INSTITUTIONAL REVIEW BOARD – UNIVERSITY OF WEST GEORGIA

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Procedures for Completing the IRB Application | Forms | Criteria | Exemptions | Expedited Review | Informed Consent | Summary

ADAPTED FROM PENN STATE GUIDELINES:

Distinguishing Class-Related Pedagogical (Instructional) Assignments/Projects and Research Projects

Guidelines for Computer- and Internet-Based Research Involving Human Participants

BOARD MEMBERS

Costas Douvanis, Legal Advisor 
College of Education
Myrna Gantner
College of Education 
Kathryn Grams
College of Arts and Sciences 
Cher Hendricks
College of Education
Jack Jenkins, Special Associate to the President
Minority Affairs
Karen Kagiyama
St. Andrews Methodist Church
Kareen Malone
College of Arts and Sciences
Abbot Packard
College of Education
Michael Aldrich, Chair
Academic Affairs 
John Storer, Director
Sponsored Operations
Salil Talpade
Richards College of Business
Satyanarayana Swamy-Mruthinti
College of Arts and Sciences

PURPOSE

The institution is required by federal law (Title 45, Public Welfare, Part 46, Protection of Human Subjects, 56FR28003, June 18, 1991, DHHS Policy for Protection of Human Research Subjects) to maintain a committee that is responsible for the review and monitoring of all research conducted by faculty, staff and students that involves human subjects and meets the criteria set forth in the law.  The law may be reviewed in full at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

The primary purpose of the committee is to ensure that human subjects are not placed at undue risk of harm during the research process. 

Research projects that involve human subjects and that meet the requirement(s) for review must be approved by the Institutional Review Board (IRB) PRIOR TO ANY DATA COLLECTION.  Research is defined as any systematic investigation designed to develop or contribute to a body of knowledge, including basic inquiry, various forms of replication/testing, and evaluation.  When an application is submitted for review, IRB members will evaluate the proposed project in terms of potential risk of harm to participating subjects.  Following their review, IRB members may decide to approve the application, request additional information and/or a revision, or deny the application.  Decisions will be based on the following criteria:

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1) the application clearly states the nature and purpose of the study;

2) the application clearly states the procedures that will be used in conducting the study so that level of risk can be determined;

3) the procedures are appropriate for the proposed study and are designed to minimize risk of harm to participating subjects;

4) any risks that do exist are reasonable in relation to the anticipated benefits;

5) safeguards are in place in the event that subjects may experience harm (e.g., counselor on site, EMT or other health care provider on site, researchers trained in emergency response procedures, etc.);

6) selection of subjects is equitable;

7) procedures are in place to obtain and document informed assent (agreement by the subject) and/or consent (agreement by someone who legally speaks in the subject’s behalf, such as a parent or guardian) from each participant and/or his/her parent or guardian;

8) data collection procedures will be monitored to insure the safety and well-being of subjects;

9) subjects’ privacy will be protected and proper mechanisms will be in place to protect the confidentiality of the data; and

10) additional safeguards will be put in place as required by federal law to protect the rights, safety and welfare of subjects from “vulnerable populations,” defined as minor children, prisoners, pregnant women, disabled persons, and persons who are economically or educationally disadvantaged. 


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POSSIBLE EXEMPTIONS

Some types of research involving human subjects may be exempt from review by the IRB unless review is required by the researcher’s department or work unit and/or any agencies where such research will be conducted, such as schools, government agencies, non-profit organizations, etc.  It is the researcher’s responsibility to check with his/her department, work unit, and/or any participating agency to determine if IRB review is required even if the project is exempt under federal law.  According to the DHHS policy, research that is exempt from review includes the following: 

1) research conducted in established educational settings involving normal educational practices, such as research on regular and special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

a. This exemption assumes that all students in the classroom will be participating.  If there are to be treatment and control groups, and thus the potential for any individual or group to be disadvantaged, then the proposal needs IRB review.

b. If the educational practice is such that the school requires parental consent in order for a student to participate, then the proposal needs IRB review.

2) research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the information obtained is recorded in such a manner that human subjects can be identified, directly or indirectly, and/or any disclosure of the subjects’ responses outside the research project could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

a. If the selection of subjects is such that there is the potential for any group to be disadvantaged, then the proposal needs IRB review.

b. In an educational setting, if the survey or interview includes questions on topics outside of the instrumental process of a designated educational practice, then the proposal needs IRB review.

c. In any setting, if the survey questionnaire or interview protocol contains questions on any topic that would be considered “sensitive,” such as use of illegal substances, sexual practices, illegal behavior, etc., then the proposal needs IRB review.   
 

3) 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 paragraph (2) if the subjects are elected or appointed public officials or candidates for public office, or federal statutes require without exception that the confidentiality of personally identifiable information will be maintained during and after the research.

4) 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 in such a manner that subjects cannot be identified directly or indirectly.

5) research and demonstration projects which are conducted by or subject to the approval of 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.

6) research involving taste and food quality evaluation and consumer acceptance if wholesome foods without additives are consumed or if food is consumed that contains an 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 Environmental Protection Agency or the Food Safety and Inspections Service of the U. S. Department of Agriculture.


Agency heads retain final judgment as to whether a particular activity is covered by the exemption criteria.  Agency heads may also require that specific research activities conducted, supported, or otherwise subject to regulation by such agency but not otherwise covered by this policy comply with some or all of the requirements for IRB review.  In addition to compliance with the IRB policies, researchers must also comply with all other federal laws or regulations that provide protections for human subjects.  Further, compliance with this policy does not affect any international, state or local laws or regulations that may otherwise be applicable and provide protections for human subjects. 

Generally, these activities will not require IRB review: use of existing data that is in the public domain or that the researcher has gained permission to use where there will be no contact with human subjects; service learning/community service activities that are performed as part of a course requirement that also meet the criteria for exemption as outlined in this section; action research in education in which the researcher is studying something the teacher is already doing and that also meets the criteria for exemption as outlined in this section unless IRB review is required by the participating school system; and surveys/interviews with consenting adults where participation is voluntary and the questions are not of a sensitive nature (ex: market surveys regarding product preferences).  If a researcher is not sure whether his/her research project requires IRB approval, he/she should send an inquiry to the IRB chair.  If a project meets the criteria for exempt status but there is a need for documentation that the project has been reviewed by the university’s IRB committee, as is the case with projects involving schools, the researcher should do the following:

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EXPEDITED REVIEW

According to the federal guidelines, certain categories of research may be subject to an expedited review if the study involves no more than minimal risk to human subjects and/or if the study only involves minor changes in a research project that has been approved within the past year.  An expedited review may be done by the IRB chairperson or by one or more members of the IRB Committee.  If the reviewer(s) subsequently decide that the study does not meet the criteria for expedited review, then the study is subject to review by the full committee.  Categories of research approved by DHHS for expedited review include the following:

1) clinical studies of drugs and medical devices when an investigational new drug application is not required or an investigational device exemption application is not required, or the medical device is cleared/approved for marketing and is being used in accordance with its cleared/approved purpose.

2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults who weigh at least 110 pounds, or from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected.

3) Collection of biological specimens for research purposes by noninvasive means (ex: hair and nail clippings, extracted teeth, sweat, saliva, etc.).

4) Collection of data through noninvasive procedures routinely employed in clinical practice, excluding x-rays or microwaves (ex: physical sensors applied to the surface of the body or at a distance, weighing, testing sensory acuity, MRI, EKG, EEG, thermography, naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, echocardiography, moderate exercise, muscular strength testing, body composition assessment, flexibility testing as appropriate to the age, weight and health of the persoon).

5) Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes.

6) Collection of data from voice, video, digital, or image recordings made for research purposes.

7) Research on individual or group characteristics or behavior (ex: perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies if such research is not exempt from human subjects review.

8) Continuing review of research previously approved by the IRB.

9) Continuing review of research not conducted under an investigational new drug application or investigational device exemption where other categories do not apply but the IRB has determined that the research involves no greater than minimal risk.


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INFORMED CONSENT

According to federal guidelines, no investigator may involve a human subject in research covered by this policy unless the investigator has obtained the informed consent of the subject or the subject’s legally authorized representative.  The information given to a subject and/or the subject’s representative must be in language that is easy for that person to understand.  No informed consent may include any language requiring the subject or his/her representative to waive or appear to waive any of the subject’s legal rights or release or appear to release the investigator, the sponsor, the institution or its agents from liability for negligence.  The informed consent form shall include the following elements:

1) a statement that the study involves research, an explanation of the purposes of such 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;

2) a description of any reasonably foreseeable risks or discomforts to the subject;

3) a description of any benefits to the subject or to others which may reasonably be expected from the research;

4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be beneficial to the subject;

5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

6) for research involving more than minimal risk, an explanation as to whether any compensation 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;

7) 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; and

8) 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 he/she is otherwise entitled.

When appropriate, these elements may also need to be included:

1) a statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable;

2) anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;

3) any additional costs to the subject that may result from participation in the research;

4) the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;

5) 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; and

6) the approximate number of subjects involved in the study.


Under certain circumstances, the IRB may approve a modified consent form or waive the requirement for a consent form altogether.  These circumstances include the following situations:

1) the research 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 public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs/procedures, or possible changes in methods or levels of payment for benefits or services under those programs;

2) the research could not practicably be carried out without the waiver or modification;

3) the research involves no more than minimal risk to subjects;

4) the waiver or modification will not adversely affect the rights and welfare of the subjects; 

5) when appropriate, the subjects will be provided with additional pertinent information after participation;

6) 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; and

7) 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.

Investigators may obtain informed consent by a written consent document that contains the required elements stated above, or by a short form stating that the required elements of informed consent were presented orally to the subject and/or the subject’s legal representative.  In the case where the oral presentation is made, there shall also be a written summary of what is said, and there shall be a witness to the presentation who shall sign both the short form and the summary.  The person doing the oral presentation shall also sign the summary, and a copy of both the summary and the short form shall be given to the subject or the subject’s representative.  If the IRB waives the requirement for documentation for informed consent, it may still require the researcher to provide subjects with a written statement regarding the nature of the research.

VULNERABLE POPULATIONS

Investigators who wish to conduct research using vulnerable populations, defined as minor children, pregnant women, prisoners, mentally disabled persons, and persons who are economically, educationally or otherwise disadvantaged, should consult the federal guidelines regarding specific safeguards required for these populations. 

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SUMMARY

Generally, these conditions may not require that the activity be submitted for IRB approval unless another party involved in the study requires documentation of IRB review:

1) the activity is a one-time event or a series of events (certain number of hours) engaged in to fulfill a course requirement (ex: interview a resident in a nursing home, spend time tutoring  children in an after school program);

2) the activity is systematic but does not require the subjects to do anything different than what they would normally be doing (ex: observe instructional technique in a particular classroom, help teach a new curriculum and monitor scores on exams; observe a group);

3) the activity does not involve vulnerable populations, does not involve invasive procedures, participation and stopping participation are completely voluntary, topics covered are not of  sensitive nature, and participation is anonymous and confidential (ex: phone survey of adults in selected households regarding product preferences);

4) the activity involves traditional educational instruction, educational testing, surveys, interviews, or observation of public behavior and meets the requirements in # 3, where there are no treatment and control groups or other system whereby any subject may potentially be disadvantaged, and, if minor children are involved, the activity is not one which would normally require parental consent;

5) data, documents or other information is publicly available or was collected for use other than research and no personal identifiers will be attached;

6) the project is being conducted by or has been approved by an agency head for the purpose of studying or evaluating public benefit programs and their associated procedures (ex: request by a local, state or federal official for a study to evaluate the effectiveness of a publicly funded program); and

7) the study involves educational tests, surveys, interviews, or observations of public behavior where individual subjects cannot be identified, and if they were, such identification would not cause them any harm, such as damage their reputation, negatively affect their financial status or employability, or place them at risk for any type of liability (ex: surveying classmates regarding meal plan preferences, interviewing athletes regarding practice schedules, observing fan behavior at an athletic event, etc.).

On the other hand, if any of these conditions is present, or if you are required to obtain IRB approval from the participating agency, then you will need to proceed with the IRB application:

1) the study involves a vulnerable population;

2) the study involves the selection of treatment and control groups or otherwise potentially places individuals and/or groups at a disadvantage;

3) the study involves minor children and procedures that would require parental consent;

4) the study involves questions of other than an instrumental nature (ex: alcohol/drug use and abuse, sexual behavior, attitudes about parental discipline, etc);

5) the study is such that if participants’ involvement were known it could possibly cause them harm, either physically, mentally, emotionally, socially, financially, or legally;

6) there is more than minimal risk of harm to subjects; and

7) some degree of deception may be necessary in order to conduct the study (ex: giving a control group a placebo drug, telling a control group that a majority of students engage in X behavior when that really isn’t true to see if it affects their own answers, etc.).

8) the researcher may not be completely able to guarantee confidentiality (ex: if there is disclosure of actual or potential danger for self or other; disclosure of child abuse or neglect).

The best policy is that if you are not sure, ASK.

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PROCEDURES FOR COMPLETING THE IRB APPLICATION

Read the information about requirements for IRB approval.  If you think your study requires IRB approval, or if you are not sure and want to be on the safe side, please follow these procedures.

1) Print off the IRB application checklist and be sure your application packet is complete before submitting it for review.

2) Print off the IRB application and complete every section.  Provide enough information so that it is clear to anyone reading the application exactly what your study is about, how it will be conducted, who will be the subjects and how they will be selected, how confidentiality will be maintained, and how consent will be obtained.  Students and professors in the College of Education need to check with the school system officials in the location where they intend to conduct their research and complete any additional forms and other requirements as instructed.  These forms need to be submitted with your application.

3) Submit three or four copies of the application with checklist on top to the Office of the Vice President for Academic Affairs, depending on whether you are a student (four copies) or independent investigator (three copies).  After processing, one copy is retained for the institution’s files in the Office of Sponsored Operations, one copy is returned to the supervising professor if the investigator is a student, and one copy is returned to the investigator.  If there are multiple investigators, please submit as many extra copies so that each one can have a signed application.  In addition, if the participating agency requests a copy, please submit an extra copy for that purpose and indicate where it should be sent after a decision has been made. 

4) The VPAA’s Office staff will check in the application and enter the identifying information into the IRB database.  If any information is missing, the investigator will be notified and asked to submit the additional material. 

5) After the application has been checked in and cleared, it will be sent to a member of the IRB committee for a preliminary review.  If the committee member determines that it is exempt or can receive an expedited review, then he/she will indicate such and return it to the IRB chair for a final review and signature.  If the committee member determines that the application requires a review of the entire IRB committee, he/she will notify the chair and a meeting will be scheduled. 

6) After a decision has been made by either the full committee, or by the chair in consultation with another committee member when a full committee review is not required, the investigator will be sent a letter notifying him/her of the decision.

7) At the completion of the study, the investigator is required to submit a report to the IRB chair summarizing the study and results.  This report will be filed with the original application in the Office of Sponsored Operations.

If you believe your study is exempt from IRB review based on the criteria listed in the earlier section of this document, but a third party requires IRB review before you can conduct your study, please do the following:

1)Print off the IRB application checklist and be sure your application packet is complete before submitting it for review. 

2)Print off the IRB application and complete every section.  Provide enough information so that it is clear to anyone reading the application exactly what your study is about, how it will be conducted, who will be the subjects and how they will be selected, how confidentiality will be maintained, and how consent will be obtained.  Students and professors in the College of Education need to check with the school system officials in the location where they intend to conduct their research and complete any additional forms and other requirements as instructed.  These forms need to be submitted with your application. 

3)Print off the Exempt Research Study Application, complete the top part, and check the appropriate box depending on which of the exempt criteria your study meets. 

4)Attach the Exempt Research Study Application to the IRB Application and submit three or four copies of the application with checklist on top to the Office of the Vice President for Academic Affairs, depending on whether you are a student (four copies) or independent investigator (three copies).  After processing, one copy is retained for the institution’s files in the Office of Sponsored Operations, one copy is returned to the supervising professor if the investigator is a student, and one copy is returned to the investigator.  If there are multiple investigators, please submit as many extra copies so that each one can have a signed application.  In addition, if the participating agency requests a copy, please submit an extra copy for that purpose and indicate where it should be sent after a decision has been made. 

5) The VPAA’s Office staff will check in the application and enter the identifying information into the IRB database.  If any information is missing, the investigator will be notified and asked to submit the additional material. 

6) After the application has been checked in and cleared, it will be sent to the Chair of the IRB committee for review and a signature. 


If the Chair of the IRB committee determines that the application does not meet the “exempt” criteria, he/she will notify the researcher and faculty sponsor if the researcher is a student, and they will decide on how to proceed.  

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FORMS

Informed Consent Form (School) Adobe PDF MS Word
Informed Consent Form (Minor) Adobe PDF MS Word
Application Adobe PDF MS Word
Exempt Research Study Application Adobe PDF MS Word
IRB Checklist Adobe PDF MS Word

DOCUMENTS

Metro-Atlanta School System IRB Database Adobe PDF MS Word
Human Subject Regulations Decisions Chart Adobe PDF MS Word

ADAPTED FROM PENN STATE GUIDELINES:


Distinguishing Class-Related Pedagogical (Instructional) Assignments/Projects and Research Projects

Introduction

These guidelines are intended to assist instructors in differentiating pedagogical assignments/projects from research projects.

Research Projects

This differentiation is based on Title 45 Code of Federal Regulations (CFR) Part 46.102(d) where research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge (Federal Register, 56, p. 28013). Dissemination of findings to a scientific audience is a sufficient, but not a necessary, criterion for defining research. Dissemination includes, but is not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication, paper or electronic, in a scientific journal; and Internet postings. If the project falls under this definition of research, review and approval of a human participants research protocol by the Institutional Review Board (IRB) is required. Contact the Office for Research Protections (ORP) for guidance regarding the appropriate level of human participants review that must be conducted.

Please Note

Class-related instructional assignments/projects that do not fit the above criteria do not need to be submitted to the IRB for human participants protection review. If either knowledge contribution or dissemination is a possibility, IRB review and approval must be obtained prior to the involvement of human participants. IRB approval of a research protocol cannot be granted retroactively under any circumstances.

Advisory
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Guidelines for Computer- and Internet-Based Research Involving Human Participants

Computer- and internet-based methods of collecting, storing, utilizing, and transmitting data in research involving human participants are developing at a rapid rate. As these new methods become more widespread in research in the social, psychological, and social sciences, they present new challenges to the protection of research participants. The Institutional Review Board (IRB) believes that computer- and internet-based research protocols must address fundamentally the same risks (e.g., violation of privacy, legal risks, psychosocial stress) and provide the same level of protection as any other types of research involving human participants. All studies, including those using computer and internet technologies, must (a) ensure that the procedures fulfill the principles of voluntary participation and informed consent, (b) maintain the confidentiality of information obtained from or about human participants, and (c) adequately address possible risks to participants including psychosocial stress and related risks.

At the same time, the IRB recognizes that computer- and internet-based research presents unique problems and issues involving the protection of human participants. The IRB further recognizes that computer and internet technologies are evolving rapidly, that these advances may pose new challenges to the protection of human participants in research, and that both the IRB and researchers employing new technologies must maintain their diligence in addressing new problems, issues, and risks as they arise in the coming years.

The purpose of these guidelines is to help researchers plan, propose, and implement computer- and internet-based research protocols that provide the same level of protection of human participants as more traditional research methodologies. The guidelines are comprised of requirements and recommendations that are consistent with the basic IRB principles applied to all research involving human participants.

RECRUITMENT:
  1. Computer- and internet-based procedures for advertising and recruiting potential study participants (e.g., internet advertising, e-mail solicitation, banner ads) must follow the IRB guidelines for recruitment that apply to any traditional media, such as newspapers and bulletin boards (see the IRB "Guidelines for Subject Recruitment and Advertising").
  2. Investigators are advised that University policies AD 20 and AD56 prohibit unsolicited group e-mailings to faculty, staff, and students. Recruitment of research participants by unsolicited group e-mailings ("spam") is against University policy. Exceptions to these policies may be considered on a case-by-case basis.
  3. Investigators are advised that authentication - that is, proper qualification and/or identification of respondents - is a major challenge in computer- and internet-based research and one that threatens the integrity of research samples and the validity of research results. Researchers are advised to take steps to authenticate respondents. For example, investigators can provide each study participant (in person or by U.S. Postal Service mail) with a Personal Identification Number (PIN) to be used for authentication in subsequent computer- and internet- based data collection.
DATA COLLECTION:
  1. It is strongly recommended that any data collected from human participants over computer networks be transmitted in encrypted format. This helps insure that any data intercepted during transmission cannot be decoded and that individual responses cannot be traced back to an individual respondent.
  2. It is recommended that the highest level of data encryption be used, within the limits of availability and feasibility. This may require that the study participants be encouraged or required to use a specific type or version of browser software.
  3. Researchers are cautioned that encryption standards vary from country to country and that there are legal restrictions regarding the export of certain encryption software outside US boundaries.
SERVER ADMINISTRATION:
  1. It is recommended that for online data collection a professionally administered survey server be used.
  2. If researchers choose to run a separate server for data collection and/or storage, the IRB recommends that:
DATA STORAGE/DISPOSAL:
  1. If a server is used for data storage, personal identifying information should be kept separate from the data, and data should be stored in encrypted format.
  2. It is recommended that data backups be stored in a safe location, such as a secure data room that is environmentally controlled and has limited access.
  3. It is recommended that competent data destruction services be used to ensure that no data can be recovered from obsolete electronic media.
INFORMED CONSENT PROCESS FOR INTERNET-BASED RESEARCH:
  1. For anonymous Internet-based surveys, it is sometimes appropriate to use implied informed consent. Participants would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey. Please see [http://www.research.psu.edu/orp/areas/humans/samples.asp] for a model implied informed consent.
  2. Other Internet-based surveys include "I agree" or "I do not agree" buttons on the website for participants to click their choice of whether or not they consent to participate.
  3. Instead of "signed" informed consent, the researcher may email the consent form to participants who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email, if the IRB determines that some sort of documented consent is required,
  4. Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is in question. A statement in the informed consent form indicating the limits to confidentiality is typically required. The following statement may be used: "Confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties."
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