2. Training for Investigators and Research Staff
Typical Informed Consent Mistakes and How to Address Them (Part I Activity)
Training for Investigators and Research Staff

3. First Let’s Talk About Specific Situations

4. Scenario #1
I am a research coordinator for the Oncology department. Recently, Dr. Smith reached out to Amgen in regards to a study that they had announced on their website. Amgen has already sent a Clinical Research Associate (CRA) from Quintiles (CRO) to our site for a pre-qualification visit which showed that we are qualified to run the study at our site. I am currently working on the initial IRB submission for this study and have been told that we will be recruiting both English and Non-English speakers onto the study. What steps do I need to take to ensure that I am submitting all of the study documents appropriately?

5. Scenario #1 Response
According to our Human Research Protection Program Manual “If the investigator or IRB determines that the research project is likely to involve the participation of subjects whose primary language is not English, a translated consent document is required. The foreign language version of a consent document should be a certified translation of the IRB approved English version. It is, therefore, submitted after the IRB has approved the English version along with a certificate verifying the translation was provided by a certified translation service. Certified translations may be acknowledged and stamped with approval by IRB administrative staff.
In limited cases the IRB may consider non-certified translations of English consent documents if the investigator has provided the qualifications of the translator and ensures the accuracy of the document (by having someone else back-translate the document, for instance). Submission of a non-certified translation is likely to delay the approval of the translated document.”

6. Scenario #1 What Does This Mean?
The research coordinator will need to:
Submit the English Informed Consent to the IRB for approval
Upon receiving IRB approval, submit the English Informed Consent to:
the sponsor’s translating service
to the sponsor so that they can submit it to the translating service
Or, have a qualified faculty or staff member translate the document (investigator-initiated studies)
Submit the translated document to the IRB within 30 days of initial approval. This submission should include:
The certificate of translation or a statement listing the qualifications of the faculty or staff member
Submit any other subject questionnaires, diaries, surveys that also required translation

7. Scenario #2
I am a research coordinator for the Oncology department and am conducting the informed consent process for a new study that we just initiated. Dr. Smith has recently notified me that he has two potential subjects coming to their routine clinic visit soon that may qualify for this study. Recruitment has been slow, and we are struggling to find subjects that qualify for enrollment so this is exciting news. The only drawback is that one of the two subjects speaks Chinese, but we only have English Informed Consents and Spanish translations of those consents. What steps do I need to take to provide this subject with proper consent if they decide that they would like to participate on this study?

8. Scenario #2 Response
According to our Human Research Protection Program Manual “Circumstances may arise where a potential participant is identified whose native language is not frequently encountered and no certified translation of the informed consent document is available. If there is sufficient time before subject enrollment is to take place, investigators should seek a translation of the informed consent document and IRB approval of the document prior to enrolling the subject. If the time frame for enrollment does not permit translation of the entire consent document, a translated short form of the informed consent document or an oral presentation may be used...”

9. Scenario #2 What Does This Mean?
Short Form - The research coordinator will need to:
Create a translated short form that includes the elements of informed consent required by 45 CFR and 21 CFR 50.27(b) and submit this to the IRB for approval.
The IRB approved short form may be presented orally to the subject or their representative in their language with the assistance of an interpreter (if needed).
Ensure that all of the prospective subject’s questions are answered.
A witness must be present for the oral presentation. The interpreter may serve as the witness.
The potential subject is then given the IRB approved short form and a copy of the regular IRB approved English consent (long form).
The subject signs both the short form and the long form.
Then the witness signs both the short form and the long form.
Then the coordinator or the person obtaining consent signs both the short form and the long form.
A copy of the signed forms are then provided to the potential subject.
As soon as possible after enrollment, the subject will need to be provided with a translated version of the IRB-approved long form of the informed consent.

10. Scenario #2 Or?
Oral Presentation - The research coordinator will need to:
The IRB approved English Informed consent form may be read to the subject (by research personnel that speaks the language) in its entirety in the language understood by the subject or their representative.
An impartial third party witness that understands the language must be present for the reading.
Ensure that all of the prospective subject’s questions are answered.
The subject signs the English Informed Consent form.
Then the impartial witness signs the English Informed Consent form.
Then the coordinator or the person obtaining consent signs the English Informed Consent form.
A copy of the signed informed consent is then provided to the potential subject.

11. Scenario #2 Note That…
The responses to this scenario do not apply to Spanish. Since Spanish speakers make up a good part of our subject population, the fact that Spanish speakers may be enrolled onto a study is something that would need to have been addressed during initial submission to the IRB and with appropriately translated documents.
“For FDA-regulated research or research that is funded by a federal agency, a short form written consent document…must also be used.”

12. Scenario #3
Dr. Smith is seeing patients in the clinic and has just identified a potential subject. One of Dr. Smith’s clinical staff members has just called me to notify me that I am needed at the clinic as soon as possible so that I can consent the prospective subject. The staff member mentioned that the patient is blind and does not have a legally authorized representative with them. What steps do I need to take to provide this subject with proper consent if they decide that they would like to participate on this study?

13. Scenario #3 Response
If a potential subject is blind, illiterate or mute this should not disqualify them from participating on a clinical research study. According to the FDA website “…can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.”

14. Scenario #3 What Does This Mean?
The research coordinator will need to:
Read or ask the legally authorized representative to read the entire informed consent form to the subject.
Remember that an impartial witness should be used and should be present during the entire process, and that the subject’s family or legally authorized representative cannot serve as a witness.
You may consider video taping the process and providing the subject with a copy of the tape.
When having the subject sign the consent, they can be guided to the location on the page where they can “make their mark” (FDA Website)
The coordinator or person conducting the consent process should not write in the potential subject’s printed name, date and time on the subject’s designated lines. Instead a note should be made by the person obtaining consent at the bottom of the page. The note can include the subject’s name, but should be signed and dated by the person obtaining consent.

15. Scenario #3 Note That…
The witness language has been removed from the TTUHSC El Paso informed consent template.
If the coordinator or the PI feel that a situation might arise where a witness is needed, then they should contact the IRB administrators in order to request the appropriate “witness language” for the consent during the initial submission process to the IRB.
During previous trainings I have stated that no other marks should be made on the consent, but the suggestion included at the bottom of the previous slide that mentions that a note may be added to the bottom of the consent. This is an exception and not something that should occur often. If this is occurring often, then I recommend contacting the IRB administrators or the Research Compliance Officer in order to determine what can be added to your study to capture notes about the consent and to review your process.

16. Scenario #4
Dr. Smith is seeing patients in the clinic and has just notified me that she has another potential subject. As I arrive at the clinic, I realize that the prospective subject is cognitively impaired and has a legally authorized representative with them. What steps do I need to take to provide this subject with proper consent if they decide that they would like to participate on this study?

17. Scenario #4 Response
According to our Human Research Protection Program Manual “If a subject is not legally capable of giving informed consent or if the subject is cognitively impaired, the IRB must find that adequate provisions are made for soliciting the assent of the subject, when in the judgment of the IRB the subject is capable of providing assent. Failure to object to participate in a research study is not assent. In determining whether subjects are capable of providing assent, the IRB shall take into account the age, maturity, cognitive, and psychological state of the subjects involved. This judgment may be required for each subject individually or for all subjects in a particular research study, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the subjects is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the subject and is available only in the context of the research, the assent of the subject is not a necessary condition for proceeding with the research. ”

18. Scenario #4 What Does This Mean?
The research coordinator will need to:
Informed consent will need to be obtained from the legally authorized representative.
An unanticipated events form will need to be created and submitted to the IRB in order to notify them of this occurrence. The outcome letter for this should be stored in the regulatory binder/file for reference.
*If the coordinator or PI have any doubts, they can contact the IRB administrators for guidance and to determine if they should submit an assent for approval in order to consent the individual.

19. Scenario #4 Note That…
Similar cases have taken place in the hospital, but in each case the IRB has determined that an assent was not necessary, and only the LAR was required to provide consent.
If the PI and coordinator are aware that this situation may occur often, then the IRB should be notified so that they can determine whether or not assents are needed, then language regarding the use of assents would need to be added to the IRB application and the informed consents.
The LAR can write the subject’s name on the printed name of subject line but should not sign, add date or time to the subject line. They should fill out the lines specifically designated for the legally authorized representative.

20. Scenario #5
I am a new research assistant and have just started working in the Emergency Department. Dr. Jones is currently enrolling subjects that have brought into the emergency room for a stroke. I am new to consenting subjects with temporary/permanent impairment. What steps do I need to take to provide subjects with proper consent if their legally authorized representatives decide that they would like for the subject to participate on this study?

21. Scenario #5 Response
According to our Human Research Protection Program Manual “Individuals likely to have diminished decision-making capacity include those legally determined to be incompetent or incapacitated as well as mentally handicapped or cognitively impaired. Cognitive impairment may be permanent (late stage dementia) or temporary (e.g., in emergency situations). If the subject lacks the mental capacity to offer informed consent, adequate plans describing the assent process must be submitted and reviewed by the IRB. Such plans must clearly describe the subject population as either permanently impaired or possibly temporarily impaired. If subjects with temporary impairment are included (for example: trauma studies), when the subject does resume the mental capacity to offer informed consent, they must be offered the choice of continuing with the research project or withdrawing at that time. ”

22. Scenario #5 What Does This Mean?
The research coordinator will need to:
Consent the legally authorized representative (LAR). The LAR can print the subject’s name on the line designated for the subject’s printed name, but should not sign, date or add time to the lines designated for the subject. The LAR should print, sign, date and add time on the line specifically designated for the LAR.
The situation on why the subject cannot give consent should be explained in the form of a note at the bottom of the informed consent and signed and dated by the person conducting the informed consent discussion.
If the subject is temporarily impaired, they should be consented with a regular IRB-approved informed consent form as soon as they are able to and research should be halted (once the subject is able to consent) until the subject provides consent.
Note: To enroll subjects from a subject population that is permanently or temporarily decisionally impaired, guidelines on the HRPP manual must be followed for initial submission of this research to the IRB.

23. Scenario #5 Note That…
Similar cases have taken place in the hospital, but in each case the IRB has determined that an assent was not necessary, and only the LAR was required to provide consent.
If the PI and coordinator are aware that this situation may occur often, then the IRB should be notified so that they can determine whether or not assents are needed, then language regarding the use of assents would need to be added to the IRB application and the informed consents.

24. Scenario #6
I am a research associate and have conducted several pediatric studies and studies with pregnant women in the past. I am fully aware of the types of consents that are typically needed. What I don’t know is what happens for a study that requires us to enroll subjects right before they give birth so that we can get information from the mother and the baby’s medical charts once the baby is born.

25. Scenario #6 Response
According to our Institutional Privacy Officer and our IRB Director, the subject (pregnant mother) must be consented with a regular consent. The consent must contain language explaining that the subject will have to come back to sign a HIPAA for their baby once the baby is born. The HIPAA must be the same HIPAA that is used for the Parental Informed Consent and must be submitted to the IRB during the initial study submission with a description of why a separate HIPAA page is being submitted. The application, protocol (if applicable) and informed consent must explain that a separate HIPAA will need to be signed once the baby is born and why.

26. Scenario #6 What Does This Mean?
The research coordinator will need to:
Consent the subject and have them sign the IRB-approved informed consent form and HIPAA.
Request that the subject sign the IRB-approved HIPAA for their baby after the baby is born.
Note: The HRPP manual has specific guidelines that need to be followed in order to conduct a study with vulnerable populations such as:
Pregnant Women
Children
Minors
Fetuses or Neonates
Terminally Ill Patients
Economically Disadvantaged Patients
Employees
Students
Others

27. Scenario #6 Note That…
If difficult questions arise in regards to the subject population, conditions that they are in, or any other circumstances then don’t hesitate to contact the IRB administrators for guidance.

28. Scenario #7
I am a principal investigator in the psychology department. I am in the process of opening a new study in which I will be enrolling English and Spanish-speaking subjects from ages 12 – 35 to study schizophrenic behavior. For this I will be reviewing the subject’s medical chart to collect information on their diagnosis and I will be giving the subjects standardized questionnaires. What types of consent forms will I need for this study?

29. Scenario #7 Response
This study will require Biomedical Informed Consents since it is a study that requires access to medical records and a HIPAA is required. Since the PI will be enrolling subjects from ages 12 – 35, we will need Biomedical Informed Consents, Parental Biomedical Informed Consents, and Assent forms. The PI is also enrolling English and Spanish-speaking subjects so all of the forms will need to be in both English and Spanish.
Note: If the PI were not collecting medical record information then a SocioBehavioral consent could be used.

30. Scenario #7 What Does This Mean?
The research coordinator will need to:
If the subject is 17 years of age or younger, then the parent must sign the Biomedical IRB-approved parental informed consent/HIPAA and the minor must sign the IRB-approved assent. (Except in special cases)
If the subject is 18 years of age or older, then they must sign the Biomedical IRB-approved informed consent/HIPAA.
If both the parent and the child qualify to be subjects on the study, then the parent must sign the Biomedical IRB-approved informed consent/HIPAA for themselves, and the Biomedical IRB-approved parental informed consent/HIPAA for the minor. The minor must sign the IRB-approved assent.
Note: Keep in mind that if the subjects are decisionally impaired, then the rules discussed during our previous scenarios will apply, and the IRB will need to be informed during the initial submission of the study that this population may be decisionally impaired.

31. Scenario #8
I am currently in the process of trying to consent this subject, but when I handed the subject the consent they told me that they didn’t want to read it but would agree to anything I was presenting. After explaining to the subject that I must give them sufficient time to review the informed consent and then go through the consent with them to make sure that they understand the study, the subject got angry and demanded that I just tell them where they need to sign.

32. Scenario #8 Response
According to the FDA website “To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject's signature on the consent form. FDA believes that obtaining a subject's oral or written informed consent is only part of the consent process. Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject's comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject's voluntary agreement to participate, and 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 subject to consider whether to participate. (21 CFR ) FDA considers this to include allowing sufficient time for subjects to consider the information and providing time and opportunity for the subjects to ask questions and have those questions answered.”

33. Scenario #8 What Does This Mean?
The research coordinator will need to:
Decide whether or not this subject is a good candidate for research.
Consider that the subject must be provided with adequate time to review the consent and the person conducting the informed consent discussion must go through the informed consent with the subject. The subject must be allowed to ask questions in order to decide whether or not they would like to participate in the study. The subject cannot be coerced and cannot waive or appear to waive any of their legal rights.
Notify the investigator of this occurrence and let them know that this subject is not a good candidate for research.
If the PI insists that the subject must be consented, allow the PI to consent the subject themselves and consider reporting this concern to the Research Compliance Officer, the Institutional Compliance Officer, your supervisor, EthicsPoint, the Office of Research Resources, the IRB…

34. Resources
HRPP Manual:
FDA Website for Scenario 3:
FDA Website for Scenario 8:
IRB Administrators:

35. Questions?