Drug Study Institute
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For Patients

Standard Operating Procedure
Informed Consent Form

21 CFR
Subpart B/ 50.20-50.27
ICH 4.8-4.8.15

Purpose:
To ensure that written Informed Consent is obtained from each patient in accordance with Regulatory requirements, GCP/ICH, and the Declaration of Helsinki.

Scope:
This SOP applies to all Informed Consents obtained at this clinical site.

Responsibility:
The Principal Investigator Study Coordinator and/or other designated site staff will obtain written Informed Consent from all Research patients.

Procedures:
  • The patient or legally authorized representative will be given ample time to completely read the Informed Consent Form and ask study related questions.
  • It is established by the Principal Investigator or his designee that the patient verbalizes understanding of the study and study related procedures.
  • Both the persons obtaining consent should personally sign and date the consent form.
  • Study specific procedures can begin at this point.
  • The PI educates the patient about research, and co-signs the consent form.
  • The patient will then be provided with a copy of his/ her consent form.
* Note: Written Informed Consent must be given prior to any study related procedures being performed.

Appendices:
  • Outpatient Informed Consent Procedure.
Review & Revisions:
The Clinical Research Director and Project Manager will review this SOP annually, with advice being sought from the Medical Advisor. This SOP may be reviewed more frequently if the site staff reports that it does not reflect current operating procedures.

Appendix One: Informed Consent Form

We have two types of patients, who may become volunteers for a clinical trial: the ones from our practice and the ones who come as a result of advertisement. Although the final procedure (Informed Consent Form) is performed in the same way, there are some differences in the way they get to know about the studies we do.
  • For the patients from our own practice, the study coordinator contacts them by phone and invites them to participate in the study. The study coordinator explains the study and answers the questions that the patient may have. If the patient decides to participate, he/she will be scheduled for a study screen visit in the morning. During this visit the patient will be consented according to our SOPs. If the patient expresses interest, but has some doubts, he/she will be scheduled for an interview with Dr. Saponaro. There are other times where the patient is invited to participate in a study during a regular office visit. If the patient feels comfortable enough with the explanation that the study coordinator gives him/her, the study coordinator obtains inform consent according to our SOPs. On the other hand if the patient expresses some doubts, Dr. Saponaro will talk to them and answer all the questions. If the patient agrees to participate, Dr. Saponaro, himself, will obtain inform consent according to our SOPs. Study procedures will begin after that.
  • For study volunteers who come to us as a result of an advertisement campaign, they are always pre-screened over the phone by the Study Coordinator or Research Assistant. If the patient is willing to participate in the study, he/she will be scheduled for the first visit. A detailed medical history will be obtained to verify applicable inclusion and exclusion criteria. If the patient is still eligible, ICF will be obtained according to our SOPs. If there is any doubt about his/her past medical history the doctor will request past medical records and the consent form will be obtained at the next visit after verification of the applicable inclusion and exclusion criteria. On the other hand if the patient expresses some doubts, he/she will be scheduled for an interview with Dr. Saponaro.
  • During the interview with Dr. Saponaro (PI), he will explain the study in detail, review the consent form with them, and answer all the possible questions. If the patient agrees to participate and study procedures can be completed at that visit, Dr. Saponaro will obtain inform consent according to our SOPs. Otherwise, he/she will be scheduled for the first visit of the study in the morning. In the interim, Dr. Saponaro will request and evaluate his/her medical records (applicable for new patients only). At this point the patient does not sign the consent form, but will do it during visit 1 before any study procedures. Dr. Saponaro believes that it is important for them to take this information back home and discuss with their family members at their convenience.
Appendix Two: The Informed Consent Process
  1. The CRC introduces the prospective research subject volunteer to the study; goes over the details and determines if there’s interest.
  2. If so, read the ICF (Informed Consent Form) with the subject and explain the details in such a way that they understand what it would be like to be a participant in this experimental drug study.
  3. The CRC witnesses the subject sign and date the ICF as part of the IC (Informed Consent) process and signs as the person obtaining IC.
  4. Then, the subject hears another summary of the trial along with describing the risks, benefits and alternative procedures form the PI, Dr. Saponaro. He double checks that the subjects thoroughly understand the ins and outs of the trial and that IC is adequate and understood. He then signs the ICF also signifying that he has repeated the IC process and codifies first hand knowledge that the subject understands the issues.
  5. After the patient leaves the PI, Dr. Saponaro starts to fill out his paperwork. This used to include dictating a standard paragraph describing the details of IC. In the name of efficiency, we have begun referencing that we are utilizing our standard IC process in the plan. This will help us to be more cost effective.
The IC summary states:
I told him/her about the study being sponsored by the pharmaceutical company and he/she has decided to get involved. I provided the research subject volunteer with informed consent. We discussed the purposes of this voluntary investigational clinical research trial, the expected duration, the procedures to be followed, and exactly which procedures are considered to be experimental. I provided him/her with an opportunity to thoroughly review the ICF document, and to clarify any questions and/or concerns. I explained the risks of the procedures and the tests, the potential benefits to both him/her and to others. I described the alternative treatment options that are currently available, and the ability to withdraw himself/herself from the study at any time for any reason without prejudice. We discussed the confidentiality of his/her medical records and how the following companies will have access to his/her medical records for research purposes only including: the sponsor; the central IRB; the central Laboratory and the FDA. I pointed out the telephone number of the contact person at the Central IRB in case of ethical research questions that might arise during the experimental drug study. I explain to the subject that if they become unhappy with something I do and they don't feel comfortable complaining to me, that this company is independent and will represent their wishes and well being with an eye towards protecting their rights and safety.

Then the subject is given an ample period of time to think things over. If they have further questions or concerns, the CRC sends them to the PI prior to the subject signing the ICF. In all cases before written consent is obtained the subjects questions and concerns are addressed adequately and they feel comfortable about getting involved with this experimental drug study.

At this point, I re-review the Inclusion/Exclusion Criteria to double check that the subject meets eligibility criteria. Then, study related procedures are officially allowed to begin including the withdrawal or washing out of medications. I document in my note how I followed the steps listed above in appendix two regarding the informed consent process and that the SOPs have been observed.

Sincerely:

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCRI, CCRC, CCRP
Board Certified Internist, JPMC
Principal Investigator, DSI
Diplomat American Board of Internal Medicine
Fellow American College of Physicians
Certified Physician Investigator by the AAPP
Certified Clinical Investigator by the DIA
Certified Clinical Research Investigator by the ACRP
Certified Clinical Research Coordinator by the ACRP
Certified Clinical Research Professional by SoCRA
Member: The American College of Preventive Medicine