Informed Consent Flashcards
What are the essential components of an informed consent form?
1) Purpose of the study
2) Known and foreseeable risks
3) Compensation and contact for injury
4) Participation is voluntary and you can withdraw anytime
5) Benefits to the subject
6) Alternative treatment, therapy, etc. to the investigational product
7) Confidentiality / HIPPA and how subjects data will be maintained
8) Contact info for the investigator
What are the additional components of an informed consent form?
1) Number of patients
2) Unforeseeable risks to subject
3) Additional costs to subject
4) You can be withdrawn from study by Investigator if they choose
5) What happens when the subject withdraws
6) Statement of new findings will be provided to subject that may affect their decision to stay in study
A sponsor is arguing informed consent to be waived for a study they wish to perform (non-military). What must the investigator and physician certify to the IRB about the study to justify the waiver? (Hint: emergency use)
1) The subject is confronted by a life-threatening condition which necessitates the use of the test article.
2) Informed consent cannot be obtained from the subject because of an inability to communicate
3) Time is not sufficient to get consent from a LAR
4) There is no alternative method approved or generally recognized that can be used to save the subject
True or False: The president may waive prior informed consent for non-military members partaking in a study.
False. The president can waive prior consent for armed forces members in connection with a military operation.
Certain types of investigational in vitro diagnostic devices can be deemed feasible for an informed consent waiver. What do these devices typically diagnose and when can consent be waived?
These devices typically identify chemical, biological, radiological or nuclear agents. Consent can be waived if:
1) The subject is confronted with a life-threatening situation necessitating the use of the diagnostic (or it suggests a terrorism/public health event)
2) Time not sufficient to consent subject or LAR without risking subject’s life
3) No alternative available for diagnosing the same target
What is required for exception to informed consent for emergency research?
1) Subjects are in a life-threatening situation with no satisfactory alternatives
2) Obtained informed consent is not feasible (Subject/LAR have no time/unable to give consent)
3) Research holds out prospect of direct benefit to
subject
4) Research couldn’t be carried out without the waiver
5) Efforts will be made within therapeutic window to contact LAR for consent (If can’t, contact family member)
6) IRB approves informed consent procedures/documents
7) Consultation provided with subjects and communities from which subjects come
8) Public disclosure of information of trial being conducted and information upon completion
9) Establishment of an independent data monitoring committee
What is required for an IRB to waive informed consent?
- Research involves no more than minimal risk
- Waiver will not adversely affect the rights and welfare of subjects
- Research could not be carried out without the waiver
- Subjects will be provided with additional pertinent information after participation
What is a short form written consent document?
The informed consent is presented orally to subject or LAR. There must be a witness present for this. IRB approves a written summary of what should be said which is signed by the witness and consentor. The short form is signed by the witness and the subject. The subject receives a copy of both the short form and summary.
True or false: IRB approval is required for any update to the informed consent form.
True.
The ____ can waive prior consent requirement for military personnel administration of IND if:
President.
-It’s not feasible to get consent
-Consent is contrary to the best interests of the military
-Safety/effectiveness of IND is acceptable
-Without the IND, military operation at substantial risk and could result in death or serious/life-threatening injuries
-No available alternatives
-IRB approved protocol
If refusing the IND could seriously affect the safety/health of military members/mission
Under what conditions can an IRB waive assent for a clinical trial?
- No more than minimal risk
- Waiving assent won’t adversely affect the rights/welfare of subjects
- Trial can’t be performed without a waiver
- Subjects provided with any additional pertinent info after participation
True or False. Both parents need to provide consent for a childs assent?
True. Not required if one parent is deceased, unknown, incompetent, not available or 1 parent has custody.
If an investigator uses the test article in an emergency use situation, what must happen afterwards and in what time frame?
The investigator must have an independent physician review the reason for use within 5 working days of use. This documentation must be submitted to IRB within 5 working days of use.
If a trial that uses children is greater than minimal risk and presents the prospect of direct benefit, what characteristics of the trial are required for IRB approval?
- Risk is justified by the benefits
- Benefit is is similar to those presented by available alternatives
- Adequate provisions made for getting assent/consent
What is the different between assent and consent?
Assent - approval from child.
Consent - approval from adult or parent/guardian
