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					           Preparing Informed Consent Documents


This document contains guidance for principal investigators (PI) and faculty sponsors (of student
PIs) in creating informed consent documents (ICDs). The IRB has prepared this guidance, based
on the observation that approval of projects is often delayed because the ICD does not meet the
requirements of ISU policy and Federal regulations. It is important to emphasize that informed
consent is not just a form; it is a process of informing subjects of their rights, responsibilities,
and risks that continues throughout the study. If the PI is a student, the faculty sponsor must
be actively involved in developing the informed consent process and in creating the ICD.

We recognize that writing an informed ICD is not straightforward, so we have prepared
templates to follow when preparing your ICD, along with examples of ICDs that meet the
requirements of ISU’s policy and Federal regulations. For more information, refer to the
discussion of the informed consent process in ISU policy on ISU’s IRB website (IRB Policy). An
Informed Consent Checklist is available to help you make certain that you have covered all
required areas of the consent process (Informed Consent Checklist).

If you have any questions, contact the IRB before creating the ICD (x8217 or irb@indstate.edu).

This document is not intended to cover all possible types of studies, but rather focuses on the
most common types of studies conducted at ISU.




                                         Guidelines

Basics of Preparing Informed Consent Documents
Regulations recognize two broad categories of research: socio-behavioral and biomedical. The
nature of the specific study, rather than the researcher’s academic discipline, determines whether
the research is considered biomedical or socio-behavioral.

Socio-behavioral studies include methodologies such as surveys, interviews, focus groups,
observations of children in classrooms, educational tests, and evaluation of nonmedical treatment
programs. Biomedical research includes methodologies such as medical tests (e.g., drawing
blood), physical interventions (e.g., exercise, induction of muscle cramp), or medical or surgical
procedures. Some studies contain aspects of both types of research. Either type of study can be of
“no more than minimal risk” or of “greater than minimal risk.”




Indiana State University                                                                   7/7/2010
Institutional Review Board                                                               Page 1 of 6
In certain cases, some or all of informed consent may be waived or altered. For the conditions
under which waiver is possible, refer to the Informed Consent Checklist. If you believe that your
study qualifies for a waiver or alteration of informed consent, you should request the waiver or
alteration in your IRB application and provide a rationale for the waiver or alteration based on
the conditions described in the Informed Consent Checklist.

In general, when preparing an ICD you should:

 Consider the reading level of the potential participants.
 Regardless of reading level, use simple language. If you need to use scientific terms, define
  them.
 Avoid using abbreviations or acronyms unless they are spelled out first.
 Be concise.
 Use the pronoun “you” consistently throughout to refer to the subject/participant (except for
  the last section of the ICD).
 Number the pages if the ICD is more than one page.
 Spell everything correctly and use correct grammar. The most common error is the spelling
  of principal investigator: it is principal not principle.

If your study is to be conducted in a foreign language, you must prepare an ICD in English and
in the language in which the research is to be conducted. You should first prepare the English
version. Once it is approved by the IRB, translate it and submit the translation for approval. Both
the English and foreign language versions must be approved before the IRB can give final
approval. The local culture will dictate the appropriate type of informed consent. If you have
questions, please contact the IRB chairperson or vice chairperson.


Some Common Myths about Informed Consent
 The PI determines the level of review required.
   The PI initially proposes a level of review (exempt – see Form B, expedited – see Form
     C, or Full) and develops an informed consent process and ICD based on that opinion.
     Only the IRB can determine the review level that is required before the study can be
     approved.
 Exempt studies do not require informed consent.
   ALL studies involving human subjects require informed consent or require a waiver of
     informed consent. Only the IRB can authorize a waiver.
 All ICDs require a signature.
   Anonymous surveys do not require a signed ICD.
        If the only information linking a subject to the study is a signature on the ICD, this may
         only increase the risk of disclosure of information that may be harmful to the subject.


Indiana State University                                                                    7/7/2010
Institutional Review Board                                                                Page 2 of 6
        Many studies of no more than minimal risk do not require a signature even if they are not
         anonymous. Whether a signature is required depends on the nature of the study and the
         likelihood and consequences of a breach of confidentiality.
 If you cannot obtain informed consent, you cannot do the study.
   Many record-based studies preclude the possibility of obtaining informed consent.
      Hospitals and other types of organizations often have mechanisms to “de-identify”
      records of individuals that would otherwise be private. Alternatively, organizations may
      have mechanisms by which certain types of confidential records can be made available to
      researchers. It is frequently possible to conduct such studies without informed consent.
        Only the IRB can determine whether a researcher may pursue a study in the absence of
         informed consent.
 All studies involving children require signed parental permission.
   Under Federal human subjects protection regulations and ISU policy, it is sometimes
      possible to waive signed parental permission for certain types of studies – BUT 
        Other Federal regulations (e.g., PPRA) and local policies not related to human subjects’
         protection govern whether parental permission is required to collect data from children at
         school. Many school districts require signed parental permission to conduct any research,
         regardless of risk level. ISU requires a letter of approval from the school
         district/corporation and usually the individual school(s) for ALL studies conducted in
         schools.




                     Templates and Example Consent Forms

This document provides templates and example consent forms for the most common types of
research conducted at ISU.

Vulnerable populations, including children, prisoners, and decisionally impaired persons require
special steps to be taken in the informed consent process. The only such population for which we
have included templates is children. If your research includes some other vulnerable population,
please refer to Federal regulations and ISU policy or contact the ISU chairperson or vice
chairperson for additional guidance.

The level of risk determines the type of ICD and informed consent process. When considering
the level of risk, think about the potential for the study to harm to the individual. Several
potential types of harm are to be considered:

     Emotional or psychological harm, for example when a research interaction causes upset
      or worry
     Social harm due to stigma or other negative social outcomes (e.g., embarrassment,
      damage to subject’s reputation) of breach of confidentiality


Indiana State University                                                                   7/7/2010
Institutional Review Board                                                               Page 3 of 6
     Physical harm of the research procedures themselves or through a breach of
      confidentiality. For example, physical harm may occur if a subject reveals information
      about someone else who may be violence-prone. Such harms may occur when
      researchers study topics such as domestic violence, gang activity, or political activity in a
      conflict zone.
     Financial harm if revelations can potentially result in loss of employment or insurance
      coverage, such as when an individual may reveal a heretofore unknown medical
      condition
     Legal harm when illegal activities are disclosed. Such disclosure may lead to arrest for
      criminal activity or incur civil liability.
     Moral harm when participation in research strengthens subjects’ inclinations to behave
      unethically

Your ICD does not have to look exactly like the templates and examples presented here, but
must contain all of the relevant elements of informed consent. Refer to the Informed Consent
Checklist (Informed Consent Checklist) for a detailed list.

On the templates presented here, the words in red italics provide instructions to the PI.


Survey of Not Greater than Minimal Risk
To be considered not greater than minimal risk, a study must be unlikely to cause any of the
harms described in the previous section.

         Minimal risk means that 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. The definition of minimal
         risk is somewhat different for children and prisoners.

Many surveys in this category are anonymous. Be aware that anonymous and confidential do not
mean the same thing. Anonymous means that the investigator does not know the identity of the
research subject or cannot link data to a specific subject. Confidential means that the investigator
knows the identity of the research subject and usually can link data to a specific subject, but
promises not to reveal any information provided by the subject. This distinction is important. Be
sure to use correct term in your ICD. Another important aspect of identification is that the
identifier can be something other than a name, e.g., Social Security number, student ID number,
street address, medical record number.

Anonymous surveys are generally self-administered; they may be completed through the mail, in
a group (e.g., classroom), or by the individual respondent sitting alone in a room. Telephone
surveys are also usually anonymous, as are some face-to-face interviews (not in-depth
interviews).




Indiana State University                                                                      7/7/2010
Institutional Review Board                                                                  Page 4 of 6
Generally, the ICD for such studies is short and may serve as an introduction to a survey. It does
not need to be signed by the research subject. The survey can begin on the same page as the
introductory paragraph.

Exhibit A is the template for an anonymous survey of no more than minimal risk. If this is a
mailed survey, you may adapt this same template for use as an introductory letter. If it is a
telephone survey, it may be converted to a script.

If you plan a survey or interview that is not anonymous, but is of no more than minimal risk,
then you will need to inform the subject of that fact. You may be able to adapt the template in
Exhibit A for this type of study, as well.

The ICD template included here contains all of the required elements from the Informed Consent
Checklist. Your specific study may require additional (or possibly even fewer) elements; be sure
to refer to the Informed Consent Checklist to make sure.

The subject normally reads this material to himself or herself. Be sure that the reading level is
appropriate to the population you are studying. There are certain instances in which the ICD does
not have to be as detailed as this example.

Exhibit B is an example of an ICD using the template in Exhibit A. Exhibit C is an example of
a survey cover letter that has been adapted from this template. A cover letter may be used alone
if it is provided to the subject along with the survey. If you provide the subject with the survey
and ICD at the same time, you do not need both the cover letter and the ICD.


Informed Consent Form for Research involving Greater than Minimal
Risk or in which Subjects Are Not Anonymous
Exhibit D is the general template to be used for all studies that are considered to be of more than
minimal risk, based on the categories of harm described above. It is also used for studies in
which the subject’s information is confidential rather than anonymous. Normally, only the
subject needs to sign the ICD. Under certain circumstances, the IRB may require the signature of
a witness, investigator, or legal representative.

Again, your ICD does not have to look exactly like the template, but it must contain all required
elements of informed consent. Although subheadings are not required, using them often helps to
communicate with the subject and frequently improves the readability of the ICD. Be sure to
tailor the ICD to the reading level of your subjects. Exhibit E is an example of a consent form
using this template.


Informed Consent Forms for Research with Children
When children (defined by Federal regulations as persons who have not yet reached their 18th
birthday) are involved in research, special rules apply and the informed consent process requires

Indiana State University                                                                   7/7/2010
Institutional Review Board                                                               Page 5 of 6
an additional step. First, a parent or guardian must normally give written permission for the child
to participate in research. (Sometimes it is possible to waive signed parental permission.) Then
the child is asked to give his or her assent to participate.

Be aware that you cannot have a single form that obtains both parental permission and child
assent. They must be two separate forms. One reason for this is that the reading level will
generally need to be different for the child assent than for the parental permission form. Also,
even if a parent gives permission for his or her child to participate, in most cases, the child can
refuse. (Research conducted on very young children is an exception.) Normally, only one parent
or legal guardian is required to sign the permission form. Rules are different for children who are
wards of the state; refer to Federal regulations (45 CFR 46, Subpart D) and ISU policy for more
details.


Parental Permission Form

For most studies involving children, a permission form from a parent or legal guardian is
required before the study can be conducted. Most such studies are conducted in schools, but may
also be conducted at recreation centers, clinics, and day care centers. School district policies
often require signed parental permission even when Federal regulations may allow a waiver of
such permission. In these cases, the IRB must follow the school district’s policy.

Exhibit F is the template for a parental permission form. The form should be adapted to the level
of risk and the age of the child. For parents of older children, some elements may not be
necessary. If more than one child in a family is to be involved in the research, only one
permission form is required, but it should contain sufficient space to list the names of all children
in the family being asked to participate.

Exhibit G is an example of a parental permission form using the template in Exhibit E. In this
study, the children are between about 9 and 13 years old.


Child Assent Form

Most children who are in research studies are capable of understanding enough about the study
to decide whether they want to participate. For them, the assent form serves the same function as
an ICD. Federal regulations set no specific minimum age above which assent must be obtained.
Use of assent will depend on the age and developmental characteristics of the children in the
study. Sometimes the assent is verbal only and no signature is obtained. If a study encompasses a
wide age-range, you may need to prepare more than one assent form, each tailored to the age and
reading level of the children involved.

Exhibit H is a template for a child assent form. Remember that the actual assent language must
be tailored to the age of the children in the study. Exhibit I is an example assent form for the
same study as that in Exhibit F.



Indiana State University                                                                    7/7/2010
Institutional Review Board                                                                Page 6 of 6

				
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