Regulatory Science Symposium: Clinical Trial Startup Session 4: Administering Informed Consents: Special Populations/Panel Discussion (2016)

1. History of Informed Consents
   1. Long history development (20-30 documents to now 70 pages of informed consent)
2. Belmont Report
   1. Respect for Persons (autonomy)
   2. Beneficence
   3. Distributive Justice  
3. Common Rule (a set series of parameters)
4. IRB
   1. 5 members, one from scientific field, one from non-scientific field, and one who is not affiliated with institution
5. Informed Consent constitutes of the following…
   1. This study involves what research
   2. Risks and discomforts
   3. Disclosure of appropriate alternative procedures
   4. Confidentiality of records will be maintained
   5. Compensation- if accidents happen, “no cost” liability
   6. Who to contact
   7. Participation is voluntary; refusal will not affect treatment; free to discontinue any time
6. Cultural Considerations
   1. Defn: Culture influences how we view world around us via. Language, beliefs, and traditions
   2. Linguistic Cues - symbols ie. hand symbols (normal to one culture yet can be vulgar to another)
   3. Shared Decision Making (culture sets parameters for decision making)
7. Informed Consent

   
   

   1. Pregnant woman’s consent may require both approval from woman and husband
   2. Disparities between races, sexes, and ages of those included in a study (inequality/misrepresentation)
8. Cognitive ability is measured by competence and voluntariness
9. Prisoners - have different rights from those who are not
10. Emergency Care is not clinical care
    1. Must have legally authorized individual there when patient ability to provide consent is compromised
11. Terminally Ill Patients - Expanded Availability and Therapeutic Intent
12. Elderly/Aged Persons - No age that will make anyone ineligible, no specific regulations
13. Minorities - include more than racial minorities also sexual identity/genders etc. (IRB will prompt question why a study targets homogenous population)
14. Students, Employees, and Normal Volunteers –
1. Students- Cannot guarantee confidentiality or prior agreements/incentives ie. extra credit
2. Employees- Coercion/Incentives issue, Confidentiality issue
1. Normal Volunteers- Do not harm, maximize possible benefits and minimize possible harms
15. Clinical Trials
1. Using photos to communicate with children
2. Interpreters with those who may not speak English
16. What Can Go Wrong?!
    1. Lack of signatures
    2. Forged signatures
    3. Patient who may not understand completely the entire research

Accompanying text created by Annie Ly | Undergraduate Research Associate and Provost's First Generation Research Fellow | lyannie@usc.edu