Informed Consent

by SSS
(Kansas)

Original Text: Informed Consent


Informed Consent
The following are the issues identified in the informed consent form which requires a review of an IRB member are as follows:
Initially, the protocol title section did not specify the site or the information of the institution responsible to conduct the trial. The first element of the consent form did not explain the main purpose of the research study such as the effects of WD100 and the action of it in combination with aspirin related to the study.
The purpose of the study as to why the research being conducted has overly represented a statement such as “ less side effects than the current standard” which needs to be removed . According to 21 CFR part 50.20 the consent form should not unduly influence the participation of the subjects or any possible coercion included statements which explains certainty of benefits or unproven claims of effectiveness which inclines to influence the participation of the subjects in the study.
When not participating in the research study, the other available options such as standard treatment or other alternative treatments which are advantageous to the subject have to be disclosed in a more detailed manner. The unforeseeable risks, possible benefits if any are to be listed and reasonably explained in a lay language understandable to the subject.
There may be some risk of loss of confidentiality to the subjects who participate in the study. Therefore, to minimize these types of risks the research team must provide information to the subjects about the protection of privacy records. The requirements of the Health Insurance Portability Act of 1996 needs to be incorporated in the consent form or a certificate of confidentiality must be included in the form to reduce the risks. The age or eligibility criteria of the participants is needed as to include the documentation of assent in the consent form.
For questions by participants about the rights of the research the contact information of the institutions IRB or the list of phone numbers of office individuals not involved in the research study and the emergency contact information for health care or any possible injuries must be included in the consent form along with the investigators information.
The specific costs and the payment amount numbers should not be included in the research study as it may lead to financial bill risks. The financial institutions and the sponsor contact information should ne included to assist in any problems associated with costs.
The subjects should have the right to withdraw from the research study in addition to the termination by the researchers.. In the documentation of consent the signature of the participant must consider the voluntary participation and withdrawal of the participants from the study along with the other requirements.

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Revised Text:

Informed Consent

The following are the issues identified in the informed consent form which require a review by an IRB member:

Initially, the protocol title section did not specify the site or information on the institution responsible for conducting the trial.

The first element on the consent form did not explain the main purpose of the research study, such as the effects of WD100 and the action of it in combination with aspirin related to the study.

The purpose of the study as to why the research being conducted has overly represented a statement such as “less side effects than the current standard”, which needs to be removed.

According to 21 CFR part 50.20, the consent form should not unduly influence the participation of the subjects or any possible coercion included in statements which explain certainty of benefits or unproven claims of effectiveness, which inclines to influence the participation of the subjects in the study.

When not participating in the research study, the other available options, such as standard treatment or other alternative treatments which are advantageous to the subject, have to be disclosed in a more detailed manner. The unforeseeable risks, possible benefits (if any) are to be listed and reasonably explained in a lay language understandable to the subject.

There may be some risk of loss of confidentiality to the subjects who participate in the study. Therefore, to minimize these types of risks the research team must provide information to the subjects about protection of records privacy.

The requirements of the Health Insurance Portability Act of 1996 need to be incorporated into the consent form, or a certificate of confidentiality must be included in the form, to reduce the risks.

The age or eligibility criteria of the participants needs to be included in the documentation of assent on the consent form.

For questions by participants about the rights of the researchers, the contact information for the institutions IRB or the list of phone numbers of office individuals not involved in the research study, and the emergency contact information for health care or any possible injuries must be included in the consent form along with the investigators' information.

The specific costs and the payment amounts should not be included in the research study, as it may lead to financial bill risks. The financial institutions and the sponsor's contact information should be included to assist in any problems associated with costs.

The subjects should have the right to withdraw from the research study, in addition to the termination by the researchers. In the documentation of consent, the signature of the participant must allow both the voluntary participation and withdrawal of the participants from the study along with the other requirements.

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