Protocol Development

Prerequisites

• Training: The CPHS requires all members of a research team who are "interacting or intervening with subjects", OR will have "access to personally identifiable private information" of subjects OR who could "reasonably ascertain the identity of a subject from the data" be trained in the protection of human subjects prior to submitting a protocol. At a minimum, this includes: Training certification, reading the CPHS Guidelines, and reading CSUMB's Human Subjects Research Policy.

• Is Review Required? Some research designs do not require IRB review so you must first determine if your project is or is not "research involving human subjects" per the Code of Federal Regulations Title 45, Part 46 — Protection of Human Subjects. Refer to Is CPHS Review Required for guidance.

• Other Laws, Policies, Regulations, and "standards of professional conduct and practice": Many research designs are subject to other/additional laws, policies, regulations, and "standards of professional conduct and practice". It is the responsibility of the researcher to disclose all laws, policies, regulations, and "standards of professional conduct and practice" applicable to their research design.

Electronic Submission System

Applications for Human Subjects Research are developed and submitted within the current electronic research administration (eRA) system. Currently we use Kuali Protocols at: https://csumb.kuali.co/protocols/portal/dashboard. Only staff and faculty at CSUMB may log into Kuali Protocols and initiate a submission. Additional staff and faculty may be added to the protocol by the researcher. Students and external researchers may be added to the protocol by the researcher BUT if they need to view or edit the protocol (in Kuali Protocols), email a request to CPHS@csumb.edu including:

1. First and Last Name of individual to be added/permissioned

2. Email address NOT @csumb.edu (i.e.: students cannot use their @csumb.edu email address for login to Kuali Protocols)

3. Role of individual in THIS research: Researcher (external professionals), Research Assistant (students, etc.)

4. Permission to be granted: View (only), or Edit (view+edit).

Details at: About Kuali.

A companion guide statically replicating Kuali Protocols sections and questions is available for reference.

Details at: Kuali Protocols Sections.

Components of an Application

1. Protocol (narrative component of application)

   • See below for all sections.

2. Attachments

   • Training Certifications (attachments)

   • Instruments or Diagrams (attachments)

   • Recruitment Documentation (if applicable - attachments)

   • Consent Documentation (attachments)

   • Site Authorization (if applicable - attachments)

   • Safety & Privacy Monitoring Plan (if applicable - attachment)

   • Other (if applicable - attachments)

Details at: What goes in a protocol?

Protocol Sections in Kuali Protocols

Section 1: General Information

Section 2: Is it "Human Subjects Research"?

Section 3: Funding Source

Section 4: About the Researcher(s)

Section 5: Research Summary

Section 6: Subject Population

Section 7: Recruitment, Enrollment & Compensation

Section 8: Consent Procedures

Section 9: Activity Site & Data Source

Section 10: Anticipated Risks & Benefits

Section 11: Safety & Privacy Monitoring

Details at: Companion guide to Kuali Protocols Sections.

Studies Involving Vulnerable Subjects and Protected Populations

Individuals are considered vulnerable when they lack the decision-making capacity to provide voluntary informed consent. The degree to which these potential subjects are vulnerable is directly related to the degree to which these individuals are capable of volunteering or providing informed consent to research participation.

There are specific federal regulations (45 CFR 46 Subparts B - D) that protect certain vulnerable populations: Human Fetuses and Neonates, Prisoners (and individuals under the "supervision of the courts" such as parolees), and Children (minors). Other populations will be assessed by the CPHS for "vulnerability" based on the criteria below.

Selection Criteria

Per 45 CFR 46 111(3), the CPHS reviews the criteria by which subjects will be selected for study participation to determine whether subject selection practices are equitable, reasonable and justified. In order for the CPHS to know that subjects will be selected appropriately, the protocol should include rationale to support the selection criteria, and a description of how the inclusion/exclusion criteria will be assessed and by whom. A description of the assessor’s professional qualifications or credentials may be included when relevant.

Subject selection criteria which do not equitably represent the larger population, such as under-sized sample proportions, should be justified in the application. Additional guidance on Sample Selection and Proportion is provided on our website.

Screening Procedures

The CPHS reviews procedures planned to protect subject confidentiality and for obtaining informed consent from an individual before he/she discloses private information. In certain cases, researchers are interested in screening individuals before they are formally enrolled into the study to determine whether they meet the basic study selection criteria. This process can often lead to disclosure of private information prior to obtaining and documenting informed consent. Therefore, if a screening procedure will be used, the CPHS requires information about how screening will take place (e.g. interview, survey, records review) and how data collected during screening will be handled if the person is found to be ineligible (e.g., used as research data or destroyed).

If individuals will disclose private information, the CPHS reviews the procedures used to obtain consent from the person in advance of implementing screening procedures. If the protocol identifies specific inclusion and exclusion requirements to determine subject eligibility (e.g., age, physical or psychological condition), the CPHS will review a screening checklist in which specific inclusion and exclusion criteria are listed and defined. The CPHS will review the procedures used to document appropriate screening of subjects. For example, it is recommended that a screening checklist is completed for each subject enrolled and that a checklist is maintained in the study master file or in individual subject files.

Recruitment

The CPHS requires a description of how and by whom potential subjects will be identified and recruited. If records are accessed to identify potential subjects, the CPHS reviews a description of procedures used to ensure that records are only accessed by those with consent from the individual.

Advertisement/Announcements/Flyers/Scripts

Advertising a research study for the purpose of recruiting participants is part of the informed consent process. Printed or electronic media intended for use in subject recruitment are reviewed by the CPHS to ensure accuracy and appropriateness. The researcher must ensure that the procedures proposed for informing potential subjects are not coercive and do not state or imply an outcome or other benefit beyond what is outlined in the consent documents and the protocol. Recruitment incentives are discussed additionally in Recruitment Incentives.

Recruitment advertisements, such as flyers, postcards, brochures, newspaper advertisements, press releases, or postings on the Internet are reviewed for the accuracy and presentation of information the prospective subject needs to determine their eligibility and interest. This includes the review of content, language, and design. Information should not be misleading to subjects, as such, the use of words that appear neutral as opposed to sensational are encouraged. Attention should be paid to the use of appropriate graphics, font size and format/design, and to accurate spelling and punctuation.

The following information should be included in recruitment materials:

1. Lead researcher’s name and institutional address (affiliated university department and/or research facility);

2. Concise description of the purpose of the research;

3. Eligibility criteria for subject participation;

4. Time or other commitment required of the subjects; and

5. Location of the research and person to contact for further information.

6. Please note: In medical studies, advertisement materials should make no claims, either explicitly or implicitly, that the research activity is safe, effective, equivalent, or superior to any other current practice.

7. Reference to incentives offered may include that subjects will be paid but should not emphasize the payment or the amount to be paid.

Legitimate Access to Records

A primary concern of the CPHS specific to subject recruitment involves protecting the privacy and confidentiality of prospective subjects. Recruitment procedures in which names of individuals are released from private sources to a researcher are generally not endorsed by the CPHS. Recruitment procedures should allow for the individual to consent to the release of information in advance of being contacted directly by an researcher.

Established Legal/Ethical Protections:

1. The CPHS advises against the release of identifiable private information from a source to an unaffiliated researcher without the permission of the potential subject where legal and ethical guidelines prohibit the source from doing so.

   • An example of when this may occur is when a researcher is attempting to identify prospective subjects according to specific eligibility criteria for recruitment to a study by accessing private files through a hospital or medical clinic.

2. To obtain permission to access private and identifiable information about a prospective subject, the researcher will need to propose procedures to obtain consent from the individuals involved.

   • This may be in the form of a release form used by the source to document permission to release information to the researcher. The consent statement should include information about what information is requested, how it will be used and to whom it will be given. Review and acceptance of this consent document by the CPHS is required in advance of its use.

No Established Legal/Ethical Protections:

1. The CPHS does not endorse the release of information about an individual in cases where the individual may normally consider the information to be private regardless of whether or not this information is protected by law or the ethics of a specific profession.

The CPHS advises against procedures that involve a person or organization providing information about another individual/potential subject without his/her permission for the purpose of recruitment.

The CPHS recommends procedures that allow for an organization or an enrolled subject to provide information about the study to a prospective subject (flyer, postcard or other announcement) that allows for the prospective subject to initiate contact if he/she would like additional information about the study.

Please note: Research that involves the collection or study of existing data, documents, records or specimens where the sources are either publicly available or recorded in a manner that subjects cannot be identified, directly or through identifiers linked to the subject may meet the criteria for Exempt (Level I) review.

Recruitment Incentives – Finder’s Fees and Bonus Payments

Any remuneration (in cash or in kind) for patient referral is considered unethical and is not permitted as it may compromise the provider-patient relationship. The policy set forth by the American Medical Association Code of Ethics states: “Payment by or to a physician solely for the referral of a patient is fee splitting and is unethical." Referral incentives may include, but are not limited to monetary compensation, stock options, material goods or other incentives such as food or entertainment. In addition, bonus payments to the researcher, study coordinator or provider for the purpose of encouraging recruitment of subjects to the study may compromise the judgment of the research team and is not acceptable.

The CPHS does not endorse practices that involve remuneration of any kind to a provider for patient referrals or bonus payments to members of the research team for purposes of subject recruitment.

Please visit the American Medical Association web site for more information on this topic.

Informed Consent Process

“Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. This assurance protects all parties - both the subject, whose autonomy is respected, and the researcher, who otherwise faces legal hazards. The "proxy consent" of someone other than the subject is not the same as the subject's own consent, although it may be an acceptable substitute when a subject is unable to give informed consent.” (OHRP’s IRB Guidebook: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm).

Per §46.117 Documentation of informed consent pertaining to informed consent, the CPHS will review:

• The procedures that will be followed during the informed consent process;

• The process used to introduce the informed consent document and procedures used by the researcher to ensure full disclosure of the research (i.e., purpose of the study, study description risks, benefits, confidentiality, researcher's telephone number to call for questions, etc.); and,

• Also review procedures developed by the researcher that will enhance the potential subject's understanding of the research (e.g., use of audio/visual materials or reiterating complex information in lay terminology).

It is important to document the person who will make initial contact with the potential subject to demonstrate that this individual is knowledgeable about the study, can present the information to potential participants and will promote voluntary participation.

The CPHS will consider how and where the research will be introduced to the individual to assess whether the timing and setting of the informed consent process is conducive to objective decision making. If minor children are involved in the study, the CPHS will also review: the process used to obtain parental consent as well as assent from the minor child; and, the consent document(s) for use in obtaining and documenting consent from study participants. Consent forms must adequately describe the study using language appropriate for the target audience. If relevant, the researcher will be asked to translate consent documents into the subject’s primary language after the English version of the consent form has received CPHS approval.

Alteration of Basic Informed Consent Elements

If waiver of consent, alteration of consent content or waiver of consent documentation is requested, the CPHS must review justification to support the request.

Per §46.116 General requirements for informed consent , the CPHS may waive the requirement to obtain informed consent or approve a consent procedure which alters some of the consent content if the CPHS finds and documents that:

Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.

Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.

Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

• (i) The research involves no more than minimal risk to the subjects;

• (ii) The research could not practicably be carried out without the requested waiver or alteration;

• (iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;

• (iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and

• (v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Waiver of Signed or Informed Consent Documentation

The CPHS may waive requirements to document voluntary participation via a signed consent form if 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 (45 CFR 46.117 (c)).

If waiver of informed consent is requested, the protocol must include justification to support the request. Note that the CPHS rarely approves waiver of informed consent.

Assent from Children (45 CFR 46.408)

Assent is demonstrated by a child's agreement to participate in research. In California, a child is a person who is under the age of 18 years (unless legally emancipated). It is required that the researcher makes adequate provisions to solicit assent from children unless the CPHS waives this requirement.

The CPHS will review a description of the process and procedures for obtaining assent from the child. To determine whether the child is able to assent depends on the child's age and maturity. If the child is considered to be capable of providing assent, whether or not assent is documented is also determined by the CPHS. Generally, children are able to read and write to some extent by age 7. As such, documenting assent by having the child sign an assent form is usually a procedure that is incorporated for children age 7 – 17. When documentation is not required, the CPHS requires that the researcher conduct the assent process through a verbal interaction and the CPHS will review a script of what will be said during the verbal consent process. Information presented to the child should be age appropriate and include and introduction and basic information about what he/she will be asked to do if they participate.

Parental Permission (45 CFR 46.408)

If a child will be involved as a study participant, the CPHS will review procedures used to obtain and document permission from the parent or guardian. The parental permission/consent process, including documentation, will include all information normally required for informed consent .

Non English Speaking Subjects

If non-English speaking persons will be recruited, the CPHS will review a description of the qualifications of the person who will conduct the translated consent process (verbal and written). The CPHS must review the English version of the consent document first before approving the translated version. After the English version has been approved by the CPHS, the researcher will be required to forward a copy of the translated document so that it may bear the CPHS stamp of approval.

Research Design and Methods

The CPHS evaluates the research design to weigh the potential benefits of the study in relation to the potential risks. The CPHS protocol must include adequate information about the research design for the CPHS to make an informed judgment that the design will result in meaningful and valid data. The CPHS will review a description of the research design, the scientific rationale underlying the proposed research and the statistical basis for the structure of the investigation. The CPHS will also review the specific aims of the research, the hypotheses to be tested, the questions to answer and the type of data to be gathered and tested.

OHRP’s IRB Guidebook (1993) states, “The value of research depends upon the integrity of the study results. One of the ethical justifications for research involving human subjects is the social value of advancing scientific understanding and promoting human welfare by improving health care. But if a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put subjects at risk or even to inconvenience them through participation in such a study.”

If the CPHS determines that the experimental designs or statistical methods are inappropriate, the researcher will be asked to make revisions so that review of the protocol may continue. Failure to do so may result in protocol declination.

Some common issues to consider include: the appropriate number of subjects, the power of the study (effect size estimates), the type of statistical procedure (e.g., parametric versus nonparametric) and the type of study. Please see additional resources on this subject available at the Sponsored Programs Office website on Human Subjects in Research.

Tasks Associated with Participation

The CPHS will review the tasks that subjects will be asked to complete during the course of a study. Specifically, the protocol should describe what subjects will do while involved and the amount of time that participation in each aspect of the study will take. The protocol should also discuss any investigational, experimental, or special procedures that will involve the subject (medical devices, electrical equipment, etc.). If the research involves exercise testing, blood draws or DEXA scans, the protocol must include approved procedures identified within the Exercise Protocols section of this guidance.

Tests, Questionnaires, and Interview Guides

Keeping in mind the methodological distinctions between qualitative and quantitative research, the CPHS reviews all research instruments such as surveys, interviews or questionnaires planned for use in data collection. As such, the researcher is asked to include all interview schedules and survey instruments with the completed protocol application. The researcher may submit draft versions of study instruments for review; however, the CPHS must review the final instruments (quantitative study) prior to approving the use of those instruments for data collection. Researchers conducting a qualitative study, where the development of interview questions or research instruments is dependent on the unique contexts of the study, are asked to submit draft copies of the research instruments (surveys, interview protocols, probe questions etc.) for initial review and approval. Any substantive changes to the interview or probing questions must be reported to the CPHS as a protocol modification so that assessment of risk associated with participation may be evaluated.

Deception or Incomplete Disclosure

Deception involves not fully informing subjects of the real purpose of the study or providing false information about the study to subjects. This may be appropriate and justifiable in some circumstances, particularly in social and behavioral research. If the protocol involves deception, the CPHS must review a complete description of how deception will be used. The CPHS will need adequate justification for the inclusion of deception and possible alternatives to the use of deception. In studies involving deception, the protocol should include procedures to debrief subjects following participation. The debriefing statement should be presented both orally and in writing and include a description of the deception involved and an explanation about the true purpose of the research. In addition, this statement should inform subjects of their right to withdraw their data from the study, if they feel upset or uncomfortable with the deception involved, and still receive any incentives offered to participants.

Study Location & Data Access

The CPHS will determine the appropriateness of the location and setting where subjects will participate or human subjects data access transpires. The protocol must address special considerations associated with recruitment, data collection, and/or data access as appropriate (e.g., identifying potential subjects, appropriate setting for obtaining informed consent, confidentiality of data and privacy concerns).

Site or data access authorization is required for CPHS approval. Use the CPHS Site Authorization form for additional submission guidance.

Performance Sites: If the research is supported by federal funds and persons not affiliated with CSUMB will conduct the study, it is necessary for the researcher to document that the facility has an assurance with OHRP, that a local CPHS has reviewed the study for conduct and the performance site is ADA compliant. See 2.3.9 External (nonaffiliated) researchers for additional guidance.

Potential Benefits

The CPHS uses information about anticipated benefits expected to result from the study in conjunction with potential risks associated with participation to determine whether or not the study should occur. Therefore, the researcher must provide the CPHS with a clear description of the anticipated benefits that will be derived from this study.

Risks

Research subjects may be exposed to risks as a result of participation in a study. When recruiting participants for research, information about the types of risks associated with study participation must be presented to each prospective subject. The Office for Human Research Protections (OHRP) has provided the following descriptions of risks that may be associated with research participation. Physical harm is often associated with research involving medical procedures; however, it can also be related to research testing aspects of physical fitness or public health concerns. Minor pain and discomfort, as well as drug side effects or injury resulting from an invasive procedure should be considered when evaluating exposure to physical harm. The physical risk may be minor and transient; however, some procedures may result in adverse events that may be considered serious and possibly permanent. Psychological harm may occur when subjects are asked to disclose or think about personal feelings and/or behaviors or are involved in an experiment that involves a manipulation of the environment or deception. The subject may experience changes in awareness, thought processes and emotion as a result. Social or economic harm is associated with research where sensitive information about the subject (e.g., alcohol and other drug use, mental illness, illegal activities, etc.) is obtained. A breach in the confidentiality of this information may lead to the individual being labeled in a way that could affect their reputation, insurance eligibility, or employment.

Data Safety Monitoring Board (DSMB)

“Monitoring of the research by the researcher is important because preliminary data may signal the need to change the research design, change the information presented to subjects, or even to terminate the project before the scheduled end date.” (OHRP’s IRB Guidebook: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm).

When applicable, the CPHS will review the process used to monitor data collected to ensure the safety of subjects (e.g., clinical trial studies) (45 CFR 46.111(a)(6)). Note that all Phase III randomized clinical trials supported or performed by the National Cancer Institute (NCI) require monitoring by a DSMB. For more information on DSMBs, please visit the NCI website at: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.

Assessment of Risk

The CPHS will review information provided by the researcher to assess whether the risks and inconveniences associated with the research are reasonable in relation to the anticipated benefits to the subjects and in relation to the knowledge that may reasonably be expected to result from this research (45 CFR 46.111).

Confidentiality Procedures

To maintain confidentiality of research data, the researcher should protect information obtained from the subject to avoid the unintentional access by others (45 CFR 46.111(a)(7)). A federal Certificate of Confidentiality may be issued to protect sensitive data from being subpoenaed by a court of law (see 4.16.8 for more detail). The CPHS may determine that documentation of informed consent be waived if this process increases the risk of a breach of confidentiality. Subjects should be provided with information about the procedures used to protect confidentiality.

Guidelines for developing procedures to address confidentiality include:

1. Limit the personal information recorded to that which is essential to the research;

2. Store personally identifiable data securely and limit access to the lead researcher and authorized staff;

3. Code data as early in the research as possible and dispose of the code linking the data to individual subjects when data have been processed;

4. Do not disclose personally identifiable data to anyone other than the research team without the written consent of the subjects or their legal representative. (Exceptions may be made in case of emergency need for intervention or as required by regulatory agencies).

5. If the data are considered to be sensitive (e.g., sexual preference or practices, use of alcohol or other drugs, illegal conduct, psychological or mental health records, etc.) and place the subject at legal risk, more elaborate measures to protect confidentiality may need to be implemented. In some cases, it may be appropriate to apply for a federal Certificate of Confidentiality. For more information about the purpose and use of a federal Certificate of Confidentiality, please visit the NIH Office of Extramural Research website: http://grants1.nih.gov/grants/policy/coc/.

Anonymity and Confidentiality

Anonymity means that the identity of the subject is never recorded or associated with the data collected. Maintaining confidentiality involves recording but concealing the subject’s identity or codes linked to the individual’s identity. The CPHS will review the procedures used to maintain either anonymous or confidential data. If the subject’s identity will be recorded or a code will be created which is linked to the subject’s identity, the CPHS will review the rationale for doing so. If it is necessary to track information over time, use of a coding strategy that is not linked to the subject’s identity should be considered.

Reportable Disclosures

State law and mandated reporting requirements may limit the extent to which the researcher is able to protect the subject’s confidentiality. If through interview or measurement, the subject is likely to disclose illegal or dangerous behavior (e.g., if the subject reports any kind of abuse or serious harm to self or others) the researcher must disclose whether and to whom information will be reported. The consent form should include a description of the limits to confidentiality.

Coding Data for Tracking Purposes

In survey research, an researcher may wish to code data that would otherwise remain anonymous in order to track respondents. The researcher may wish to track respondents for the purpose of contacting non-respondents at a later time or to publish information about non-respondents to describe the study sample. The CPHS considers these tactics appropriate as long as individuals are informed at the beginning of the study during the informed consent process that their identity will be linked to a code and that they may be contacted at a later time. If coding will be used for tracking purposes, the CPHS will review a description of the coding scheme used to track respondents and non-respondents to ensure that confidentiality is maintained. If the individual's identity is linked to the code, the CPHS will review how this information will be used once data collection is complete.

Image and Voice Recording

The CPHS will review where the subject’s image or voice will be presented and to whom if the study involves the use of the audio or video recordings. The subject should be informed about how images may be used within the consent document. If the researcher would like permission to present the recorded image for purpose other than the specific research for which the subject is consenting, an addendum to the consent is used to obtain this authorization.

Record Storage and Access

In an effort to further protect subject privacy, the CPHS will review where and for how long research records will be stored and who will have access to the study data (hard copy or electronic files) once data have been collected and filed. The CPHS will review procedures used to dispense of research records, samples/specimens upon completion of the research activity.

Data Security Planning

Pursuant to 45 CFR 46.111(7) in order to approve research the CPHS must ensure there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. When research involves the use or transfer of "Level 1 - Confidential" or "Level 2 - Internal Use" data, per CSU Information Security Policy: Information Asset Management (Policy No: 8065.0), the researcher may be required to submit a Data Security Plan. Due to the rapidly evolving nature of data security planning and management, refer to detailed CPHS guidance on Data Security Planning in CPHS Applicant Materials.

Release of Test Results

Data collected for research purposes may also be relevant to the participant’s physician or other professional. In some cases, it may also be appropriate to disclose test results to the participant. This may depend on the researcher's training in accurately interpreting the results of a test that has been used for research purposes and the implications of imparting this information to the subject (e.g. access to healthcare or mental health counseling services). The protocol should address the collection of data that may also have clinical relevance and describe whether this information will be disclosed to the participant and/or to a clinical professional determined by the participant.

Transportation of Data

If data are collected utilizing a mobile device or internet-based data storage service, the protocol should include procedures to ensure that data will be transported in a manner that minimizes risks associated with the inadvertent loss or theft.

Certificate of Confidentiality

If the research includes disclosure of potentially sensitive or illegal information, additional measures to protect the participant’s privacy and confidentiality may be needed. A Federal Certificate of Confidentiality provides additional protection for the subject in that the data would be protected from subpoena by a court of law. Upon receipt of the Certificate, forward a copy to the CPHS.

To initiate the process to obtain a Certificate of Confidentiality for your study, contact: National Institute of Mental Health, 6001 Executive Boulevard, Room 8102, MSC 9653, Bethesda, MD 20892-9653, Phone: 301-443-3877, Fax: 301-443-2578. For more information visit the NIH Office of Extramural Research website at http://grants1.nih.gov/grants/policy/coc/.

Costs

“Participation in research may result in additional actual costs to individuals. Any anticipated costs to research participants should be described to prospective subjects during the consent process.” (OHRP’s IRB Guidebook: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm). If the study exceeds minimal risk, information about compensation for costs associated with research-related injury must be included. A study that exceeds minimal risk means that the probability or magnitude of harm or discomfort anticipated in the research are greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102).

Compensation and Incentives

To assist in subject recruitment, an incentive may be offered. The CPHS considers the appropriateness of study compensation/incentives when reviewing protocols. The incentive should be reasonable compared to the burden or inconvenience incurred by study participants. It is important that the incentive be awarded for participation in the study rather than for completing a specific task. The purpose of the incentive is to encourage participation. By awarding the incentive only when a task is completed, it may create an undue influence that does not allow for the participant to discontinue if uncomfortable. The amount and type of incentive should not coerce or unduly influence the prospective subject into participating. Receipt of the incentive should not be contingent on study completion. Potential participants should understand what incentives will be offered before agreeing to participate in the study. The terms of the incentive should be described during the consent process and within the consent form. Incentives may also be described on recruitment materials, but should not be sensationalized or exaggerated.

Prorating

The CPHS encourages the use of a prorated incentive payment system when appropriate. This allows for the subject to be paid as the study progresses and does not create the perception of a penalty for discontinuing participation. In some cases, the incentive structure involves graduated payments over the course of the study to encourage continuation without creating an undue influence for participation. The CPHS may accept procedures to pay the incentive in one payment at the end of the study when there is a direct benefit to the subject and a complete data set (all sessions, all interviews, all surveys) must be acquired in order to draw any conclusions.

Coercion/Undue Influence

Voluntary participation is achieved when the possibility of coercion or undue influence is minimized. An incentive payment or compensation for participation may compromise a person’s ability to volunteer. The CPHS reviews the type and amount of incentive offered to determine if it is appropriate given the potential for risk or significant discomfort that research participants may experience. There are other situations that also present the potential for coercion or undue influence that the CPHS will evaluate to enhance the likelihood that the person is able to volunteer and not feel pressured to participate in the research.

Lottery

If a lottery incentive will be used, the consent form will include an estimated timeline for when the information about the drawing will occur, how the person will be notified, how many prizes will be offered and the chances for winning one of the prizes (e.g., You have a one in five chance of winning a prize in the drawing.).

Amount

The CPHS will consider the value of the incentive in order to determine its appropriateness and to minimize the potential for coercion.

Payment Type

The CPHS must determine whether paid research participants are paid appropriately. If a monetary incentive will be offered, the researcher must consider how subjects will be paid – either through cash, check/money order or other type of redeemable coupon. The researcher must consider potential breeches in confidentiality if payment type is provided in a form other than cash.

Staggered Schedule

The researcher may want to consider compensating participants for each task in the study that is completed. A payment schedule allows for subjects to receive partial payment even if they do not complete all study activities. The amount of the incentive may change depending on the nature of the task that the participant is asked to complete. The researcher may want to consider increasing the amount of compensation each time the subject completes a study task to promote continued study participation (for example, if the study is longitudinal). The CPHS will review the payment schedule to determine that the incentive schedule does not appear coercive to unduly influence the subject’s decision to participate.

Researcher Experience

The CPHS considers the researcher’s experience in the area of research to be undertaken to ensure that the research will be carried out appropriately. The CPHS will review a brief summary of the researcher's relevant research experience including valid, current training in all applicable compliance (FERPA, Data Security, RCR, HIPAA, etc.).

Conflict of Interest

The CPHS considers the researcher's financial interests and potential for conflict of interest when evaluating the protection of human subjects. If a financial interest is reported that is associated with the research, the CPHS will assess the researcher's objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing and reporting data. CSUMB’s Business Support Services office may also review disclosures where a financial interest is reported. The CPHS will review whether the researcher (including the researcher’s spouse or dependent child) or any person affiliated with the project has any financial interest, financial relationship, governance or administrative affiliation with any entity that is providing funds for or which has rights to intellectual property resulting from this study. If a financial interest is reported, the researcher must complete and attach the Conflict of Interest Disclosure form to the protocol.

Identification and Management of Potential Conflict

If a financial interest is reported that can be managed, the CPHS will determine a management plan appropriate for the study.

Disclosure within Consent Form

If the researcher has disclosed a financial interest in the research, the consent form may include a description of the financial interest as well as how the interest has been managed to avoid the possibility of a conflict in the conduct of the research.

Internet Research

As Internet research has become more and more common, guidance to assist researchers in developing research protocols in compliance with the ethical standards applied to standard survey and observational research is needed. Research conducted in the virtual world of the Internet is subject to the same CPHS review process and human subjects protections as research conducted in the physical world. The main concerns of the CPHS for protecting subjects involved in research on the Internet are informed consent, protection of privacy and confidentiality. These concerns pertain to survey and observational research conducted with human participants on the Internet.

Informed Consent

The informed consent process is reviewed by the CPHS to determine whether appropriate information regarding the study (e.g., study purpose, participant involvement, risks, benefits, confidentiality) is provided to the prospective subjects.

Survey Research

Similar guidelines to obtaining consent for Exempt (Level I) research apply in anonymous, Internet survey research. A statement containing the following information to obtain consent for survey research conducted on the Internet will be reviewed by CPHS:

1. Describe why the study is being conducted.

2. State who is being recruited and why they have been chosen.

3. Explain what each participant will be asked to do and estimate how long it will take to complete the task.

4. Emphasize that participation is voluntary.

5. Clarify whether participant's information will be anonymous (no identifiers, including on-line pseudonyms) or confidential. If confidential, indicate whether any information linked to the individual's identity (in the physical or virtual world) will be used.

6. Describe incentives/compensation offered or costs that may be incurred.

7. Explain added risks associated with privacy violations and strategies developed to reduce the risk of privacy loss or breech of confidentiality.

8. Provide contact information including the name of the researcher, department phone number and E-mail address for inquiries. Include the CPHS telephone number and E-mail address (cphs@csumb.edu) for questions related to their rights as a participant in research.

Observational Research

Observational research conducted on the Internet is subject to CPHS review.

Examples of observational research include monitoring chat room discussions, tracking frequency of Internet use or following consumer patterns of behavior on the Internet. For Internet observational research, the CPHS recommends the following procedures to obtain consent:

1. Prior to initiating observation or data collection from a particular site, the researcher will contact the domain host, webmaster or equivalent to provide a description of the study and request that information about the study be presented to the community. Should the host agree, study information is presented to the community for discussion. If the community indicates agreement to the host, the researcher is notified of permission to access the site.

2. New users that join once the research has begun must be informed of the research in the first welcome message from the domain host, webmaster or equivalent.

3. The user/prospective subject should have an opportunity to refuse participation in the observational research study.

Note: Deception in observational research, where the researcher identity is concealed or falsified on the Internet must include solid rationale to support the methodology and must meet criteria to waive the informed consent process (refer to 45 CFR 46.116).

Privacy & Confidentiality

Survey Research

Confidentiality and privacy are of particular importance for Internet research, given that information may be stored and accessed for indefinite periods of time. The researcher must assure the CPHS that data collected will only be accessible to the researcher.

If there are plans to collect data via the Internet, efforts to enhance participant privacy and reduce risks associated with a breech to confidentiality must be considered. The protocol must address the following issues as they pertain to data collection and submission procedures utilizing the Internet.

Privacy/Access: Describe procedures planned to protect participant identity when entering and submitting data via the Internet. For example, will the subject have a user name and/or password to gain access to the study site? If so, develop instructions for the participant to use when creating a user name or password that enhances protection of her privacy (e.g., not using own name, not sharing password, etc.). Will data be transmitted in encrypted format? In an anonymous survey, will a name-blind survey URL be assigned to each individual survey to guarantee privacy?

Confidentiality of Data: Develop procedures to advise a participant on how to prevent another computer user from gaining access to his/her data. This concern focuses on accessing a computer for data entry that is shared with others (e.g., form autocomplete feature, Password Saving feature). Caution the participant to finish the survey in one setting and to shut down the computer after the assessment is completed.

Secure Data Storage: Incorporate procedures to not include the participant’s name or identifiers within the database. Develop a coding scheme to protect subject privacy and confidentiality of data. Describe how/whether data will be backed-up and kept in a secure location, how long it will be stored, who will have access to the data collected.

Describe systems in place to prevent unauthorized persons (hackers) from accessing the database. For highly sensitive topics, CPHS recommends that the subject have the option of printing out a blank copy of the survey and mailing it back to the researcher.

Observational Research

Researchers conducting observational research studies on the Internet must consider the perception that contributors have regarding the privacy and confidentiality of the information that they disclose. The researcher must also abide by rules that govern the on-line community regarding disclosure of information outside the realm of the group. The researcher must consider the degree to which publication of information disclosed on the website could place subjects at risk. Given the search capabilities of the Internet, even direct, anonymous quotes from subjects could be linked back to the subject with a verbatim search of that direct quote. Researchers must ensure the Committee that all possible precautions have been taken to ensure subject privacy and confidentiality.

These guidelines are evolving as Internet research becomes more prevalent. Each research study is unique and poses different ethical issues and challenges for human subjects protections. Although Internet research may offer great benefit to science, it is imperative that human participants in these studies are adequately informed of the research and protected from associated risks.