Trinity Valley Community College

   

Getting Started
   
Posted: 11/15/2012 12:35:46 PM


Getting Started

As a principal investigator or project director, you want your protocol reviewed in a timely manner. To ensure that this occurs, the Office for Human Research Protections of the Department of Health and Human Services provides a decision tree to help you determine:
  • Is my project considered research?
  • Does my research activity have to be reviewed by the IRB?
  • Can the review go through the expedited process?
  • Does my project involve human subjects?
  • Does my project involve only minimal risk?
According to federal regulations, principal investigators have an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.

Can informed consent be waived?
  • Informed consent helps assure that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. Consent forms tell subjects they are free to withdraw from participation at any time, as well as convey other critical information; see informed consent guidelines listed below.
If answers to these questions indicate that your project requires approval by the IRB, review your protocol for completeness prior to submission:
  • All required forms must be complete and correctly filled out and enrollment criteria must be clearly and completely described
  • If your protocol will involve surveys, provide the committee with the actual instrument(s) to be used (current, up-to-date copies must be included with your submission)
  • The process of obtaining informed consent must be fully and clearly described
  • Subjects must be fully informed that this is research and the purpose of the research, and must be aware of any and all risks, benefits, or costs to them
  • Provide the curriculum vitae of the Principal Investigator/Project Director
Complete and clearly written applications are reviewed more quickly. Each time a question must be asked or a revision made, the process will be delayed. If you have questions, please consult with the IRB Chair before making your submission.

IRBs must adhere to federal regulations found in the Code of Federal Regulations (Title 45 Part 46, Protection of Human Subjects). Some basic definitions and informed consent guidelines are listed below to assist researchers in understanding these regulations.

Definitions

Published in the Code of Federal Regulations, Title 45
Public Welfare Department of Health and Human Services
Part 46 Protection of Human Subjects

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

Human Subject: "Human subject means 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. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Minimal risk: 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.

Informed Consent Guidelines

The regulations regarding informed consent are complex. Generally speaking, research subjects need to have sufficient information on the project in which they are being asked to become involved, and should voluntarily agree to participate. The information given to the prospective subjects or their representatives needs to be in language they can understand. For those less than 18 years of age, the researcher must obtain the informed consent of parents or legal guardians.

The informed consent must include the following in sequential order and in language which the participants can understand:
  1. Statement of purpose of the study.
  2. Short description of methodology and duration of participant involvement.
  3. Statement of risks/benefits to the participants.
  4. Statement of data confidentiality.
  5. Statement regarding the right of the participant to withdraw from the study at any time without negative consequences.
  6. An offer to answer any questions the participant may have.
  7. Contact information of all Principal Investigators, and also contact information for Trinity Valley Community College Institutional Review Board (IRB Chair, Tina Rummel, 903-675-6282).
  8. Line for signature of participants and/or parents or legal guardian except for questionnaire research in which return of questionnaire gives implied consent.
  9. Statement that participant is 18 years of age or older unless parent or legal guardian has given consent.
In situations where participants will be deceived, items 1 and 2 are omitted and participants are told (on the signed form) that disclosure of the purpose and/or methodology could bias the outcome of the study. In this case, after the study is complete, each participant must be presented with a description of the purpose and methodology as carried out and this document must be signed by the participants "after the fact" in order to guarantee informed consent.