Southeastern Faculty Senate

Human Subjects Research Review Policy

Research Involving Human Subjects at Southeastern Oklahoma State University

 

(Note: Permission was granted by the University of North Texas to use and modify the UNT policy for human subjects research.)

What is human subjects research?

All research which involves any form of participation of human subjects qualifies as human subjects research, and as such must be reviewed and approved by an institutional committee. This includes survey research, research by students as well as by faculty and staff, and both internally and externally funded research. The university’s policy is mandated by federal regulations and is meant to safeguard the welfare of human subjects in research.

Functions of the Human Subjects Research Review Committee (HSRRC).

Review by an HSRRC is meant to assure that (1) risks are minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, (2) there is informed consent by the subjects, and (3) rights and welfare of subjects are maintained in all respects.

Filing for review.

A researcher who plans any project which involves human subjects research should obtain a form entitled “Request for Approval of Human Subjects Research” in the Appendix of the Academic Policy and Procedures Manual. Once the form is completed, it is returned to the Chair HSRRC.

The review process.

As previously stated, all proposed human subjects research, including proposed thesis research, is subject to review and cannot take place without institutional approval. The review process begins with a determination by the committee chair as to whether the proposed research qualifies as being exempt from further review. The criteria for exemption are listed. If the proposed research does not qualify as exempt, it will then be subjected to further review. The research may qualify for expedited review if certain criteria are met. This determination is made by the chairperson or an appointed subcommittee of the HSRRC. If the proposed research is not exempt and does not qualify for expedited review, it is then sent to full review by the HSRRC. If a research project (that was already approved) extends longer than one year, the principal investigator is required to submit the proposal annually to the HSRRC to ensure compliance with the guidelines.

Criteria for approval.

In general, a human subjects research protocol should provide that (1) risks are minimized through procedures consistent with sound research design, using, whenever available, procedures already being performed on the subjects for diagnostic or treatment purposes, (2) any risks beyond those incurred in daily life are outweighed by benefits to the subjects, (3) selection of subjects is equitable and the setting appropriate, (4) informed consent is adequate, (5) consent is documented, (6) continued monitoring takes place to insure the safety of the subjects, and (7) privacy and confidentiality are maintained.

Time required and notification.

Submitted proposals are initially reviewed by the chair to determine if they can be treated as exempt or expedited. If the proposal is classified as either exempt or expedited, notification is given to the investigator with the decision subject to confirmation by the full HSRRC at its next meeting. Proposals that are subject to full HSRRC review are discussed and decisions made at the next meeting of the HSRRC. The researcher is notified in writing of the review’s outcome by the committee chairperson.

Cooperative research.

In many cases, human subjects research will involve cooperation among two or more institutions. In such cases, the institutions may use joint review, reliance on the review of another qualified Institutional Review Board or similar arrangements aimed at avoidance of duplication of effort. However, the researcher at SOSU is still obligated to file the form “Request for Approval of Human Subjects Research” with the SOSU HSRRC.

DEFINITIONS OF TERMS USED IN HUMAN SUBJECTS RESEARCH

Research means a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Identifiable private information is data in which the identity of the subject is associated with the information or may be readily found out by the researcher.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or an associate with the information) in order for obtaining the information to constitute research involving human subjects.

Informed consent means that the subject, or a legally authorized representative, has received an explanation of the research involved and its potential risks, and has agreed to participate. Informed consent has eight essential points, which are listed on a separate page.

Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. The use of a legally authorized representative to gain approval of human subjects research is by analogy with clinical treatment where consent must be obtained, for example from parents or guardians in the case of minor children.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

An assurance is a document sent with a research proposal to a federal, state, or private agency to affirm that the institution will observe all mandated and ethical considerations in the research project. The university has a “general assurance” which it has filed with the federal government, but the existence of the general assurance does not eliminate the requirement for filing an assurance form with a specific proposal when the granting agency requires it.

 

QUALIFICATION FOR EXEMPTION

The chair of the HSRRC or his/her designate may determine that the proposed research is exempt from further review if the research in which human subjects are involved falls into one or more of the following categories:

  • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
    • Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    • Any disclosure of the human subjects’ responses outside the research could responsibly place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

The exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, that is not exempt under (2) above, if:
    • the human subjects are elected or appointed public officials or candidate for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research thereafter.
  • Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
  • Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
    • public benefit or service programs;
    • procedures for obtaining benefits or services under those programs;
    • possible changes in or alternatives to those programs or procedures; or
    • possible changes in methods or levels of payment for benefits or services under those programs.
  • Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the EPA or the Food Safety and Inspection service of the U.S. Department of Agriculture.

 

QUALIFICATION AND EXPEDITED REVIEW

Research may qualify for expedited review by the chair of the HSRRC or an appointed subcommittee if the research involves no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories:

  • Collection of : hair and nail clippings in a nondisfiguring manner; deciduous teeth; and permanent teeth extracted through normal dental therapeutic practice.
  • Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
  • Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible spectrum (e.g., x-rays, microwaves).
  • Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
  • Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
  • Voice recordings made for research purposes such as investigations of speech defects.
  • Moderate exercise by healthy volunteers, consistent with the guidelines published by the American College of Sports Medicine.
  • The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
  • Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
  • Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

QUALIFICATION FOR FULL REVIEW

All proposed research which does not qualify for either exemption or expedited review must go to the full HSRRC for review. Typically, the project description is sent by mail to the HSRRC members who then discuss the proposal at the next monthly meeting of the HSRRC with a recommendation to approve, deny, or approve the project with specific modifications. NOTE: Survey and interview research involving children is NOT exempt, but rather requires full HSRRC.

 

ESSENTIAL COMPONENTS OF INFORMED CONSENT

No investigator may involve a human being as a subject of research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

Conditions of consent

An investigator shall seek consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

Language

Information given to the subject or his/her representative shall be in language understandable to the subject or representative. This will usually be language understandable to a layperson.

No exculpatory language

Informed consent, whether oral or written, may not include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability or negligence.

The basic elements of informed consent include:

  • A statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  • A description of any reasonably foreseeable risks or discomforts to the subject;
  • A description of any benefits to the subject or to others which may reasonably be expected from the research;
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  • For research involving more than minimal risk, an explanation as to whether any compensation is to be given 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;
  • An explanation of whom to contact for answers to pertinent questions about the research and subject’s rights, and whom to contact in the event of a research-related injury. The name of whom to contact should be accompanied by an office location and a telephone number;
  • A statement that participation is voluntary, refusal to participate will involve no penalty 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.

Altered or waived consent

In some cases, HSRRC may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent. This is usually the case where the informed consent would seriously compromise the research. In most such cases the HSRRC would insist on (1) minimal risk, (2) no adverse effects on rights and welfare, and (3) the research could not practicably be carried out without the waiver or alteration, and (4) providing additional information to the subject at a later time. Rarely does the HSRRC agree to waive informed consent, but some familiar kinds of research that might justify alteration or waiver include (1) necessary deception in behavioral or social science, (2) examination of existing data, documents, records, or specimens, (3) research on medical emergencies, and (4) subjects whose comprehension varies over time.

Documentation of informed consent shall include a signed form, with a copy provided to the subject or his representative. In certain cases, the signed form may be waived, for example if the consent document is the only link between the subject and the research and the main risk to the subject is a breach of confidentiality. For example, if the only record linking the subject to the research or data is the written, signed informed consent, its use may be waived by the HSRRC. However, a statement describing the procedures and objectives of the research shall still be supplied to the subjects in a written format. An example of such a project would be the analysis of a questionnaire which is distributed and returned anonymously through the mail. A cover letter should include all the elements of informed consent. If informed consent is to be obtained orally (i.e., prior to a telephone interview) a written summary of what the subject will be told must be provided to the HSRRC for review and approval. In such cases, the subject decides whether or not to use a signed form. The signed document may also be omitted if the risk is minimal and written consent is not normally required outside the context of the research.

Examples of various types of informed consent forms are attached. These are only to be used as examples or guides for the formulation of individual informed consent forms and not as standard forms.


EXAMPLE A: MINIMAL RISK POTENTIAL

 

I, _____________________________________________, agree to participate in a study of individuals involved in the New Options Transitional Living Program at the Texas Institute for Rehabilitation and Research. New Options is six-week live-in program designed to help severely physically disabled persons acquire adaptive skills. The purpose of this study is to evaluate the effectiveness of this program. We hope to use the information obtained from this study to modify this program so that it will better serve physically disabled persons.

As a participant, I understand that my involvement in the Transitional Living Program will be coincident with my participation in this research project. I understand that periodically (2-4 times) I will be expected to participate in a number of experimental tasks including the completion of forms, checklists, and questionnaires relating to my knowledge, attitudes, and behavior, and the occasional observation of my activities. These instruments may include behavioral logs or diaries, attitudinal surveys, activity checklists, and informational quizzes. In addition, I have been told that I may be asked to participate further in this research several months after my involvement in the Transitional Living Program is ended. If I am asked to continue participation, I will be told exactly what further participation will entail.

I have been informed that any information obtained in this study will be recorded with a code number that will allow Dr. xxx to determine my identity. At the conclusion of this study the key that relates my name with my assigned code number will be destroyed. Under this condition, I agree that any information obtained from this research may be used in any way thought best for publication or education.

I understand that there is no personal risk or discomfort directly involved with this research and that I am free to withdraw my consent and discontinue participation in this study at any time. A decision to withdraw from the study will not affect the services available to me or my participation in the New Options Transitional Living Program.

If I have any questions or problems that arise in connection with my participation in this study, I should contact Dr. xxx, the project director at xxx-xxxx (work) or xxx-xxxx (home).

____________________ _________________________________

(Date) (Signature of Transitional Living Participant)

___________________ _________________________________

(Date) (Investigator)

____________________ _________________________________

(Date) (Witness)*

This project has been reviewed by Southeastern Oklahoma State University Human Subjects Research Review Committee.

*Witness signatures are required whenever the capacity of the subject to understand the description of the project and its associated risks is in question or when required by the HSRRC.


EXAMPLE B: MEDICAL/BIOLOGICAL STUDY WITH AN UNKNOWN RISK

POTENTIAL

CONSENT FOR TREATMENT RADIO-ISOTOPE FORM OF AHA

I am well aware of the investigative use of Acetohydroxamic Acid (AHA) for the treatment of patients with infection-induced urinary stones. I have read the AHA brochure and understood to my satisfaction the risks and uncertainties involved in treatment with AHA. Information from this study will be used by physicians in order to better enable them to treat patients with infection-induced urinary stones. I have given consent for treatment with AHA, but I understand that I might not experience any therapeutic benefits from AHA.

I herewith recognize that I have been asked to take a single dose (250 mg) on two separate occasions of AHA that contains a small amount of (160 mCi) of radioactivity. I recognize that radioactive drugs are commonly given on an investigative basis to study the metabolism of new drugs. I understand that various biological specimens (urine, blood, saliva and stool) will be taken and analyzed during the 72-76 hours after I receive radioactive AHA.

I recognize that use of the radioactive drug complies with FDA, Southeastern Oklahoma State University Human Subject Research guidelines. I have been informed that the radioactive AHA is thought to convey minimum risk; however, I understand that no assurances regarding my safety or the effectiveness of the treatment with AHA can be made.

I hereby volunteer to be a part of this investigational treatment and give permission to Southeastern Oklahoma State University and to such other institutions as may be involved and to the investigators involved to release all or part of the information contained in my medical record. I understand that I may revoke this consent and discontinue treatment with these drugs at any time without affecting the services available to me at the XX College of Medicine. If I suffer any adverse effects as a result of my participation in this project, XX College of Medicine will provide medical care, which I will be required to pay for; however I will not be compensated for any adverse effects I might suffer as a result of my participation.

I recognize that collection of biological specimens (blood, urine, saliva, and stool) will require my being “on-site” for the first 12-16 hours and that additional specimens will be collected periodically from me for another 60 hours. Each blood sample taken will be about one teaspoonful, and there will be approximately 14 samples taken. Urine collection will be made at specific intervals into pre-labeled containers.

If I have any further questions or problems connected with my participation in this project, I should contact the project director, Dr. xxx, at xxx-xxxx (work) or xxx-xxxx (home).

Signed this ________ day of _______________, 19___, in the presence of the witnesses whose

signatures appear below.

Signed:____________________________________

Witnesses:*________________________ _________________________________________

(Signature) (Address)

________________________________ _________________________________________

(Signature) (Address)

This project has been reviewed by Southeastern Oklahoma State University Human Subjects Research Review Committee.

*Witness signatures are required whenever the capacity of the subject to understand the description

of the project and its associated risks is in question or when required by the HSRRC.


EXAMPLE C: COVER LETTER FOR MAILED QUESTIONNAIRE WHEN USE OF

AN INFORMED CONSENT COULD PRESENT RISK IN AN OTHERWISE

ANONYMOUS, RISK-FREE PROJECT

Dear _______________________,

We are asking for your help. Please take a minute to read this letter. The Personnel Psychology Services Center in the Department of Psychology of the Southeastern Oklahoma State University currently is involved in a multi-organization study of employee turnover. This research project is funded by the Department of Labor. The objective of this research project is to attempt to understand why people leave their jobs.

Enclosed with this letter is a brief questionnaire that asks a variety of questions about your attitudes toward your job with the University. We are asking you to look over the questionnaire and, if you choose to do so, to complete the questionnaire and to send it back to us at the Department of Psychology. Do not write your name on the questionnaire. We do not need to know who you are. The results of this project will be summarized and appropriate people with the University will be given a summary report. We emphasize that this is a research project. We guarantee that your choice to participate and your responses if you do participate will not be identified with you personally. Nothing you do or say will in any way reflect your past or even future employment with the University.

We hope you will take a few minutes to complete this questionnaire and to return it in the enclosed self-addressed and stamped envelope. Without the help of people like yourself, research on employees would not be conducted. Regardless of whether you choose to participate or not, we will send you a summary of our findings. To receive a summary, use the enclosed letter size self-addressed and stamped envelope and the address form. To preserve your anonymity, you can send this request by separate mail. In this way, we have no way of knowing who sent back a questionnaire and who requested a summary of the results.

Understanding why people quit their jobs is very important. Through your participation, we eventually hope to understand how to best satisfy the needs of organizations and the needs of employees. We ask your participation, and thank you for reading this letter.

Cordially,

xxxxxxxx

This project has been reviewed by Southeestern Oklahoma State University Human Subjects Research Review Committee.


EXAMPLE D: PARENTAL CONSENT LETTER

Dear Parents:

I will be conducting a research project designed to study how children think and develop strategies in games. I request permission for your child to participate. This study consist of two twenty-minute sessions where children will play Tic-Tac-Toe one day and a Guessing Game on another. The goals of the study are to detail the strategies of game-playing used by children of different ages, and to see how thinking strategies differ in the two games.

Each child will be invited to leave the classroom to participate in this special activity, and will accompany me only if he or she is willing to do so. Children usually enjoy games, so I expect that children will be interested and enthusiastic about participating; however, any child who expresses a desire to return to the classroom will be escorted back immediately. Interviews will be conducted by me and videotaped by my research assistant. Children’s responses will be reported as group results only. Individual taped responses will be used as examples of scoring procedures; however the children will not be identified by name. Videotapes will be retained by me at the study’s conclusion. These tapes may be viewed by the child’s teachers, and some may be shown to groups when the study is presented to students, teachers, and at professional conferences. To preserve confidentiality, only first names will be used to identify children. In addition to game participation, I will need to look at the school’s records in order to obtain your child’s birth date and mathematics scores on the Iowa Tests of Basic Skills.

Your decision whether or not to allow your child to participate will in no way affect your child’s standing in his or her class/school. At the conclusion of the study, a summary of group results will be made available to all interested parents and teachers. Should you have any questions or desire further information, please call me at xxx-xxxx. Thank you in advance for your cooperation and support.

Sincerely,

xxxxxxx

This project has been reviewed by Southeastern Oklahoma State University Human Subjects Research Review Committee.

Please indicate whether or not you wish to have your child participate in this project, by checking a statement below and returning this letter to your child’s teacher as quickly as possible.

I do grant permission for my child, __________________________ to participate in this project.

I do not grant permission for my child, __________________________ to participate.

____________________________

(Parent/Guardian’s signature)


EXAMPLE E: FORM THAT COULD BE ADAPTED FOR USE WHEN SUBJECT WILL

READ OR BE VERBALLY INFORMED OF THE PROCEDURES, RISKS/BENEFITS,

ETC. OF THE STUDY.

USE OF HUMAN SUBJECTS

INFORMED CONSENT

NAME OF SUBJECT:________________________________________________

I hereby give consent to _______________________________________________ to perform

or supervise the following investigational procedure or treatment:

_________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

I have (seen, heard) a clear explanation and understand the nature and procedure or treatment; possible appropriate alternative procedures that would be advantageous to me (him, her): and the attendant discomforts or risks involved and the possibility of complications which might arise. I have (seen, heard) a clear explanation and understand the benefits to be expected. I understand that the procedure or treatment to be performed is investigational and that I may withdraw my consent at any time without prejudice or penalty. With my understanding of this, having received this information and satisfactory answers to the questions I have asked, I voluntarily consent to the procedure or treatment designated in Paragraph 1 above.

___________________ (Date)

Signed: __________________________ Signed: ____________________________

(Witness) (Subject or person responsible)

Signed: __________________________

(Witness)

Instructions to persons authorized to sign:

If the subject is not competent, the persons responsible shall be the legal appointed guardian or legally authorized representative. If the subject is a minor under 18 years of age, the person responsible is the mother or father or legally appointed guardian. If the subject is unable to write his name, the following is legally acceptable:

John H. (His X Mark) Doe and Two (2) Witnesses.


REQUEST FOR APPROVAL OF HUMAN SUBJECTS RESEARCH

 

Southeastern Oklahoma State University

 

This application should be submitted to the Chair of the Human Subjects Research Review Committee.

1. Principal Investigator’s Name:_________________________________________________
Department & Campus Address:________________________________________________

Campus Phone No.:________________________ Home No.:_________________________

2. If you are a student, provide the following:
Home Address of Student:_____________________________________________________ Name of Faculty Sponsor:Phone Ext:___________________

Is this your thesis research? Yes___ No___

3. Title of Project:______________________________________________________________
___________________________________________________________________________

4. Total Project Period: From:__________________ To:_______________________

5. Is a proposal for external support being submitted? Yes__ No__

If “Yes,” you must submit one complete copy of that proposal as soon as it is available and complete the following:

a) Is notification of Hum. Subj. Approval Required? Yes__ No__

b) Is this a renewal application? Yes___ No___

c) Funding agency’s name:_____________________________________________________

6. Has this proposal already been approved and you are seeking annual renewal? YesNo

7. In making this application, I certify that I have read and understand the guidelines and procedures developed by SOSU for the protection of human subjects, and I fully intend to comply with the letter and spirit of the SOSU policy. I further acknowledge my responsibility to report any significant changes in the protocol, and to obtain written approval for these changes, in accordance with the procedures, prior to making these changes. I understand that I cannot initiate any contact with human subjects before I have received approval and/or complied with all contingencies made in connection with that approval.

Signature of Principal Investigator Date

______________________________________________ ________________

8. Approval by Faculty Sponsor (required for all students): I affirm the accuracy of this application, and I accept the responsibility for the conduct of this research and supervision of human subjects as required by law.

Signature of Faculty Sponsor Date

______________________________________________ ____________________

9. I have included copies of all pertinent attachments including, but not limited to: questionnaire/survey instrument, informed consent, letters of approval from cooperating institutions, copy of external support proposal if applicable, etc.

Yes____ No____ (If no, explain on an attached sheet)

For the following items, attach your answers, appropriately numbered on a separate sheet of paper.

10. Identify the sources of the potential subjects, derived materials or data. Describe the characteristics of the subject population, such as their anticipated number, age, sex, ethic background, and state of health. Identify the criteria for inclusion or exclusion. Explain the rationale for the use of special classes of subject, such as fetuses, pregnant women, children, institutionalized mentally disabled, prisoners, or others, especially those whose ability to give voluntary informed consent may be in question.

11. Provide a description of the procedures to be used in the study including major hypotheses and description of the research design.

12. Describe the recruitment and consent procedures to be followed, including the circumstances under which consent will be solicited and obtained, who will seek it, the nature of information to be provided to prospective subjects, and the methods of documenting consent. (Include applicable consent form(s) for review purposes). If written consent is not to be obtained, specifically point this out and explain why not.

(Note: Informed consent must normally be obtained in a written form which requires the subject’s signature or that of the subject’s legally authorized representative. A waiver of this requirement may be granted by the HSRRC if adequate justification for the requirement is provided by the investigator in # 12. However, if the procedures pose no more than minimal risk to the subjects, informed consent may be documented via a written cover letter which does not require the subject’s signature. In all cases, a copy of the written informed consent must be given to the subject. Consult the document “Research Involving Human Subjects at Southeastern Oklahoma State University” for more information on informed consent requirements and specific examples of possible informed consent documents.)

13. Include a discussion of confidentiality safeguards, where relevant.

14. Describe the anticipated benefits to subjects, and the importance of the knowledge that may reasonably be expected to result.

15.Describe the risks involved with these procedures (physical, psychological, and/or social) and the precautions you have taken to minimize these risks. Do the benefits described above outweigh the described risks?