Evidence-Based Practice for Nurses

If there are risks to subjects, those risks must be clearly

detailed and include any physical, emotional, spiritual,

economic, social, or legal risks.

There are other factors to consider when obtaining in-

formed consent. Informed consents should be written in

simple language. If subjects cannot read, forms should be

read to potential subjects. For subjects who speak English

as a second language, consent forms should be read by an

interpreter or written in the subjects’ native language. Subjects should have suf-

ficient time to carefully think about whether or not to participate. Both subjects

and researchers must sign consent forms after researchers assure subjects that

participation is voluntary. Consent forms should not be kept with data; this protects

subjects’ confidentiality. A copy of the signed form should also be given to subjects.

There can be some unique circumstances for obtaining informed consent. For

example, if there is minimal risk associated with participation in the study, the

IRB may not require the signing of consent forms. Rather, it may be required

that a statement indicating that completion and submission of the survey im-

ply that the subject is giving informed consent. With vulnerable populations,

the researcher needs to have clearly stated guidelines as to how the informed

consent will be obtained (Polit & Beck, 2014).

Title of study

Invitation to participate in the research study

Participation is voluntary

Basis for subject selection

Purpose of study

Explanation of procedures

Benefits and risks

Alternatives to participation

Financial obligations/compensation

Confidentiality assurance

HIPAA disclosure

Subject withdrawal without penalty or consequences

Offer to answer questions

Consent statement

Identification of researchers

Modified from U.S. Department of Health and Human Services.

(2009). Code of Federal Regulations. Title 45: Public welfare. Part 46:

Protection of human subjects. Retrieved from http://www.hhs.gov

/ohrp/humansubjects/guidance/45cfr46.html

BOX 11-2

Mandatory Components

of Consent Forms

FYI

When inviting subjects to participate in

studies, researchers must obtain informed

consent, with particular regard for vulnerable

populations. With children, nurses should

obtain assent. Nurses should also maintain

anonymity and confidentiality as well as avoid

coercion when sampling.

304 CHAPTER 11 Using Samples to Provide Evidence