Students in Research

Question 0

What were the major contributions of the Declaration of Helsinki?

Answer 0

• Research with humans should be based on the results from laboratory and animal experimentation.
• Research protocols should be reviewed by an independent committee prior to initiation.
• Informed consent from research participants is necessary.
• Research should be conducted by medically/scientifically qualified individuals.
• Risks should not exceed benefits.

Question 1

What is the Nuremberg Code, and what is its major premise?

Answer 1

It was developed following the Nuremberg Military Tribunal, which judged human experimentation conducted by the Nazis. It encompasses many of the basic principles governing the ethical code of human subjects research today. It states that “the voluntary consent of the human subject is absolutely essential” and it further explains the details implied in this requirement: capacity to consent, freedom from coercion, no penalty for withdrawal, and comprehension of the risks and benefits involved.

Question 2

What is the Common Rule?

Answer 2

Subpart A of the policy for the protection of human subjects. It provides for the basic foundation of the Institutional Review Boards. This Federal Policy has been codified by the federal agencies that conduct, support, or otherwise regulate human subjects research.

The Common Rule is a short name for “The Federal Policy for the Protection of Human Subjects” and was adopted by a number of federal agencies in 1991.

The Common Rule applies to human subjects research conducted, supported or otherwise subject to regulation by the VA.
The Common Rule:
• Describes the types of research subject to regulation
• Defines key terms such as research, human subject and
minimal risk
• Requires a written assurance of compliance with the
common rule
• Sets forth requirements for an Institutional Review Board’s
(IRB) membership, authority, review procedures, records
and criteria for approval
• Lists the general requirements for informed consent

Question 3

What are the 3 principles outlined in the Belmont Report?

Answer 3

Respect for persons (autonomy), beneficence, justice

Question 4

What are the requirements for IRB composition?

Answer 4

At least five members from relevant academic disciplines or experiences, at least one member must not be affiliated with the institution. It must be diverse and must include at least one member whose primary concern is in a scientific area and one who is not a scientist. Must be diverse in terms of race, gender, cultural backgrounds, and include members from the community.

Question 5

What is the responsibility of the IRB?

Answer 5

To review and oversee human subjects research whereby they protect the rights and welfare of human subjects by ensuring equitable subject selection, assuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality.

To review all projects involving human subjects for compliance with institutional policies and state, local, and federal laws, as well as the ethical principles contained in the Belmont Report (respect for persons, beneficence, justice).

Question 6

What is exempt review?

Answer 6

Exempt research is research with human subjects that generally involves no more than minimal risk. It is “exempt” from the Common Rule. And exempt research project does not require ongoing review by the IRB, unless the project is amended in such a way that it no longer meets the exemption criteria.

Question 7

What are the requirements for a research project to be exempt?

Answer 7

• Research conducted in established or commonly accepted educational settings, involving normal educational practices.
• Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior.
• Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
• Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine [particulars].
• Taste and food quality evaluation and consumer acceptance studies.

Question 8

What is an expedited review?

Answer 8

If the research presents no more than minimal risk, the IRB may determine it qualifies for an expedited review. The expedited review covers the same elements as a full/convened committee review but can be conducted by the IRB chair or designated experienced reviewer rather than the whole convened committee.

Question 9

What are the requirements for research project to be considered for an expedited review?

Answer 9

-Clinical studies of drugs and medical devices when one of the following conditions is met: research on drugs for which an investigational new drug application is not required; research on medical devices for which an investigational device exemption application is not required or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
-Collection of blood samples by finger stick, he’ll stick, your stick, or venipuncture from certain populations.
-Perspective collection of biological specimens for research purposes by noninvasive means.
-Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. When medical devices are employed, they must be cleared/approved for marketing.
-Research involving materials that have been collected or will be collected solely for non-research purposes such as medical treatment or diagnosis.
-Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (such as research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factor evaluation, or quality assurance methodologies.

Question 10

Who conducts an expedited review?

Answer 10

The IRB chair or a designated experienced reviewer rather than the whole convened committee.

Question 11

What is the definition of “research?”

Answer 11

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Question 12

What is the definition of a “human subject?”

Answer 12

A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Question 13

What is meant by non-engagement in research?

Answer 13

This occurs when an institution’s employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research.

Question 14

Who completes the IRB application?

Answer 14

The student completes the IRB application under the guidance of her faculty advisor.

Question 15

What are the 4 IRB review outcomes?

Answer 15

Approval; Approval with contingencies/stipulations; Deferred; Non-approval

Question 16

When do you recruit subjects?

Answer 16

Once the application is approved.

Question 17

When can you implement modifications to your research proposal?

Answer 17

After such changes to the original submitted study are reviewed and approved by the IRB.

Question 18

What is an adverse event?

Answer 18

Any undesirable experience associated with the use of a medical product in a patient.

Question 19

What are the reporting requirements for the researcher?

Answer 19

• When modifications and amendments to the approved protocol occur
• Adverse events/effects and unanticipated problems involving risk to subjects or others occur
• Complaints regarding human subjects research occur
• Breach of confidentiality occurs
• Status report prior to the expiration of the study to assess the study’s progress or a final report when the study is completed

Question 20

What is PHI?

Answer 20

Protected health information is health information transmitted or maintained in any form or medium that includes all three of the following characteristics:

• identifies or could be used to identify an individual
• is created or received by a healthcare provider, health plan, or healthcare clearinghouse
• relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual

e.g., name, social security number, telephone number, etc.

Question 21

What are the general guidelines for writing an informed consent document?

Answer 21

Clearly written and understandable to subjects; nontechnical language; jargon must be plainly defined; informed consent written at the sixth to eighth grade level maybe best.

Question 22

What are the specific requirements for informed consent?

Answer 22

• Purpose of the research.
• Procedures involved in the research.
• Alternatives available should the subject decide not to participate in research.
• All foreseeable risks and discomforts to the subject.
• Benefits of the research to society and possibly to the individual human subject.
• Length of time the subject is expected to participate.
• Payment for participation if applicable.
• Person to contact for answers to questions or in the event of a research related injury or emergency.
• Statement that participation is voluntary and that refusal to participate for not result in any consequences for any loss of benefits but the person is otherwise entitled to receive.
• Subjects right to confidentiality and right to withdraw from the study at any time without any consequences.

Question 23

What is consent, and what is assent?

Answer 23

Consent: an adult capable of giving permission to participate in the study can provide consent. In most states, the subject must be 18 years of age and competent to make the decision to participate. Parents/legal guardians of minors can also provide consent to allow their children to participate in the study.

Assent: in most states if the subject is under 18 years of age, assent must be obtained. I sent as a child affirmative agreement to participate in research. The assent form must include simple language written at the appropriate reading level of the youngest subject and youth age range. An assent form may also be used if the subject is cognitively impaired.

Question 24

What is privacy?

Answer 24

Having control over the extent, timing, and circumstances of sharing oneself physically, behaviorally, or intellectually with others.

Question 25

What is confidentiality?

Answer 25

Treatment of information that an individual has disclosed in a relationship of trust with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.

Question 26

What is a risk?

Answer 26

The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.

Question 27

What is meant by benefit?

Answer 27

Potential benefits for individual subjects may be easy to find and studies offering interventions for behavioral, psychological, or physical problems. However, researchers often conducted as part of a faculty member or graduate student investigation into specialized field of study. The research may provide no direct benefit to the subjects but benefit the researcher who is trying to learn something. Benefits may also not be apparent for a long time.

Question 28

What is minimal risk?

Answer 28

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Question 29

What are primary and secondary sources of data?

Answer 29

Primary data collection involves direct contact with, or observation of, one or more people for the purpose of collecting data about them. Secondary data collection involves accessing information that has already been obtained about humans, either individually or in aggregate form. Secondary data may only be used when the original consent allows the information to be used in this manner.

Question 30

What is deception?

Answer 30

The intentional misleading of subjects or withholding of four information about the nature of the study. This may include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. Subjects have the right to full disclosure as soon as possible.

Question 31

What is meant by vulnerable populations?

Answer 31

People who cannot competently understand the information regarding the study and cannot give true consent. Such populations may include individuals with psychiatric, cognitive, or developmental disorders and substance abusers. Three federally-specified groups of people are pregnant women, fetuses, and neonates; prisoners; and children.

Question 32

What considerations are necessary to involve students in research projects?

Answer 32

Awareness of HIPAA, informed consent, privacy/confidentiality, risk/benefit analysis.

Question 33

What are the responsibilities of faculty members?

Answer 33

• Be familiar with the ethical and regulatory requirements of human subjects research.
• Determine whether projects require IRB review and assist students with the process.
• Discuss research ethics with the students.
• Advise students conducting international studies on understanding the local customs and ethics.
• Monitor student projects, paying special attention to maintaining confidentiality, privacy, level of risk, voluntary participation and withdrawal, and informed consent.
• Assure that any unexpected or adverse events are reported to the IRB.

To consult with students who are planning on conducting research project involving human subjects. Guidance while the student completes the IRB approval application. Reviewing and signing off on this application.