Tutorial Chapter 10: What criteria does the Committee use when evaluating applications?

Case Study:

University researchers associated with an innovative tutoring program in a school for children with physical disabilities are trying to find out whether parents of the children in the program employ special methods for encouraging the children to complete their homework. The researchers would also like to find out whether these strategies differ from those used by parents whose children do not have special needs, a group about which much is already known. The researchers propose to hold a series of focus groups, which are guided group discussions on particular topics, for parents with children who are in the tutoring program.

Although there is some risk involved for some parents - they may find it painful to talk about their special needs children and problems experienced in helping them with their schoolwork - researchers believe the benefits far outweigh this risk.

The researchers believe that parents will benefit from the generally supportive environments that will be created by the proposed focus groups. The parents will meet people coping with similar challenges and this may provide an opportunity for them to share winning strategies with each other.

How should the researchers treat the possible risk in their study?

  • A: The researchers are convinced that they have created an acceptable risk to benefit balance, and that this will satisfy the requirements of the UCAIHS, so submit the study as designed.
  • B: The researchers decide to offer substantial monetary compensation to induce parents to participate in this study and include this in the Application for Review.

When the UCAIHS reviews an application, it is evaluated according to the following criteria:

  • Risks to subjects are minimized
  • Risks to subjects are reasonable in relation to anticipated benefits
  • Selection of subjects is equitable
  • Informed consent is sought and received
  • Informed consent is appropriately documented
  • Adequate protection exists for information gathered about the subjects
  • Study includes a plan for monitoring data

Chapter Review

Question 1

Which criterion is not used to approve research involving human subjects (select one)?

  • selection of subjects is equitable
  • risks are reasonable in relation to benefits
  • future benefits are guaranteed
  • informed consent is obtained

Question 2

Informed consent needs to be sought and appropriately documented.

Question 3

When protected populations are involved, additional safeguards may be required by the UCAIHS for approval of research.

Question 4

Protected populations include which of the following (select all that apply):

  • children
  • prisoners
  • pregnant women
  • mentally disabled people
  • economically or educationally disadvantaged people

Next Chapter: How should researchers select and recruit subjects?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Take the Certification Exam!
  • Glossary
  • References