Evaluating IACUC members’ beliefs in assessing scientific merit and alternatives in research protocols
Animals and Public Policy
Center for Animals and Public Policy
Tufts University School of Veterinary Medicine
copyright November 4, 1998
It is now thirteen years after the legal authorization of Institutional Animal Care and Use Committees and the IACUC process is far from being polished. There remain many controversies and problems, starting with the function of the IACUCs themselves. Before 1985, Animal Committees (if in existence at all) were more concerned with animal husbandry than animal welfare. The committees did not have the power to regulate research as they do now. Not surprisingly, some researchers and universities resisted the change. The scientists did not want their research to be governed by a committee. Nicholas Steneck, of the University of Michigan, believes that IACUCs should be limited to an advisory role only, and that if a protocol review must be done, the scientist’s peers should perform it. He claims that IACUCs "do not necessarily have the expertise needed to carry out their duties" (1). He also claims that by having a committee outside the governance of the university, academic freedom of the researchers is restricted. Furthermore, he declares that animal welfare:
This project looks at the IACUC system from the perspective of the committee members. The members were observed at committee meetings and then surveyed for their own beliefs about assessing scientific merit and searching for alternatives in research protocols. They were later personally interviewed in regards to their survey answers, and asked what they believed were the merits and the limitations of the IACUC process. The purpose of this project is to give insight into the people behind the review process, and to see how they judge scientific merit, alternatives, and their own general effectiveness as an IACUC member. With the members’ own opinions, a more accurate assessment of the true merits and limitations of the IACUC system can be made.
Background and Laws
President Johnson first signed the Animal Welfare Act (AWA) into law on August 24, 1966. At that time it was called the Laboratory Animal Welfare Act, or LAWA, and was the first piece of legislation ever in the United States that protected animals in biomedical research. The public uproar that causes LAWA to be written and passed began with a Dalmatian named Pepper.
Subsequent amendments to the Laboratory Animal Welfare Act were passed in 1970, 1976, 1985, and 1990. The 1970 amendments (P.L. 91-579) first changed the name of the Act from the Laboratory Animal Welfare Act to the Animal Welfare Act (AWA). It also expanded the list of protected animals to include all warm-blooded animals as determined by the Secretary of Agriculture. Surprisingly, after the 1970 amendments were passed, the Secretary of Agriculture regulated that rats and mice, the most common animals used in biomedical research, were to be excluded from protection due to time, manpower and money constraints. Also excluded from protection were birds, horses not used for research purposes, and farm animals when used for improving animal nutrition, breeding, management, production efficiency, or the quality of food or fiber. Exhibitors were now covered by the AWA. Pet stores, state and county fairs, rodeos, dog and cat shows, and agricultural exhibitions were exempt. Standards concerning record keeping and appropriate anesthetic, analgesic and tranquilizer use were also created.
The 1976 amendments further defined animal transport and commerce regulations. It also covered animal fighting and deemed it illegal to exhibit or transport animals used for fighting, such as dogs or roosters, between states. State laws previously in existence ruling dogfighting or cockfighting legal are not changed because of these amendments. It is only the interstate transport that is prohibited. A person violating these new amendments could be fined up to $5,000, imprisoned up to a year, or both. Intermediate handlers and carriers now had to keep records of transporting, receiving, handling, and delivering animals. Dealers now had to have a certificate accompanying each of their animals, issued by a veterinarian, stating that the animal was inspected not more than 10 days before the delivery and found to be free of all infectious diseases or physical abnormalities that would endanger the animal or public health.
Besides creating Institutional Animal Care and Use Committees or IACUCs, the 1985 AWA amendments introduced specifics such as sanitation, housing and ventilation into regulation. Exercising laboratory dogs and providing for the psychological well-being of primates was now required. In experiments, alternatives must be sought and pain and distress must be minimized. Alternatives are defined as refinement (of the protocol design), replacement (using phylogenetically lower animals or using no animals at all), and/or reduction (in the number of animals used in the protocol). In addition, the 1985 amendments said that multiple operative experiments not resulting in the death of the animal could not be done without scientific justification. The National Agricultural Library was created to act as a database to help halt duplicative research, help researchers learn about alternatives (refinement, replacement, and/or reduction) and about easing the pain and suffering of their animals, and also to help with the IACUC’s duty of employee training.
In 1990 the Protection of Pets section of the Food, Agriculture, Conservation and Trade Act, became the most recent amendments to the Animal Welfare Act. "It established a holding period for dogs and cats at shelters and other holding facilities before sale to dealers. It also required dealers to provide written certification regarding each animal’s background to the recipient" (9). The final USDA regulations required pounds and shelters to hold dogs and cats for at least 5 days (including one weekend day) before selling them to dealers. Together, the Animal Welfare Act and its amendments are recorded in the United States Code (U.S.C.) under Title 7, Part 2131-2157. The regulations are documented in the Code of Federal Regulations (CFR) under Title 9, Chapter 1, Subchapter A- Animal Welfare, Parts 1, 2, and 3.
The "Improved Standards for Laboratory Animals Act" or the AWA amendments of 1985 (P.L. 99-198) created IACUCs, or Institutional Animal Care and Use Committees. Each research facility was now required to have at least one committee, appointed by the Chief Executive Officer (CEO) of that facility. A research facility, as defined in the 1970 Animal Welfare Act amendments, refers to any school (except an elementary or secondary school), institution, organization, or person that uses or intends to use live animals in research, tests, or experiments. The committee was required to have at least three members, one of whom must be the chairman, and one of whom must not be affiliated with the research facility in any way. This is the member whose job is to represent the surrounding community’s interests and feelings. The third member must be a Doctor of Veterinary Medicine "with training or experience in laboratory animal science and medicine and who has direct or delegated responsibility for activities involving animals at the research facility" (10).
The duties of the IACUC include reviewing research protocols to ensure the humane care and use of the experimental animals covered by the Animal Welfare Act. This is usually done by having the principal investigator submit a form to the IACUC outlining the project, which is then discussed at committee meetings. The committee members review all new protocols, protocols that are due for annual renewal, and changes or modifications to already accepted protocols. All research proposals must be approved by the IACUC before proceeding. Each IACUC is mandated to determine that the principal investigators has:
Other duties of the IACUC, as mandated by the 1985 Animal Welfare Act amendments, include inspecting the animal housing and research facilities at least once every six months. Both the condition of the animals and all practices involving pain to the animals must be reviewed. Reports citing minor and major deficiencies of the regulations are then given to the CEO of the research facility, including a plan and timetable for their corrections. These reports are then kept on file for at least three years and are made available to USDA inspectors.
The IACUC is also responsible for educating the scientists, research technicians, animal technicians, and other staff. Topics covered in the training must include:
The Issue of Scientific Merit
One of the ethical dilemmas that IACUCs face today is the issue of assessing scientific merit. Scientific merit can be defined as having two parts. The first is the "scientific, human, and social significance of the proposed use" of animals and the second is the "methodological merit of the research proposal, how carefully crafted and likely to yield that data required the protocol design is" (15). The AWA was not passed to hinder biomedical research. Section 2.31a of the AWA regulations state that
Some believe that assessing scientific merit is not the duty of the IACUC and that research should not be hindered in any way. This is because there is no way of knowing how beneficial today’s basic research might be in the future. All research could possibly be valuable some day. It could be a stepping stone to a major discovery down the line. "Indeed, the nature of science, as the committee saw it, was incremental, and did not occur in the big leaps and bounds often portrayed by pro-research organizations" (17). "There are also factors of serendipity, luck, or chance in biomedical inquiry, which defy rational calculation. Given the many uncertainties endemic to the generation of importance scientific knowledge, what constitutes a judicious and ethically responsible use of animals?" (18). To consider if the animal cost is worth the knowledge that will be gained, the IACUC has to prospectively determine what the results of the experiment will be. It is possible that the IACUC makes mistakes using this method and that worthy protocols are denied as well as worthless ones.
Another reason why some say that IACUCs should not assess scientific merit is that the committee members do not have the scientific expertise necessary to adequately judge the protocol. While the Animal Welfare Act amendments and the Guide for the Care and Use of Laboratory Animals (19) state that at least three people need to serve on an IACUC, the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (20) requires at least five. One member must be a D.V.M., one a non-affiliated member, one a scientist who does animal research, and one must be a person that is a non-scientist but may be affiliated with the institution. In addition, the IACUC is permitted to bring in experts to explain to the committee the specifics of new research or a certain procedure. Nevertheless, critics of IACUCs say that this is not enough. There would have to be an expert in every field serving on the IACUC for the critics to be satisfied that a valid scientific merit assessment is being performed and this of course is impossible.
The critics’ answer to this problem is the peer review. Peer reviews can be completed by "the process of preparing, submitting, and reviewing grant proposals…the selection and discussion of papers presented at professional meetings; or the evaluation of papers submitted for publication in scientific journals" (21). A form of peer review can also be done when the researcher is considered for tenure by their university or when colleagues observe their laboratory. Where IACUCs are concerned is the first definition, when peer reviews are completed by the funding agency. At the National Institutes of Health "grants are examined by specific review groups and later by the National Advisory Council" (22). The review groups are separated by specialty and the NIH selects their members. For this reason, there may be no need for the IACUC to assess merit also.
Even so, critics cite problems with the peer review system. Dr. John McArdle, of the National Anti-Vivisection Society, mentions three problems. First, that there is a lack of objectivity in the review process. Celebrated scientists have an easier time getting funds than new scientists who have not "proven" themselves yet. Second, the NIH is unwilling to support alternative research by "the new breed of biomedical researchers who are not prejudiced by the establishment bias towards vivisection and the sanctity of the animal ‘model’ " (23). Third, the peer review system relies on the honesty of the researcher in thoroughly completing the forms. Scientists can get away with not considering the validity of the animal model, not searching for alternatives (refinement, replacement, and/or reduction), and not showing how they plan to minimize stress for the animals (24). "At present, the peer review process is not addressing the issues of concern to the animal welfare movement," (25) says Dr. McArdle.
Unfortunately, some IACUC members also feel that they do not have the expertise to judge the merit of the protocols they discuss. "As a result, some IACUCs avoid any questions that impinge upon research design, such as asking if the numbers of animals used are appropriate, or inquiring what alternatives have been considered by the investigator" (26). This is detrimental to the primary goal of ensuring laboratory animal welfare, and is not as uncommon as one would think. The same thoughts are echoed by Julian McAllister Groves, of the Hong Kong University of Science and Technology, who researched laboratory animal cruelty. He found that
IACUCs can assess scientific merit by comparing the animal costs with the gains in knowledge. According to Andrew N. Rowan, of Tufts University School of Veterinary Medicine, humans are ethically justified for using animals in research only when:
The Issue of Alternatives
Another controversy in the IACUC process is the issue of alternatives as required in the 1985 amendments of the Animal Welfare Act. The amendments require the IACUC to ensure that the principal investigator has considered alternatives in procedures that may cause more than momentary or slight pain or distress to the animals, has searched for alternatives, and listed the methods and sources consulted. Alternatives can be defined as the three R’s, or refinement, reduction, and replacement. Refinement means changing the protocol design to reduce the pain or distress to the animals, replacement means using phylogenetically lower animals or using no animals at all, and reduction mean reducing the total number of animals used in the protocol. Whether refinement, replacement, or reduction methods are used, the experiment’s end results must be as accurate as if no alternative methods were used at all.
Perhaps the greatest controversy lies in the idea of replacement. Some alternatives used to replace animals include cell or tissue cultures, mathematical modeling, and computer simulations. However, as Sheila Silcock of the Royal Society for the Prevention of Cruelty to Animals explains,
Policy 12 of the USDA-APHIS concerns what the IACUC must require of researchers when searching for alternatives to painful procedures.
The fact remains, nevertheless, that there is a wealth of information on animal research and not as much concerning alternatives. It is easy to do what has been proven by time and in some types of research whole organisms are genuinely needed. On the other hand, investigators are sometimes unaware that alternatives exist at all and would not know where to look if they wanted to search for alternatives. To complicate matters, the testing of possible alternatives and then the validation process is proceeding slower than expected and as a result more animals are being used in experiments than probably are necessary.
To test how IACUC members personally feel about the issues of scientific merit and alternatives, three IACUCs were surveyed. The IACUCs chosen represented the three campuses of a university, which included a veterinary school campus, a medical/dental/graduate school campus, and an undergraduate campus, hereon noted as campus #1, campus #2, and campus #3. Campus #1 and 2 are AAALAC accredited, while campus #3 is not. The types of studies and animals varied for each campus. Campus #1 contains biomedical companies and their research projects as well as Campus #1’s own researchers and students are monitored by IACUC #1. Campus #2 has primates as well as rats and mice and IACUC #2 is the most busy and biggest IACUC of the three. IACUC #3 monitors biology and psychology department research and has the least amount of protocols to review.
Both IACUCs #1 and 3 have 9 voting members, and IACUC #2 has 11. IACUC #1 is made up of 4 veterinarians, one non-affiliated member, one non-scientist member, and 3 scientists. Non-voting members on IACUC #1 consist of the Biosafety officer and the Department of Laboratory Animal Medicine (DLAM) staff veterinarian. IACUC #2 is made up of 2 veterinarians, one non-affiliated member, and 8 scientists. Non-voting members on IACUC#2 consist of the Biosafety officer, the Radiation Safety Officer, a veterinarian from Campus #1, and the Animal Care supervisor of DLAM. IACUC #3 chose not to divulge the consistency of their committee but includes at least one non-affiliated member, one non-scientist member, a veterinarian, two scientists, and a non-voting Biosafety officer member. The Biosafety officer is the same person for all three committees.
All of the IACUCs have monthly meetings and were observed to determine group interaction and procedures. IACUC #1 was visited three times, IACUC #2 was visited twice and IACUC #3 was visited once, due to the fact that they do not hold meetings during the summer. All voting members were given a 19 question subjective survey (see Appendix A) along with their monthly packet to fill out that asked about their personal feelings. Most questions used the Likert scale for answering, so the member could check "Strongly Agree", "Agree", "No Opinion", "Disagree" or "Strongly Disagree".
The survey first asked about the background of the person and the group dynamics of the IACUC, followed by sections titled Personal Beliefs, Scientific Merit and Alternatives, and General Impressions. Under the Personal Beliefs section, the member was asked what the most important reason was why we have an obligation to laboratory animals. The Scientific Merit part asked if they believed that scientific merit should be more diligently assessed when higher animals or more pain was involved and asked them to rate their IACUC is assessing scientific merit. The Alternatives part asked the same questions as the Scientific Merit part, with the same wording, and again asked them to rate their IACUC. Next the member was given a list of different types of animals and was asked to rate how important a convincing justification was if the following animals were used in the protocol. Following that was an identical question, only reworded to ask about the number of animals instead of the type of animals. The General Impressions section asked if the member believed that they were effective in promoting the proper care and use of research animals. The member was then given the choice to agree to a short interview and could list their name and phone number if they wished.
In-person or phone interviews were conducted of 13 respondents. The Biosafety Officer was interviewed, as was the chairman, the veterinarian, the non-affiliated member, and a scientific member from each committee. The members were asked about their rationale in answering certain questions and were asked about apparent inconsistencies in their reasoning. In addition, each of the 13 members were asked to describe the merits and limitations of the IACUC process.
Twenty-one of the twenty-seven surveys were returned. Two members served on both IACUC #1 and IACUC #2, and only one survey was recorded for each person. Both surveys were attributed to IACUC #2. The response rate from IACUC #1 was 100%, and all 9 surveys were accounted for, after taking the doubles into account. The response rate from IACUC #2 was 90.9%, with only one person not responding. IACUC #3 had a much lower response rate (44.4%) with only 4 out of 9 members responding. Twenty out of twenty one respondents chose to write their name on the survey, thus agreeing to a short interview.
Descriptive statistics (frequency tables and pie charts) were constructed for the responses to each question. Due to the small number of members surveyed, statistical comparisons between the IACUCs were not possible. Of the respondents, 13 or 61.9% were female and 8 or 38.1% were male (see Appendix B, page 1). Nineteen percent had served on their IACUC for less than one year, 19% had served 1-3 years, 23.8% had served 4-6 years, 4.8% had served 7-9 years, 19% had served 10-12 years, and 9.5% had served 15 or more years (see Appendix B, page 2). Nearly fifty three percent of respondents had served on an IACUC previously, while 47.6% had not (Appendix B, page 3). Of those that had previous experience, none had served less than 4 years on another IACUC. Almost ten percent had served 15 or more years on a previous IACUC (Appendix B, page 4). Ninety five percent agreed or strongly agreed to the statement "I feel a part of the committee" (Appendix B, page 6), while 100% agreed or strongly agreed that their opinion was valued by others on the committee (Appendix B, page 7). Ninety percent said that they did not feel intimidated by the committee (Appendix B, page 8), and 100% agreed that they felt free to speak up at meetings (Appendix B, page 9). When asked if the committee members work well together, 95% agreed or strongly agreed (Appendix B, page 10), and when asked if others on the committee ask for their input, 90% agreed or strongly agreed (Appendix B, page 11). Ninety five percent disagreed or strongly disagreed when asked if other members of the committee were openly hostile to them (Appendix B, page 12).
For the Personal Beliefs section (see Appendix B, pages 13-18), no one listed "because of your own religious beliefs" as their most important reason why we have an obligation to laboratory animals. Likewise, no one listed "because of evolutionary similarities to humans" as their most important reason. Twenty out of twenty one respondents listed "because they can feel pain" as their most important reason, and three listed "because of federal, state or local laws or regulations" as the most important reason. Many respondents misinterpreted this question. Members were asked to rate the above four answers from one to four, with one indicating the most important reason and four indicating the least important reason. Each number was to be used only once and many respondents used numbers twice. As a result, the percentages from this question are not completely accurate. Still, unquestionably more people answered "because they can feel pain" than any other answer. Five percent of respondents said that they ethically disagreed with the rest of the committee on 16-20% of the protocols they review. Five percent said that they disagreed on 11-15% of the protocols they review, 30% disagreed on 6-10%, 45% disagreed on 1-5%, and 15% said less than 1%.
In the Scientific Merit part (see Appendix B, pages 19-22), 15% of members believed that assessing scientific merit is not the role of the IACUC. Fifty percent believed that the most important factor in assessing scientific merit was the opinion of the IACUC members at the committee meeting and 25% said the most important factor was the peer review done by the funding agency. An even 50% believe that the scientific merit of a proposal should be more diligently assessed if the experiment involves primates as compared to rats or mice, and 50% do not agree with that statement. Close to seventy six percent agree or strongly agree that scientific merit should be more diligently assessed if more than momentary or slight pain or distress is caused. When asked to rate their IACUC, 15.8% said that it does an excellent job in assessing scientific merit and 57.9% said that it does a good job. Almost sixteen percent of respondents believe that their IACUC does a moderate job in assessing scientific merit and 10.5% answered that their IACUC does not assess merit.
In the Alternatives part (see Appendix B, pages 23-26), 80% agreed or strongly agreed that alternatives should be discussed for every protocol. When asked if the search for alternatives should be more diligent for protocols that involve primates as compared to rats or mice, 42.9% agreed and 42.9% disagreed. On the other hand, 85.7% agreed or strongly agreed that the search for alternatives should be more diligent for protocols that involve more than momentary or slight pain or distress to the animals. Sixty five percent of respondents rated their IACUC as excellent or good in assessing the availability of alternatives. 30% said that the IACUC does a moderate job and 5% said that they do a poor job.
The respondents then answered how important a convincing justification is for certain types of animals, if they were used in a protocol (see Appendix B, pages 27-35). About sixty three percent answered very important or important when justifying using any invertebrates and 95.2% answered very important or important when justifying using any vertebrates. All of the members answered that it is very important or important to have a convincing justification for rats or mice and 85.7% said the same for fish. Amphibians and reptiles rated 95.2% very important or important, birds and livestock also rated 95.2%, and cats/dogs and primates rated 100%.
The same question was asked again, only this time replacing "type of animal" with "number of animal". Respondents answered how important they believed it was to provide a convincing justification for the number of following animals, if used in a protocol (see Appendix B, pages 36-44). Nearly fifty eight percent of respondents answered that it was very important or important to provide convincing justification for all invertebrates and 100% answered that it was very important or important when justifying the number of all vertebrates used. The members also answered 100% for rats and mice, 85.7% for fish, 90.5% for amphibians/reptiles, 95.2% for birds, and 100% for livestock, cats/dogs, and primates.
When asked if species influences the number of animals approved in a protocol, 70% said strongly agree or agree (see Appendix B, page 45). The last question asked if the respondent believed that they were very effective in promoting the proper care and use of research animals (see Appendix B, page 46) and everyone agreed or strongly agreed.
Question 5 of the survey, which asked about the group dynamics between the committee members, was taken directly from the SCAW (Scientists Center for Animal Welfare) survey for unaffiliated members of IACUCs. Their nationwide survey was sent to 1200 institutions, of which 427 unaffiliated members replied (which gives a response rate of about 36%). From their results, "90% felt a part of the committee; 88% felt the committee valued their opinion; 86% did not feel intimidated by the committee; 94% felt free to speak up; 90% felt that the committee worked well together; 72% indicated the committee asked for their input; and 94% did not feel the committee was openly hostile to them" (38). It is important to note that the author’s survey can not be compared to the SCAW’s IACUC survey. The SCAW survey was a probability sample, while the author’s was a convenience sample. The author’s survey also included a relatively small sample size and members responded voluntarily. The voluntary response has a high degree of bias because the respondents probably felt strongly (either positively or negatively) about the topics of scientific merit and alternatives, which is why they took the time to fill out the survey in the first place. In addition, the majority of the author’s survey asked committee members to answer using a Likert scale. While this method is easy to use for categorization reasons, there is the difficulty in determining the magnitude between answers. The difference between "Strongly Agree" and "Agree" for one respondent may not be the same as another respondent and thus there is no way to determine if all "Strongly Agree" answers are the same. At best, the author’s survey should be seen as a pilot study, to determine broad trends in IACUC members’ beliefs. Only strong trends would be apparent in a project of this size. Even so, further research could be done with a larger sample size to determine if these trends are indeed nationwide.
The first interesting discovery from the survey data was that most IACUC members thought that we had an obligation to animals because they, like us, can feel pain. The respondents included a majority of scientists and the expected answer was that our obligation stems from our evolutionary similarities. The reason scientists are able to do research on animals at all is precisely because of these similarities, yet this was not listed as the most important reason. One reason for this difference could be because of the misinterpretation of the question, as stated before (see page 20). Another reason could be that the public has misinterpreted research scientists, a persona that is partly sustained by animal rights organizations. The public is indoctrinated by the image of the "mad scientist" as shown in movies, books, and the news. Scientists are seen as cold, uncaring, only interested in their results and being published in prestigious journals. This result could be an indication that this stereotype is wrong. A third possible reason why evolutionary similarities was not listed as the most important reason could be that the IACUC members have a different rationale for why we use animals in experiments (evolutionary similarities) than for why we have an obligation to them (because they can feel pain).
One interesting result from the same question, asking about why we have an obligation to laboratory animals, was that 14.3%, or 3 respondents, answered that the most important reason why we have a duty is because of federal, state, or local laws. Nearly forty three percent, or 9 respondents, listed this answer as the second most important reason. This is a very disturbing discovery. It means that the Animal Welfare Act and such laws are not just beneficial, but are in fact vital and indispensable to laboratory animal welfare. This answer implies that without these laws, the care and concern given to animals would be less. In the interviews that were conducted, one committee member, a former research scientist, agreed to this fact. Both the research the member performed in the past and the methods the member used then might not pass a protocol review today, the individual said. It is possible, though, that the respondents thought this to be a distant second to the ability to feel pain. The question’s rating system did not allow that type of distinction to be made.
Fifteen percent of the committee members answered that assessing scientific merit was not a function of the IACUC. This has been seen in other studies, including Julian McAllister Grove’s research.
Another 25% of the surveyed IACUC members believed that assessing scientific merit should be done by a peer review conducted by the funding agency. When interviewed and asked why they believed that assessing scientific merit was not a function of the IACUC, one surveyed member answered that IACUCs should evaluate the justification for killing animals and that this is not the same as assessing scientific merit. The individual also believed that the committee was not knowledgeable enough to judge merit and that this needed to be done by a peer review. In addition, this member said that companies fund around 50% of the proposals this person’s IACUC reviews. As a result, these proposals never get peer reviewed, in comparison to federally funded research. Another interviewee agreed that there is a difference between assessing scientific merit and judging the experiment’s design. This member stated that scientific merit relates to how relevant the research is to the scientific field and experimental design describes how well the protocol will test the hypothesis. IACUCs can look at and judge the experimental design, but assessing scientific merit is best left to the funding agency and a peer review, said this member.
One disturbing result of the survey was the amount of reviewed protocols on which respondents ethically disagree with the rest of the committee. Five percent said they disagreed on 16-20% of the protocols and 5% said the disagreed on 11-15% of the protocols. When asked about their answers in personal interviews, one IACUC member explained that while this individual entered the meetings with one opinion, other members often presented new questions or viewpoints. With this additional information, this individual would often change the initial attitude about a protocol during a meeting. Sometimes this person would still disagree when the vote was taken for the protocol, but would go along with the majority of the members. While sometimes there is dissention among the committee members, of the six meetings observed by the author, votes were nearly always unanimous. Members abstained from voting when the protocol involved research conducted under the member’s own supervision or in their laboratories. If the above percentages are true indications of how often members go along with the majority opinion; perhaps this result is indeed as frightening as it looks. It would mean that members do not always bring up their own doubts or questions about a protocol. As a consequence, research may be approved when it should not be. The unsaid comments could help scientists create better protocols.
Half of the IACUC members agreed that the scientific merit should be more diligently assessed when primates are used as compared to rats or mice and half believed that scientific merit should be assessed the same, regardless of the type of animal involved. When interviewed, one member said that animals are not equal in laboratory situations. This individual stated that phylogenetically higher animals feel more pain and have more thought processes about pain sensations, meaning that they realize that they are in pain. Therefore a primate should have more consideration than a rat or a mouse. This type of belief was echoed by another member, who said that a fruit fly, for example, is not the same as a rat. Another member said that protocols involving primates should be more diligently assessed because primates are so similar to humans. On the other hand, three interviewed members said that all animals should be treated equally and that species shouldn’t matter. The first answers were somewhat unexpected. Over 95% of the surveyed members wrote that the most important reason why we have an obligation to laboratory animals is that they can feel pain. Since all vertebrates by categorical definition share the feature of a dorsal hollow nerve cord, it is fair to say that all vertebrates feel pain and it was not expected that respondents would differentiate between how much pain they thought an animal may feel when discussing different species. It was expected that all vertebrates would be seen as the same because they all feel pain. If indeed members did feel an added responsibility to phylogenetically higher animals, it was expected that it would be because of the similarity in their DNA sequence when compared to humans, not because they felt "more" pain or were more sentient.
The respondents’ reasoning did make sense when compared to the answers for the next question, which asked if the scientific merit should be more diligently assessed if more than momentary or slight pain is involved. Over 76% of the IACUC members said that the scientific merit should in fact be more diligently assessed. Even in this question, though, there is an inconsistency. Four people who answered that pain was the most important reason why we have an obligation to animals also said that the scientific merit of a protocol should not be more diligently assessed if more than momentary or slight pain is involved. Three of these four people were interviewed and asked about this discrepancy. One member said that the scientific merit should be assessed diligently in every protocol, regardless of the amount of pain. Another member responded that the scientific merit should be diligently assessed if pain is involved at all, regardless if it is slight or extreme. The third member stated that scientific merit was not a function of the IACUC and therefore it did not matter to the IACUC if pain is involved. Inconsistencies in the respondents’ thinking and therefore their answers were the most frustrating part of this survey. The same reasoning did not always carry over from question to question. This was seen many times in the results of the survey and interviews.
Over ten percent of the respondents disagreed when asked if alternatives should be discussed for every protocol. When asked about her answer in the personal interview, one respondent was quite adamant. This person stated that asking the principal investigator to search for alternatives was pointless, because none were out there. This member knew it, the IACUC knew it, and the PI knew it, but they still had to go through the hoop because the law said they did. This member believed that the USDA pushes too hard for alternatives and that this reduces their credibility in this person’s eyes. Whole animals are needed for research, this individual said. Reduction of numbers of animals used and refinement of the protocol design are easier to accomplish, this member said, but replacement (using phylogenetically lower animals or using no animals at all) is impossible. Another respondent who also said that alternatives should not be discussed for every protocol was asked their reasoning. This member responded that it depended on the specific protocol and on the types of animals used in the protocol. This was interesting, especially because the 1985 Animal Welfare Act amendments states that one of the duties of the IACUC is to make sure that the principle investigator has considered all alternatives (refinement, replacement, and/or reduction) in procedures that may cause more than momentary or slight pain or distress to the animals. Neither respondent said that the law was necessary or important. In addition, the IACUC is mandated to make sure every principle investigator has searched for alternatives and listed the methods and sources consulted, regardless if the experiment involves pain or not. In effect, this means that alternatives have to be sought for every protocol, every time. The neglect of the importance for alternatives in every protocol could be one of the major flaws in the IACUC system. If alternatives are not investigated for every protocol, animal lives could be wasted needlessly. That is exactly what the 1985 amendments were made to prevent.
The respondents were also asked whether the search for alternatives should be more diligent if primates are used in a protocol as compared to rats or mice. Eleven people (52.4%) agreed or strongly agreed. Yet before when they were asked if the scientific merit of a protocol should more diligently assessed if primates are used, as compared to rats or mice, ten people (47.6%) agreed or strongly agreed. It was expected that these two questions would be answered identically, with the same proportion of people strongly agreeing, agreeing, disagreeing, and strongly disagreeing. In the scientific merit question, the proportion was 5, 5, 8, 2, and in the alternatives question it was 2 people strongly agreeing, 9 people agreeing, 1 that had no opinion, and 9 that disagreed. When asked why they answered differently on the two questions, IACUC members stated that the two issues were separate and could not be compared. The one respondent who answered "no opinion" said that alternatives are already asked about in the protocol form. There is a question asking the justification of the use of animals and the member equates this with assessing the species and number of animals used, in essence the reduction and refinement ideas that are part of alternatives. Another member when interviewed stated that primates are not as available as rats or mice and so alternatives are naturally sought for more diligently in protocols that request them. In theory though, this member still believes that species is irrelevant when talking about scientific merit or alternatives. Another member echoed this thought, saying that different species just experience pain or distress differently, but they all do experience those feelings. There is no "lower animal" according to this respondent. One member when interviewed said that they believed primates should be used only when absolutely necessary. They have a more complex nervous system and there are environment enrichment issues to consider. Others said that primates feel more stress than any other animal because they are a higher animal on the phylogenetic scale and that primates are more dangerous to have because of zoonosis and safety issues.
When asked how well their IACUC assesses alternatives, it was expected for all of the respondents to answer good or excellent. While most did just that, 6 people said their IACUC does a moderate job and 1 person said they do a poor job. When asked why the respondent answered "moderate", one interviewee stated that the problem is ignorance. The IACUC and the PIs are both unaware of what alternatives can be used in certain situations. To rectify this problem, this individual’s IACUC is starting to create a web page with links to various alternatives organizations so it is easier to search for possibilities. Another respondent answered "poor" when asked how well the IACUC assessed alternatives. When asked what the respondent would like to see changed, the answer was that IACUCs are very uninformed. Technology such as computer databases is not used. This person also would like a biostatistician to sit on every IACUC who would have the expertise to know if the number of animals used in a protocol are justified or could be lowered. This member believes that many times IACUCs approve protocols without adequately looking at the possibility of using fewer animals.
One interesting contradiction was in the results to questions 16 and 17, which asked the respondent to indicate how important they felt it was for an investigator to provide a convincing justification for the types and then numbers of following animals in a protocol. The list included any invertebrates, any vertebrates, rats and mice, fish, amphibians/reptiles, birds, livestock, cats/dogs, and primates, and the respondent rated each one from 1 (very important) to 5 (not important at all). For the list that asked about the type of animal, excluding invertebrates and fish, nearly everyone answered very important or important for every animal. For 21 respondents and a list of 9 types of animals, there was a total of 189 answers and all of them were very important or important except for 4 no opinions. Frequently the survey would have a series of 1’s circled or 2’s circled, straight down the page. Likewise, when the question asked about the justification for the number of animals, the same response happened. Everyone answered very important or important, excluding invertebrates and fish, except 3 no opinions. What is especially interesting about these two questions is that they ask the respondent to answer about all vertebrates together as a group, before breaking it down into easier categories. It was expected that this answer in particular would reflect the way the respondent answered other questions, such as those that asked about primates as compared with rats or mice. It was expected that people who answered very important or important for all vertebrates (in this case everyone) would also be the same people that said earlier that species was irrelevant when discussing scientific merit or alternatives. This was not the case. People included all vertebrates together as a group more frequently when talking about a convincing justification than when talking about assessing scientific merit or searching for alternatives. It is possible that this is because justification is included on every protocol form, while a question about scientific merit and alternatives is not. It is also possible that members do not believe that scientific merit is a function of the IACUC or that alternatives are not necessary for every protocol, while justification of the use of an experiment is an obvious duty the IACUC has to perform. This would explain part of the differences.
Question 18 asked whether the respondent believed that their IACUC would be stricter about approving 100 dogs as compared to 100 mice. This was the question that moved the territory from personal beliefs to actual practice, as two interviewed members said. Surprisingly, 70% strongly agreed or agreed that their committee would be stricter about dogs than mice. When asked why, one member stated that in this case it was hard to separate out personal feelings because of owning pet dogs in the past. Others stated practical reasons, such as dogs being more expensive, taking up more room, and needing more time care from the staff. Members also said that it is easier to use large numbers of mice for statistical significance and that mice are less cognizant than dogs. Mice are easier to house and are less expensive, members declared. One member stated that a researcher needs to use the right number of the right species and that the facility has to be able to house and care for that animal to adequately answer the question the researcher is asking. It may be that the researcher can learn what he or she needs from mice or they may have to use dogs. This question also was part of the SCAW IACUC survey, as was question 5. In their results,
During the personal interviews, each of the 13 members were asked what they believed were the merits and limitations of the IACUC process. The members had very different answers for each question. When asked about the merits, one member said that the IACUC process does a good job of ensuring the care of the animals both in research and teaching. The pain an animal might experience is taken into account in the protocol review system, which helps determine if an experiment is justified. Another member also said that the largest merit of the IACUC process is that it reviews painful procedures, and determines if they are absolutely necessary.
One IACUC member stated that the system maintains institutional control over the use of animals so that there is real oversight of the projects being done. This person also stated that the protocol review system keeps experiments as humane as possible. Similarly, two other members expressed that the IACUC system puts the authority of the university behind the research and commits the facility to provide the resources for that research. They prefer this type of regulating rather than an outside body. This way the committee can make the federal rules and regulations applicable to their particular campus.
Two members stated that the best aspect was the committee itself with its broad body of individuals and knowledge. They believed that each person on the committee added to their overall effectiveness. These people believed their committees to be very responsible, as are the principle investigators they deal with. One IACUC member said that the justification question on the protocol review forms makes scientists think about the animals they are using and that the IACUC has power over the scientists to stop painful procedures if necessary. A different person liked knowing the researchers personally and the work they are doing. Another member simply said that the people this individual deals with, both the committee members and the researchers, genuinely care about the animals and this was the best merit of the IACUC process.
When asked to state the largest limitation of the IACUC process, members also had a range of answers. Two members stated that nothing is 100% effective; that neither the committee nor individual people can always be correct in their actions. One member stated that the committee may sometimes be reluctant to criticize the researchers or their friends. One member wanted more education of student workers in the laboratories and another wanted more education of the scientists before they submit protocols to the IACUC. This way a more humane, possibly better project could be designed. One member said that the worst limitation of the IACUC process was not being able to evaluate the scientific merit of proposals. This member believed that assessing scientific merit was not a function of the IACUC.
Four members said that serving on a committee takes a lot of time from people’s lives, both the long meetings and reading all the proposals each month. And no matter how many people sit on the committee, the group will never be an expert in all scientific fields. Three members wished for more expertise and a broader range of people on the committee to get more viewpoints. One person wanted more community members to better represent their concerns. Another said that an ethicist should sit on each committee.
One member expressed displeasure at having regulations come from the federal government saying that in the end they may harm more animals than they help. This individual would like more ability to report back to the rule makers about what the committee really needs and how they feel. This member also would like a government run accreditation association, like AAALAC, for institutions and facilities that are not AAALAC accredited. We need more standardization in this area, that member said. On the other hand, another member of the same committee said that there is too much paperwork and bureaucracy in the IACUC system for this person’s liking.
Another stated concern, saying that the committee has to trust the researchers in effect. The committee can only go by what is in the protocol and that if information is incorrect or misleading, the IACUC may never know. One other member also stated that trusting researchers was a limitation of the IACUC process. The committee has to trust the scientist to comply with the regulations. One member said that the IACUC has no "teeth" and that to be truly effective in stopping animal cruelty, the committee needs more power to penalize non-compliant scientists.
From the members’ own statements, it has been shown that while IACUCs have helped animal welfare, there are still problems that can be worked on to make the system even better. USDA regulations need to state once and for all if scientific merit is a duty of the IACUC. The confusion this has caused can be seen clearly in the survey results. Fifteen percent of respondents believed that assessing scientific merit was not a function of the IACUC and 25% said that scientific merit should be assessed by a peer review conducted by the funding agency. On the other hand, 50% believed that scientific merit should be assessed by the IACUC at committee meetings through the discussion of the members. There is also the added problem of protocols that are not federally funded and therefore never get peer reviewed beyond the IACUC’s evaluation. It needs to be clear for all committee members what exactly their duties are and if scientific merit falls under them or not.
In addition, the concept and worthiness of alternatives needs to be taught to committee members and principal investigators. This was seen by one member’s comments that searching for alternatives is pointless because none are out there. This member knew it, the IACUC knew it, and the PI knew it, but they still had to go through the hoop because the law said they did. And yet six other members rated their committee moderate in assessing alternatives and one member said they do a poor job. It seems that part of the problem lies in the lack of scientifically validated methods. Alternatives have taken longer to be discovered, tested, and validated than has been expected. But this does not mean that there are not any options for the researcher when he formulates a possible project. Part of the problem also lies in the lack of knowledge or willingness on the scientist’s part to search for a more humane way of conducting the experiment. The 1985 amendments mandated the principal investigators to search for alternatives and list the databases searched. It seems that this step of the IACUC process should be improved to abide by our national laws.
IACUC members also need to understand that while they may be disagreeing in the meetings, inside they are more alike than they realize. This was shown by the amount of members that ethically disagree with the majority opinion about reviewed proposals. Members do not always voice their concerns and most likely just go along with everyone else. Yet in the questions that asked about how important a convincing justification was for the following types of animals and number of animals, everyone overwhelmingly voted the same. Survey after survey had a straight row of all 1’s (very important) or all 2’s (important), straight down the page. This indicates that the members believe the phylogenetic status of a species should not influence the degree of justification. Yet in the next question, which asked about how strict their committee is in approving 100 dogs to 100 mice, the answers changed. When people answered as they personally believed, everyone was in agreement. But when they changed to what actually happens in committee (question 18), 70% agreed or strongly agreed that their committee would be stricter about the dogs. If only the committee could act together the same way that everyone feels separately (e.g. to be as careful about 100 mice as compared to 100 dogs), then the welfare of some laboratory animals would undoubtedly increase dramatically.
This project assessed how twenty-one IACUC members believed concerning scientific merit, alternatives, and their own effectiveness. The next step in this research would be to test a larger sample size and determine if the same types of answers occur. If the conclusions from this project are indeed validated by the larger sample, then this would indicate possible areas of improvement in the IACUC system, as well as its significant merits. Those results could possibly dispel inaccurate beliefs about the way IACUCs function, the convictions held by its members, and their overall effectiveness in protecting laboratory animals.
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