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We have learned that this study has demonstrated the need for consents that covers specific items in order to protect the participants of a study. Human rights also needs to be addressed and should include the following: self-determination, privacy, anonymity and confidentiality, fair treatment, and protection from discomfort and harm. As research continues to evolve, human rights and ethical considerations must be acknowledge and protected.

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The Stanford Prison Experiment was not ethical. Participants of the study were not fully informed of what the experiment encompassed. This includes being arrested at home, harm to the participants, along with stress and humiliation.

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According to Ann, the following is the laundry list of violations to the Code of Ethics and General Principles that this experiment involved:

General Principle's not adhered to by this study:

•       Principle A: Beneficence and Nonmaleficence - to do good and avoid harm

•       Principle B: Fidelity and Responsibility - to show high standards of competence in their work

•       Principle C: Integrity - honest communication and truth telling

•       Principle D: Justice

•       Principle E: Respect for People's Rights and Dignity

Code Violations:

•       Standard 2.01a, 2.01c, Boundaries of Competence

•       Standard 3.04, Avoiding Harm

•       Standard 3.05, Multiple Roles (Phillip Zimbardo functioning in two roles: in charge of experiment and participating as the warden)

•       Standard 3.08, Exploitive Relationships

•       Standard 3.06, Conflict of Interest (Phillip Zimbardo functioning in two roles: in charge of experiment and participating as the warden)

•       Standard 8.02a (1,2,3,4), Informed Consent to Research

•       Standard 8:04, Client/Patient, Student, and Subordinate Research Participants

•       Standard 8.07a & 8.07b, Deception in Research

Standard 8.08a, b, & c, Debriefing

Reference:
Ann, S. (2016). The Stanford Prison Experiment - Ethical or Not? Retrieved September 11, 2016, from http://sheilaann33.blogspot.com/2012/09/httpwww.html

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Stanford Prison Experiment - AP Psych 3A

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Realistically, do you think that this experiment can be repeated and follow all necessary requirements in this era given the current ethical restrictions and guidelines of the APA?

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Should it have ever been
approved? Why or Why not? 

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Should it have ever been
approved? Why or Why not? 

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I feel like this is a hard question to answer. The main problem with this study was that there was a lack of detail and information in the consent. If the originally consent had all four elements in which the prisoners knew exactly what the study involved, would the Stanford Prison Experiment even be an issue? The Stanford Prison Experiment was reviewed and approved by a committee, although, there are needs for stricter review panels due to the outcomes of this experiment. With stricter review panels, this can identify if there are ethical concerns and if so, address them prior to the start of the research. That being said, the consent did lack important information which ultimately led to harm for the participants. With this, the experiment should have not been approved. After the study was complete, participants involved had to have extensive follow-up to ensure there was no emotional trauma from the experiment itself.

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In regards to the Stanford Prison Experiment, disclosure of essential information is the first thing that is missing. There was no information in the consent regarding a description of the purpose or the duration of the study. Also, there was lack of a description regarding procedures that the participants in the study needed to follow and identification of procedures that might have been experimental. Participants were not informed regarding probable risks or discomforts that might arise from the study such as; physical, emotional, social or economic. There was no information regarding the benefits of the study in the consent that was signed by each participant. The participants were not given an explanation regarding any compensation or medical treatments if an injury were to occur. If there were any type of medical injury, treatment would have to be described by the type and extent of treatments. There was no information in the consent regarding who to contact for answers to questions about the research during the conduction of the study and whom to contact in the event of a research related problem, such as an injury.

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 Review the informed consent for this study. Does it contain all essential elements of an informed consent?

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 Review the informed consent for this study. Does it contain all essential elements of an informed consent?

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The Stanford Prison Experiment does not include all the elements of a informed consent, which is one of the reasons is was so unethical. Essential elements for an informed consent must include: disclosure of essential information, comprehension, competence, and voluntarism.

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On this page you will find information on:

To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with:

adequate information to allow for an informed decision about participation in the clinical investigation.

facilitating the potential participant's understanding of the information.

an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.

obtaining the potential participant's voluntary agreement to participate.

continuing to provide information as the clinical investigation progresses or as the subject or situation requires.

To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. ( 21 CFR 50.20.) FDA considers this to include allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)

What is Informed Consent?

As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find. Clinical trials are used to answer questions such as:

Are new medical products safe enough to outweigh the risks related to the underlying condition?,

How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),

How effective is the medical product at relieving symptoms, treating or curing a condition.

The main purpose of clinical trials is to "study" new medical products in people. It is important for people who are considering participation in a clinical trial to understand their role, as a "subject of research" and not as a patient.

While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:

may not benefit from the clinical trial,

may be exposed to unknown risks,

are entering into a study that may be very different from the standard medical practices that they currently know

To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:

what will be done to them,

how the protocol (plan of research) works,

what risks or discomforts they may experience,

participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.

A central part of the informed consent process is the informed consent document. The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document, but does require certain basic elements of consent be included.

Before enrolling in a clinical trial, the following information must be given to each potential research subject:

A statement explaining that the study involves research.

An explanation of the purposes of the research.

The expected length of time for participation.

A description of all the procedures that will be completed during enrollment on the clinical trial.

Information about all experimental procedures the will be completed during the clinical trial.

A description of any predictable risks.

Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the research.

Any possible benefits that may be expected from the research.

Information about any alternative procedures or treatment (if any) that might benefit the research subject.

A statement describing:

the confidentiality of information collected during the clinical trial,

how records that identify the subject will be kept

the possibility that the FDA may inspect the records.

For research involving more than minimal risk information including

an explanation as to whether any compensation or medical treatments are available if injury occurs,

what they consist of, or

where more information may be found.

questions about the research,

research subjects' rights,

injury related to the clinical trial.

Research subject participation is voluntary,

Research subjects have the right to refuse treatment and will not losing any benefits for which they are entitled,

Research subjects may choose to stop participation in the clinical trial at any time without losing benefits for which they are entitled.

Contact information will be provided for answers to :

A statement that:

When Appropriate, one or more of the following elements of information must also be provided in the informed consent document:

A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).

Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).

Added costs to the research subject that may result from participating in the trial.

The consequence of leaving a trial before it is completed (e.g. if the research and procedures require a slow and organized end of participation).

A statement that important findings discovered during the clinical trial will be provided to the research subject.

The approximate number of research subjects that will be enrolled in the study.

A potential research subject must have an opportunity to:

Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, friend or advocate.

An investigator should only get consent from a potential research subject if:

The information must be in language that is understandable to the research subject.

Informed consent may not include language that:

the research subject is made to ignore or appear to ignore any of the research subject's legal rights,

releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.

Participating in clinical trials is voluntary. You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully. Ask questions about any information you don't understand or find confusing.

Draft Guidance: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors

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On this page you will find information on: To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process.