As no generic consent document can perfectly suit every by ypq25841


									As no generic consent document can perfectly suit every study, individual investigators must exercise their
own judgment in numerous places in this document. This document is formatted as a group of directions
and questions that if answered should result in a consent form that includes most of the elements that the
SBSIRB requires. The questions are followed by examples that can be used as a template for your own
consent documents but additional information that is specific to your study will almost always be needed.

Unhighlighted areas- Headings and things that should probably be left “as is.”
Red- Items that must be filled in with information unique to your research.
Pink- Directions- These sections should be deleted in the final consent document as they are directions and
not a part of the final consent document.
Blue- Example text- Use the words in Blue highlight as a template for your text adapting as needed.

If using Word, all highlighting can be turned off in the final document at one time by selecting all the text
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  TITLE OF RESEARCH PROJECT - this MUST be the same as the protocol title on the IRB application
                              Informed Consent Document

This consent form explains the research study. Please read it carefully. Ask questions about anything you do
not understand. If you do not have questions right now, you should ask them later if any come up.

You must list here the name of the principal investigator and his/her official contact information. If this is a
student project, the student’s faculty advisor and contact information must also be listed. Contact
information (phone, e-mail, federal mail) must be appropriate for the subject population (e.g. an e-mail
address should not be the only contact method given to a study population made up of nursing home
residents) and should direct subjects to university or professional (not home) locations.

This study is being conducted by John Smith ( under the supervision of Dr.
Jane O’Connell ( Any questions, concerns or complaints that you may
have about this study can be answered by John Smith. Mr. Smith and Dr. O’Connell can be reached through
the Department of NNN, University at Buffalo, Amherst NY 14260 or by telephone at (716) 645-XXXX.

If you have any questions about your rights as a participant in a research project, or questions, concerns or
complaints about the research and wish to speak with someone who is not a member of the research team,
you should contact (anonymously, if you wish) the Social and Behavioral Sciences Institutional Review
Board, 515 Capen, University at Buffalo, Buffalo, NY 14260, e-mail, phone
716 / 645-6474.

The purpose of the research project must be explained in language that is readily understandable by ordinary
people including the subject population. Jargon and technical terms should be avoided. Also tell how many
people you expect to enroll in the study. If subjects are being followed for survival, it must be indicated that
the investigator intends to do so.
You are invited to participate in a clinical research project that examines the way that school-age children
communicate with each other in a social setting. The results of this study should help to further our
understanding of how young children communicate with each other both verbally and nonverbally. This
understanding will help us (and other therapists) to develop more effective intervention programs to assist
children that have difficulty communicating with their classmates. Approximately 50 participants will be
involved in this segment of the study.

Describe what participants will be asked to do. A step by step approach is often helpful in keeping this
clear. Tell about types of questions that will be asked, especially for sensitive topics such as illegal
behavior, depression, sexual behavior, AIDS/HIV, drug or alcohol abuse, suicide, abusive behavior, child
abuse, etc. The option of a participant to not answer questions, if that is their wish, must also be given in the
procedures. The approximate time commitment for participants must also be given. The procedures given
in the consent document must be consistent with those in your protocol. Anticipated circumstances under
which the subject's participation may be terminated by the investigator without regard to the subject's
consent should also be included. The consequences of a subject's decision to withdraw from the research if
any, and procedures for orderly termination of participation by the subject, must be included when there is
possibility that a participant will decide not to continue in the study until completion and the participant’s
involvement may be longer than a single research session.

If you agree to be a part of this study, you will first be asked to fill out a demographic questionnaire about
your family. Filling out the questionnaire should take about 10 minutes. You will then be asked to
participate in an interview about your child’s social skills. Some of the questions may be a bit personal or
sensitive (for example, Has your child ever been diagnosed as having ADHD? Does your child ever refuse
to cooperate with you when asked to do something? Does your child ever throw a temper tantrum?) This
interview should take about an hour to complete. You are free not to answer any questions you do not wish
to answer. After the interview is completed, you will be asked if you are willing to be interviewed a second
time at a later date. If you agree to do so, you may be contacted by Mr. Smith for a second interview. As
this portion of the study is designed to focus on children who exhibit disruptive behavior but are not
currently diagnosed as having ADHD or other similar behavioral diagnosis, the data you provide will not be
used for this study if your child is currently diagnosed with ADHD or a similar condition. You may
withdraw from the study at any time. Just let your interviewer know that you no longer wish to continue
with the interview. Withdrawing would have no foreseeable negative effects.

For clinical research, a disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject must also be given. When applicable, if blood samples will be drawn,
information regarding the amount of blood that will be drawn should be provided.
Describe to your participants the extent, if any, to which confidentiality of records will be maintained. Study
records include any data recorded on study instruments, notes, transcriptions, electronic files, pictures, audio
or video tapes. Make sure that the confidentiality procedures described to participants are consistent with
those in your protocol. Inform participants if medical records, court records, grades, exam scores, or other
personal documents will be examined or used. Tell participants how long tapes or other materials will be
kept; who will be able to view or listen to the tapes; and if and how the tapes will be destroyed or erased. If
a subject refuses to be taped but still may participate in the research, state the options with a line to initial for
each option (see below). If your research includes videotaping classrooms, you must provide an option to
participants who do not wish to be videotaped, such as allowing them to sit outside the microphone or
camera range, or in the back of the classroom. There is an important distinction here between confidentiality
and anonymity that should be made clear to participants and the following examples with sample wording
for the consent document are given to assist you in preparing the confidentiality section.
For any given method of data collection there are a number of ways that data can be recorded and it may be
appropriate for your study to use selected parts from any or all of the examples below in one consent
    1. Information can be obtained anonymously so that once the researcher is in possession of it, no one
        (even the researcher) can ever tell where it came from. An example of this type of data collection is
        a mailed survey where the participant returns the survey in an envelope provided by the researcher
        with no return address. The information you provide by filling out the survey is completely
        anonymous and therefore no one will be able to identify your responses. The data from your survey
        will become a part of a public national database and retained indefinitely for use in future studies of
        mathematics competency and education levels. Your identity will in no way be related to the study.
    2. Information can be obtained confidentially but recorded anonymously. An example of this type of
        data collection would be an interview process done in a private setting where the researcher meets
        with a participant but does not record any identifying information in the interview notes. While
        your responses to the interview questions will be known to the research assistant who interviews
        you, they will be recorded anonymously in the research notes. All proper names will be replaced by
        pseudonyms. The only connection between your participation in this study and the study itself will
        be this signed consent form but there will be no association between your identity and the
        information you provide in the interview. Your identity will not be made a part of any published
        findings resulting from this study. The research notes will be destroyed within 1 year of the date of
        the interview.
    3. Information can be obtained confidentially, recorded confidentially and later made anonymous. An
        example of this would be the use of an audiotape for recording a focus group where after the focus
        group was completed, the researcher transcribes the tape and removes all identifiers in the written
        transcription. The tapes and any transcription notes with identifiers are then destroyed. A second
        example of this would be the use of a numeric code on a mailed survey that would be linked to the
        participants’ identities through a master list retained by the PI so that subsequent mailings in a
        longitudinal study can be equated to the same individual. After the final mailing was sent out to
        participants, the master list could be destroyed thus making the data anonymous. If you choose to
        be a part of the focus group, the discussion will be audio taped. Within one week of the creation of
        the tape, it will be used by the researcher, Mr. Smith, to create a transcript of the discussion. All
        transcribed data will have proper names including those of people, schools and towns replaced by a
        pseudonym. The tapes will then be erased so that there is no remaining link between any statements
        you have made and your identity. Mr. Smith and Dr. Jones will be the only people to listen to the
        tapes. The only connection between your participation in this study and the study itself will be this
        signed consent form but there will be no association between your identity and the information you
        provide in the interview. Your identity will not be made a part of any published findings resulting
        from this study. The transcriptions made from the tapes will be destroyed within three years of the
        completion of the study.
    4. Information can be obtained confidentially and recorded confidentially but will never be made
        anonymous. This type of data collection will seldom be accepted by the SBSIRB because data that
        is linked to an individual always poses a confidentiality risk and there is rarely compelling scientific
        reason for not minimizing this risk at some point in time. One notable exception might be in a
        clinical treatment protocol where the research data becomes a part of the participants’ medical
        records. There may be other circumstances where this type of procedure could be acceptable but the
        burden of convincing the IRB rests with the investigator.
    5. Information can be obtained confidentially, recorded confidentially but will be presented with the
        identity of the participant revealed upon receiving permission of the participant to do so. Again, the
        SBSIRB does not usually accept this type of procedure because revealing the participant in
        publication along with their data usually puts them at risk. One notable exception to this is a
        situation where the research responses present no risk whatsoever to the participant and their
        participation requires acknowledgment of the researcher (e.g. linguistic ellicitation where the
        language of interest is spoken by very few persons). You will receive recognition for your
        participation in this research by acknowledgement in any publication that results from this research.
        The information recorded by the researcher will be recorded along with your identity so that this
        acknowledgement can be made. Be aware that any statements you make related to this research
        project will become public and will be linked to you.

The confidentiality section of a protocol should also state any cases where confidentiality may be
purposefully breached by the researcher if there is a potential that the study may obtain information that
must be reported to authorities or to avoid imminent danger to the participant or others. Confidentiality will
not be maintained in the event that child abuse and/or homicidal or suicidal intentions are identified. In
these instances, a report to the appropriate governmental authorities will be made.

Describe any foreseeable risks or discomforts to participants including those that may result from an
unintentional breach of confidentiality and any steps you have taken to minimize these risks in language that
is readily understandable to ordinary people. The statements made here must be consistent with those made
in the risks section of your protocol. Select one of the following as a starting point: A statement that
significant new findings developed during the course of the research, which may relate to the subject's
willingness to continue participation, will be provided to the subject should be included.

For applicable studies, a statement should be made that the particular treatment or procedure may involve
risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently

For applicable studies, state that there is a risk of breach of confidentiality until tapes are transcribed, the
transcript is de-identified, and the tape is erased.

For focus groups, there is always a risk of breach of confidentiality because other participants are present.

Option#1:The known risks associated with this study include the possibility that you might become upset
thinking about some of the questions or topics in this study. If this occurs, you should notify the interviewer
and you will be provided with an appropriate referral for assistance. The risk of a breach of confidentiality
that might affect your employment status has been minimized by the confidentiality procedures discussed
above. Any significant new findings developed during the course of this research that uncover new risks,
which may affect your willingness to continue participation, will be provided to you in writing.

Option #2 If there are NO known risks simply state this. There are no known risks to participating in this
research. If the research involves treatment, a statement that the particular treatment or procedure may
involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are
currently unforeseeable, should also be included. Any significant new findings developed during the course
of this research that uncovers new risks, which may affect your willingness to continue participation, will be
provided to you in writing.

All research must have some potential benefit or else there is no reason to carry it out. The statements made
here must be consistent with those made in the benefits section of your protocol. Note that any
compensation may not be listed as a benefit of the research. Select one of the following as a starting point:
Option #1 Describe any direct benefits that may be expected to individuals who participate in the project.
The direct benefits that may reasonably be expected to result from participating in this study include
learning new techniques for coping with stress related to caring for a disabled relative, and the opportunity
to verbally share thoughts and feeling related to the research with others who are in a similar situation. Then
describe any indirect benefits. The study may also help researchers to improve future services for those who
are faced with providing physical care for others.

Option #2 If there are no direct benefits to participants state that fact and then describe the indirect benefits.
There are no anticipated direct benefits to you for participating in this study but the study will assist
educators in developing better mathematics curricula in the future.

The appropriate examples from the costs section and the compensation section can be combined to form one
paragraph. Describe any additional costs to study participants that may result from participation and any
reimbursement procedures.

Example #1 (No costs). There is no cost to you for participation in this research.

Example #2 You will be required to provide your own transportation to each of the four interviews that take
place at one month intervals. No direct reimbursement for transportation costs will be provided.

Describe any compensation that will be given to participants including monetary payments, class credit, or
other forms of reimbursement. A prorated compensation scheme should also be given in appropriate cases
for participants who complete only part of the study. State the timeline for payments if payment will be
delayed for any reason. Indicate any alternative procedure for compensation that might be available to the
subject such as writing a paper, etc. Any alternative means of obtaining compensation / equivalent credit
must take approximately the same length of time as participation in the study.

When applicable, the following should be added to the compensation section:
   Subjects should be informed that compensation of $600 or more paid to them within one calendar
      year is required to be reported to the IRS.
   Subjects should be informed if any information is required (social security #, address, etc.) in order
      to receive payment.
   Identification of the sponsor in sponsor–initiated studies
   A disclosure statement if the Investigator is being directly compensated for conducting the study or
      has a significant financial conflict of interest

Example #1 You will receive a $20 mall gift card for participation in the interview even if you decline to
answer some of the questions.

Example #2 You will receive 10 points of extra credit added to one of your three 100 point test grades in
CHE 101 for completion of the research computer assignment on molecular modeling. Five points will be
given for completion of between half and all of the assignment. No credit will be given for completing less
than half of the assignment. As an alternative to completing the research computer assignment, you may
write and turn in by December 10th, a 2-page review paper on molecular modeling based on the article
handed out in class.

Example #3 (If there is no compensation) There is no compensation provided for participation in this study.
(Only for studies that are greater than minimal risk): Provide an explanation regarding availability of
compensation for medical treatment if injury occurs, what the treatment consists of, where further
information may be obtained and whom to contact in the event of a research-related injury to the participant.
Do not use legalese in doing this. The following should be made a part of this statement: “This document is
to provide the information participants need to know in order to make a good decision about study
participation. It is not to execute a waiver of liability on behalf of the researcher or sponsor. By signing this
form, you are not waiving any legal rights.”

Your participation is voluntary. Your refusal to participate will involve no penalty or loss of benefits to
which you are otherwise entitled as an (e.g., employee, student, client, inmate) of (e.g., employer, school,
clinic, detention center, prison, etc.). You do not have to answer every question and may refuse to answer
any questions that you do not want to answer. (If not answering questions would cause you to have to dis-
enroll participants from the study, be sure to note this, and any resulting consequences of being withdrawn,
in the consent form.). You may withdraw from the study at any time by contacting the investigator and all
data that can still be identifiably attributed to you will be withdrawn by the investigator.

If applicable, explain the consequences of a subject’s decision to withdraw from the research, and
procedures for orderly termination of participation by the subject. If there are anticipated circumstances
under which the subject’s participation may be terminated by the investigator without regard to the subjects
consent, these must be stated.


I have read the explanation provided to me. I have had all my questions answered to my satisfaction, and I
voluntarily agree to participate in this study. I HAVE BEEN GIVEN A COPY OF THIS CONSENT

NAME OF SUBJECT (Please Print)



"I certify that I obtained the consent of the participant whose signature is above. I understand that I must
give a signed copy of the informed consent form to the participant, and keep the original copy on file in the
repository location designated on my IRB application files for 3 years after the completion of the research



                             (If applicable) Video / Audio Tape Release Form
(If applicable) I give consent to be audiotaped/videotaped during this study:

Please initial: ____Yes ____No

(If applicable) I give consent for my identity to be revealed in all written data resulting from this study.

Please initial: ____Yes ____No

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