C.

Informed Consent

Informed consent means that participants have adequate information regarding the research, are
capable of comprehending information, and have the power of free choice, enabling them to consent to
decline participation voluntarily. Self- determination or autonomy requires that the prospective participant
has been fully informed about the study before he consents to participate and before he signs the consent
form. Polit and Beck (2004) present in full the pieces of information to be communicated to each study
participant:

1. Participant Status- Prospective participants should clearly understand the distinction between research
and treatment and should be informed that the data they will provide will be used for research purposes
only.

2. Study Goals- Overall goals should be stated in clear, understandable layman’s term, rather than
technical terms.

3. Types of Data- Prospective participant should know the types of data to be collected or the data they
need to provide.

4. Procedures- Data collecting procedures must be explained including those to be used any innovative
treatment.

5. Nature of the Commitment- Information should be provided regarding the schedule of the contacts
and the number of contacts within the specified time frame.

6. Sponsorship- The prospective participant should be given information on the study’s sponsorship and
funding, or if the study is part of an academic requirement.

7. Participant Selection- Information on participant selection- the how and the how many- should be
shared.

8. Potential Risks- Information on the any foreseeable risks or discomforts and any possibility of
unforeseeable risks should be shared and discussed. The participant should be assured that treatment will
be made available to him/her in the event of an injury.

9. Potential Benefits- Benefits and possible benefits to participants and others should be described in
specific terms.

10. Alternatives- If appropriate, information about alternative procedures or treatment that might be
advantageous to the prospective participants should be shared.

11. Compensation- Arrangements regarding stipends, reimbursement, and or free use of treatments
should be discussed.

12. Confidentially pledge or anonymity guarantee- Prospective participants should be assured that their
privacy will be protected and their anonymity will be guaranteed.

13. Voluntary Consent- the researcher should explain that participation in the study is strictly voluntary
and will not result in the loss of benefits or in penalty.
14. Right to withdraw and withhold information- Prospective participants should be told that they have
the right to withdraw from the study and to withhold specific information even if they signed the consent.

15. Contact Information- The researcher should provide prospective participant information on whom to
contact in case of questions, problems or concerns related to the study.

ACTIVITY:

1. Read the following and determine the elements of informed consent that are present. What you do
is to extract the statement from the paragraph then write the element beside it.

Example: Participation in this project is strictly voluntary - voluntary consent

You are being invited to participate in a research project concerning assertiveness levels and locus of
control. Participation in this project is strictly voluntary, and your grade in this class will not be
influenced by your failure to participate in this study. You may choose to write a short research paper to
earn the equivalent class credit.

Your participation in this study will require approximately 30 minutes of class time and will involve
completion of two questionnaires. There are no risks involved in this study other than the uncomfortable
feelings that may arise when reading the questions. There are several potential benefits of participating in
this study. You may learn more about yourself and also learn about the research process. Additionally, the
knowledge gained from this study will help nurse educators to predict assertiveness levels and locus of
control levels of nursing students in the future.

Answers will remain anonymous. Please do not put your name or any identifying information on the
questionnaires. If you have any questions, please feel free to ask them. Results will be available on
completion of the study.