the regulatory protections. This researcher commented, “I can do anything to anybody here at the University as long as I don’t call it research.”
Perceived value of the IRB

All the participants saw the value of the IRB process in theory. The process can strengthen the conceptualization of the project, as it not only forces applicants to carefully explain the design but also provides applicants with feedback. For example one researcher described an iterative process in which the IRB “would problem solve and toss some of those questions back at us,” which led to a more thorough design.

The process also can counter the tendency for researchers to think predominantly in terms of benefits, and instead encourages researchers to think carefully about the potential harms and how to minimize these. As one researcher stated, the IRB is positioned well to “closely examine the protections for the subjects…and to look for potential problems with the procedures, to find our blind spots.” The notion of finding “blind spots” was voiced by another researcher who equated the IRB’s approval as an assurance that the research team was “not blindly fooling ourselves that these things will work or won’t hurt people.” Others voiced concern that without an independent review there is a risk of intentional or inadvertent harm to study participants.

Other researchers voiced mixed feelings about the process. For some it seems burdensome yet also is understandable given the historical violations. One researcher’s comment exemplifies this conflicted feeling, “When I look at it from my own point of view, I think of it as a big headache, but when I am … thinking about it from a point of view of participants or how things ought to happen, I think of it as extremely important.”

For others, the stated purpose of the IRB was valued, but the actual process did not necessarily strengthen the ethics. The actual value of the IRB review may depend upon whether the committee understands the research proposal, which requires that the proposal is conceptualized well and/or that the review committee is familiar with the proposed methodology. The value may be undermined, however, if researchers complete their applications with an emphasis on gaining approval rather than critically examining the ethics. As one researcher shared, “More seasoned researchers know how to word IRB applications so they could pass muster for the review board, but that doesn’t necessarily reflect the content of their research.”
Perceptions of the IRB application process

The application provides a structure to strengthen research ethics; for example completion of the application can help minimize problems with coercion. A researcher described the application as a means “to crystallize what is the purpose of the study, what are the benefits, and what are the risks…it also helps us think through what are the supportive measures we need.” “Supportive measures” include having trained professionals on staff or strategies to assure data security. The application was also equated to a final checklist, which helps assure a clear presentation of the information.

In completing the application, several researchers reported that the anticipation of IRB feedback also strengthens ethics. For example, one researcher described omitting sensitive questions when she could not justify these questions given the project’s stated purpose. Another researcher shared that the application “sharpens your awareness of the rational process of seeking an exception …When you know that this kind of question is coming at you and you have to think through ‘just how are we going to be responsive to that special vulnerability,’ you’re likely to be a more competent researcher.”

For others, ethical issues were considered prior to submission and consequently the application did not strengthen the ethics. A researcher described how ethics were considered at the time of the grant submission, and that the application was just a means to tell the “tale” to the IRB. For others, ethical issues were covered within the social work curriculum, and therefore researchers tend to be “pretty well-versed in the ethics of the situation by the time we get to the IRB process.” Other comments suggested that the application fails to effectively highlight all the relevant ethical issues and for one researcher it seems to create a sense of paranoia since it “takes it to extremes where you are asked to think of every contingency,” which in theory might be a good idea, but “in practice ends up taking a lot of energy.”
4.2 Areas of feedback

As part of the review, researchers receive written IRB feedback on their human subjects application that may include questions of clarification or required revisions. The feedback is oftentimes quite lengthy, which one researcher described as “shocking.” The IRB feedback was assessed in terms of 1) its perceived impact on the research project, 2) whether it was perceived as negotiable or mandatory, and 3) whether the IRB raised recurring questions or concerns.
Recommendations that strengthened

IRB feedback at times clarified consent forms and reduced potential risks to study participants. One researcher described the feedback process as having to “spell out in our consent form where audiotapes would be stored and how the identifiable data would be kept, and destroyed by a certain date. It helped us create a protocol about what are we going to do.” Other examples of valuable feedback included recommendations to develop community resource lists for study participants, and feedback on interview questions to reduce the potential risk to study participants. IRB feedback also helped researchers understand and apply the human subjects regulations, such as how to ethically proceed with a passive consent process.
Recommendations that did not strengthen

Many researchers did not think the IRB feedback strengthened the research. For some, this was because the application process acted as a checklist and the ethical issues were identified prior to feedback, and for others the feedback seemed more about semantics or details. This type of feedback potentially hindered the research progress, yet was not viewed as weakening the study. Comments regarding feedback that did not strengthen the design focused primarily on issues with the consent form.

At times, the requirements for informed consent appear “unwieldy.” One researcher shared that her initial consent seemed more readily understandable than the revised form. The IRB required a level of detail and formality that may have decreased the likelihood that study participants would actually read and retain the information. Similarly, another researcher commented that while the level of detail required made the consent form “more exact,” it also made it “more onerous to read,” which is particularly problematic for study participants with limited reading skills.

The language requirements did not always seem to strengthen the ethics. For one researcher, the revisions to the consent form were “just a lot about conforming to the established acceptable language.” For others, the language requirements were perceived as disconcerting or even inappropriate. Examples of this include:



* A requirement to use the term “subject” rather than “study participant,” which created a “power relationship” that was “philosophically at odds with how we try to interact with people.”
* A recommendation to reduce the consent form’s reading level, in essence requesting a “dummying down effect.”
* A requirement to translate a consent form, even though the study participants were unlikely to be literate in their native language.


Responding to IRB feedback

After identifying feedback that did not strengthen the design, researchers were asked whether they incorporated these changes. Some researchers sensed that certain changes were negotiable while others were mandatory.
Negotiable

Primarily experienced researchers, defined as having submitted at least three applications to the IRB, saw recommendations as negotiable. One researcher stated that investigators should not unquestioningly incorporate IRB feedback if it potentially weakens the ethics. This researcher cited an example in which the IRB recommended the consent form include a statement about repercussions to future insurance. The researcher felt that while the risk existed, the prominence of a statement would suggest that participants decline STD screens in order to avoid future problems securing health insurance. Morally and ethically, the researcher opposed this suggestion and negotiated with the committee for an acceptable approach. Another researcher provided an example of how she successfully negotiated an informed consent format by explaining “if the format is not something that people are going to read and understand accurately, in fact that is deterring our ability to fully inform participants.”
Mandatory

Some researchers complied with the requested IRB changes even when they questioned whether the feedback actually strengthened research ethics. The language and tone of the written IRB feedback contributed to an assumption that the feedback was mandatory or at least required if approval was to occur in a timely fashion. In some instances, researchers questioned the ethical rationale for certain requirements, yet they realized state or federal regulations required these changes. This issue arose mainly in the context of requirements for research with prisoners.

Within the response to why changes were made, several researchers used either an analogy that conveyed a sense of the IRB’s power or battle metaphors. These included:

* “The sense I have is that this is a body that can completely hold up your research or not. They could hold it hostage for months, so unless it’s something that I really feel is worth bickering over, and it would have to be fairly significant for me to want to bicker over it, I would just answer the question. Pick your fights, pick your battles.”
* “I guess there is this sort of aura of combat…that this is an adversarial relationship and I think that I suffer from some of those assumptions myself, but in fact when I have asked people for help, they have been very helpful.”
* “It feels quite often that the IRB is this sort of god to which we must bow if we’re going to be allowed to do what we want to do.”

Analysis of IRB written feedback

A content analysis of the written IRB feedback was conducted to assess the repeated concerns or questions raised by the IRB. Additionally, researchers rated the frequency of IRB feedback they received in eight topics, which were chosen by the authors based on their experiences in helping researchers with the IRB process. These topics included: informed consent language, content, and format; recruitment approaches; confidentiality; anonymity; sampling concerns; and scientific merit.
Content analysis of written IRB feedback

Nineteen of the researchers provided a copy of their IRB feedback and their responses to the IRB. One researcher did not provide feedback, as her co-investigator was also interviewed and submitted the information. There were six categories within the structure of the IRB feedback form. Analysis entailed tabulating the number of IRB comments that fell within each of these categories. Across the 19 feedback forms, there were 255 comments. The categories and their frequency were as follows: “additional information” (n=139), “revisions in the consent form” (n=92), “revisions in the recruitment advertisement” (n=9), “revisions in the initial contact letter” (n=7), “revisions in the telephone script” (n=6), and “revisions in the eligibility screen” (n=2). The majority of the “additional information” items asked the researcher to clarify or confirm. The revision items primarily asked the researcher to add or modify. In all instances, the researchers complied with the IRB feedback by either making the required modifications or providing clarification. Below is a detailed description of the two largest categories.

Additional analysis was done on the two larger categories, “additional information” and “revisions in the consent form.” The authors independently coded these two categories to identify sub-categories. The five most frequently cited areas within “additional information” were study procedures (n= 59), data management (n= 30), discrepancies within the application materials (n= 9), submission of finalized materials (n= 8), and submission of letters of cooperation (n= 7). Many of these IRB comments requested clarification or confirmation, followed by the requirement to revise the consent form accordingly. The following tables provide greater detail on the three most frequently cited topics within the study procedures and data management sub-categories.
Table I. Most frequent feedback issues regarding study procedures (n=59)

Issue

Example questions or concerns

Recruitment (n=16)


Who will approach participants and how, content of the recruitment texts

Survey/interview procedures (n=16)


Content issues, specifics of administration

Sampling (n=9)


Eligibility criteria, selection process


Table II. Most frequent feedback issues regarding data management (n=30)

Issue


Example questions or concerns

Confidentiality (n=18)