Resources for Investigators

IRB Policy & Procedures: Section 2

Policy 3: Research and HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule Compliance

POLICY:

An individual's protected health information (PHI) may only be used for research after the investigator has obtained the approval of the IRB. Where the Privacy Rule, the Common Rule, and/or the FDA's human subject regulations are applicable, each set of requirements must be met. When there is a difference in the requirements, the highest level of protection shall be followed. The IRB shall serve as the Privacy Board for research.

The full text of the HIPAA regulations is available at: http://www.hhs.gov/ocr/hipaa.

GUIDANCE:

HIPAA stands for the Health Insurance Portability and Accountability Act. It is federal legislation designed to enable a person to go from one health insurance plan to another with continuity of care and to ensure that he/she will not be denied coverage for a "pre-existing condition" (portability); it details government oversight to protect fraud and finally adds protections for confidentiality of protected health information (PHI) that is collected (accountability).

Applicable Terms and Definitions

Authorization: An individual's signed permission that allows a covered entity to use or disclose the individual's PHI for the purpose(s), and to the recipient(s), as stated in the Authorization.

Covered entity: A facility that conducts health care operations involving the creation and transmission of protected health information or PHI. In our health system, each separate legal entity (facility) is a separate covered entity.

Disclosure: The release, transfer, access to, or divulging of information in any other manner outside the entity holding the information.

Member of the workforce of the covered entity: An individual who is employed or credentialed or holds privileges at a specific entity.

Privacy Rule: A federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that protects certain individually identifiable health information.

Research Privacy Board: A group of individuals responsible for the review and approval of requests for the disclosure of PHI for research purposes.

Research Privacy Officer: A person designated by the covered entity to oversee HIPAA compliance specific to research. Responsibilities include handling patients' privacy complaints, and training and auditing for HIPAA compliance.

Use: With respect to individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within the entity that maintain such information.

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3.1 Protected Health Information

Protected health information (PHI) is individually identifiable health information that is collected for treatment, diagnosis or research purposes. HIPAA details eighteen items that render PHI identifiable:

Names
Geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code in certain situations.
All elements of date (except year) for dates directly related to an individual, including birth date, discharge data, date of death; and all ages over 89 and all elements of dates indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
Telephone numbers
Fax numbers
Electronic mail addresses
Social security numbers
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers
Medical Device Identifiers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code.

Research Categories Under HIPAA

There are three categories of research data to be considered under HIPAA:

Identifiable information (to which the rule applies)
De-identified information (to which the rule does not apply)
Limited data set (a middle option, to which limited parts of the rule apply)

De-identified Information

PHI that is stripped of all of the eighteen identifiers listed above is considered de-identified and is not subject to requirements under HIPAA.PHI can be de-identified for research purposes by removing the 18 identifiers and using a linked code (not derived from any identifying information, i.e., initials), to which access is extremely limited and well protected.

Databases containing identifiable PHI used for research purposes are subject to restrictions under HIPAA. The Research Database Decision Map provides guidance on how to utilize databases consistent with HIPAA requirements.

Limited Data Set

A limited data set (used in conjunction with a data use agreement) refers to PHI that excludes 16 categories of direct identifiers and may be used or disclosed, for purposes of research, without obtaining either an individual's authorization or a waiver (or an alteration) of authorization for its use and disclosure.

The following identifiers must be removed from health information if the data are to qualify as a limited data set:
1.	Names	9.	Certification/license numbers
2.	Postal address information, other than town or city, state and ZIP code	10.	Device identifiers and serial numbers
3.	Telephone numbers	11.	Vehicle identifiers and serial numbers including license plate numbers
4.	Fax numbers	12.	Web universal resource locators (URLs)
5.	Electronic mail addresses	13.	Internet protocol (IP) address numbers
6.	Social security numbers	14.	Biometric identifiers, including fingerprints and voiceprints
7.	Medical record numbers	15.	Full-face photographic images and any comparable images
8.	Account Numbers	16.	Health plan beneficiary numbers

Only the following identifiers may be used in a limited data set:

Dates
Geographic information (except for street address)
Other unique identifying numbers, characteristics, or codes that are not expressly excluded

When a limited data set is used, there is no requirement to track disclosures. The minimum necessary standard does apply (see below). The recipient of the limited data set must sign a data use agreement.

Data Use Agreement

A data use agreement is an agreement into which the covered entity enters with the intended recipient of a limited data set that generally describes the permitted uses and disclosures of the PHI in a limited data set and how the data will be protected.

If an investigator plans to use a limited data set for research, he/she must submit a data use agreement with his/her IRB protocol submission. See Policy 2: How to Submit a Protocol to the IRB for guidance.

Minimum Necessary Standard

HIPAA also requires that researchers comply with a "minimum necessary standard." This means that a research protocol must limit the PHI it uses, discloses, or requests to the minimum necessary to achieve that purpose. The standard applies to all research involving the use of PHI, including protocols involving the use of a limited data set and/or a waiver of authorization, and for reviews preparatory to research.

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3.2 Authorization from the Research Subject

(Revised 02/28/07)

Authorization is a person's signed permission allowing a covered entity to use or disclose that person's PHI as specified in the authorization form. There are important differences between Privacy Rule requirements for individual authorization, and Common Rule and FDA requirements for informed consent (see Policy 5 - Informed Consent). HIPAA requires more specific details about all possible uses and disclosures of PHI ("use" refers to the sharing of PHI within the covered entity, "disclosure" refers to the sharing of PHI outside the covered entity). The information required under HIPAA for authorization may be incorporated into the research consent form. Therefore, a subject may provide consent and authorization together as part of the informed consent process, if determined by the IRB to be appropriate.

Authorization may cover uses and disclosures of PHI for multiple activities of a specific research study, including the collection and storage of tissues for that study. In addition, where two different research studies are involved, such as where a research study collects information for the study itself, and collects and stores PHI in a central repository for future research, authorization for both studies could be combined into a . The consent/authorization form and process must clearly specify the different research studies covered by the compound authorization so the individual is adequately informed. (See Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule).

However, a compound authorization is not allowed where the provision of research-related treatment is conditioned on only one of the authorizations, and not the other. See section 164.508(b)(3)(iii) of the Privacy Rule.

For example, a covered entity that conducts an interventional clinical trial that also involves collecting tissues and associated PHI for storage in a central repository for future research would not be permitted to obtain a compound authorization for both research purposes if research-related treatment is conditioned upon signing the authorization for the clinical trial. In such cases, a study participant would have to provide a separate authorization for the treatment portion of the study and a separate authorization for collecting tissue for future use. For further guidance, click on Research Repositories, Databases, and the HIPAA Privacy Rule.

The following items must be detailed in an authorization:

The PHI that will be used or disclosed
The people/organizations who will use or disclose the PHI
The people/organizations who will receive the PHI
The purpose of the use or disclosure
An expiration date or event for the use or disclosure of the information
The right to refuse to provide the authorization (which would exclude the individual from participating in the research)
The right to revoke authorization including the procedure for doing so (in writing).
The research subject's dated signature
The investigator's obligation to provide a signed copy of the authorization to the subject
The PHI may no longer be protected by the Privacy Rule once it is disclosed by the covered entity

Individual Rights

Under HIPAA, individuals have the right to:

Access their PHI: The individual may request a copy or the opportunity to inspect the PHI that has been utilized as part of the research study.This access is limited to a "designated record set" which includes PHI that is used to make clinical or billing decisions about a subject.In order to prevent the compromise of research data, access can be postponed until the research is complete, as long as this is clearly explained in the authorization (or research consent form).
Request amendment to their PHI: The individual has the right to request an amendment to their PHI.The institution will determine whether or not the request is appropriate.
Receive a record of certain disclosures of their PHI made within the previous 6 years: This does not apply to disclosures that were made pursuant to an authorization, or disclosure of a limited data set.Individuals may request a record of disclosures made under a waiver of authorization or disclosures required by law and for public health purposes. Therefore, any such disclosures must be tracked. (See Tracking Disclosures).
Request restrictions on uses and disclosures: Individuals can request certain restrictions on uses and/or disclosures of their PHI, if it is determined that the request is appropriate and feasible.
Request receipt of communication of their PHI by alternative means/location: An individual may request, for example, that a different address be used to communicate information (home vs. work).Reasonable request must be accommodated, and the individual does not have to explain the basis for the request.
Revoke their authorization: A revocation of authorization must be made in writing. If research authorization is revoked, PHI may no longer be used or disclosed, except to the extent that the PHI has already been included in study analyses, or if the use or disclosure is needed to maintain the integrity of the research study (i.e. account for withdrawal, report adverse event, etc.).

Note: Because New York State Law does not distinguish between living and deceased individuals in their definition of human subject, the same privacy rule standards shall apply to the use of decedent PHI.

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3.3 Waiver of Authorization

There are situations in which the IRB can waive the requirement that subjects sign an authorization form. In general, a Waiver of Authorization could be granted under similar circumstances that the IRB grants a Waiver of Informed Consent (e.g., for retrospective chart reviews, etc.).

Any study granted a waiver of informed consent and approved by the IRB on or after April 14, 2003, must also have a Waiver of Authorization. Any study approved with a Waiver of Informed Consent before April 14, 2003, does not need a Waiver of Authorization.

Note: A Waiver of Authorization does not mean the research is exempt from HIPAA privacy rules. It only means the investigator does not need to obtain signed authorization from each research subject.

In order to qualify for a Waiver of Authorization, an investigator must represent the following:

The use of PHI for research does not represent more than a minimal risk to privacy
The research could not be done without the requested PHI.
It would not be practical to obtain signed authorization from research subjects.
The specific elements of the requested health information are not more than the minimum necessary to conduct thestudy.

Partial Waiver of Authorization

There are circumstances that would require a PI to obtain a partial waiver (or alteration) of authorization. See Reviews Preparatory to Research Recruitment by the Researcher.

below and Policy 4: Recruitment by the Researcher

Tracking Disclosures

Any disclosures (release outside the covered entity) of PHI made without the written authorization of the research subject must be tracked.This includes studies conducted under a waiver of authorization, as well as situations where consent/authorization was obtained but the recipient of the PHI is not listed on the consent/authorization form.

Note: When a limited data set is used, there is no requirement to track disclosure

The information that should be tracked includes:

Date of disclosure
Name of the person/entity who received it and their address (if known)
A brief description of the disclosed PHI
A brief statement of the purpose of the disclosure.

A modified tracking mechanism is available for research involving the disclosure of PHI from 50 or more subjects (i.e. during epidemiological research). Under a modified tracking mechanism, the researcher must be prepared to provide:

The name and description of all protocols involving disclosure of 50 or more subjects
A brief description of the types of PHI disclosed
The dates or time periods of the disclosures
Contact information of the recipients
A statement that a specific individual's PHI may or may not have been disclosed for a particular study.

3.4 Reviews Preparatory to Research

"Review preparatory to research" is the mechanism by which an investigator may access PHI for the purpose of designing a research study, generating a research hypothesis, or to assess the feasibility of conducting a study (e.g., to see if there are enough potential subjects, etc.). In order to review PHI preparatory to research, the PI must be able to establish that:

PHI is necessary for the research activity
PHI will not be used for any other purpose
PHI will not be removed from the covered entity

An investigator who is a member of the workforce of a covered entity may review madical records of subjects at that covered entity preparatory to research without any specific authorization.

However, if an investigator is NOT a member of the workforce of a covered entity and wishes to review medical records of subjects at that covered entity preparatory to research, he/she must apply for a partial waiver of HIPAA authorization by submitting IRB Form 4c (section IV). Please contact the Research Privacy Officer at 516-562-2018.

Institutional policy prohibits any contact without IRB approval. Therefore, a researcher may not contact individuals indentified during this activity.

Note: If a researcher wishes to contact potential participants, he must submit a protocol to the IRB requesting approval, including the intent to recruit subjects through use of PHI. See Policy 4: Recruitment of Study Subjects.

Policy 4: Recruitment of Study Subjects

POLICY:

The IRB shall review and approve, prior to utilization, all documents and activities that affect the rights and welfare of research subjects, including all methods and materials intended to recruit human subjects.

GUIDANCE:

4.1 Recruitment Mechanisms

Potential subjects may be recruited by either of the following mechanisms. The mechanism for recruitment must be described by the PI in the protocol and submitted to the IRB for approval before implementation.

1. Recruitment by Clinician or Treatment Staff- Acceptable Methods

A clinician, who is also a researcher, may approach a patient he/she is treating about participating in any IRB-approved study for which that clinician is conducting research. The clinician's treatment personnel (who already have access to a patient's identifiable health information by virtue of the treatment relationship) may also approach the patient about participating in research. The clinician and the treatment staff must note any such communication in the patient's medical record.

Note: Direct recruitment for a study by a clinician/researcher or his/her treatment staff is not affected by HIPAA. These personnel already have a reason to know the patient's PHI and, assuming the study (and the recruitment process) has been approved by the IRB, these personnel may approach the patient about participating in the study without HIPAA authorization.

A clinician, who is NOT the researcher, and that clinician's treatment staff, may approach a patient about participating in another researcher's study. The clinician or staff must note such communication in the patient's medical record. If the patient agrees to bereferred to the researcher, the following language is suggested:

I discussed the possibility of referring the patient to [doctor or team] for [describeresearch study]. The patient agreed to the referral, and to sharing information about his/her condition with the researcher.

A clinician, who is NOT the researcher, and that clinician's treatment staff, may give the patient another researcher's name and contact information. The patient may then choose to contact that researcher directly.

A clinician, who is NOT the researcher, and that clinician's treatment staff, may discuss a patient's eligibility with the research personnel as long as all information about the patient has been de-identified. If the research personnel think the de-identified patient would be eligible for the study, the treatment personnel could then obtain the patient's permission to give the research personnel the patient's name or give the patient the researcher's contact information (see b and c above).

A clinician, who is NOT the researcher, and that clinician's treatment staff, may send a letter to the patient about how to join an IRB approved study as long as the content of the letter is approved by the IRB.

Note: Unless the IRB approves awaiver of authorization for study recruitment purposes, the letter may NOT be co-signed by the researcher and the researcher may not have a copy of the letter.

2. Recruitment by the Researcher

If the treating clinician's direct approach to the patient or the patient's prior authorization is impracticable, the researcher may ask the IRB to grant a partial waiver of the patient's authorization for recruitment purposes.

A partial waiver of authorization may be requested for the following:

a)	To allow treatment staff to refer patients to the researcher or to share PHI with the researcher without first speaking to the patient about the referral. .
b)	To advertise about the study and screen by phone potential subjects for thestudy.

4.2 Recruitment Methods

POLICY:

Potential subjects may be recruited for research studies using a variety of methods, including direct contact (where appropriate), advertising, chart reviews, database review, or other written/verbal correspondence. All of these methods must be consistent with federal regulations regarding the rights and welfare of potential subjects (Common Rule Requirements), the Privacy rule (HIPAA Privacy Rule Requirements), and Institutional policies.

Recruitment through Chart Reviews

GUIDANCE/PROCEDURE:

Investigators may use medical records, or other private information, including databases, that they would normally have legitimate access to as part of their clinical practice in order to identify potential research subjects.

An investigator may need to review charts to which he/she does not have legitimate access in order to identify potential research subjects. Since this activity involves the use of PHI, a waiver of authorization must be obtained from the Privacy Board (see Policy 3 - HIPAA).

Note: Subjects identified through chart reviews may only be contacted for research recruitment by the clinician who is treating them.

Using Letters to Contact Potential Research Participants

GUIDANCE/PROCEDURE:

In most cases, contacting potential research subjects by letter will occur only when that subject is familiar with the person writing the letter. If personal information about the subject is necessary in order to identify them as a potential participant (such as having a certain disease or clinical condition) then the contact shall come from a person that they would expect to have that information about them (e.g. their physician, a disease-related organization to which they belong, etc.).

Any letter that is sent to a potential research participant is subject to the same requirements as advertising, and must contain no coercive language. The letter should briefly explain the study, its purpose, and the reason why the person is being asked to participate. There should be a mechanism by which the person can express an interest (by calling their physician or a researcher, sending back a card, etc.). Failure to respond should never be construed as a willingness to participate. It should be clearly stated if a follow-up phone call is to come from the person who wrote the letter. It must also be clearly stated that participation is voluntary, and the subject has the right to refuse to participate without any loss of benefit to which he/she would otherwise be entitled. If possible, a consent form should be included, and a phone number where the person can direct questions about the study should be provided.

Optional Authorization for Research Contact

GUIDANCE/PROCEDURE:

At the discretion of a clinical department, a clinician, who is not the researcher, may use the Optional Authorization for Research Contact form to obtain a patient's permission to be contacted by researchers at NSLIJHS to discuss his/her possible participation in research.

The Optional Authorization for Research Contact is approved for use by the IRB. A researcher may ask a clinician or other researcher to use it on his/her behalfwithout obtaining approval by the IRB.

By signing the Optional Authorization for Research Contact form, a potential subject, or his/her LAR, agrees to allow his/her name, date of birth, address, telephone number, and diagnosis to be shared with researchers. After receipt of the signed authorization, the researcher may contact the potential subject to discuss possible participation in a research study. If a potential subject agrees to be in the study, he/she must go through the process of informed consent (documented by a consent form), specific to that study.

The patient or his/her LAR must be given a copy of the signed Optional Authorizationfor Research Contact form. A copy of the signed form must also be kept in the patient's record at his/her doctor's office and in the study's critical documents at the researcher's office.

Advertising

Revised 3/1/07

POLICY:

No advertising material may be used prior to approval by the IRB. The IRB shall review all printed media advertisements, internet advertisements (which include more information than simply a listing of available trials), scripts of radio and television commercials, flyers, postcards, letters, pamphlets, brochures, videos, and any other advertising material proposed for use in recruiting study subjects.

GUIDANCE/PROCEDURE:

For studies to be advertised exclusivelywithin the NSLIJ Health System:

The investigator shouldsubmit the advertisements, scripts, etc. with the initial submission packet (fornew submissions) or IRB Form 8a (for approved studies) to the IRB for approval prior to utilization.

For studies to be advertised outside the NSLIJ Health System:

All materials to be utilized for recruitment via the mass media (print media such as newspapers or television and/or radio air time) shall be developed in conjunction with the NSLIJHS Marketing Department. The Marketing Department will assure that the materials are designed and presented in accordance with HealthSystem guidelines. (Click here for further guidance and submission form.)

Once approved by Marketing, the investigator should submit the advertisements, scripts, etc. with the initial submission packet (for new submissions) or IRB Form 8a (for approved studies) to the IRB for approval prior to utilization.

Note: No "open reads" for radio or television are permitted. Open reads are live discussions by a person on radio or television that are intended as advertisements. For example, when a radio host talks about how great a particular store is, and you are led to believe that it is his personal opinion when, in fact, he is reading or acting out an advertising script.

See the following guidance provided by FDA for Media Advertising: http://www.fda.gov/oc/ohrt/irbs/toc4.html#recruiting .

The IRB uses the principles set forth in this FDA guidance when reviewing advertising materials for clinical trials and other studies that advertise for potentialsubjects.

Recruitment of NS-LIJHS Employees and Students as Research Subjects

POLICY:

The use of employees and students as research subjects may be permitted depending on the nature of the research and as long as they are treated as any other research subjects would be in compliance with federal, state, and institutional policy regarding the use of human subjects in research.In most cases, investigators will not be allowed to recruit employees who work directly under their supervision. The final decision to allow employees as subjects will be made by the IRB on a case-by-case basis.

GUIDANCE/PROCEDURE:

Employees and students who wish to become involved as research participants are subject to the same protections as any other human subjects. This applies to all research activities, including when the person volunteers as a normal control. A consent form (if applicable) must be signed by all subjects, there are no exceptions made for employees or students.

Recruitment Incentives and Conflict of Interest

(Revised 3/6/07)

POLICY:

Investigators and other members of the study staff (study coordinators, research assistants, etc.) shall NOT accept monetary or other bonuses as incentives to recruit or refer patients to research studies. Examples of such bonuses include but are not limited to payments for rapid recruitment, extravagant gifts such as computer or other office equipment, expensive meals, books, etc. Such payments or incentives may lead to the appearance of inappropriate practices in an effort to increase enrollment for personal gain, and might compromise the integrity of the research. For further guidance, click on Gifts, Gratuities and Business Courtesies on the Corporate Compliance Office website.

GUIDANCE:

It is against the policy of the NSLIJHS for an employee to solicit or accept gratuities from patients, their families or friends for any services provided by the employee during work hours, or for any member of the employee's immediate family to accept gifts, gratuities, or entertainment that might influence the employee's judgment or actions concerning business of the NSLIJHS. For employees involved in research, this includes any payment from study sponsors above and beyond payment that has been approved in the study budget. Budgets that include bonuses for recruitment or other activities are never allowed.

Payment to Research Participants

Revised 8/8/07

POLICY:

It is the policy of the North Shore-LIJ Health System Institutional Review Board (IRB) to review and approve payments to human research participants.

Applicable Terms and Definitions

Research Payments:
Cash and non-cash compensation for time and expenses associated with participation in research activities.

The IRB must determine that the risks to research participants are reasonable in relation to the anticipated benefits and that the informed consent document contains an adequate description of the study procedures as well as the risks and benefits. Payment to research participantsis not considered a benefit. Rather, it should be considered:

reimbursement for expenses incurred due to study participation, and/or
compensation for time and inconvenience, and/or
a recruitment incentive.

GUIDANCE:

The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coerciven or present undue influence.

Timing of Payments

Credit for payment should accrue as the study progresses and not be contingent upon the participant completing an entire study. Participants should be paid in proportion to their time and inconvenience as a result of participation in a research study. Unless it creates undue inconvenience or a coercive practice, payment to participants who withdraw from a study may be paid at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB committee may find it permissible to allow a single payment date at the end of the study, even to participants who withdraw prior to conclusion of the study.

Completion Bonus

While the entire payment should not becontingent upon completion of the study, payment of a small proportion as an incentive for completion of the study may be acceptable, providing that such incentive is not coercive. The IRB will determine whether the amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study.

Disclosure of Payments

All information concerning payment, including the amount and schedule should be described in the informed consent document.

Advertisement of Payments

Advertisements may state that participants will be paid orcompensated, but should not emphasize the payment or amount to be paid, by suchmeans as larger or bolded type.

Alterations in Payments

Any alterations in research participant payment or liberalization of the payment schedule must be submitted as a modification (IRB Form 8a) to the IRB for approval prior to implementation.

Reporting Payments to the IRS

The Internal Revenue Service (IRS) requires that institutions report payments to an individual in excess of $600 per calendar year on Form 1099-Misc. As a result, investigators should be aware that Finance will require that the name and social security number of participants be collected on a check request form and released to the Office of Procurement/Accounts Payable for processing, unless a specific request is made not to capture this information due to confidentiality or other study concerns. The collection and release of this information must be addressed thoroughly in the informed consent document so that it is clear to participants that their identity will be released for the purpose of payment and reporting.

If the study involves sensitive information and/or the amount of compensation provided will not exceed $600 in aggregate during the calendar year, investigators must submit a signed Research Study Participant Payment Form in addition to the Check Request Form.

Note: The NSLIJHS IRBs carefully consider payment to minors who are subjects in a research study. It may be appropriate to offer a non-cash option to minors who are enrolled in a research study in order to provide acknowledgment of their participation that can be understood and appreciated by the minor. The IRB may suggest that payment to minor research subjects be made in the form of a gift certificate to an age-appropriate store (toy store, etc.), toys, stickers, etc.

Recruitment on the Internet

POLICY:

Recruitment of research subjects via the internet must be approved by the IRB before implementation. Recruitment plans will be reviewed and evaluated in accordance with the basic principles governing human subject protections.

Policy 5: Informed Consent

POLICY:

An investigator may NOT involve a human being as a subject in a research study unless the investigator has obtained the approval of the IRB for that study. The legally effective informed consent of the subject or the subject's legally authorized representative shall be required, except when a waiver is granted under FDA and OHRP guidelines (as described below). All consent forms shall conform with 45 CFR 46.116, 21 CFR 50.20, and Institutional requirements.

The ethical principle of respect for persons(autonomy) is maintained by the process of informed consent from human subjects involved in research, and is a necessary process to help ensure that research is conducted in an ethical manner.

GUIDANCE:

The informed consent process is a comprehensive discussion between the investigator and a prospective subject of the:

nature of the research study,
risks and the benefits,
alternatives to research, and
rights of a study subject.

An investigator must ensure, to the best of his/her ability, that prospective subjects understand why the research is being done and why they are being asked to participate.

Federally Mandated Elements of Informed Consent
The following are the Common Rule guidelines regarding informed consent (45 CFR 46.116) which all NSLIJHS researchers are required to follow.

In seeking informed consent, the following information must be provided to each subject:

A statement that the study involves research, an explanation of the purposes of the research and 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 proceduresor courses of any treatment that might be advantageous to thesubject.
A statement describing the extent, if any, to which confidentiality of records identifying the subject will bemaintained
A statement describing the Institution's policy on liability for research-related injury
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 to thesubject.
A statement that participation is voluntary,refusal to participate will involve no penalty or loss of benefits to the subject and that the subject may discontinue participation at anytime without penalty or loss of benefits to which the subject is otherwise entitled.

Note: In addition to the Common Rule requirements for informed consent, HIPAA requires specific details regarding use and disclosure of PHI which may be incorporated into the informed consent process and consent form. See Policy 3: Authorization from the Research Subject for guidance.

Additional Elements of Informed Consent

When appropriate, one or more of the following elements of information must also be provided to each subject:

A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant or father a child) which are currently unforeseeable.
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
Any additional costs to the subject that may result from participation in the research.
The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue to participate will be provided to the subject.
The approximate number of subjects involved in the study.
If there is a potential for marketed products resulting from the research, a statement should be included which explains that the subject will not share in any profits or losses.
If a study sponsor agrees to reimburse for research-related injury, such a statement should be added following the Hospital's standard policy for such.
Such other information which the IRB recommends as meaningfully adding to the rights and protection of subjects.

The investigatorshould note his/her general impression of the subject's understanding, including any questions that have been raised during the consent process. Where possible, the investigator should document the process in the subject's medical record and/or research record.

A subject's autonomy must be respected at all times, and the consent process must be free of all elements of coercion. The patient's ability to understand and process the information must be assessed by the person obtaining consent (see Research Involving Incapacitated orDecisionally Impaired Subjects).

5.1 Documentation of Informed Consent

(Revised 12/13/10)

POLICY:

Except where a waiver of documentation of informed consent is granted, obtaining legally effective consent must be documented by 1) the use of an IRB approved consent form that is signed and dated by the subject or his/her legally authorized representative at the time of consent; and 2) an enrollment note describing the consent process and information related to the subject’s enrollment into the study.

See Guidelines for Preparing Research Consent Forms: Required and Suggested Language for assistance in preparing consent forms to be used within the North Shore-Long Island Jewish Health System and the enrollment note template and checklist available through the regulatory binder online.

GUIDANCE/PROCEDURE:

All potential research participants or their legally authorized representatives should be provided with the information in the IRB approved consent form both verbally and in a copy of the consent form. They must be given ample time to think about whether or not they wish to participate, and must have the opportunity to ask questions. Ideally, the potential subject should be given the form to take home, and should be advised to think about his/her participation and discuss it with family and friends. Informed consent should be obtained prior to the initiation of study-related procedures.

Informed consent is not valid unless the subject or his/her legally authorized representative is fully informed about all the information in the consent document. Once there is agreement to participate, the subject or his/her legally authorized representative must sign and date the consent form in the appropriate places. The witness who observed the subject signing the consent form is required to sign and date the consent form unless a waiver is granted (see 5.9 Obtaining a Witness Signature).The IRB may determine for a particular protocol that there must also be a witness to the entire consent process, not just the signature, which would be indicated as a condition of approval in the IRB's decision letter.

The person obtaining consent (see 5.4 Persons Authorized to Obtain Informed Consent from Research Participants) must sign the form after the subject (and/or his/her legally authorized representative) and witness sign and in so doing, affirm that the person providing consent has been fully informed about all aspects of the study, alternatives to participation have been discussed, and the subject is willing to participate in the study. The subject (and/or his/her legally authorized representative), witness, and investigator should sign the consent form on the date that they were actually involved in the consent process. If a signature was missed on the consent form, but later obtained the date must not be back dated; instead, study staff should indicate the date s/he actually signed the form with an explanation of the discrepancy within the research records.

Note: Consent for research participation must be obtained by an IRB approved member of the research team credentialed to perform the intervention(s) in the study.

One copy of the signed consent form must be given to the person signing the form (subject or representative) and a second copy should be placed in the subject's medical record (if appropriate). The original, signed consent form should be retained in the PI's research records. Consent forms must be retained for all subjects enrolled in the study, regardless of whether they withdraw or are withdrawn. A subject is considered enrolled at the moment s/he or his/her legally authorized representative sign the consent form, whether or not the person actually participates in the research or any of the procedures involved.

After consent is obtained, an enrollment note that is signed and dated should be written in the subject’s medical record and/or research record that describes the consent process and information related to the subject’s enrollment into the study. In general the enrollment note should describe the basic elements of the consent process for the particular protocol and any issues or substantive questions from the subject that arise during the process. It should also include circumstances related to the subject’s ability to provide consent (e.g. capacity assessment, assent of minor, consent translation, use of a legally authorized representative, consent quiz completion, etc.). Alternatively, an enrollment note checklist that is signed and dated can be used to document this process. See sample enrollment notes provided in the Helpful Tools section of the NSLIJ regulatory binder.

Signatures on the consent form represent only part of the consent process - Obtaining consent is an ongoing process that requires the investigator to keep subjects apprised of issues that arise which may affect their willingness to continue participation. The subject's continued willingness should be documented periodically in the subject's medical record and/or research record, and in some cases a revised consent form or addendum may be appropriate. There are certain circumstances where a subject may be asked to re-consent to participation in the research study (See 5.7 Reconsenting Subjects and 5.8 Expiration of Consent).

5.2 Waiver of Informed Consent Requirements

POLICY:

The IRB 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 in instances where the IRB finds and documents that certain criteria (as listed below) are met. Any waiver that is requested will be considered by the IRB on a case-by-case basis within the framework of the following criteria. IRB Form 4b must be completed when requesting a waiver of the informed consent requirement. The IRB may decide not to grant a waiver, and to require all of the elements of consent, for protocols which appear to meet this criteria if it determines that doing so is in the best interest of the subjects.

GUIDANCE:

A complete waiver of informed consent can only be granted if one of the two following sets of criteria is met:

Either
1.	The research or demonstration project is to beconducted by or is subject to the approval of state or localgovernment officials and is designed to study, evaluate, or otherwise examine (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in methods or levels of payment for benefits or services under those programs;
and
2.	The research could not practicably be carried out without the waiver or alteration.
Or all of the following must be met:
1.	The research involves no more than minimal riskto the subjects.
2.	The waiver or alteration will not adversely affect the rights and welfare of the subjects.
3.	The research could not practicably be carried out without the waiver or alteration.
4.	Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

AND the following criteria are met for a waiver of HIPAA authorization to use ordisclose PHI in the conduct of research:

The use or disclosure of PHI involves no morethan minimal risk to the privacy of individuals, based on, at least,the presence of the following elements:

An adequate plan to protect the identifiersfrom improper use or disclosure.
An adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; and
Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, (except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by regulation).

The research could not practicably be conducted without the alteration or waiver; AND

The research could not practicably be conducted without access to and use of the PHI.

Note: The informed consent requirements in this policy are not intended to preempt any applicable federal, state or local laws which require additional information to be disclosed in order for informed consent to be legally effective. Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent that the physician is permitted to do so under applicable federal, state or local law.

PROCEDURE:

The IRB will use the criteria above in determining whether or not the consent requirement can be waived.The PrincipalInvestigator must include a request for such a waiver (IRB Form 4b) in the IRB application and must provide justification for the request.

FDA regulations permit a limited class of research in emergency settings without consent. See: Appendix A: Exception From Informed Consent for Studies Conducted in Emergency Settings.

5.3 Waiver of Documentation of Informed Consent

POLICY:

The IRB shall use the criteria in 45 CFR 46.117(c) when considering a request for waiver of documentation of informed consent.

GUIDANCE:

Consistent with 45 CFR 46.117(c), the IRB may waive the requirement for the investigator to obtain a signed consent form from some or all subjects if it finds that either:

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. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.

or

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.

In cases where the documentation requirement is waived, the IRB may require that a written statement summarizing certain elements be provided to the subject.

Note: A waiver of signed consent does not exempt an investigator from obtaining verbal informed consent.

[See Emergency Use Exemption from Prospective IRB Approval for additional exceptions to informed consent requirements in an emergency setting.]

PROCEDURE:

The IRB will use the criteria above in determining whether or not the documentation of the consent requirement can be waived. The Principal Investigator must include a request for such a waiver (IRB Form 4b) in the IRB application.

5.4 Persons Authorized to Obtain Informed Consent from Research Participants

POLICY:

Informed consent for research involving medical/psychiatric intervention shall be obtained by a physician member of the medical staff who is familiar with all aspects of the research protocol, unless an exception is made by the IRB which allows for consent to be obtained by another investigator who is licensed to perform the intervention (e.g., RN, PA, etc.). Any investigator, including an investigator who is not a physician, who is familiar with all aspects of the research protocol and is listed on the protocol as a research investigator, may obtain consent for research that does not involve medical/psychiatric intervention.

The person obtaining consent must sign the form. By so doing, he/she attests that the subject has been fully informed about all aspects of the study, alternatives to participation have been discussed, and the subject willingly gives his/her consent to participate in the study.

5.5 Persons Authorized to Give Permission for a Subject (Other Than Themselves) to Participate in Research

POLICY:

Consent, or agreement to participate in a research study, shall be given by the individual who will be the research subject or a person who is permitted to act on behalf of that individual (a legally authorized representative). A persons consenting on his/her own behalf must be an adult over the age of 18 years whose clinical condition does not preclude him/her from making a sound judgment regarding the risks/benefits of participation. For adult subjects incapable of consenting to participation due to their clinical or mental condition, the IRB may approve a process whereby permission may be obtained from the subject's legally authorized representative or, in limited cases, next of kin (see Research Involving Incapacitated or Decisionallly Impaired Subjects).

For children, the parent or legal guardian shallbe permitted to act on behalf of the child and give permission for his/her participation. However, the assent of the child shall be obtained from any child considered mature enough to understand (usually in the range of 7-9 years of age), unless the IRB determines that the assent requirement can be waived (see Waiver of the Assent Requirement).

All research involving children as subjects shall be placed into one of the four categories of risk as outlined at 45 CFR 46.404, 405, 406, 407. The categories are as follows:

Research not involving more than minimal risk. 46.404
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. 46.405
Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. 46.406
Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (Approval of research included under this category is very rare). 46.407 Note: Research in this category needs approval of the Secretary - DHHS in addition to IRB approval.

Where research is covered under category 3 or 4 above (45 CFR 46.406 or 45 CFR 46.407), and when permission is to be obtained from parents, both parents shall give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. In this case, when only one parent is giving permission, the justification for not requiring theother parent's signature shall be documented in the research record and on the consent form. When research is covered under category 1 or 2 above (45 CFR 46.404 or 45 CFR 46.405), the permission of one parent shall be considered adequate unless the IRB indicates otherwise in its approval letter.

5.6 Waiver of the Assent Requirement

POLICY:

The IRB may grant a waiver for the assent requirement when it is determined that there is a prospect of direct benefit, no standard approved therapy exists which is equally effective, and/or the child may not have the ability to understand the ramifications of not participating. (See Policy 7.1 – Research Involving Children).

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5.7 Re-consenting Subjects

POLICY:

Subjects may need to be re-consented due to changes in their status (i.e., previously enrolled by proxy and now able to consent on their own behalf) or due to changes in the protocol and/or consent form as follows:

The protocol and/or consent form has been modified since the subject enrolled and the changes are more than administrative (i.e. the information which has been added/deleted may have an impact on risk to subjects and their willingness to participate).
The subject was initially enrolled in a study by parents, a legally authorized representative or a research proxy because:

GUIDANCE/PROCEDURES:

All protocol and or consent modifications should be submitted to the IRB according to instructions outlined in Policy 6.6: Modifications. Modifications must be reviewed and approved by the IRB before they may be implemented.

Investigators may have subjects who are re-consenting for follow up only sign the Research Consent/Authorization Addendum for Follow-up Only, without additional IRB approval if the Addendum is used verbatim.

The Office of the IRB will process protocol and consent form modification requests. Each request will be evaluated on a case-by-case basis by the IRB chair or designee, and when appropriate, by the convened IRB committee. Investigators will be informed in writing regarding the IRB’s decision. No modifications to the protocol or the consent form may be implemented without IRB approval.

Regarding subjects asked to re-consent due to modifications to the consent form and/or protocol:

If the modifications are minor (see Policy 6.6: Modifications) it may be appropriate to provide the subject with an addendum to the original consent form that provides the new information, or to verbally inform subjects of an administrative or other minor change with documentation in the medical record that such notification took place. If an addendum is used, it must clearly state that the information in the original consent form is still current and valid, and that the information is the addendum is supplementary.
If the modifications are major, subjects must be given a completely revised consent form to sign.

Regarding subjects asked to re-consent after initial enrollment by proxy:

If subjects are consenting to remain in the study for ongoing and/or future treatments/procedures, they must sign the most recently approved consent form and the Addendum to Consent by Research Proxy for Continuing Participation in a Research Study, at their next scheduled visit.
If subjects are consenting to remain in the study for follow-up only, they may sign a Research Consent/Authorization Addendum for Follow-up Only at their next scheduled follow-up visit.

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5.8 Expiration of Consent

POLICY:

The process of informed consent shall take place no more than 30 days prior to the initiation of the research. If more than 30 days has elapsed since the subject provided consent, the process shall be repeated. The same requirements for signatures and obtaining consent apply when re-consenting or presenting an addendum to a study subject.

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5.9 Obtaining a Witness Signature

(Revised 3/6/07)

POLICY:

The Institution shall require that the signature of a witness be obtained on all research consent forms. In signing the consent form, the witness attests to the fact that they were present when the subject signed the consent form, not necessarily that they witnessed the entire consent process.

A witness may be anyone over the age of 18, and may be an employee of the hospital or a family member/friend. The use of patient’s relatives/friends as witnesses is encouraged.

Note: The investigator obtaining consent may NOT serve as the witness.

The IRB may determine for a particular protocol that there must also be a witness to the entire consent process (as is the case for illiterate, non-English speaking, or particularly vulnerable subjects). Such a requirement would be indicated in the protocol approval letter.

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5.10 Obtaining and Documenting Informed Consent of Subjects with Limited English Proficiency
(Revised 1/19/11)

POLICY:
It is the policy of the Health System that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117).

PROCEDURE:

Providing Subjects with Understandable Language

Investigators who plan on enrolling subjects with limited English proficiency from a particular population must provide them with an IRB-approved translation of the approved English version consent form in their native/preferred language.

Investigators who do not anticipate enrolling subjects with limited English proficiency may use a short, generic foreign language consent form for the occasional circumstance in which a potential subject who is not proficient in reading or understanding English. Short forms are available in various languages on the Office of the IRB website. See Short Informed Consent Translations.

In order to provide effective informed consent for subjects with limited English proficiency, investigators must do the following:

Step 1: Identify the subject’s language preference
Step 2: Inform the potential subject of his/her right to free interpretation services via a telephonic interpreter.

If the potential subject agrees to use the telephonic interpreter services, proceed as follows:

Refer to your facility’s process for telephonic interpretation. If needed, contact your site’s business/human resources partner for the name of your Language Access Coordinator (LAC). S/he will be available to explain/review the following:

   a. Location of dual handsets and instructions on their use
   b. Use of speaker phones and splitters
   c. Patching in the telephonic interpreting service to an existing/incoming call
   d. Disinfecting procedures after a phone is used.

If the potential subject refuses the offer of free interpretation services, the following resources can be considered, when available:

1. Family/Friend/Non-Hospital Resource serving as interpreter, whom the investigator has determined to be:

   a. At least 18 years old
   b. Competent to act as interpreter
   c. Able to understand and maintain confidentiality
   d. Free of any conflicts of interest that would influence his ability to interpret without bias

Note: If the investigator is not satisfied that the above criteria have been met, s/he may prohibit a family member or friend from acting as the interpreter, or stipulate that the interpretation be augmented by the telephone interpreter.

2. A bilingual investigator or employee who is fluent in English and the potential subject’s language may serve as interpreter.

Documenting Informed Consent of Subjects with Limited English Proficiency

The rules for documenting informed consent using a foreign language version of the English consent form versus a short, generic foreign language consent form are not the same. Each has specific regulatory requirements regarding signatures and witnesses:

When using a foreign language version of the approved English consent form, there are two possible scenarios:

1)   An approved bilingual investigator obtains consent for the study in a manner consistent with Policy 5.1
2)   A third party acts as the bilingual translator. Then the consent process should be conducted in the manner indicated below:

A translator must discuss the entire IRB-approved foreign language consent form with the subject. The translator may serve as the witness.
An investigator approved to obtain consent should be present for the consent process.
The IRB approved foreign language version of the consent form must be signed and dated by the witness and the research subject.
The IRB approved English version of the consent form should be signed and dated by the witness and the investigator approved to obtain consent.

If a telephonic interpreter is used, there will be no witness signature on either consent form. The telephonic ID # can be recorded on the foreign language consent form in conjunction with an enrollment note describing the process.

When using a short, generic foreign language consent form with the English consent form:

A translator must orally translate the entire IRB-approved English version of the consent form to the subject in a language understandable to him/her.
The subject must be given a copy of the written short form in the language understandable to him/her.
The entire consent process must be witnessed by an individual who is fluent in English and the language understandable to the subject. The translator may serve as the witness. The bilingual witness may be anyone over the age of 18, whose competency and language proficiency are acceptable to the investigator (i.e., a bilingual adult family member or friend; a bilingual clinician, a self-reported proficient bilingual employee, a dual role interpreter, etc.).
The IRB approved English version of the consent form must be signed and dated by the investigator obtaining consent. The witness should also sign and date this form. The research subject should not sign the English version of the consent form.
The short form should be signed and dated by the subject and the witness to the consent process. In signing both consent forms, the witness attests to the fact that s/he was present for the entire consent process and that s/he observed the subject signing the short foreign language consent form.

If a telephone interpreter is used, then there will be no witness signature on the short foreign language consent form or on the English consent form. The telephonic ID # can be recorded on the short foreign language consent form in conjunction with an enrollment note describing the process.

If the English consent form contains optional tiering sections, these sections should be completed by the investigator obtaining consent, per instruction from the research subject/representative. An enrollment note should indicate that the tiers were completed based on the research subject’s choice.

The subject should receive a copy of the signed short form and the English version of the consent form. A second copy should be placed in the subject’s medical chart (if appropriate). The original, signed consent form or short foreign language consent form (along with the signed English consent form) must be retained in the PI’s research records. Consent forms must be retained for all subjects enrolled in the study, regardless of whether they withdraw or are withdrawn. A subject is considered enrolled at the moment they sign the consent form, whether or not they actually participate in the research or any of the procedures involved.

See Short Informed Consent Translations available on the IRB website.

Documentation of Interpretation Method

Communication with subjects regarding provision of interpretation services must be documented in the subject’s medical/research record. Documentation should include the following:

1. Note indicating that:

Subject was offered facility-provided interpretation services;
Subject’s acceptance/refusal of offer;
Date and time of discussion

2. Identity of interpreter used:

Telephonic ID#, or
Name of family/friend interpreter (including documentation of age, competency, confidentiality, and conflicts of interest), or
Name of bilingual investigator/employee

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5.11 Obtaining and Documenting Informed Consent of Illiterate Subjects

POLICY:

A person who can comprehend English but cannot speak or write can be enrolled into a research study if they are otherwise competent and able to communicate approval or disapproval. The subject may be asked to “make his/her mark” on the consent form. The person shall be provided with a verbal explanation of the study, and the consent form shall be read to them and explained in detail. All of the other requirements of informed consent must be followed. The consent form should document the way in which information was conveyed to the subject, and the means by which the subject communicated agreement to participate in the study. An impartial third party must witness the entire consent process and sign the consent document.

5.12 Mailed/Emailed/Faxed Consent/Authorization Forms

With IRB approval, research subjects may participate in studies in which they do not have to meet directly with the investigator (i.e., questionnaires, buccal smears, prospective chart reviews, etc.). In general, informed consent and authorization may be initiated and obtained through the following methods as recruitment policy allows (see Policy 4). The IRB may request additional steps/procedures depending on the study.

Telephone Contact

Investigator may contact (or be contacted by) a potential subject by telephone to discuss participation in a research study. Investigator must provide subject with all the information contained in the written consent form.
Investigator will answer any questions regarding the research and give subject ample time to consider participation in the study. (May require follow-up phone conversation).
If subject indicates interest in participating in the research study, investigator will provide his/her contact information. Investigator will explain (and repeat) the next steps necessary for subject to provide informed consent, which include the following:

A written consent form will be sent to the subject by regular mail or as an email attachment;

The subject must read the consent form and call or email the investigator if he/she to discuss research and resolve issues/questions;
If subject agrees to participate in research, investigator should direct him/her to sign the consent form and return it to the investigator by mail or fax. Another option would be to scan the signed consent form to a PDF file and return it to the investigator as an email attachment.
An enrollment note must be written by the investigator documenting all phone conversations with the subject. Printouts of any email correspondence must be placed in the subject’s file.
After the signed consent form is received, investigator will sign the consent form. A copy will be made and sent to the subject for his/her records.

Email

Investigator may contact (or respond to) a potential subject by email – providing him/her with an attachment of the written consent form to download. In his email message, the investigator should:

    a) give a brief description of the research;
    b) invite subject to download and read the consent form;
    c) ask subject to contact him/her by telephone or email to discuss research and resolve issues/questions.
If subject agrees to participate in the research, investigator should direct him/her to sign the consent form and return it to the investigator by mail or fax. Another option would be to scan the signed consent form to a PDF file and return it to the investigator as an email attachment.
An enrollment note must be written by the investigator documenting any phone conversations with subject. Printouts of all email correspondence must be placed in the subject’s file.
After the signed consent form is received, investigator will sign the consent form. A copy will be made and sent to the subject for his/her records

Letter

Investigator may send a letter to the subject by regular mail and include a copy of the written consent form. In his/her letter, the investigator should:
     a) give a brief description of the research;
     b) invite subject to read the consent form
     c) ask subject to contact him/her by telephone or email to discuss research and resolve issues/questions
If subject agrees to participate in the research, investigator should direct him/her to sign the consent form and mail or fax it to the investigator. Another option would be to scan the signed consent form to a PDF file and return it to the investigator as an email attachment.
An enrollment note must be written by the investigator documenting all phone conversations with the subject. Printouts of any email correspondence must be placed in the subject’s file.
After the signed consent form is received, investigator will sign the consent form. A copy will be made and sent to the subject for his/her records

Fax

Investigator may fax a letter to the subject with a copy of the written consent form. In his/her fax, the investigator should:
      a) give a brief description of the research;

      b) invite the subject to read the consent form

     c) ask the subject to contact him/her by telephone to discuss research and resolve issues/questions
If the subject agrees to participate in the research, investigator should direct him/her to sign the consent form and send it to the investigator by mail or fax. Another option would be to scan the signed consent form to a PDF file and return it to the investigator as an email attachment.
An enrollment note must be written by the investigator documenting all phone conversations with the subject. Printouts of any email correspondence must be placed in the subject’s file.
After the signed consent form is received, investigator will sign the consent form. A copy will be made and sent to the subject for his/her records

Note:

Although fax and PDF copies are acceptable forms of documentation, investigators should strongly encourage participants to mail them the original signed consent forms.

If a consent form is returned missing a signature, the participant will be notified by phone or email. A copy will be made and kept in the participant’s file and the original will be sent back to the participant for completion and resubmission to the investigator.

A witness signature is NOT required when a research consent form is signed at home. However, a research investigator must be available to answer any questions that a study participant may have regarding the consent form.

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Last Update

November 14, 2011

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