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Research on Human Subjects Tutorial (Dr. Joan E. Aitken, Park University)

If Dr. Aitken is your advisor,

DON'Ts. 

• You canNOT use participants under 18,

• cannot use participants who are members of a protected population (no one pregnant, no one in prison, no one with a mental disability),

• cannot conduct research that provides any financial gain to anyone,

• cannot collect health information,

• cannot collect names or demographic information,

• cannot conduct research that involves anything beyond minimal risk,

• cannot use deception.

• cannot use of  Video or Audiotaping.

• cannot use a sensitive topic (e.g., sensitive topics include drug use, sexual practices, aggressive behavior, criminal activity). 

DOs.  Plan out every word in advance.  You will need to develop, attach, and label all  supporting documentation as part of your thesis/project proposal, which you submit to your committee for their approvals.  Make sure you also include all these items which are  relevant to your IRB application: 

• consent form(s),

• survey instruments,

• permission from the publisher to use published measures

• interview questions,

• solicitation letters,

• flyers,

• telephone scripts,

• e-mails,

• letters,

• verbal statements,

• advertisements used to recruit participants

• written letters of approval from each  performance site including cooperating businesses, schools, hospitals, organizations, clubs, or similar type of groups.  Letters must be on letterhead and from an individual authorized to approve such activities..

Informed Consent Form Template

This template has been developed to assist investigators develop an informed consent document that contains all of the elements of informed consent required by the federal guidelines and additional language required by the University.

The template should be downloaded and modified to meet the specific needs of the study.

The sections appear in an order intended to promote understanding of the research participants  but sections may be re-ordered as appropriate. Suggested and or required language for sections is printed in lowercase, guidance is italicized.

Consent for Participation in a Research Study

[  Project Title]

[Dr. Joan E. Aitken, Professor of Communication Arts, Park University and name of student investigator]

Invitation to Participate

“You are invited to participate in a research study”

Who will Participate

Identify the population eligible to participate as well as the number of participants sought.

Purpose

Include a brief statement which explains the research question and purpose in language that is not technical, and doesn’t use jargon or acronyms, unless they are defined. If the study includes deception , or the withholding of information, this section should be written so that the least possible withholding of information occurs.

Description of Procedures

Describe what will happen to the participant if they decide to participate, detail in a step-by-step manner the activities participants will be asked to engage in, how long it will take, where the research will take place, and how often they will be asked to perform the research tasks

Voluntary Participation

Explain that participation is voluntary , that research participants may choose not to participate at all, or may refuse to participate in certain activities or answer certain questions, or may discontinue participation at any time without penalty or loss of benefits to which the research participant is otherwise entitled.  Describe procedures for withdrawing as well as what will happen to any data collected from the participant prior to withdrawal.

 “Participation in this study is voluntary at all times.  You may choose to not participate or to withdraw your participation at any time.  Deciding not to participate or choosing to leave the study will not result in any penalty or loss of benefits to which you are entitled.”

“If you decide to leave the study the information you have already provided _________________.”

Fees and Expenses

"We know of no monetary costs to the participant."

Compensation

"There is no compensation for  participation or reimbursement for expenses." If class points or some other token are to be received by participants include that information here.  If compensation is pro-rated when a participant withdraws prior to completing the study, explain how it is pro-rated.

Risks and Inconveniences

Tell participants about any risks or discomforts that might occur including psychological, emotional, physical ,social , privacy issues, economic harm, risk of criminal or civil liability, damage to financial standing, employability, or reputation etc. If there are no known risks say so.

"There are no known risks or inconveniences to participating in this research.  If you feel any discomfort during the process, I will provide a list of local counselors or HR personnel who may be able to help you."

Benefits

List any direct benefits to research participants or others that may be expected from the research.  Usually there is only a possibility of benefit or no benefit (state accordingly). Benefits may apply directly to the participant or indirectly to society at large.

"There are no benefits to participating in this study, although we hope you will feel good talking about this topic and contributing to the academic research process."

Alternatives to Study Participation

Disclose appropriate alternative procedures or courses of treatment.  If there are no alternatives it may be stated “the alternative is not to participate”.  This section can be deleted if it does not impact the information needed for research participants to decide about participation.

"You have the alternative of not participating.  Participation is totally voluntary.  You should feel free to stop at any time, skip any questions, and know that we sincerely appreciate your willingness to participate in any way even if you decide not to continue."

Confidentiality

Describe the methods to be used to help ensure confidentiality.  Explain how the information will be stored, who will have access, and  when it will be destroyed. When applicable, explain any foreseeable circumstances, under which the Investigator will be required to give information about the research participant to a third party, such as mandatory reporting of child abuse.

"Your name will not be recorded, nor will any personal or demographic data be recorded that could allow other people to identify you. 

"This information will be stored on a computer where I am recording my notes.  Access to this information will require a password, which is unknown to others.  Neither your name or identifying information will be recorded on my computer.  I will be the only person who can access this information.  I will not repeat any information you tell me except to other researchers and faculty advisors.  When I report or publish the information you give me, there will be nothing to indicate you were the person who gave me this information."

Required text:  “While every effort will be made to keep confidential all of the information you complete and share, it cannot be absolutely guaranteed. Individuals from the University's Institutional Review Board (a committee that reviews and approves research studies) , Research Protections Program, and Federal regulatory agencies may look at records related to this study for quality improvement and regulatory functions.”

In Case of Injury

The University requires formal (but not informal) consent documentation to include the following paragraphs dealing with the University's liability to research subjects.

Required text:   “The University appreciates the participation of people who help it carry out its function of developing knowledge through research.  If you have any questions about the study that you are participating in you are encouraged to call my faculty advisor, who is Dr. Joan E. Aitken, Professor, Communication Arts, 229 Copley, 8700 NW River Park Drive, Park University, Parkville, MO 64152, 816-584-6785 joan.aitken@park.edu or me (student name), the investigator, at (phone number).”

Required text:  “Although it is not the University’s policy to compensate or provide medical treatment for persons who participate in studies, if you think you have been injured as a result of participating in this study, please call the IRB Administrator of University's Institutional Review Board at 816-____________.

Questions

Provide contact information for researchers including name, address, area code and phone number, and email address.

Faculty Advisor:  Dr. Joan E. Aitken, Professor, Communication Arts, 229 Copley, 8700 NW River Park Drive, Park University, Parkville, MO 64152, 816-584-6785 joan.aitken@park.edu

Student Investigator:

Authorization

Include a line for participant’s printed name, signature of participant and date, investigator’s printed name, signature of investigator and date. 

EXAMPLE FORMS AND PROCESSES

 THE CONSENT PROCESS

With very few exceptions research protocols must include a consent process providing the opportunity for potential research participants to make a fully informed decision whether or not to participate in the research. Informed consent is one of the basic ethical obligations for researchers.

Informed consent is a process not a form

Informed consent is a term which describes the communication process that enables individuals to make an informed choice about participation in a research study.  Consent is an ongoing process which starts well before any forms are signed and continues until the research subject’s  participation is complete.

The informed consent process includes the discussion which takes place between the investigator and the research participants and the written document that formalizes the agreement to participate and documents the process.

For consent to be informed, the research participants must fully understand the study.  Therefore information must be conveyed in a manner to enhance understanding rather than to just provide disclosure.

What needs to be said about the research

Although each research study is unique, the federal regulations for human research and the Institutional Review Board (IRB) identify basic elements of informed consent  [(45 CFR 46.116(a)&(b)] which are required to be contained in all consent forms:

1.  a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

2.  a description of any reasonably foreseeable risks or discomforts to the subject;

3.  a description of any benefits to the subject or to others which may reasonably be expected from the research;

4.  a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

5.  a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

6.   an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and

7.  a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

8.  the approximate number of subjects involved in the study.

What needs to be said about the conduct of the research

1.  Confidentiality

The best approach is to NOT collect any names or maintain any records that contain names.  The research cannot orally or in writing discuss information about or data collected about anyone in the study to anyone other than the faculty advisors or other researchers.

2.  No Conflict of Interest/ Financial Interest

3.  No payments to research participants

Documenting the research participant’s consent with a consent form

1.  Language used in consent forms and or information sheets must be understandable to the research participant, therefore:

o       It should be written at no higher than an 8^th grade reading level

o       Use short sentences and non-technical terms

o       The second person should be used since the first person can be interpreted as suggestive.

      ( the second person pronoun e.g., “you are being asked to participate in a study because….”

      is preferred because it is inherently more open and conversational with subjects.)

o       Do not use qualifying phrases such as   “you understand that” or substitute wording such as “you have been told” or “it has been explained to you.” 

o       Avoid language which may appear to waive any rights to which the research participant is entitled.

o       All scientific, medical and technical terms should be defined or explained.

o       No children can be involved.

o       All persons involved must be able to give informed consent.

o       No non-English speaking people can be used in the study. 

o       Check spelling and grammar.

2.  Format and specific requirements include the following:

o       Make sure there is at least a 1” margin on all sides.

o       Do not use a font smaller than size 12

o       Consent forms must be typewritten

o       Use headings and “white-space” to improve readability in long forms

o       Number  pages page x of y on each page

o       Include footer with current version date on each page.  This date should be updated each time a new version of the consent form is approved by the IRB.

Anonymous and Confidential Data must be clearly identified in the consent form. Promises of anonymity should not be made to subjects unless the research data is truly anonymous.  Anonymity can only be promised if there is no method by which anyone including the investigator can connect the research results with individual research participants providing the data.  If you're doing the data collection in SurveyMonkey and have no idea who might have received a participation request, it may be anonymous. 

The existence of codes or master lists that enable the investigator to identify research participants prohibits anonymity from being possible even though the research participants names may not appear in the data set.  In this instance the data would be considered confidential rather than anonymous.  Typically, you need to say you will keep information locked and indicate who--if anyone--of the researchers or faculty advisors will have access.

When to submit the form to the IRB

Investigators must submit consent forms when they first apply for IRB review and approval, and when they apply for continuing review.  Because the requirements for consent forms change over time, due in part to changes in regulatory mandates, the IRB reviews the form at renewal to ensure that it is consistent with current requirements.  In addition the IRB may ask investigators to revise consent forms at other times, when circumstances warrant.  Any revisions made to a previously approved consent form must be submitted to the IRB for approval BEFORE use.

Assent

In the State of Missouri only individuals 18 years or older may legally consent to participate in research.  This legal authority may be withheld for some groups of individuals with limited decision-making or cognitive ability.  In addition, some individuals voluntarily give this authority to another through a power of attorney or other legal instruments.  You cannot use these participants in your study.

Waiver or Alteration of Informed Consent

There are two types of waivers or alterations which may be presented to the IRB:

1.  Waiver or alteration of the PROCESS of obtaining informed consent can be obtained under certain circumstances.  In this instance the investigator would not obtain informed consent from the participant and there would not be an informed consent document reviewed and approved by the IRB.  The research however must meet certain conditions in order for such a waiver to be granted.  These conditions are outlined below.

o       An example of such a condition might be if an investigator wishes to review and record existing identifiable information from a dataset for the purpose of analysis. The information might have been recorded several years ago and therefore the likelihood of being able to contact participants is not practicable.  If the information to be recorded would not place research participants at risk should there be a breach of confidentiality it is possible that this type of research may meet the acceptable conditions in which a waiver may be granted.

2.  Waiver or alteration of the DOCUMENTATION of informed consent can also be obtained under certain circumstances.  In this instance the investigator obtains informed consent however a signature is not obtained.  Again, there are specific conditions which must be met which are described below.

o       An example of such a condition might be if an investigator wanted to conduct an interview by telephone  in order to determine the participant’s satisfaction with a new service available currently.  A script containing all of the required elements of informed consent would be required for review and approval however no signature would need to be obtained.

Waiver for Minimal Risk Studies

The IRB may also approve a consent procedure which does not include, or which modifies, some or all of the elements of informed consent, or waive the requirement to obtain informed consent entirely provided the IRB finds and documents that:

o       the research involves no more than minimal risk to the subjects;

o       the waiver or alteration will not adversely affect the rights and welfare of the subjects;

o       the research could not practicably be carried out without the waiver or alteration; and

o       whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Documentation of Consent Process

Under limited circumstances, the IRB may approve procedures which waive the requirement of a signed written consent document.  The IRB must find either:

o       That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or

NOTE:  If this requirement is waived by the IRB under this condition then each research participant must be asked whether they want documentation linking them with the research, and their preference shall govern.

o       That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

When the documentation requirement is waived, the IRB may require the investigator to provide written information statements regarding the research. This information sheet or letter should include the majority of the information that would be found in a consent form without the UMKC Disclaimer Statement and Signature Lines.

Certificates of Confidentiality

When additional protections are needed for the collection of sensitive data, the IRB may request or the Investigator may choose to obtain a Certificate of Confidentiality.  The existence of such a certificate should be described in the informed consent document.  For more information regarding this issue, see the excerpt below from the OHRP Guidance Document “Certificates of Confidentiality 2/25/2003”

            Certificates of confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or compelled disclosure.  They allow the Investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether Federal, State, or local.  Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for participants, such as damage to their financial standing, employability, insurability, or reputation.  By protecting researchers and institutions from being compelled to disclose information that would identify research participants, Certificates of Confidentiality help to minimize risks to participants by adding an additional level of protection for maintaining  confidentiality of private information.

For more information on Certificates of Confidentiality and their use see

http://grants2.nih.gov/grants/policy/coc

Consent and Language Barriers

When research will include non-English speaking participants, researchers should prepare both English-language and translated consent/assent forms. An explanation for the translation process and the expertise of the translator as well as a “back-translation” should be provided to the SSIRB. A back-translation process consists of the following steps : (1) the consent form written in English is translated into the subject’s language (2) The version in the subject’s language is translated back into English by someone unfamiliar with the original translation (3) the two English versions are compared for accuracy. This process requires the use of two translators.

[SAMPLE CONSENT FORM]

Consent for Participation in a Research Study

Physiological and Emotional Responses to Video Game Playing

Introduction

As an undergraduate student at __________ University who is at least 18 years old, you are one of  80 students being invited to participate in a study on playing video games.  This study will examine the physiological and emotional effects of video game play.  This study will take place in the ABC Laboratory of Dr. XXX.  The Laboratory is located in the UMKC XXX Department , at  123 XXX St.

Methods/Procedures

Your participation in this study will involve filling out a questionnaire about your current mood before and after playing a video game for approximately fourteen minutes.  You have been assigned to play a violent video game named Perfect Dark.  Perfect Dark is a game that is played in first person.  The goal of the game is to shoot and kill as many animated characters as possible within the allotted time without your character being killed.  You will see animated scenes containing guns, bloodshed, and characters being shot.  Perfect Dark is Rated “M” for mature by the Entertainment Software Rating Board ( ESRB).  The rating means that this game is only intended for people 17 and older and contains animated violence and animated bloodshed.  During game play your blood pressure and heart rate will be monitored by an automated blood pressure cuff on your left arm.  Skin conductance will also be monitored during game play by two sensors taped to the palm of your left hand.  Prior to, and immediately following game play you will be presented with a series of computer displayed photographs of some people, places, or objects.  While looking at the photographs a noise will be presented to you through a set of headphones, which will elicit a startle eye-blink response that will be measured by two small sensors taped to your cheek below your left eye.  The size of your eye-blink response will be used as a measure of your arousal level.  The study will take approximately one hour to complete.

Voluntary Participation

Your participation in this research is voluntary.  You may choose to participate or to withdraw your participation at any time. Deciding not to participate or choosing to discontinue participation in the study will not result in any penalty or loss of benefits to which you are entitled.  If you decide to leave the study the information you have already provided will be discarded and not used.

Fees and Expenses

You are not responsible for any costs or expenses associated with this study.

Risks and Inconveniences

You have been told that due to the violent nature of Perfect Dark  you could be bothered by some things involved in playing this game.  You have also been informed that you can terminate your participation at any time if you feel uncomfortable for any reason during the study.  If you are bothered by the experience of playing this game and would like to talk to someone about your experience you can contact the University Counseling Center located at __________________, phone __________________. 

Benefits

You will not benefit directly by participating in this study.  The main benefit will be to help researchers better understand the relationship between video game entertainment and physiological changes.

Alternatives to Study Participation

You can choose not to participate in this study.  Your decision to not participate will not affect your relationship with _____________ University  now or in the future.

Confidentiality

The researchers will keep secret all research-related records and information from this study to the extent possible by law. All of the records and information will be kept in a locked file drawer  and destroyed three years after the end of the study. Your name will not be on the information you give. While every effort will be made to keep confidential all of the information you complete and share, confidentiality cannot be absolutely guaranteed.   Individuals from the University's Institutional Review Board ( a committee that reviews and approves research studies), Research Protections Program, and federal regulatory agencies may look at records related to this study for quality improvement and regulatory functions. The researchers will not reveal your identity if they publish the results of this study.

In Case of Injury

The University appreciates the participation of people who help it carry out its function of developing knowledge through research.  If you have any questions about the study that you are participating in you are encouraged to call (name), the investigator, at (phone number).

Although it is not the University’s policy to compensate or provide medical treatment for persons who participate in studies, if you think you have been injured as a result of participating in this study, please call the IRB Administrator of  Institutional Review Board at (816) 741-2000 or (800) 745-7275.

Questions

You have been encouraged to ask questions about the study.  The questions you asked have been answered.  if you have any more questions about this study at any time, you may contact Dr. XXX at the University, XXX Department 123 XXX St. ,Kansas City, MO 64152 or you may phone her at (816) 741-2000 or (800) 745-7275 , or e-mail her _________ and she will be happy to answer any of your questions.

Authorization

The researcher has given you information about the study.  You have been told what will happen, and what you will have to do and how long it will take.  You were told about risks you may experience by participating in this research.  Your signature below signifies your agreement to take part in this study as a research participant.  You can decide not to participate or to quit at any time without penalty.  If you decide to participate you will be given a copy of this consent form.

 ______________________________           _________________________          ______

Printed Name of  Participant                             Printed Name of Investigator                 Date

_______________________________          __________________________        ______

Signature of  Participant                                    Signature of Investigator                        Date

[SAMPLE CONSENT FORM]

Consent to Participate in a Research Study

Process Evaluation of the Development of the Kansas City Youth Violence Prevention Coalition

Investigator

This study will be conducted by Dr. XXX  a faculty member in the College of Arts and Sciences at Park University.

Invitation to Participate & Purpose

You are being invited to participate in evaluating the process of coalition-building in the Youth Violence Prevention Project of Central City . Thank you for taking time out of your busy schedule to consider participation.

Voluntary Participation

Your participation in this evaluation is completely voluntary and you may withdraw your consent to participate at any time during the process.  If you choose to do so, any information derived from your participation will be deleted from the evaluations findings.

Methods/Procedures

The methods of data collection for this study will be focus groups and individual interviews.  No audio, video, or computer recording will be made.  Information will be recorded through notetaking.  Ttranscriptions will be destroyed 3 years after the completion of this evaluation. 

Confidentiality

If you choose to participate, you will not be asked your name at the focus group or individual interview.  You will not need to use your name in the focus groups or individual interviews.  If by chance, you or someone you know addresses you by name in the sessions, the transcriber will be instructed to delete all names from the transcription.  Individuals from the University's Institutional Review Board and Research Protections Program, and federal regulatory agencies may look at records related to this study for quality improvement and regulatory functions.

There will however be no names attached to the tapes or transcriptions, and there will be no identifying information or names used in any written reports or publications which result from this evaluation project.  Your participation in this evaluation will be strictly confidential. 

All findings used in any written reports or publications which result from this evaluation project will be reported in aggregate form with no identifying information.  It is, however useful to use direct quotes to more clearly capture the meanings in reporting the findings from this form of evaluation.  You will be asked at the end of the interview or focus group if there is anything you said which you do not want included as a quote, and we will ensure that they are not used.

Risks and Inconveniences

There are no anticipated physical risks to participants.  Focus group members will be asked to keep the information provided in the groups confidential; however, a potential risk that might exist for some would be that information about your workplace might be discussed outside the group by other participants and be traced back to you.  If this is a potential issue for you , you are encouraged to ask for an individual interview with one of the researchers who would then be knowledgeable of and bound by confidentiality.

Benefits

A potential benefit of participating in this evaluation for you could be having an opportunity to describe your experience with this Project with others who have shared the experience.  Additionally, the opportunity to connect with other allies and share similar and divergent experiences may help clarify and validate your experiences within this Project.  The benefits to society would be based on establishing a clearer understanding of the experiences faced by coalition members and some of the obstacles and benefits of being a member of such a community based coalition.  This information can help the current coalition be more effective, and may provide guidance through :lessons learned: for future coalitions addressing similar issues.

In Case of Injury

The University appreciates the participation of people who help it carry out its function of developing knowledge through research.  If you have any questions about the study that you are participating in you are encouraged to call (name), the investigator, at (phone number).

Although it is not Park University’s policy to compensate or provide medical treatment for persons who participate in studies, if you think you have been injured as a result of participating in this study, please call the (Chair’s name) of the Institutional Review Board, at ( Chair’s phone number).

Questions

If you have any questions about this study at any time, you may contact Dr. XXX at ________________________or you may phone him at _________________, or e-mail him at __________________ and he will be happy to answer any of your questions.

Authorization

You will be given a copy of this consent form to keep for your records. 

Once again, we thank you for taking time out of your busy schedule to participate in this evaluation process.

Printed Name of the Participant  ______________________________________

Signature of the Participant  __________________________________________

Date_______________________________

Printed Name of the Investigator  ______________________________________

Signature of the Investigator  ____________________________________________

This sample is a template from which a verbal consent script can be developed. Please modify it as needed.  Since the presentation is verbal, the script may be somewhat shorter but should still include the required elements of consent.  The consent script should be written in simple terms understandable to the subject. Information provided in italics needs to be filled in and the italics deleted.

SAMPLE VERBAL CONSENT SCRIPT

I am [name of investigator], from [name of institution/University] [departmental affiliation and status; if student, indicate that you are working on your thesis or dissertation ]. I am conducting a research study on [state topic of research].  The research will help me understand [state expected benefits to participants and to society from this research]. 

Today you will be participating in a [individual phone interview, focus group, etc.], which should take approximately [state time needed to complete activity]. Your participation is voluntary. If you do not wish to participate, you may stop at any time. Responses will be [describe confidentiality procedures – e.g. responses will be completely anonymous; your name will not appear anywhere in the final write up; I will assign you a pseudonym, etc.]. There are minimal risks associated with this [activity]. Taking part in this [activity] is your agreement to participate.  

[If this is a group interview, the following language needs to be included: “During the group interview, I will not be able to guarantee confidentiality because we will be discussing information as a group. Therefore, if you would feel uncomfortable with any of your statements being shared with others in or outside the group, please do not share them during the process.]

If you would like a copy of this letter for your records, please let me know and I will [give you a copy now]. If you have any questions regarding the research, contact [give name, department, phone number, and department address if applicable. Include advisor name/phone if student, and identify as advisor]. If you have any questions regarding your rights as a research subject, please contact the IRB Administrator of Park University’s Institutional Review Board at __________________.

Protecting Human Research Participants (PHRP) Certification Tutorial

You need to work through the program on your own without my help. 

Make sure you GET THE CERTIFICATE and save the verification/certification

information in a safe place.  YOU WILL NEED TO PROVIDE THE

CERTIFICATE INFORMATION TO THE IRB.

Below are questions and answers about the certification from their website.

The main menu looks like this: