A. Additional Protections of Minors:

Minors are considered a vulnerable population. Additional protections that must be considered in all research activities in which minors are, or may be, included are:

1) Allowance of participation in only certain categories of research. The three main categories are:

a) minimal risk, b) more than minimal risk with the possibility of direct benefit, and c) more than minimal risk without the possibility of direct benefit, BUT all of the following conditions must be met:

• The risk must represent a minor increase over minimal risk;
•  The research 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;
•  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
• Tthe assent of the minor subject and permission from BOTH parents/guardians are solicited, in accordance with 45CFR46.

2) Obtaining parental permission in most cases:

 The exception being if the CORIHS 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). An appropriate mechanism for protecting the children who will participate as subjects in the research must be in place, and the waiver has to be consistent with Federal, state or local law. A waiver of parental permission must also meet the criteria for consent waiver outlined in Section 12.A. Sections 12 (General Issues in Informed Consent) and Section 15 (Consent (Permission)/Assent Requirements: Minor Subjects) should be reviewed for full details concerning the documentation of parental permission.

3) Obtaining minor assent, in most cases:

In November of 2007, a subcommittee of IRB, ORC, and investigator representatives drafted guidance to assist you in knowing the general protocol parameters under which assent would be required, and what type of age-dependent documentation should be used when assent must be obtained. In all cases below where assent is required, CORIHS expects that the person obtaining assent first assesses the child’s capability to assent (e.g., maturity, mental and physical state, age, etc).

• In reviewing this guidance, please note that each protocol is unique and is reviewed by CORIHS accordingly. As such, the IRB’s decision regarding assent (and documentation thereof) may necessarily vary from that provided in the guidance below. For example, the minor population to be studied may a wide range of ability to provide assent. Some potential subjects may lack the cognitive or developmental ability to provide assent, regardless of chronologic age. Some children will have the capacity to assent, while others will not. In this situation, CORIHS may require the PI to have a plan of assessing and documenting each child’s capability of assenting, and of being able to comply with the study procedures.

But, in general:

a. Assent will be required for:

(i) Non-therapeutic protocols. Assent must be documented as follows:

1. For 12-17 year olds: via a ‘full’ assent form (containing highly simplified 'consent' information-- see section below "About Full Assent Form") that the child signs, and
2. For 7-11 year olds:  a note in the subject's research record that the assent discussion has occurred and the child's agreement has been obtained

(ii) Potentially therapeutic protocols involving either FDA-approved, or experimental, drugs, devices or procedures where there are alternatives available outside of the research with similar risk/benefit profiles. Assent must be documented as follows:

1. For 12-17 year olds: via a ‘full’ assent form (containing highly simplified 'consent' information—see section below "About Full Assent Form") that the child signs, and
2.  For 7-11 year olds: via a note in the subject's research record that the assent discussion has occurred and the child's agreement has been obtained

(iii) Potentially therapeutic protocol involving FDA- approved drugs, devices, radiation, procedures, etc. used in an experimental way (dosages, scheduling etc). Assent must be documented as follows:

1. For 12-17 year olds: via a ‘full’ assent form (containing highly simplified 'consent' information—see section below "About Full Assent Form") that the child signs, or alternatively, via an assent 'short form' (see section below 'About the Assent Short Form'-this latter method must be specifically approved by the IRB for this category of research) 
2. For 7-11 year olds: via a note in the subject's research record that the discussion has occurred and the child's agreement has been obtained

(iv) Protocols that do not fit into categories (i), (ii), or (iii) above, but where assent is none-the-less required by NCI CIRB (for cooperative oncology protocols), or as otherwise required by the IRB. Assent must be documented as follows:

1. For 12-17 year olds: via an assent 'short form'  (see section below, 'About the Assent Short Form')
2.  For 7-11 year olds: via a note in the subject's research record that the discussion has occurred and the child's agreement has been obtained.

b. Assent is waived for:

(i) Non-therapeutic protocols where results of biological tests are required in order to determine eligibility for potentially therapeutic protocols (certain COG protocols)

(ii) Potentially therapeutic protocols involving an experimental drug or procedure where there are no standard alternatives available, or where the risk/benefit profile of the standard alternatives that are available are such that participation in the protocol would be important to the health or well-being of the children. 

c. Whether assent is required or waived Whether assent is required or waived, no physical or chemical means of restraint may be used on a minor subject unless specifically approved prior to use by CORIHS. 

About the Full Assent Form:

This document must be an accurate and complete, but highly simplified version of the approved consent form/permission form for the study. It must be understandable to a 12 year old (approx 7^th grade).

About the Assent Short Form:

Where CORIHS approves use of an assent short form process, an assent discussion is held with the minor subject. The 'script' to be followed in that discussion must be reviewed and approved by CORIHS. If the minor agrees to be in the study, the short form is signed, along with a witness (not the person assessing ability and obtaining assent). The witness should also sign a copy of the script that was used in the process.

Title of Study: Principal Investigator:                                       

____________________ has talked with me, using words I know, about me being in a research study. I’ve been told:

1. I don’t have to be in this research study if I don’t want to be. 2. What will happen to me if I agree to be in this study, and how long this study will go on for me. 2. The bad things, if any, that may happen to me by being in this study. 3. The good things, if any, that may happen to me by being in this study. 4. What my choices are, if I don’t want to be in this study. 5. That my being in this study will be mostly kept a secret. If anyone needs to know I’m in this study, I was told who, and why they have to know.    6. What happens if I get hurt while in the study.

If I have questions, or want to talk about this study with Dr. ________, I can do this by calling:

If I want to talk to someone else about being in this study, I can do this by calling Judy Matuk, someone who helps people who are in research studies, at 631-632-9036, or judy.matuk@stonybrook.edu.

I know I don’t have to be in this study if I don’t want to be. If I say yes now, I can change my mind at any time without getting in any trouble. If I say no, Dr. ________ will still be my doctor.

I will get a copy of this form, and it will be attached to the consent form that has all the information in it that was used to explain the study to me. 

I do____  do not____ agree to be in this study.

____________________________        _______________________ 
Printed Name of Minor Subject/Date      Signature of Minor subject

________________________               _______________________ 
Printed Name of Witness /Date                Signature of Witness

B. Assent: An Example

Most children will not willingly submit to a blood drawing procedure for their own clinical care, let alone for a research study. If CORIHS determines that assent is required for a research study involving blood draws or other painful procedures, CORIHS expects that the investigator will speak with each child in a simple manner about why the child is being asked to do something they don’t have to do, and honestly explain the study in terms of what is expected, what will hurt, and how long they will be asked to be in the study. If initial assent is obtained as required above, reasonableness must be the guide in monitoring assent. For example, most children require that a parent hold their arm or hug them/shield their eyes when blood is being drawn. However, significant distress at the time of the blood draw or other procedure, characterized by verbal or behavioral indications of an unwillingness to continue with the procedure, implies that the child is not assenting to the procedure. His or her wishes must be respected, and the procedure should not be done. Depending on the extent of the child’s distress, s/he should be removed from the study, with reasons documented in the subject’s study file.

C. Types of Activities involving minors that qualify for exemption or expedited review

1. The exempt review category, and corresponding review procedure, as outlined in Section 2.A of this handbook, applies to research involving minor subjects with the exception of exemption #2. The exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with minors (17 years old or younger), except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
2. The expedited review category and corresponding review procedure, as outlined in Section 2.B, is applicable to research involving minor subjects, as long as the particular activity in that section does not require that the subject be 18 years old or older.
3.  All other research involving minor subjects must be reviewed by the full committee, as discussed in Section 2.C.

D. When enrollment of minors is possible, but rarely anticipated

For those studies where minors will be included, but rarely, CORIHS may waive the requirement for submission of a parent permission form and minor's assent (if applicable) as a condition for study approval. However, these documents will need to be submitted for review and approval prior to enrollment of minors into the study.

E. Involvement of Minors in the Departmental Subject Pools

No high school students taking introductory courses may participate in experiments utilizing a departmental subject pool, unless prior approval for use of this specific subject population is granted by CORIHS for a given experiment. Parental permission and subject assent will be required.

College students who are under the age of 18 may participate in studies that are specifically approved for the use of minors. Further, unless a waiver of parental permission has been requested by the investigator and granted by CORIHS, permission of the parent of the minor subject will need to be obtained (see Section 10.A and Section 12.A for conditions that need to be satisfied for such a waiver to be granted). Regardless of whether or not such a waiver is granted, assent of the minor subject will be required in all cases. Referenced approvals and waivers will be granted for projects for which the risks to the subject are determined by the committee to be minimal.

No student, minor or otherwise, can be required to participate in departmental subject pools, as participation in such activities must be voluntary. Alternatives to serving as a human subject via the departmental subject pool process must be available to all students.

Return to Human Subjects Research at SBU

Last Updated: 2008-06-16