OHRP Informed Consent Tips: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ictips.htm

45 CFR 46: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

For drug studies where female subjects with child-bearing potential can not participate while pregnant, a paragraph that includes the following statements is required:

"possible risk to embryo/fetus, extent of risks not completely known, importance of adequate birth control methods, and discussion with physician regarding appropriate birth control methods and recommended duration of use after the study ends".

If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are re-contacted or newly contacted.

Risks may be:

Physical - pain, physical discomfort, injury, illness or disease brought about by the methods and procedures of the research;

Psychological - anxiety, fear, stress, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and/or altered behavior, occurring during the research situation or later, as a result of participation;

Social - alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and status in relation to others;

Economic - cost to subjects for procedures, loss of wages or income, damage to employability;

Legal - risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally liable;

Loss of confidentiality - confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks include invasion of privacy, as well as the social, economic, and legal risks outlined above.

These other elements of informed consent may also be required by the IRB, and investigators are encouraged to include them during the informed consent process and document:

1. A description of any benefits to the subject or to others which may reasonably be expected from the research. Describe direct benefits to the subject that may reasonably be expected. Do not promise any benefits which do not exist or are speculative. If the subject will not benefit directly, indicate how society or medical science may benefit. For example, "Participation in this study may not benefit you directly. However, the knowledge that we obtain from your participation, and the participation of other volunteers, may help us to better understand....." or "You may benefit from participation by gaining insight into your students' learning styles."

2. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. If there are no alternative treatments, then this should be stated. All alternatives to participation should be listed, including standard therapy, if applicable. For example, "You may choose not to participate in this study and instead receive routine treatment and care, as there are no other treatment options available at this time" or "An alternative to participation in this research project may be to participate in other research studies for which you may receive the same research credit. Consult your instructor for options."

3. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Some studies require disclosure of information to other parties. Others inherently are in need of a Certificate of Confidentiality which protects the investigator from involuntary release (e.g.,subpoena) of the names or other identifying characteristics of research subjects. If a Certificate of Confidentiality will be obtained by the investigator to provide protection from involuntary release of the subject names or other identifying information, this should be indicated. Information regarding the procedure to obtain a Certificate of Confidentiality may be obtained from the IRB office or NIH via the web at:  <http://grants1.nih.gov/grants/policy/coc>.

If the data collected contain no identifying information that could link the data to the subject, then "confidential" should be replaced by "anonymous" in this section.

Definition of Anonymous: Data are recorded such that no identifier whatsoever exists to link a subject's identity to that subject's response. Examples: (1) subject fills out and mails back to the investigator a questionnaire that does not provide subject's name, social security number, phone number, or any other identifier; (2) investigator interviews subject by phone and notes responses, but does not have any record connecting any response to any phone number.

Definition of Confidential: There exists a documented linkage between a subject's identity and his/her response in the research, and the investigator provides assurance in the protocol and in the informed consent form that the identity of any individual subject will not be revealed in any report of the study. Example: a subject's data record is assigned a code, and a "master list" that links the code to the subject's identity is maintained in a secure location.

Sample text: "The information in the study records will be kept strictly confidential. Data will be stored securely in a locked cabinet and/or restricted-access computer and will be made available only to persons conducting the study unless you specifically give permission in writing to do otherwise. No reference will be made in oral or written reports which could link you to the study."

The IRB will determine the level of adequate requirements for confidentiality in light of its mandate to ensure minimization of risk.

1. For research involving more than minimal risk, an explanation as to whether any compensation is available, and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. State precise amounts of financial compensation, if applicable, and explain the pro-rating scheme of payment that will apply if the subject withdraws before completing the study. For example, "For participating in this study you will receive (describe compensation). Other ways to earn the same amount of credit are (describe options here). If you withdraw from the study prior to its completion, you will receive (describe partial compensation system)" or "If you are harmed by being in this study, we will provide or arrange care as needed. Payment will be your responsibility, or that of your health insurance carrier (or Medicaid, etc.)."

2. 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. Two statements are required: contact information for the investigator, and contact information for the IRB. For example, "Any questions about this study should be directed to the principal investigator at (phone number) (Note: email address is optional)" and "If you have any questions about your rights as a research subject, you may contact the IRB Administrator at Rutgers University at 732-932-0150 ext. 2104."

3. 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. For example, "Your child's participation in this study is completely voluntary and you may withdraw your child at any time without prejudicing your child's present or future care" or "Your participation in this research is voluntary. You may refuse to answer any questions with which you are not comfortable, and you may withdraw from the study at any time without penalty."

Additional Elements of Informed Consent

One or more of the following elements may be necessary for specific research projects:

• 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. This would apply primarily to initial testing of new devices or drugs. Sample text: "In addition, there is always the risk of uncommon or previously unknown side effects" or "It is important that you not become pregnant while in the study, because it is not known what effect the study drug may have on the embryo or fetus."

• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. For example, "The investigator may withdraw you from the study if he/she finds that it is necessary and/or in your best interests."

• Any additional costs to the subject that may result from participation in the research. For example, "All costs for the study procedures are the standard fees charged for these services, and will be submitted to your insurance carrier for payment. Some carriers refuse payment for investigational treatment. If your insurance carrier refuses to cover the cost of some procedures, you will be responsible for these costs."

• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. For example, "If you withdraw from the study before completing all study procedures, you will be encouraged to discuss follow-up procedures with your primary care provider to ensure that your regular medications are resumed in a timely manner."

• 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. For example, "You will be notified in writing of any significant new findings, especially risks and benefits, that are discovered during your participation in the study."

• The approximate number of subjects involved in the study. For example, "You are one of 240 patients at this facility who will be participating in the study. A total of 3000 subjects at similar facilities around the nation are expected to participate."

Waiver of Requirement for Signed Consent Document

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either:

• 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. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

• 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.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

IRB Latitude to Approve a Consent Procedure that Alters or Waives Some or All of the Elements of Informed Consent

An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB finds and documents that either of the following apply:

• The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and the research could not practicably be carried out without the waiver or alteration.  Please note that most projects do not qualify under this subpart.

• The research involves no more than minimal risk to the subjects; the waiver or alteration will not adversely affect the rights and welfare of the subjects; the research could not practicably be carried out without the waiver or alteration; and whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Special Requirements of 45 CFR 46 Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research

• Assent of Children

a. Children are defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (usually state law, which may vary according to the child's situation, e.g., emancipated minor).

b. The IRB must determine that adequate provisions are made for soliciting the assent (agreement) of the children, when in the judgment of the IRB the children are capable of providing assent. Assent is usually required in addition to parental permission; in rare cases, the requirement for parental permission may be waived (see Section 2, item d. in the Parental Permission section below).

c. In determining whether children are capable of assenting, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgement may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate (i.e., in some cases, all children who participate in a particular study may be capable of providing assent, and in other cases, only some of the children may be capable; the IRB may leave this judgement up to the investigator and is not obligated to require that ALL of the children in a study must or must not agree to participate).

c. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research (i.e., assent may be waived if the children are not cognitively able to understand the concept of participating in a particular study, or if participation is likely to benefit the child, and the benefit can only be obtained by participation).

d. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived in accord with 45 CFR 46.116 of Subpart A (waiver requirements described earlier in this document). Note: See the section immediately preceding this section, entitled "IRB Latitude to Approve...".

e. There is no required format for assent, the text of which must be submitted to the IRB with the protocol for review. It must, however, be age appropriate, offer an explanation of the study, and provide the child with the opportunity to agree to participate or refuse participation. Written documents, as well as oral scripts, are acceptable. The child may be asked to sign a document or agree verbally; in cases where verbal assent is obtained, the investigator must document the assent. (I.e., the format and content of an assent statement is highly variable, but must be tailored to the particular child or children involved.)

• Parental Permission

Permission from one or more parents is required when a minor will be involved in research. Assent (agreement) from the child may or may not be required, depending upon the particular study and characteristics of the child (see Assent of Children section above). Under very specific circumstances, the requirement for parental permission may be waived by the IRB (see item d. below). Sections a. through c. that follow describe the circumstances under which the permission of either one or both parents is required. If you cannot make a determination after reading each section, contact Michelle Gibel B.A. by phone at (732) 932-0150 ext. 2104 or by email at: gibel@orsp.rutgers.edu for guidance.

a. The permission of one parent is sufficient for research in which:

1. no greater than minimal risk to children is presented;

2. more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being. The following conditions apply:

(a) the risk must be justified by the anticipated benefit to the subjects;

(b) the relation of the anticipated benefit to the risk must be at least as favorable to the subjects as that presented by available alternative approaches; and

(c) adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.

b. Both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, for research in which:

1. more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject. ALL of the following conditions apply:

(a) the risk represents a minor increase over minimal risk;

(b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(c) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(d) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.

c. Both parents must give their permission, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, for research that is:

1. Not otherwise approvable (i.e., not included in categories a. or b. described above) which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The following conditions apply:

(a) the research must present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b) if the project is funded by DHHS, the DHHS Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, must determine either:

(1) that the research in fact satisfies the conditions of categories a. or b. previously described; or

(2) the following:

(i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) the research will be conducted in accordance with sound ethical principles;

(iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in 45 CFR 46.408.

If the project is not funded by DHHS, the IRB must determine that the conditions set forth in (2) are satisfied.

d. If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements as previously described, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.

• Wards of the State

a. Children who are wards of the State or any other agency, institution, or entity can be included in research described in categories b. and c. under "Parental Permission" only if such research is:

(1) related to their status as wards; or

(2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

b. If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

Special Requirements for Obtaining Consent for Cognitively Impaired Individuals

Consent to research involving cognitively impaired subjects through any of the intramural programs of the National Institutes of Health (e.g., the National Institute of Mental Health, the National Institute of Neurological and Communicative Disorders and Stroke, the National Institute on Aging, and the National Institute on Alcohol Abuse and Alcoholism) is guided by NIH policy on consent to research with impaired human subjects. This policy sets out, in matrix form, conditions under which cognitively impaired subjects may participate in research of varying risk.

As a general rule, all adults, regardless of their diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability that would impair reasoning or judgment. Even those who do have a diagnosed mental disorder may be perfectly able to understand the matter of being a research volunteer, and quite capable of consenting to or refusing participation. Mental disability alone should not disqualify a person from consenting to participate in research; rather, there should be specific evidence of individuals' incapacity to understand and to make a choice before they are deemed unable to consent.

Persons formally adjudged incompetent have a court-appointed guardian who must be consulted and consent on their behalf. Officials of the institution in which incompetent patients reside (even if they are the patient's legal guardians) are not generally considered appropriate, since their supervisory duties may give rise to conflicting interests and loyalties. Family members or others financially responsible for the patient may also be subject to conflicting interests because of financial pressures, emotional distancing, or other ambivalent feelings common in such circumstances. IRBs (and investigators) should bear this in mind when determining appropriate consent procedures for cognitively impaired subjects.

Procedures can sometimes be developed to enhance the possibility that subjects can consent for themselves. Criteria for determining competence might vary according to the degree of risk or discomfort presented by the research procedures and the extent to which therapeutic gains can be anticipated. The setting in which consent is sought and the person seeking it can also influence a potential subject's ability to comprehend or appreciate what is being asked. An uncomfortable chair, a room that is either too noisy or lacking in privacy, or a physician the patient dislikes may all create anxiety or resistance that would not exist if the information were presented by another person, at another time, or in another place. The National Commission recommended that, in certain cases, a consent auditor be appointed by the IRB to determine whether proposed subjects consent, assent, or object to their participation in research, especially if the research involves more than minimal risk and no foreseeable direct benefit.

Consent documents for individuals who are determined to be incompetent to consent must contain a signature line for a legally authorized representative, in addition to the elements of informed consent described earlier in this document. The subject may also be asked to provide assent, if it is determined that they are capable of doing so. A sample certification statement that may be included in consent forms intended for legally authorized representatives of subjects who are cognitively impaired follows: "As the legally authorized representative, your signature authorizes the participation of (name of subject) in this research study, which has been explained to you. The investigator has offered you the opportunity to ask questions, and they have been satisfactorily answered."

Informed Consent in Studies that Include Deception

Some behavioral research is designed to deceive the subjects about the true purpose of the study because the subjects' behavior would be altered if they knew the real objectives, and the data would then be inaccurate. Whenever possible, deception should be avoided to minimize the potential negative effects that may result as a consequence: guilt, embarrassment, psychological stress. However, when the research will not have scientific validity without the use of deception, the investigator and the IRB must carefully consider whether the human subjects that will be involved are adequately protected.

• The proposed subject population must be suitable for the purposes of the study (i.e., an IRB may find that individuals with diminished mental capacity or those with paranoid tendencies may not be suitable subjects for a protocol that involves deception, whereas the same study may be approved if a subject population that has normal mental capacity and no history of mental illness is used).

 

• If a study involves deception, than it may be proposed that the subject not be fully informed when they agree to participate in the study. They may be told that the actual objectives of the study will not be known to them until after their participation has ended, or they may be intentionally mislead about the intent of the research. The IRB must decide whether the study is so designed that the subjects will be adequately protected without having given informed consent, and if a waiver of some or all of the elements of informed consent can be approved. According to the regulations, research should not be permitted at all if the risk to subjects is more than minimal and the subjects are not being informed of things they would consider material to a decision to participate. In deciding whether to waive or alter consent requirements, IRBs must consider the risks to which subjects will be exposed. To receive a waiver of consent requirements, the study must present no more than minimal risk. Further, the waiver must not adversely affect the rights and welfare of subjects, and must be essential to the ability to carry out the research. A final condition for waiving some or all of the elements of informed consent is that, whenever appropriate, subjects will be given additional pertinent information after they have participated in such a study. The IRB must decide if subjects should be debriefed either after participating in research unwittingly or after knowingly participating in research that involved some form of deception.

• A debriefing statement that informs the subjects of the true nature of the study is required for most studies that involve deception. However, there are some instances in which debriefing may cause more harm than good, and is therefore not recommended (e.g., if the study results would provide subjects with information that is disturbing about themselves). Debriefing is appropriate if it contributes to the subject's welfare, e.g., by reducing stress or correcting misconceptions about themselves that resulted from participation in the study. After debriefing, the subject must be given the opportunity to confirm or rescind their consent. In essence, this is the actual informed consent for the subject's participation in the study, and should be prepared, presented and documented in accordance with the guidelines for informed consent.

 

References

OPRR IRB Guidebook, 1993, Robin Levin Penslar, J.D., principal author and editor: http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm

NOTE: Sample Consent Documents follow.

All information appearing in [brackets] is for informational purposes for the PI.  The PI should choose the appropriate confidentiality/anonymity statement to include in the consent form/oral script.

Sample Consent Form #1

Non-clinical, Minimum Risk Study

The Effect of Gum Chewing on Attention

You are invited to participate in a research study that is being conducted by John Doe, Ph.D., who is a professor in the Psychology Department at Rutgers University. The purpose of this research is to determine whether gum chewing has an effect on the ability to perform tasks that require concentration.

Approximately 100 subjects between the ages of 18 and 40 years old will participate in the study, and each individual's participation will last approximately two hours. The study procedures include completion of a questionnaire, and several tests that are designed to measure attention.

• Subjects will first be asked to complete two tests of attention. One will be taken while chewing gum and the other without gum. These will take approximately 40 minutes.

• Then a brief questionnaire will be given that includes questions about your work or study habits, gum-chewing habits, and personality traits. The questionnaire will take approximately 20 minutes to complete.

• The final phase will be two additional tests of attention, one to be taken while chewing gum, and the other without gum. These tests will take approximately 50 minutes.

 

If you agree to take part in the study, you will be assigned a random code number that will be used on each test and the questionnaire. Your name will appear only on a list of subjects, and will not be linked to the code number that is assigned to you. There will be no way to link your responses back to you. Therefore, data collection is anonymous.

There are no foreseeable risks to participation in this study. While your attention skills are not likely to improve from participation in this research, the study may produce valuable data about attention. You will receive $15.00 for completing the entire study. If you do not complete all three phases, you will receive $5.00 for each phase that you finish (tests, questionnaire, tests).

Participation in this study is voluntary. You may choose not to participate, and you may withdraw at any time during the study procedures without any penalty to you. In addition, you may choose not to answer any questions with which you are not comfortable.

This research is confidential/anonymous [PICK ONE, AND INCLUDE THE APPROPRIATE STATEMENT BELOW].  Anonymous means that I will record no information about you that could identify you.  This means that I will not record your name, address, phone number, date of birth, etc.  / Confidential means that the research records will include some information about you, such as [SPELL OUT SOME OF THE ELEMENTS].  I will keep this information confidential by limiting individual's access to the research data and keeping it in a secure location. The research team and the Institutional Review Board at Rutgers University are the only parties that will be allowed to see the data, except as may be required by law. If a report of this study is published, or the results are presented at a professional conference, only group results will be stated, unless you have agreed otherwise.

If you have any questions about the study procedures, you may contact Dr. Doe at (732) 555-4321. If you have any questions about your rights as a research subject, you may contact the Sponsored Programs Administrator at Rutgers University at:

Rutgers University Institutional Review Board for the Protection of Human Subjects
Office of Research and Sponsored Programs
3 Rutgers Plaza
New Brunswick, NJ 08901-8559
Tel: 732-932-0150 ext. 2104
Email: humansubjects@orsp.rutgers.edu

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

Sign below if you agree to participate in this research study:

Subject ________________________________________ Date ______________________

Principal Investigator ______________________________ Date ______________________

All information appearing in [brackets] is for informational purposes for the PI.  The PI should choose the appropriate confidentiality/anonymity statement to include in the consent form/oral script

Sample Consent Form #2

Clinical, Greater-Than Minimal Risk Study

Consent for Participation in a Clinical Study

Title of Study: Comparison of the Effects of Regular vs. Sugarless Gum in Prolonged Chewing Trials

Principal Investigator: Jane Doe, Ph.D.

INVITATION TO PARTICIPATE:

You are invited to participate in research that is being conducted by Jane Doe, Ph.D., who is an Associate Professor in the Department of Nursing at Rutgers University. This consent form contains information about the study that a member of the research team will go over with you. You will have the opportunity to ask questions and have them answered. When all of your questions have been answered, you will be asked to sign this consent form if you agree to be in the study. A copy of the form will be given to you to keep for your records.

PURPOSE:

The purpose of the study is to determine whether people experience different effects on the nervous system when they chew regular gum that contains sugar versus sugarless gum during periods of prolonged gum chewing. Previous studies conducted by Dr. Doe have shown that people who chew gum for prolonged periods have changes in the nervous system when compared to people in similar circumstances who are not chewing gum. This study will try to find out if there are different changes when regular or sugarless gum is used.

SUBJECT SELECTION:

You must be an adult between the ages of 18 and 50 to participate in this study. You may not participate in the study if you have any condition that causes physical problems if you eat either sugar or sugar substitutes, or if you have any medical condition that affects the nervous system.  If you are unsure about whether you have any such physical disabilities, you should consult your primary doctor before participating in the study.

PROCEDURES:

Your participation in this study will last for approximately two hours. Study procedures are as follows:

• The investigator will ask you several questions about yourself and your medical history, such as age, health status, and eating habits.

• A medical doctor who is a member of the research team will then test your reflexes by doing several tests like those that your doctor may do during a routine physical examination, such as tapping your knee with a rubber mallet. A blood sample (about two teaspoons) will also be taken from your arm to find out what your normal blood chemistry levels are.

• You will randomly (by chance, like flipping a coin) be assigned to either the group that will chew regular gum, or the one that will chew sugarless gum. You will not be told which group you are in.

• You will be asked to chew two sticks of gum for 10 minutes. Then you will be asked to throw the gum away and chew two more sticks of gum for 10 minutes. This process will continue for 60 minutes.

Page 1, Subject Initials ______

________________________________________________

Title of Study: Comparison of the Effects of Regular vs Sugarless Gum in Prolonged Chewing Trials

PI: Jane Doe, Ph.D.

• During this time, you will not be permitted to have any food or drink. You must stay in the lab during this time but you may walk around the lab area, read magazines, or watch television.

• At the end of the chewing session, the medical doctor will repeat the tests to measure your reflexes, and another blood sample (about two teaspoons) will be taken from your arm to see if there have been changes in any elements in your blood.

 

BENEFITS:

You will not receive any direct benefit for participating in this research, but the research may provide scientists with a better understanding of the physical changes that occur when people chew gum for a long period of time.

RISK:

Since prolonged gum chewing has been shown to produce changes in reflexes, your reflex actions may be slower than usual. This should not present any danger to you, although you will be asked to remain in the lab until your reflex times return to normal. The blood draw may be uncomfortable for a short time, and some people experience bruising at the site. Although it is unlikely, if you experience a reaction to the gum, the medical doctor will evaluate the symptoms and either treat minor symptoms, or call emergency personnel if the problem is more severe. Blood samples will not be retained for any purpose.

COMPENSATION:

You will receive $10 for participating in this research project. If you decide to withdraw from the research before the medical evaluation and blood draw is started, then you will not receive any payment. However, if you complete the study or withdraw at any time after the medical evaluation has started, then you will receive the $10.

COST:

There is no cost to you for participating in this research project.

ALTERNATIVES:

This is not a treatment study, and you it is not intended that the research project will treat any health issues that you may be afflicted with. Your alternative is to not participate.

CONFIDENTIALITY:

This research is confidential/anonymous [PICK ONE, AND INCLUDE THE APPROPRIATE STATEMENT BELOW].  Anonymous means that I will record no information about you that could identify you.  This means that I will not record your name, address, phone number, date of birth, etc.  / Confidential means that the research records will include some information about you, such as [SPELL OUT SOME OF THE ELEMENTS].  I will keep this information confidential by limiting individual's access to the research data and keeping it in a secure location. The research team and the Institutional Review Board at Rutgers University are the only parties that will be allowed to see the data, except as may be required by law. If a report of this study is published, or the results are presented at a professional conference, only group results will be stated, unless you have agreed otherwise.

WITHDRAWAL:

Participation in this study is voluntary. You may withdraw from the study at any time, and you may refuse to answer any questions that you are not comfortable with.

Page 1, Subject Initials ______

________________________________________________

Title of Study: Comparison of the Effects of Regular vs Sugarless Gum in Prolonged Chewing Trials

PI: Jane Doe, Ph.D.

RESEARCH QUESTIONS:

If you have any questions about the study, you may contact Dr. Doe at by telephone at (555) 555-5555 or by email at: (email address).

SUBJECT RIGHTS:

If you have any questions about your rights as a research subject, you may contact the IRB Administrator at Rutgers University at:

Rutgers University Institutional Review Board for the Protection of Human Subjects
Office of Research and Sponsored Programs
3 Rutgers Plaza
New Brunswick, NJ 08901-8559
Tel: 732-932-0150 ext. 2104
Email: humansubjects@orsp.rutgers.edu

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You have been given the opportunity to ask questions and have them answered.  By signing below, you agree to participate in this research study.

___________________________________ __________________

Signature of Subject Date

___________________________________ __________________

Signature of Investigator Date

All information appearing in [brackets] is for informational purposes for the PI.  The PI should choose the appropriate confidentiality/anonymity statement to include in the consent form/oral script

Sample Consent Form #3

Non-clinical, Minimum Risk Study in a School

Parental Permission

July 14, 2001

Dear Parents,

I am a student in the Graduate School of Education at Rutgers University, and was a teaching aid for Ms. Oak's class last fall. In order to complete my degree requirements, I am required to conduct a research study with elementary school children. Dogwood Elementary School has allowed me to contact you to request permission for your child to participate in the study. I will briefly explain the study to the children who have returned this permission slip, and also ask for their agreement to participate.

The subject of my research project is: Factors that Influence Children's Study Habits. Children who participate will be given a brief questionnaire that asks them about their study habits. Their names will not be written on the questionnaires, but we will ask them for their age, grade, and gender. The questionnaire will take about 15 minutes to complete, and will be given during the time that the students are doing work at their desks, so they will not miss any instruction time. If the child indicates at any time that they want to stop filling out the questionnaire, they will be thanked for their participation, and will return to their deskwork.

There are no known risks to your child for participating in this study, and your child will not benefit directly from participation. Their grades will not be affected in any way, whether they participate in the study. However, the data collected may lead to increased understanding of the factors that influence children's study habits. If you would like to have a report of the study when it is completed, please indicate this at the bottom of this form.

This research is confidential/anonymous [PICK ONE, AND INCLUDE THE APPROPRIATE STATEMENT BELOW].  Anonymous means that I will record no information about you that could identify you.  This means that I will not record your name, address, phone number, date of birth, etc.  / Confidential means that the research records will include some information about you, such as [SPELL OUT SOME OF THE ELEMENTS].  I will keep this information confidential by limiting individual's access to the research data and keeping it in a secure location. The research team and the Institutional Review Board at Rutgers University are the only parties that will be allowed to see the data, except as may be required by law. If a report of this study is published, or the results are presented at a professional conference, only group results will be stated, unless you have agreed otherwise.

If you have any questions about the research, you may contact me at (732) 555-4321. If you have any questions about your child's rights as a research subject, you may contact the IRB Administrator at:

Rutgers University Institutional Review Board for the Protection of Human Subjects
Office of Research and Sponsored Programs
3 Rutgers Plaza
New Brunswick, NJ 08901-8559
Tel: 732-932-0150 ext. 2104
Email: humansubjects@orsp.rutgers.edu

Your child's participation in this study is completely voluntary. Please sign and return the attached permission slip if you are willing to have your child participate. Your support is greatly appreciated.

Sincerely,

Charles Maple

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___________________________ has my permission to participate in the research study, "Factors that

(Child's name)                                 Influence Children's Study Habits", that will be conducted by Charles Maple.

Signature of Parent or Guardian ______________________________ Date ________________

Sample Assent Form

 for Minors Ages 12 - 17 Years

Middle and High School Study Habits

You are invited to take part in a research study about the study habits of middle and high school students. This study is being conducted by Jane Doe, who is a student at Rutgers University. She is doing the study in order to complete requirements for an advanced degree.

If you agree to participate, you will be asked to fill out a questionnaire that will take about 20-30 minutes. Your name will NOT be on the questionnaire, but you will be asked to write your age, grade, and gender (whether you are male or female) on the form. Please don't write your name anywhere on the questionnaire.  It will not be possible to link your name with your questionnaire.

Your grades will not be affected in any way by your decision to participate or not participate in the study. You will not receive any benefits from taking part in this study; however, your answers may increase understanding of the factors that influence students' study habits.

You may skip any questions that you are not comfortable with, and you may decide to stop participating at any time without any penalty to you. One of your parents will also be required to provide permission for you to participate in the study, and they will be given a phone number for Ms. Doe, in case you or your parents have any questions about the research. They will also have a phone number for the Office of Research and Sponsored Programs at Rutgers University, in case there are any questions about your rights as a research subject. You will be given a copy of this form to keep.

If you agree to participate in the study, please sign below:

Student signature ____________________________ ____ Date ______________

Student name (printed) ____________________________ Date ______________

Investigator signature _____________________________ Date _____________

All information appearing in [brackets] is for informational purposes for the PI.  The PI should choose the appropriate confidentiality/anonymity statement to include in the consent form/oral script

Sample Oral Script

Ethnographic Study

Memo to Institutional Review Board: (Submit with the completed IRB application form and protocol.)

I would like to request that the following consent procedure be approved for my study that involves observation and possible interviews with the native people of (country):

• I will obtain permission from the (leader) of the village to visit the area and observe the villagers in public areas, without interacting with them. If the (leader) agrees, I may interview several of the adults, using the sample questions that I submitted with the attached protocol. My experience with this culture leads me to believe that the (leader) will communicate his agreement throughout the village within a day or two. I will not attempt any interviews until I am fairly certain that the villagers understand why I am there, and that their (leader) is supportive.

 

• If I decide to interview one or more of the adults, I will approach them in a public place, ask their permission to speak with them for a few minutes, and explain that I am a researcher who is studying the traditions of their culture. If they agree, I will then continue with the script, spoken in their native language, that follows. If they are nervous, upset, or otherwise seem disturbed by my interaction with them, I will thank them and end the interaction.

• Oral script:

I am a researcher from the United States who would like to learn more about the customs and traditions in your village. I have talked to the (leader) who has given me permission to observe the people in the village and to talk to some of the adults. If you agree that I can ask you about your customs, I would ask you about ten questions. If there are any that you don't want to answer, then you can just ask me to go on to the next question. You can leave at any time if you don't want to speak with me anymore. The questions that I will ask you should not embarrass you or require you to talk about anyone in the village. I would just like to hear about the way that you do certain things, like celebrate special days, or prepare meals. Do you have any questions? If not, then do you agree to let me ask you questions?

This research is confidential/anonymous [PICK ONE, AND INCLUDE THE APPROPRIATE STATEMENT BELOW].  Anonymous means that I will record no information about you that could identify you.  This means that I will not record your name, address, phone number, date of birth, etc.  / Confidential means that the research records will include some information about you, such as [SPELL OUT SOME OF THE ELEMENTS].  I will keep this information confidential by limiting individual's access to the research data and keeping it in a secure location. The research team and the Institutional Review Board at Rutgers University are the only parties that will be allowed to see the data, except as may be required by law. If a report of this study is published, or the results are presented at a professional conference, only group results will be stated, unless you have agreed otherwise.

• Verbal consent will be documented in my notes, and I will assign a pseudonym to each individual if they indicate that they don't want me to use their real name. I am requesting a verbal consent without written documentation because it would be very threatening to people in this culture to have to sign a written document. As noted in my protocol, I have spent a considerable amount of time doing ethnographic research with cultures such as this one, and I would like to continue to have access to these individuals. If my actions are considered by the (leader) to be insulting or disturbing to the members of the village, I will be asked to leave. Therefore, it is in my best interest to treat all subjects with respect, and be certain to obtain consent from them.





• If the subject declines to be interviewed, I will thank him/her and end the interaction.

All information appearing in [brackets] is for informational purposes for the PI.  The PI should choose the appropriate confidentiality/anonymity statement to include in the consent form/oral script

Generic Informed Consent Template

Instructions: In generating a form for a specific project the principal investigator will: a) fill in the underlined areas of the form; and b) replicate the bold areas. Guidance information is presented in italics.

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Consent Form to Participate in a Research Study

Title of Study

Principal Investigator

Sponsor of Study (if applicable)

INTRODUCTION

You are invited to participate in a research study. Before you agree to participate in this study, you should know enough about it to make an informed decision. If you have any questions, ask the investigator. You should be satisfied with the answers before you agree to be in the study.

[The introduction and background should be fairly simple, but enough detail must be presented so the subject understands why the study is being performed.]

BACKGROUND/PURPOSE

The purpose of this study is describe the purpose of your study in lay language. Provide a brief background and explain why the study is being performed.

INFORMATION

1. List all procedures, preferably in chronological order, that will be employed in the study. Be sure to use lay language, readable at a sixth grade level.

2. State the amount of time required of the subject per session and for the total duration of the study.

[Begin this section with a statement such as, "Participation in this study will involve the following:" Describe the study procedures; if these are extensive, numbered items may be helpful. Clearly identify the experimental procedures. In treatment protocols, routine medical care which is not part of the research should not be included.]

ALTERNATIVES TO PARTICIPATION

Describe any appropriate alternatives to participation in the research project.

[A statement that participation is voluntary should be included. If there are no alternatives to participation, this should be stated. All alternatives (procedures or courses of treatment) that may be advantageous to the subject should be listed, including standard therapy, if applicable.]

RISKS

Using lay language describe the foreseeable risks or discomforts, if any, of each of the procedures to be used in the study, and any measures which will be used to minimize the risks.

[A statement such as, "Use of Drug X has been known to cause the following side effects:", should precede a list of reasonably foreseeable risks and/or discomforts. If applicable, statements that risks may exist that are currently unforeseeable, and risks to the embryo/fetus may exist if the subject becomes pregnant, should be included.

Studies that involve only surveys, interviews, or focus groups may not pose obvious physical risks to subjects, but the risk of emotional distress must be listed. Plans for referral for counseling if needed should be included. Other potential risks include embarrassment or discomfort when answering questions, breach of confidentiality, and financial, employment, or insurability risks.

For drug studies where female subjects with child-bearing potential can not participate while pregnant, a paragraph that includes the following statements is required: possible risk to embryo/fetus, extent of risks not completely known, importance of adequate birth control methods, and discussion with physician regarding appropriate birth control methods and recommended duration of use after the study ends.]

BENEFITS

List the benefits you anticipate will be achieved from this research, either to the subjects, others, or the body of knowledge.

[Describe direct benefits to the subject that may reasonably be expected. Do not promise any benefits which do not exist or are speculative. If the subject will not benefit directly, indicate how society or medical science may benefit. A sample paragraph follows: "Participation in this study may not benefit you directly. However, the knowledge that we obtain from your participation, and the participation of other volunteers, may help us to better understand....."]

CONFIDENTIALITY

Describe the extent to which personally identifiable, private information will be held in confidence.

[ Sample text: "This research is confidential/anonymous [PICK ONE, AND INCLUDE THE APPROPRIATE STATEMENT BELOW].  Anonymous means that I will record no information about you that could identify you.  This means that I will not record your name, address, phone number, date of birth, etc.  / Confidential means that the research records will include some information about you, such as [SPELL OUT SOME OF THE ELEMENTS].  I will keep this information confidential by limiting individual's access to the research data and keeping it in a secure location. The research team and the Institutional Review Board at Rutgers University are the only parties that will be allowed to see the data, except as may be required by law. If a report of this study is published, or the results are presented at a professional conference, only group results will be stated, unless you have agreed otherwise."

If a Certificate of Confidentiality will be obtained by the investigator to provide protection from involuntary release (e.g. subpoena) of the subject names or other identifying information, this should be indicated.]

COMPENSATION

For participating in this study you will receive describe compensation. Other ways to earn the same amount of credit are describe options here (if applicable). If you withdraw from the study prior to its completion, you will receive describe partial compensation system here.

EMERGENCY MEDICAL TREATMENT (if applicable)

Include an explanation as to whether any compensation and/or medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained.

[This section is applicable if research-related injury (e.g., physical, psychological, social, financial) is possible in research that is more than minimal risk.]

CONTACT

If you have questions at any time about the research or the procedures, you may contact the researcher, principal investigator name here, at address, or phone number. If you have any questions about your rights as a research subject, you may contact the IRB Administrator at

Rutgers University Institutional Review Board for the Protection of Human Subjects
Office of Research and Sponsored Programs
3 Rutgers Plaza
New Brunswick, NJ 08901-8559
Tel: 732-932-0150 ext. 2104
Email: humansubjects@orsp.rutgers.edu

PARTICIPATION

Your participation in this study is voluntary; you may decline to participate at any time without penalty to you.  If you decide to participate, you may withdraw from the study at any time without penalty and without loss of benefits to which you are otherwise entitled. If you withdraw from the study before data collection is completed your data will be removed from the data set and destroyed.

Sign below if you agree to participate in this research study. You will be given a copy of this form to keep.

Subject's signature______________________________________________ Date _________________

Investigator's signature__________________________________________ Date _________________

Legally authorized representative's signature _________________________ Date _________________

(if applicable)