WRITING INFORMED CONSENT

-Each student will develop a consent form for a study on attitudes about risk factors for HIV transmission involving attendance of a three part educational program and collection of personal information including sexual and drug use behavior.

GUIDELINES FOR WRITING INFORMED CONSENT

An informed consent form outlines the research study and expectations for potential

participants. This document should be written in layman terms and typed on Delaware

State University letterhead. If a technical term must be used, define it the first time it is

used. Also, any abbreviation should be spelled out the first time it is used. The title of

the research project must be on the informed consent. Each consent form should

include the following elements:

Purpose - Include a statement that the study involves research, an explanation of the

purposes of the research procedure and the expected duration of the subject's

participation, a description of the procedures to be followed and identification of any

procedures that are experimental.

Risks and Discomfort - Describe any reasonably foreseeable risks or discomforts--

physical, psychological, social, legal or other associated with the procedure, and include

information about their likelihood and seriousness.

Discuss the procedures for protecting against or minimizing any potential risks to the

subject. Discuss the risks in relation to the anticipated benefits to the subjects and to

society.

Benefits - Describe any benefits to the subject or other benefits that may reasonably be

expected from the research. If the subject is not likely to benefit personally from the

experimental protocol note this in the statement of benefits. Discuss the risks in relation

to the anticipated benefits to the subjects and to society.

Alternative procedures - Include a disclosure of appropriate alternative procedures or

courses of treatment, if any that might be advantageous.

Costs and Payments - It is assumed that there are no costs to subjects enrolled in

research protocols. Any anticipated costs to the subject for tests/procedures performed

specifically for the study, experimental procedures or use of equipment must be stated.

Any payments to be made to the subject (e.g., travel expenses, stipends) must also be

stated, including when the payment will be made.

Confidential information - Provide a statement describing the extent, if any, to which

confidentiality or records identifying the subjects will be maintained, and note the

possibility that the Food and Drug Administration or drug company supplying the

experimental drug may inspect the records.

Compensation - For research involving more than minimal risk, explain whether any

compensation or medical treatments are available if injury occurs, and it so, what they

consist of or where further information may be obtained.

Inquiries - Explain whom the subject should contact for answers to questions about the

research or research-related injuries (usually the PI) and the research subject's rights

(IRB - Human Subjects Protection Committee chairperson).

Voluntary Participation - Include 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.

Required signatures - Each research subject or the surrogate decision-maker must

sign an informed consent form prior to entering the research protocol unless a protocol

was specifically exempted because of the nature of the study. Provide a statement of

consent written in the first person, i.e., "I hereby consent," etc.

Signature lines for the following should be included on the informed consent form:

a) The subject or the subject's legally authorized representative.

b) The witness of both the oral presentation and execution of the written consent.

c) The investigator or the person obtaining the subject's consent form.

Each subject (or authorized representative) should be given a copy of the signed

informed consent. Include such a statement on the informed consent form.

For further information, please contact Mr. Dennis Rubino (302) 857-6834, or Ms.

Renee S. Jones at (302) 857-6819.

DELAWARE STATE UNIVERSITY

INFORMED CONSENT AND HUMAN SUBJECTS RESEARCH

Research investigators are responsible for obtaining informed consent from human

subjects (or their legally authorized representative). The consent information must be in

language understandable to the subject or the subject's representative. Wording should

not include conditional language through which the subject or the representative is

made to waive or appear to waive any of the subject's legal rights, or release the

research investigator, the sponsor, the institution or its agents from liability for

negligence.

Avoid the person/tense used in the wording of the consent form. Statements

interchanging "I," "you," and "one" can be very confusing to the reader.

An effort should be made to be precise. As in our sample, the entire copy may be

produced on one side of paper.

A. BASIC ELEMENTS OF THE INFORMATION NECESSARY FOR "INFORMED

CONSENT" INCLUDE:

1. Statement that the study involves research, an explanation of the

purposes of the research, and the expected duration of the subject's

participation. Use the word "research" to make this element clear.

2. An invitation to participate--worded perhaps as "You are invited to

participate in a study of .... We hope to learn ...."

3. Why the subject was selected--if this is appropriate to the project.

4. A description of the procedures to be followed and identification of any

procedures which are experimental.

5. A description of any reasonably foreseeable risks or discomforts.

6. If any benefits can be reasonably expected, they should be described.

7. A disclosure of any appropriate alternative procedures that might be

advantageous for the individual.

8. Aspects of confidentiality of information--if data is in form of tape

recordings, photographs, movies or videotapes, researcher should

describe period of time they will be retained before destruction. Showing

or playing of such data must be disclosed, including instructional

purposes.

9. An explanation of whom to contact for answers to pertinent questions

about the research and whom to contact in the event of research-related

injury to subject. This is usually the researcher or the faculty advisor.

10. An explanation of whom to contact concerning issues on human subjects

rights. This is IRB - Human Subjects Protection Committee Chair or the

Office of Sponsored Programs.

11. If subjects are paid a fee or receive some service in lieu of financial

compensation for participating, this should be described.

12. A statement that participation is voluntary, refusal to participate involves

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. If the subject is receiving some form of course "credit" for

his/her participation, the effect of withdrawal from the experiment on

"credit received" should be explained.

13. For research involving more than minimal risk, an explanation as to

whether any compensation and/or medical treatments are available if any

injury occurs and, if so, what they consist of, or where further information

may be obtained.

14. Concludes with statement of acceptance to participate in the research study

including the signature of the subject or responsible agent, unless nature of

research is such that signed consent forms are unnecessary.

B. DOCUMENTATION OF INFORMED CONSENT

1. Research investigators shall be responsible for insuring that informed

consent is documented by the use of a written consent form approved by

the IRB - Human Subjects Protection Committee and signed by the

subject or the subject's legally authorized representative, unless this

requirement is specifically waived by the IRB - Human Subjects Protection

Committee. A copy of the signed consent form is given to the person

signing the form; the original signed consent form is retained by the

research investigator.

2. The requirement for the investigator to obtain a signed consent form may

be waived by the IRB - Human Subjects Protection Committee if it finds

that either:

a. the only record linking the subject and the research would be the

consent document and the principal risk would be potential harm

resulting from breach of confidentiality.

b. the research presents no more than minimal risk and involves no

procedures for which written consent is normally required outside of

the research context.

3. When the IRB - Human Subjects Protection Committee waives the

documentation requirement, it may require the investigator to provide

subjects with a written statement about the research, generally including

the relevant elements of informed consent. In all cases, a written

statement describing the informed consent procedure shall be provided to

the IRB - Human Subjects Protection Committee.

PLEASE NOTE THAT THE FINAL FORM ADMINISTERED MUST BE APPROVED BY

THE IRB - HUMAN SUBJECTS PROTECTION COMMITTEE BEFORE IT CAN BE

LEGALLY ADMINISTERED; SAMPLE COPIES OF THE FORM MUST BY LAW BE

RETAINED BY THE IRB - HUMAN SUBJECTS PROTECTION COMMITTEE.

Sample Subject's Consent Forms are attached. NOTE: Three samples are shown, a

comprehensive form, a cover letter format and oral consent--investigators should

develop a consent form appropriate to the type of subject and the nature of the

proposed research. Please remember to write at the educational level of the intended

subject population.

SAMPLE COVER LETTER FOR CATEGORY I/II PROJECTS

(When signed consent form is not required or appropriate,

e.g., anonymous research involving minimal risk, non-sensitive data, etc.)

Dear (potential subject pool, e.g., student, teacher, manager):

You are invited to participate in a research study [state what is being studied].

We hope to learn [state what the research project is designed to discover or

establish]. You are being asked to participate in this study because [state why person

is appropriate subject].

If you decide to participate in the project [describe the procedures to be

followed, e.g., please complete the attached survey and return it in the enclosed

envelope] -- [describe confidentiality conditions].

If you have any questions about this research, please call [name of faculty

advisor/investigator]. If you have questions concerning the rights of subjects involved

in research studies, please call the Office of Sponsored Programs at 302-857-6819 or

6811.

Your voluntary completion of the survey constitutes consent to participate. Thank

you for assisting us with this study.

Sincerely,

Name of faculty/student researchers

and University affiliation

e.g., John Smith

Joan Brown

Students in Management 689

Obtaining Oral Consent: If oral consent is necessary due to limited literacy or language

comprehension, the subject or his/her legal representative will be asked to sign a short

form stating that the basic consent form elements have been orally presented. Both the

short consent form and the oral presentation must be approved by the IRB - Human

Subjects Protection Committee. A witness must also be present for this presentation

and must sign both the short form and a written summary of the oral presentation. The

subject or his/her legal representative must be furnished with a copy of both signed

documents.

SAMPLE ORAL CONSENT

HELLO--I am a [describe who you are, including university affiliation, e.g.,

student in (Department) at Delaware State University]. We are conducting research

[describe project and method of data collection, e.g., telephone survey, etc.].

Your are being contacted because [explain why you are calling, e.g., random

survey, resident of Dover, listed in yellow pages].

If you agree, I would like to ask you some questions about [describe nature of

survey]. The survey should take [specify amount of time]. Your responses are

[confidential] and will be grouped with other people who are called.

Do you have any questions about the research project? May I proceed with the

first question?

Sample Subject Consent Form/Statement

Project Director or Principal Investigator:

Title of Project:

You are invited to participate in a research study of [state what is being studied]. We hope to

learn [state what the study is designed to discover or establish]. You were selected as a possible

participant in this study because [state why the subject was selected].

If you decide to participate, we [or: Dr. and associates] will [describe the

procedures to be followed, including their purposes, how long they will take, and their

frequency]. [Describe the discomforts and inconveniences. An estimate of the total time required

must be included]. [Describe the risks reasonably to be expected]. [Describe any benefits

reasonably to be expected. If benefits are mentioned, it is advisable to add:] We cannot and do not

guarantee or promise that you will receive any benefits from this study.

[Describe appropriate alternative procedures that might be advantageous to the subject, if

any. Any standard treatment that is being withheld must be disclosed.]

[A statement describing the extent, if any, to which confidentiality of records identifying

the subject will be maintained.] If you give us your permission by signing this document, we plan to

disclose [state the persons or agencies to whom the information will be furnished, the nature of

the information to be furnished, and the purpose of the disclosure.]

[If the subject will receive a fee for participating, or services in lieu of a fee, describe the

amount or nature.] [If there is a possibility of additional costs to the subject because of

participation, describe it.]

[For research involving more than minimal risk, 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.]

Your decision whether or not to participate will not prejudice your future relations with

[(Institution) and the named cooperating institution, if any]. If you decide to participate, you are free

to withdraw your consent and to discontinue participation at any time without prejudice.

Before you complete and sign the form, please ask questions on any aspect of the study that is at

all unclear to you. If you have any additional questions later, Dr. (give a phone number

or address) will be happy to answer them. If at any time you have questions concerning your rights as a

research subject, you may call the Office of Sponsored Programs, 302-857-6819 or 857-6811.

YOU ARE MAKING A DECISION WHETHER OR NOT TO PARTICIPATE. YOUR SIGNATURE

INDICATES THAT YOU HAVE DECIDED TO PARTICIPATE, HAVING READ THE INFORMATION

PROVIDED ABOVE.

I acknowledge that I have received a personal copy of this consent form. Copy received: _____

(initial)

_________________________________

Date Signature

AM

PM

Time Relationship to subject

[This line should not appear on forms that will

be given to subjects consenting for

themselves.]

Signature of Witness Signature of Investigator