Institutional Review Board and Informed Consent

By Jessica Raby and Jamelia King

Purpose of Review

     Institutional Review Board was designed to protect the rights of individuals serving as subjects in various research studies.  This policy is covered by the United States Department of Health and Human Services Public Health Service Act as amended (45 CFR 46) .  The policy requires each University President or Provost appoint a committee or IRB, which is given the authority to review and determine the acceptability of each research proposal.  Therefore, each university practice their own IRB guidelines.  Any individual conducting research must have their research proposal approved by the IRB before obtaining or gathering any information from any human subjects. 

According to most institutional review boards, the rights of individuals must be preserved in the following four areas:  consent, harm, privacy, and deception.  Participants need to be shown respect and consideration, when conducting research.

There are steps that must be conducted before beginning any kind of research in any field of studies.  Many graduate students often find themselves writing a thesis or dissertion, relating to their field of study before they graduate.  If a communication disorders graduate study is writing a thesis, most likely they are going to be using human subjects in their research. 

    Process of Submitting Research Proposals for Review

In order to be approved by the IRB, the researchers must present the board with specific information pertaining to his/her research.  According to Appalachian's IRB the researcher must give the following information: 

1.  Purpose of proposed research.

2.  A description of the research procedure informing the use of a human subject.  This description will include methods of recruiting, the subjects, inducements to participant, tests, and questionnaires.  He/she will also need to include the instructions which will be given to the participants about the activities they will be engaged in.  There also needs to be a discussion of the procedures to be used for obtaining informed consent (See informed consent checklist).  The researcher must ensure that no pressure will be employed in soliciting student involvement.  In the case that the subject is a child, prisoner, mentally or physically challenged, or pregnant, it must be noted how special conditions will be handled.

3.  Does the research entail possible risk of psychic, legal, physical, or social harm to the subjects?  If so, explain what steps have been taken to keep risks at a minimum.  What provisions have been made to insure that appropriate facilities and professional attention necessary for the health and safety of the subjects are available and will be utilized?

4.  Justify the benefits of this activity to the subjects and to humans in general.

5.  How will prior informed consent be obtained?  Please attach a copy of the consent form used.

6.  Will the confidentiality of all subjects be maintained?  If yes, how is this accomplished?  If no, has a formal release been obtained?

7.  Do the data to be collected relate to any illegal activities?  If yes, please explain.

8.  Is deception involved?  If yes, please explain.

9.  Are all subjects protected from the future potentially harmful use of the data collected in this experiment?  How is this accomplished?

Informed Consent

    An essential step in research process would be informing the individual of particular information and guidelines which would be addressed before any subject participants in a study.  Every individual involved in the study must give their informed consent before the study begins.  According to the American Psychological Association, the following are important guidelines of informed consent:

• Investigators use language that is reasonably understandable to inform participants of the nature of the research.
• Investigators appropriately document that informed consent was given by the participants
• Participants are informed that they are free to participate or to decline to participate or to withdraw from the research, and they are given an explanation of the foreseeable consequences of declining or withdrawing.
• Participants are informed of significant factors that may be expected to influence their willingness to participate (such as risks, discomfort, adverse effects, or limitations on confidentiality). If prospective participants inquire about these or other aspects of the research, the investigator must furnish an explanation.
• When prospective participants are students or subordinates, investigators take special care to protect participants from any adverse consequences of declining or withdrawing from participation.
• When research participation is a course requirement or opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.
• For persons who are legally incapable of giving informed consent, researchers nevertheless (1) provide an appropriate explanation, (2) obtain the participant's assent, and (3) obtain appropriate permission from a legally authorized person, if such substitute consent is permitted by law.

* Adopted by Section 6.11 of the American Psychological Association's  "Ethical Principles of Psychologist and Code of Conduct"

References:

www.sahs.utmb.edu/pellinore/Intro_to_research/wad/ethics.htm

www.graduate.appstate.edu/rsp/irb/reqforrev/irbpolicyfinal1202.doc

www.acs.appstate.edu/~kms/classes/psy2664/irbchk/html

www.socialpsychology.org/consent.htm