Case Study 2: Beneficence and Justice

Answer a: Continue the study as designed.

While this is certainly an option, continuing the study may not be in the best interest of the participants. The established high rate of male condom use and the uncertain post-study availability of the female condom make this a poor choice.

Answer b: Terminate the study.

This is the best answer. The study may have scientific merit, but this is clearly not the best participant population.

Answer c: Suspend the study. Seek assurance that female condoms will be made reasonably available if proved successful.

This is not the best answer. However, it would address the issue of justice. Studying female condoms in a population that will not have access to the product following the study is not a fair distribution of the risks and benefits of the research.

Case Study 3: Informed Consent

Answer a: Recommend that the study be terminated.

This is a drastic option, unless it is clear that the consent process was meaningless and could not be corrected.

Answer b: Retrain the site investigator and the study staff in the informed consent process.

This is the best answer. If documented informed consent is available at the site, and the site is able to recruit and follow the necessary number of study participants, retraining is probably the best option. If the study is to continue, the sponsor and site must be in agreement on how the study procedures and processes are to be conducted.

Answer c: Rely on the site investigator’s knowledge of the study population.

This answer, while not necessarily the best answer, identifies a choice that happens at many investigative sites. While it may be true that the investigator knows the study population, the approved informed consent form and study procedures were agreed upon prior to initiating the study. To change study procedures that are not urgently needed for the safety of the participants (without notifying the sponsor) could affect the entire study.
Look for a “better” answer.

Answer d: No action. The site investigator has signed consent forms for each participant.

This is not the best answer. Although there is documentation of informed consent in the form of signed documents, this is meaningless and shows a lack of respect for persons. Look for a “better” answer.

Case Study 4: Responsibility in Research

Question 1: What guidelines would you give observers for safeguarding client welfare? Is there a point at which intervention is warranted?

The welfare and safety of the client comes first. It should be made clear to study staff from the beginning of their training that they might need to intervene on behalf of a client. Fortunately, such problems will likely be rare, but possible scenarios should be discussed and staff told when and how to react.

Question 2: How should neutral researchers react when they observe mistakes, lapses and misinformation in the context of a study to assess quality of care?

It is the job of the researchers to observe and note such minor mistakes, which are likely to be very common. It is not possible, nor perhaps even desirable, to intervene in every case. “Doing so would prove so intrusive and detrimental to rapport with clinic staff as to ruin the possibility of gathering useful information for program and policy decision-making and thus would greatly lessen the ability to make needed improvements. It is important to discuss fully with relevant local authorities the potential ethical issues that may arise during the implementation of client-provider observations, and the type of behavior by providers that may require some form of intervention by the study observers.” [Miller R, et al. The Situation Analysis Approach to Assessing Family Planning and Reproductive Health Services: A Handbook. New York: The Population Council, 1997. pp.19-20]

Question 3: Quality of care assessments and performance evaluations are often exempted from the informed consent standards applied to clinical research. What, if any, informed consent procedures should be required of clients? Of providers?

It is essential to provide informed consent to all study participants—providers and clients—even if it is not in writing. “The principle of respect for persons establishes the right of both clients and providers to hear about the nature of the study, about any risks and benefits associated with their participation, and that they can withdraw from the study at any time. Clients must also be informed that they can receive all the services of the health facility whether or not they participate in the study. These issues should be presented in language that is easily understood, and the subject must freely and voluntarily agree to her inclusion in the study. True informed consent also requires that the subject is given the opportunity to ask questions about the study before consenting. It is also important to note that consent should only be obtained when the client is not under duress, in pain, medicated with consciousness-altering drugs, or in need of acute care.” [Ibid. p.18.]

Case Study 5: Ethics Committee Considerations

Answer a: Stop the research to protect the women.

While this is certainly an option, it is an extreme one. It may be worthwhile to look for a way to continue the study and reduce the possibility of violence.

Answer b: Amend the informed consent form and obtain new consent from all participants.

This is a better answer. Research often involves some amount of risk, and participants should be aware of the risk before enrolling in a trial. Knowing of this particular risk, some women may decide to not participate.

Answer c: Continue the study, but orally inform participants of the risks.

A good answer, but others may be better. Implementing this change would take less time than repeating the written consent process, but the quality of the information may be degraded. 

Answer d: Continue the study as designed.

This is not the best answer. Ignoring the problem altogether is not in the best interest of the participant. Look at the other answers or a combination of the other answers to address the situation.

Answer e: Add messages about domestic violence to the intervention and report the violent episodes to management at the plantations.

This is not the best answer. Exposing participants and their partners to retaliation by the plantation managers may cause more violent outbursts. However, it may be advisable to amend the intervention to include information about domestic violence.

Case Study 6: Negative Media Coverage

Question 1: Would you continue your research study?

a. This was the position of some but not all researchers and policy-makers; those rejecting the call to stop research noted that the product had been used for years, had not been shown unsafe in earlier studies, and that the reported study results are preliminary (i.e., could change). 

b. This was the position of some but not all researchers; one large study evaluating the product for less deadly infections continued to completion a couple of months after the report, with no harmful effects on participants. A clinical trial with a longer time to completion may have been difficult to complete in light of the negative media coverage.

c. A viable option scientifically, but difficult in light of negative media coverage.

Question 2: Should women who were past or current participants in studies of this product be informed of the data announced at the international conference?

a. This was the decision of one group who had completed a trial; however, others felt that it was more harmful because it could create unnecessary fear about using a marketed product based on incomplete analysis of incomplete data.

b. This was the stance of those who felt it is irresponsible to prematurely release study results, especially when evidence from other studies have not shown the product to be unsafe. How would you adequately explain results released in a 10-minute presentation that did not provide information for judging the quality of the data, had not been peer reviewed, and was based on incomplete data?  

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Case Study 7: Research with Minors

Question 1: Given the country’s conservative culture, should parental permission be sought for this study?

a. While it is important to discuss your research with school officials and make sure they are comfortable with what you are doing, the final decision to waive parental permission must be made by the ethics committee. They may, however, write letters of support to the ethics committee in which they document their policies.

b. Children have to be the age of consent in the study country. This is not a reason to waive parental consent.

c. The local culture must be considered when a research study is being designed. Information gained during pre-study collaboration should be shared with the ethics committee.

d. This answer is not necessarily wrong; however, it should not be the sole determining factor. It is possible that students’ answers will be influenced if they think that their parents could possibly have access to the responses. Working closely with school officials and the ethics committees will help guide this process.

Question 2: If it is determined that parental permission is not required, what mechanisms could be incorporated to ensure that students participate voluntarily and to protect them from peer pressure, discrimination by teachers, etc?

a. This is an excellent idea. It would be good to implement this in conjunction with answers 2b and 2c as well.

b. This is a good idea. It would be most useful if parents received a short training session from the researchers on issues related to confidentiality and protection of participants’ rights. It would also be good in combination with answers 2a and 2c.

c. This is a good idea as far as it goes, but there is a question of whether the parents actually get the information from the students. It is a good adjunct to answers 2a and 2b.

d. This is the best answer. The more community education and feedback in any research, especially with adolescent research, the better.

Case Study 8: Conflict of Interest

Question 1: Do you continue to include this health center in your study?

This is certainly a problematic situation for which there is no perfect answer. The public’s perception of this particular clinic—that it provides the best care—must be weighed here. If your research is to benefit the community, then it may be important to use this clinic. Also consider that not using this clinic may send the wrong signal to the community, thereby damaging the clinic’s excellent standing in the community.

Question 2: Are there effective alternatives to providing condoms to infected participants?

Finding acceptable alternatives may eliminate any lingering doubts about the study’s ethical underpinnings. What steps has the clinic taken in the past to prevent infection of partners? Will you be allowed to mention condoms as part of the study even though you cannot provide them? An examination of these questions may lead to an acceptable alternative, and answers will vary.

Question 3: The trial does not depend upon the provision of condoms and could still be conducted. Do you have a moral obligation to the participants?

Answers to this question will vary. While it is true that the research could be conducted without condoms, the researcher’s obligation to participants cannot be dismissed. While the research would not necessarily expose participants to additional harm, the exposure to any unnecessary risk as a part of research may not be acceptable. Is withholding condoms an unnecessary risk?