CIP Study group (FB) – Flashcards
Unlock all answers in this set
Unlock answersquestion
To receive a FWA (Federal Wide Assurance), non-U.S. institutions:
answer
International IRBs can't receive a FWA
question
The most accurate statement regarding the donation of tissue for research:
answer
The informed consent process must clarify two main issues: whether the tissue is going to be linked to personal identifiers and whether the tissue will be tested for genetic markers that are known to predict disease.
question
An investigator from Central Hospital wants to post a recruitment flyer in a specialty clinic at Western Hospital. The flyer is intended to solicit volunteer subjects for the investigator's study at Central Hospital. All procedures related to the study will be conducted at Central Hospital, but there is a potential group of subjects from the specialty clinic at Western Hospital who may be eligible and/or appropriate for the study. Choose the statement that best describes the mechanism for IRB review of the protocol and recruitment flyer:
answer
he IRB at Western hospital should be contacted to determine whether its IRB needs to review the protocol and/or recruitment flyer.AND IRB review of the protocol and/or recruitment flyer at Western Hospital would never be required.
question
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
answer
Provide parents certain rights over their children's educational records.
question
When does FERPA and PPRA not apply:
answer
In a public school and In a private school receiving no federal funding
question
Vulnerable populations
answer
In March 2001, DHHS regulations became effective that required paternal consent to enroll a pregnant woman in research.
question
Vulnerable populations- A college student makes a complaint to the IRB that they were forced to participate in research studies because their class required it. The IRB should:
answer
Determine whether there was an alternative assignment that the student could complete for the course that was comparable in scope to the study.
question
Which of the following is NOT a valid reason for IRBs to ask principal investigators of nonemergency research involving a distinct minority or vulnerable group to consult with the community?
answer
To comply with federal regulations requiring community consultation in such circumstances
question
Parental or guardian permission is treated in much the same way as informed consent, apart from some additional provisions found in 46.408. Choose the correct statement that describes these provisions:
answer
Both parents must give permission for research approved under 46.408 unless one parent is not reasonably available.
question
School based research requires the consent of only one parent when:
answer
The research involves no more than minimal risk and there is the prospect of direct benefit to the minor subjects.
question
Consent by a family member for a subject who lacks capacity is generally accepted:
answer
For research that poses minimal risk or the possibility of benefit.
question
Emergency Uses, Treatment Uses, Subject recruitment and vulnerable populations.
answer
the most accurate statement The 1993 Office for Protection from Research Risks discourages use of the term "Compassionate Use" because it may cause confusion.
question
Emergency Uses, Treatment Uses, Subject recruitment and vulnerable populations. the most accurate statement:
answer
According to FDA regulations, the study sponsor and local PI do not need prior IRB approval to use an investigational medication in a situation that meets the FDA definition of "emergency use".
question
Emergency Uses, Treatment Uses, Subject recruitment and vulnerable populations. the most accurate statement:
answer
the most accurate statement to complete the following sentence: An investigator who requests emergency us of an FDA-regulated drug, biologic or device that is the subject of research funded by DHHS and FDA.... Must request an acknowledgment letter from the IRB and may not use the resulting data as part of a prospective research study.
question
Certificate of Confidentiality prevents disclosure of all but which one of the following:
answer
Identifying information voluntarily released by either a subject or an investigator.
question
Subjects in a study will have blood drawn to test for a particular gene. The presence of the gene may predict the development of pancreatic cancer, but this is very preliminary and speculative. Investigators will have access to the identity of each subject linked to the DNA result. Should the investigators inform subjects about their own research results?
answer
B. No subjects should be informed. t is not known whether the genetic mutation is truly associated with a higher risk of pancreatic cancer. Therefore, the implications of having the genetic mutation are not known, but knowledge that one has the mutation might cause undue anxiety or distress in subjects who would then believe they are destined to die from pancreatic cancer. This answer came from 6-9 of the Amdur book.
question
The criteria for waiving the requirement for documentation of informed consent according to DHHS regulations are:
answer
A signed consent document would put the subject at risk of harm if there was a breach in confidentiality, OR the research is minimal risk and does not involve procedures for which signed consent is normally required.
question
the most accurate statement:
answer
It is impossible to study certain aspects of human behavior without deception of research subjects.
question
covering Informed consent (waivers, signature lines, etc.) and GINA & GWAS information What situation is most likely to qualify for waiver of informed consent?
answer
Research that involves retrospective review of data from the medical record to evaluate outcome following hip replacement surgery.
question
most accurately describes a situation in which a protocol that initially required full-committee IRB review may undergo continuation review with an expedited process:
answer
Research is permanently closed to enrollment, all subjects have completed research related interventions, and research remains active only for long-term follow-up.
question
A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students and what types of disciplinary actions were taken. Identifiers will be collected. This study would be categorized as which type of review?
answer
B. Expedited Review
question
A full convened IRB meeting agenda includes an amendment of a previously approved protocol. This amendment is adding study staff, updating the version of the protocol number, revising the investigator's pager number, and implementing a Quality of Life questionnaire. This submission:
answer
Requires Full Committee review. we don't know what changes were made to the protocol besides the implementation of the QOL) and the QOL survey which can be pretty heavy depending on the study pop.
question
The VA facility may not use which of the following:
answer
An independent IRB
question
The Case: A Full IRB Committee meeting is convened on October 18, 2012. The IRB Committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. One agenda item is a new research proposal to evaluate how mothers interact with their learning disabled child. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. One of the IRB members, Susan, is Principal Investigator for the study and receives a portion of her salary from the supporting grant.
answer
Defer the proposal to the next meeting because of a loss of quorum
question
The regulations define a quorum as:
answer
The regulations do not define quorum The regulations say, "In order to fulfill the requirements of this policy each IRB shall....(except when an expedited review procedures is used)...review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas." 56.102 does not have a definition for quorum. This is usually decided on the local IRB level and written into the policy & procedures for that IRB
question
What is the role of the IBC in the review of gene transfer protocols?
answer
A. Ensure compliance with NIH guidelines B. Assess the safety of recombinant DNA research C. Identify any potential risk to the public health or the environment D. All of the above
question
At a VA facility, for-cause suspension of drug research by the IRB requires reporting to which agencies?
answer
"D". Again, remember with any question about the VA, it always seem the most strict answer is usually the right one. Again, the VA goes above and beyond what is required in the regulations.http://www.hsrd.research.va.gov/for_researchers/policies.cfm
question
The document sent by the FDA to institutions/investigators after an audit that cites serious regulatory deficiencies and demands correction is called:
answer
A WARNING Letter If you have an FDA audit and there are findings (minor or serious) a 483 will be issued. A 483 is also known as a "Statment of Finding". Eventually, you will get some type of letter from the FDA. Most sites will receive a Voluntary Action Letter (VAI) and this letter will simply ask for the correction of minor deficiences that were found. Normally you would respond with what you have done and/or what you are doing to fix the problem. This will normally address all of the FDA's concerns. The second type of letter that you could receive is an Official Action Indicated letter (OAI). These demand correction of what the FDA would consider a serious deficiencies and/or violations of regulations. These letters are called a Warning Letter. You can go to the FDA website and view these letters. They are public record. With a warning letter there is usually some kind of sanction for the institution/investigator. I hope this explanation helps. I took this answer straight from the Amdur book, page 327 under Post inspection Activities. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm358744.htm
question
What's the difference between the HHS Regs and the Common Rule?
answer
The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the "Common Rule"; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.
question
The regulations define a quorum as:
answer
D The regulations do not define quorum
question
Choose the answer in which all statements correctly reflect DHHS and FDA regulatory requirements concerning the size and composition of the IRB.
answer
it is true that the IRB should have at least five members but you only need three to run a fully convened meeting: scientist, non-scientist, and non affiliate. You MUST have those three to run a meeting. There will be questions similar to this style on the exam where there can be two correct answers. I believe D could be correct also but it's missing the non-affiliate element. When you come across these questions, you just need to do the best you ca
question
For a minimal risk committee, the members may exercise all of the authorities of the IRB in making a final submission determination.
answer
FALSE The minimal risk committee (or expedited committee) can't deny or table a protocol submission. These are only actions that can be taken by a fully convened IRB meeting.
question
The Case: A Full IRB Committee meeting is convened on October 18, 2012. The IRB Committee roster consists of 15 members. However, only 9 members are in attendance for today's meeting. One agenda item is a new research proposal to evaluate how mothers interact with their learning disabled child. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk..o the child for three minutes. One of the IRB members, Susan, is Principal Investigator for the study and receives a portion of her salary from the supporting grant.
answer
The Question: The proposal does not include adequate information regarding the potential risks to the minor subjects in the research study, but is otherwise approvable. The committee considers these risks to be more than minimal risk to the minor child. Which of the following best describes how the IRB should proceedTable the protocol and ask the investigator to provide the needed information for review by the full board at the next convened meeting.
question
The most important document the FDA will review when conducting an IRB audit is:
answer
C The IRB's written procedures & policies If you go to 21 CFR 56.108 it's all about having policy & procedures. It states, " In order to fulfill the requirements of these regulations, each IRB shall: (a) Follow written procedures...." When you have an FDA audit, your P & P is their Bible. That will be the main thing you will need to provide because they will use it to perform the audit. There should be NO IRB that doesn't have P&P. The auditor may ask for minutes from the last three years and you are required to have them available, but they are not the most important document. You can read further about this on page 324 of the Amdur Book.
question
To obtain legally valid informed consent for an incapacitated adult subject, a site should:
answer
Obtain legal advice to find out who is legally authorized to give consent in that state.
question
In a limited data set with a data use agreement, the following are allowed identifiers:
answer
Dates and Zip codes he Limited Data Set and Data Use Agreement (LDS/DUA) allows more identifiers than a de-identified data set. In particular, it allows any and all dates and additional geocoding (ZIP codes are allowed but not specific street addresses). Unlike the de-identified data set, LDS/DUA is still considered PHI and is subject to the minimum necessary requirements of the Privacy Rule. I got this answer from page 276 of the Amdur book under "Limited Data Set with Data Use Agreement".
question
An investigator working for a medical university is interested in creating a protocol looking at subjects who have had an fMRI conducted before and after spinal surgery. The investigator has discussed this new protocol with a few of his patients who seem to be interested in the protocol. The investigator would like to contact his other patients to discuss the interest of enrolling in this clinical trial. The investigator would need to:
answer
Nothing. This would be considered preparatory to research and no IRB approval is requiredUnder regulations this would be considered "Prepatory to Research" A covered health care providers and patients may continue to discuss the option of enrolling in a clinical trial without patient authorization, and without an Institutional Review Board (IRB) or Privacy Board waiver of the authorization. However, a researcher who is not a part of the covered entity may not use the preparatory research provision to contact prospective research subjects. Follow the included link to the HHS regulation addressing "Prepatory to Research". http://www.hhs.gov/ocr/privacy/hipaa/faq/research_disclosures/317.html Can the preparatory research provision of the HIPAA Privacy Rule at 45 CFR 164.512(i)(1)(ii) be... www.hhs.gov
question
The Protection of Pupil Rights Amendment (PPRA) requires written parental consent for:
answer
. surveys about family income. -correct because family income is one of the sensitive topics, but incorrect because the answer doesn't specify that the survey is funded by the Dept of Education. You can have research with kids that doesn't cover those topics that would not require parental consent. Let's say you have a survey regarding speech patterns that is funded by the Department of Education. You wouldn't need to obtain a consent about that just because it is funded by the ED, but you would still have to make it available for parents for inspection. PPRA specifically states you need to obtain consent if you are addressing family income. I was told that even if it is not funded by ED, if it is taking place at a school that is receiving federal funding (free lunches, after school programs, etc.) PPRA is applicable http://www2.ed.gov/print/policy/gen/guid/fpco/ppra/index.html
question
An investigator proposes to study a market approved product sold to treat high blood pressure in individuals over age 12. This study will look at using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in children. Which of the following is the investigator's most appropriate course of action?
answer
Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting research. time ANYTHING changes on the labeling and it's going to be tested, even if it is market approved....it has to get another IND from the FDA.
question
Which statement is true about Humanitarian Use Devices (HUDs)?
answer
B. May be sold
question
Military personnel are involved in a military operation overseas. The soldiers have been exposed to a chemical agent and the known end result is death. There is currently an investigational drug that shows promise in saving the life of humans who have been exposed but the administration of the drug is time sensitive and is available to the subjects now. Under regulations, consenting is addressed by obtaining:
answer
C Nothing. The President can grant waiver of consent. In section 50.23 (d)(1)(Exception from general requirements) Under 10 U.S.C 1107(f) the President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation. The statute specifies that only the President may waive informed consent in this connection and the President may grant such a waiver only if the President determines in writing that obtaining consent: Is not feasible; is contrary to the best intersts of the military member; or is not in the interest of national security. If you would like to read further on this, it can be found on page 505 of the Amdur book first column
question
What's the difference between the HHS Regs and the Common Rule
answer
The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the "Common Rule"; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.
question
An adult presents to a physician with attention deficit hyperactivity disorder (ADHD). To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action?
answer
Treat the patient with the drug based on physician's best medical judgment Treat the patient with the drug based on physician's best medical judgment
question
A researcher contacts the IRB regarding planned research involving participant observation of children in a special need preschool. The researcher has obtained the written permission of the school's director. Information that could potentially identify the participants will not be recorded and the details identifying the research site will be obscured in all publications. The study:
answer
Must receive full committee review. if you look at Subpart D 46.101(b) it states, "The exemption at 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, EXCEPT for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed." Since the investigator in this scenario is only observing the students, the study can be exempted. he facility is a pre-school and he has received written permission from the school to be there. This would make it a public setting.
question
An IRB has received a submission for a protocol that involves an in-vitro diagnostic ABC assay device. The investigator will be obtaining de-identified, discarded specimens of individuals who were known to have been diagnosed with MRSA (Staph infection). The investigator will evaluate and validate the performance of the ABC device as compared to the device currently being marketed. This submission should be reviewed under:
answer
An exemption under FDA 21 CFR 56.111 provided for in-vitro diagnostic research t hasn't received 510(k) clearance from the FDA so C would be thrown out. If you look under 21 CFR 812.2(c)(3) there is a special exemption just for in-vitro diagnostic devices. It reads, "Is noninvasive, does not require an invasive sampling procedure that presents significant risk, does not by design or intention introduce energy into a subject, and is not used as a diagnostic, without confirmation of the diagnosis by another, medically established diagnostic product or procedure." Not only that, but the review would fall under Expedited review category #5.
question
The Principle of Justice in the Belmont Report:
answer
Justice divides responsibility equally without it all falling on the subject. Justice provides for responsibility to fall just as equal on the researcher.
question
Epidemiologic research often involves the review of thousands of records and existing data. Investigators often request a waiver of informed consent to review these materials. Select the most appropriate statement concerning the waiver of informed consent for this kind of research:
answer
The IRB must determine that each of the four criteria for waiving ICF under 45 CFR 46.116 are met before approving a waiver It doesn't matter what kind of research it is....ALL four criteria for a Waiver of Consent must be met and determined by the IRB before being granted.
question
What is the correlation between the score on the practice test and the actual test?
answer
Download the CCIP handbook from the PRIM&R website. Starting on page 12 it breaks down what is included in each category and that is what we have based our syllabus off of. I was going to upload it here but it doesn't give me that option
question
The federal regulations that govern IRB procedures:
answer
Require members with a COI not participate in the deliberations and vote on that study. regulations specifically say that member can't participate in the vote.
question
How does the International Conference on Harmonisation (ICH) differ from the FDA regulations and the Common Rule regarding the information about confidentiality that must be included in the consent form?
answer
The ICH explicitly requires that subjects be informed that various individuals might review their original medical records, including monitors, auditors, the IRB and government authorities, whereas the FDA regulations and the Common Rule are not as explicit.
question
Ms. Clean, a graduate student in education, wants to interview elementary school children about their relationships with classmates, siblings, and parents. She hypothesizes that children who "act out" and are dominant in the classroom will be similarly dominant at home. Several of her open ended questions deal with physical as well as social aggression. At the IRB meeting, members express some concerns about the study.
answer
ecause Ms. Clean is asking children to describe situations in which they are physically dominant or aggressive, she should be careful not to imply approval of those behaviors.
question
In June 1998 the US Department of Health and Human Services Office of the Inspector General (OIG) issued a series of reports. These reports list approximately six main deficiencies that threaten the effectiveness of what system?
answer
A. IRB
question
According to the Belmont Report, the process of informed consent requires three key components to be adequately addressed to be considered ethically valid. These are:
answer
C. Information, comprehension, and voluntary agreement.
question
In what way did the Beecher article impact research in the United States?
answer
B. It heightened awareness of problems with unethical research.
question
Controversial protocols in history
answer
Science Club Study Tearoom Trade Study Willowbrook Study Sloan-Kettering Study Havasupai Indian Tribe Milgram Study Jewish Chronic Disease Hospital The Malaria Research Project
question
The Tudor Study involved studying what in minors:
answer
B. The cause of stuttering-this question to show you that some of the incidents in our "history" can be called by different names. The CIP exam will always use the "proper" name. Another example would be "The Public Health Service Syphilis Study" or better known as Tuskegee
