This page consists of two documents:

1. Application for Human Subjects;

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2. Renewal Application for Human Subjects.

If you want to download a Word version of this document click here.

DEPARTMENT OF PSYCHOLOGY (Rev. 11/2003)

APPLICATION FOR HUMAN SUBJECTS

Please type all information.

SUBMIT ALL APPLICATIONS IN TRIPLICATE

1. Title of Research Project_______________________________________________

2. Faculty Member Responsible_______________ Phone_________e-mail___________

3. Project Director_________________________ Phone_________e-mail____________

Check One: Faculty Graduate Student RA Graduate Student (Thesis or Dissertation)

Post-doctoral Fellow Visiting Scientist Staff Undergraduate Honors Thesis

Other (specify)_____________________________________________________

4. Names of all others who have any contact with participants:

NAME PHONE POSITION AT UMCP

_____________________________________________________________________

5. Location____________________________________________________________

6. Subject Pool requested YES NO

Beginning in the Fall, 2003 semester, if you wish to use the subject pool, AFTER receiving HSR and IRB approval, make your request for participants to Prof. T. Nelson, Chair Subject Allocation Committee.

Note: If you plan to use the Psyc 100 pool, you MUST state in the space below, verbatim, how you plan to describe your study on the electronic sign-up sheet. Descriptions should be very brief, and limited to 250 characters, e.g., “You will be given information about various products and asked to make judgments about them.” (Also see instructions, below.)

Sign-up sheet description: _______________________________________________________________________

_______________________________________________________________________

7. Project Summary:

A. Purpose of the experiment.

B. Procedures to be followed, including the number of subjects, how they will be recruited, a summary of instructions to the subjects, and a description of their tasks.

C. Subjects to be used. Explain who is being asked to participate, how they are being recruited, and where the research is being done.

D. Include all material including consent form, questionnaires, etc

CONSULT THE SAMPLE CONSENT FORM; CONSENT FORMS MUST INCLUDE THE REQUIRED ELEMENTS.

8. Signature: The Department of Psychology requires that all individuals involved in conducting this research be cognizant of the ethical principles set forth by the American Psychological Association. The APA document, “Ethical Principles of Psychologists and Code of Conduct,” may be viewed on the website: http://www.apa.org/ethics. See especially Standard #8. Your signature below affirms your commitment to abide by this policy by ensuring all who participate as investigators or experimenters will read Standard #8.

_________________________________________ ______________

(Signature of Faculty Member Responsible) (Date)

_________________________________________ ______________

(Signature of Project Director) (Date)

Actions taken by the Committee: Date:___________

________ Approved, no more than minimal risk.

Date approval expires:__________________________

HSR Reference No.____________________________

____________________________________________

(For the Committee)

INSTRUCTIONS FOR APPLICATION FOR HUMAN SUBJECTS

Note that the Committee is responsible for ethical review of research projects. The administration of the Psyc Dept subject pool is administered by the Subject Allocation Committee.

Applying for Human Subject Approval in the Department of Psychology

Who Must Apply, and Why

The Institutional Review Board (IRB) has authorized the Human Subjects Review Committee (HSRC) of the Department of Psychology to review Applications for Human Subjects for research activities in which human subjects are at no more than minimal risk. The guidelines for review which have been established by the IRB apply to any project which involves any person associated in any manner with the University of Maryland, whether or not the subjects in question are associated with the University. Applications for such projects are approved provisionally by the HSRC and forwarded to the IRB for further review and final approval.

The completed application form and relevant materials must be submitted in triplicate. One copy will be returned to you with indication of actions taken. One copy will be sent to the IRB office.

The University has given assurance that it will comply with the Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR 46, as amended). The Institutional Review Board, maintained in the Graduate School, carries out this policy at the College Park Campus. The IRB has authority to approve, to require modification as a condition of approval, or to disapprove proposed research activities. In practice, the Departmental Human Subjects Review (HSR) Committee expedites this review process. Researchers who expect human subjects to be at more than minimal risk must submit an IRB application for human subjects directly to the IRB. SUBJECT AT RISK means any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs, or which increases the ordinary risks of daily life. An IRB Application can be obtained from the Graduate School (301 405-4180).

Where to Get Application Forms

Forms may also be downloaded from the Department’s website.

Where to Submit Completed Applications

Submit applications in triplicate to the Department of Psychology Human Subjects Review Committee. Normally, the Chair of that Committee initiates the reviewing process. In the academic year 2003-04 Professor Harold Sigall is Chair.

When to Submit

In routine cases, expect the HSR Committee to require at least one week to evaluate an application. Non-routine cases may require more time. After the HSRC approves a project, the application is forwarded to the IRB. The IRB must concur in the approval and so notify the investigator before the project may be started. Generally, the IRB requires at least one week from the time it receives the application from the Department to review the application. To avoid delays, investigators should submit application to the HSRC at least three weeks before the hoped for starting date. Please bear in mind that the Committee may function inefficiently, or not at all, during semester breaks.

HSRC approvals for all projects expire on the date indicated on the approval notice. To continue your activity beyond the expiration date, a RENEWAL APPLICATION FOR HUMAN SUBJECTS must be submitted and approved. The review of projects for renewal is comparable to the review of original applications.

What if the Application is not Approved?

The HSRC may ask for additional information, or may request alterations in the research protocol. If strong objections or disagreements arise, the committee will want to meet with you to discuss them. In the past, such disagreements have been extremely rare, and in every case they have been amicably resolved through discussion.

Specific Instructions For the Application Form

Line 1 Please use a brief and descriptive title.

Line 2 The Faculty Member Responsible for the Project must be a Regular or an Affiliate member of the Department of Psychology, holding the rank of Assistant Professor, or a higher rank. The person listed in Line 2 must sign the application in Line 8.

Line 3 The Project Director can be the faculty member listed in Line 2, faculty from another department, a graduate student employed as a research assistant (RA), a graduate student collecting data for a thesis or dissertation, a post-doctoral fellow, a visiting scientist, a staff member, or an undergraduate doing an honors thesis

Line 4 List the names of all collaborators in this research who will have contact with the human participants, or who will act as representatives of the research project in presenting or explaining the nature of the research to the community at large. Specifically include those who recruit, interview, test, instruct, or debrief the human participants. If additional space is needed, attach a continuation page.

If the research activity is conducted by undergraduate students as a required class project under the supervision of teaching assistants, list the names of the teaching assistants only.

Indicate the position at the University of Maryland held by each collaborator, e.g., faculty member, staff member, visiting scientist, post-doctoral fellow, research associate, research assistant, instructor, graduate student, undergraduate honors student, etc.

Line 5 Give the building and room number.

Line 6 Complete this section if you request use of the Psyc 100 Subject Pool.

Be sure to include the sign-up description to appear on the electronic sign-up form. This is a description, not an advertisement. Do not give a "running time" for the research. Students are told to allot one hour in their schedule to earn one-credit, two hours for two credits, etc.

Line 7 Please provide a summary of the project as requested in items A-E. This section should be limited to one page. If you use procedures that deceive a participant in any way and/or you withhold information about the full purpose of the experiment, following debriefing you must give participants an opportunity to withdraw their data without penalty.

ATTACH A COPY OF THE FORM YOU WILL USE TO OBTAIN INFORMED CONSENT. The consent form must contain the following parts (required elements):

1) Project Title.

2) Statement of age. For example, I am at least 18 years old.

3) Statement of willingness to participate. For example, "I am willing to participate in a research activity being conducted by _______ at the Graduate School, University of Maryland College Park, Department of Psychology."

4) Purpose of research.

5) Procedures.

6) Statement about confidentiality. Explain how the data will be kept confidential, i.e., where the data will be kept, how the data will be kept secure, and who will have access to the data.

7) A risk/benefit statement. For example, " There are no known risks to my participation in this research. I understand that the research is not designed to help me personally, but the investigator hopes to learn more about how ........."

8) Statement about freedom to ask questions without penalty.

9) Statement about freedom to withdraw from participation at any time without penalty.

10) Statement about freedom to withdraw their data at the end of debriefing without penalty (if deception re the purpose of the study has been used).

11) Instruction about how to contact the Chair of the Human Subjects Committee for any questions regarding the rights of a research participant.

12) Name, Address, Phone Number of Principal Investigator.

13) Subject's Name.

14) Signature of Subject.

15) Date.

16) The approval period of the project.

The form should be written in the first person, from the prospective participant=s point of view.

Researchers should keep the consent form for a period of three years after the termination of the approval period of the project. Participants should be given a copy of the consent form that they signed.

If your procedures require exceptions to obtaining advanced, informed consent, you must submit an application directly to the IRB. The IRB is allowed to waive informed consent in certain situations, but that is done on a case by case basis. IRB applications can be obtained from the Graduate School (301 405-4180). In the IRB application, you must describe the method you will actually use, and justify the following: (a) the risk of this change to the subject is minimal; (b) the use of the standard procedure would surely invalidate objectives of considerable immediate importance; (c) any reasonable alternative means for attaining these objectives would be less advantageous to the subjects.

Line 8 The faculty member and the project director must sign the form.

If you have questions about your rights as a research subject or wish to report a research-related injury, please contact: Institutional Review Board Office, University of Maryland, College Park, Maryland, 20742; (e-mail) irb@deans.umd.edu; (telephone) 301-405-4212

DEPARTMENT OF PSYCHOLOGY (Rev. 11/2003)

RENEWAL APPLICATION FOR HUMAN SUBJECTS

Please type all information.

SUBMIT ALL APPLICATIONS IN TRIPLICATE

1. Previous HSR Reference#_______________________________________

2. Date Previous HSR Approval Expires _____________________________

3. Title of Research Project_______________________________________________

4. Faculty Member Responsible________________ Phone__________e-mail___________

5. Project Director________________________ Phone__________e-mail____________

Check One: Faculty Graduate Student RA Graduate Student (Thesis or Dissertation)

Post-doctoral Fellow Visiting Scientist Staff Undergraduate Honors Thesis Other (specify)_____________________________________________________

6. Names of all others who have any contact with participants:

NAME PHONE POSITION AT UMCP

_____________________________________________________________________

7. Location____________________________________________________________

8. Complete A or B

A. Continuation of previously approved use of subject pool

B. Continuation without use of Subject Pool

Sign-up sheet description: _______________________________________________________________________

_______________________________________________________________________

9. Contents of Renewal Application:

A. Present a description of the project that was proposed in the original application. Include all human subjects relevant material, including instruments, consent forms, etc.

B. Indicate whether the project was undertaken. Indicate how many subjects have participated and summarize what you have learned so far.

C. Indicate whether there have been any problems (adverse effects, complaints) involving human subjects since the previous HSRC approval. Describe any problems, and how they were handled.

D. Indicate whether there have been, or will be, any modifications in procedures, types of subjects, or the consent process since the previous approval. Please describe the changes.

CONSULT THE SAMPLE CONSENT FORM TO MAKE SURE THAT IT COMPLIES WITH CURRENT STANDARDS; CONSENT FORMS MUST INCLUDE THE REQUIRED ELEMENTS.

10. Signature: The Department of Psychology requires that all individuals involved in conducting this research be cognizant of the ethical principles set forth by the American Psychological Association. The APA document, “Ethical Principles of Psychologists and Code of Conduct,” may be viewed on the website: http://www.apa.org/ethics. See especially Standard #8. Your signature below affirms your commitment to abide by this policy by ensuring all who participate as investigators or experimenters will read Standard #8.

_________________________________________ ______________

(Signature of Faculty Member Responsible) (Date)

_________________________________________ ______________

(Signature of Project Director) (Date)

Actions taken by the Committee: Date:___________

________Approved, no more than minimal risk.

Date approval expires:__________________________

HSR Reference No.____________________________

____________________________________________

(for the Committee)

Applying for Human Subject Approval in the Department of Psychology

Who Must Apply, and Why

The Institutional Review Board (IRB) has authorized the Human Subjects Review Committee (HSRC) of the Department of Psychology to review Applications for Human Subjects for research activities which are not externally funded and where human subjects are at no more than minimal risk. The guidelines for review which have been established by the IRB apply to any project which involves any person associated in any manner with the University of Maryland, whether or not the subjects in question are associated with the University. Applications for such projects are approved provisionally by the HSRC and forwarded to the IRB for further review and final approval.

The application form and relevant materials must be submitted in triplicate. One copy will be returned to you with indication of actions taken. One copy will be sent to the IRB office.

The University has given assurance that it will comply with the Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR 46, as amended). The Institutional Review Board, maintained in the Graduate School, carries out this policy at the College Park Campus. The IRB has authority to approve, to require modification as a condition of approval, or to disapprove proposed research activities. In practice, the Departmental Human Subjects Review (HSR) Committee expedites this review process. Researchers who are applying for external support and/or researchers who expect human subjects to be at more than minimal risk must submit an IRB application for human subjects directly to the IRB. SUBJECT AT RISK means any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his needs, or which increases the ordinary risks of daily life. An IRB Application can be obtained from the Graduate School (301 405-4180).

Where to Get Application Forms

Forms may be downloaded from the following website: http://experimetrix.com/umcp (click on read.me), as well as from the Department’s website.

Where to Submit Completed Applications

When to Submit

In routine cases, expect the HSR Committee to require one week to evaluate an application. Non-routine cases may require more time. Please bear in mind that the Committee may function inefficiently, or not at all, during semester breaks. After the HSRC approves a project, the investigator must await notification from the IRB that it concurs in the approval. Normally, such notification will not arrive until at least one week after the HSRC approves the application. If the PSYC subject pool is being used, additional time should be allotted for making the request and receiving notification from the Subject Allocation Committee.

What if the Application is not Approved?

Specific Instructions For the Application Form

Line 1 Please use a brief and descriptive title.

If the research activity is conducted by undergraduate students as a required class project under the supervision of teaching assistants, list the names of the teaching assistants only.

Line 5 Give the building and room number. This information is essential and mandatory.

Line 6 Complete this section if you request use of the Psyc Subject Pool..

ATTACH A COPY OF THE FORM YOU WILL USE TO OBTAIN INFORMED CONSENT. The consent form must contain the following parts (required elements):

1) Project Title.

2) Statement of age. For example, I am at least 18 years old.

4) Purpose of research.

5) Procedures.

6) Statement about confidentiality. Explain how the data will be kept confidential, i.e., where the data will be kept, how the data will be kept secure, and who will have access to the data.

8) Statement about freedom to ask questions without penalty.

9) Statement about freedom to withdraw from participation at any time without penalty.

10) Statement about freedom to withdraw their data at the end of debriefing without penalty (if deception re the purpose of the study has been used).

11) Instruction about how to contact the Chair of the Human Subjects Committee for any questions regarding the rights of a research participant.

12) Name, Address, Phone Number of Principal Investigator.

13) Subject's Name.

14) Signature of Subject.

15) Date.

16) The approval period of the project.

The form should be written in the first person, from the prospective participant=s point of view.