Human subjects, Evaluation - Serious Games - Spring 2009

Contents

Slides

Overview of Today's Class [1/6, 2009/05/26]

• Human subjects
• Evaluation

For next time [2/6, 2009/05/26]

Going to the school

• Hans Christian Andersen school
• 1148 N Honore St
• Blue line, Division stop
• According to Google, 22 mins from here.
• Plan on being there by 1:10. I'll leave at 12:45 sharp. Meet there or at CDM?
• Need to take evaluations
• Games on computers?

Human subject training [3/6, 2009/05/26]

What were the main points?

Research

• Subpart A defines research as “a systematic investigation...designed to develop or contribute to generalizable knowledge.” This definition includes: Research development, Testing, Evaluation
• (d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Consent and children

• Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
• (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
• (d) Parent means a child's biological or adoptive parent.
• (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
• HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in §46.408.
• In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children 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 children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.
• (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §§46.406 and 46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
• (c) In addition to the provisions for waiver contained in §46.116 of subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
• (d) Permission by parents or guardians shall be documented in accordance with and to the extent required by §46.117 of subpart A.
• (e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

Exemption

• (b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
• (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
• (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Evaluation [4/6, 2009/05/26]

What did you bring?

We'll discuss and pick out best. 5-8 questions?

Samples on next slide

from 2009 ISAT Grade 7 Sample Book [5/6, 2009/05/26]

Found: here

Items and the related item from the standards:

• 13: 12.4.47 Identify the order of planets from the sun, and know that the further planets take longer to go around the sun. Understand that all planets in our solar system revolve around the sun. Because Earth revolves around the sun, objects (e.g., stars, planets, constellations) in the sky appear to change position throughout the year. Know that it takes Earth 36541 days to revolve around the sun.
• 31: 12.7.99 Understand that the sun is an average star. Know that a solar system consists of a sun and planets and other objects that revolve around it. Know that the planets closest to the sun are hotter than the planets farther away from the sun. Understand that the color of a star depends on its temperature.
• 39: 12.4.47 Identify the order of planets from the sun, and know that the further planets take longer to go around the sun. Understand that all planets in our solar system revolve around the sun. Because Earth revolves around the sun, objects (e.g., stars, planets, constellations) in the sky appear to change positions throughout the year. Know that it takes Earth 365 ¼ days to revolve around the sun.
• 47: 12.7.92 Understand that gravity is the force that keeps planets in orbit around the sun and governs the rest of the motion in the solar system. Know that changes in gravitational forces explain the phenomenon of the tides. Know that what an object weighs on Earth is different than what it weighs on the moon or other planets in our solar system. This is due to gravity.

Answers [6/6, 2009/05/26]

Answers: B, D, A, D